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خواص دارویی و گیاهی

سیپروفلوکساسینسیپروفلوکساسین از دسته ی آنتی بیوتیک های کینولینی است که در درمان بعضی عفونت ها ازجمله عفونت های تنفسی، ادراری، پروستات، گوارشی، مفصلی و استخوانی و برخی از عفونت های تناسلی کاربرد دارد.
این دارو بصورت قرص خوراکی، قطره ی چشمی، ویال و محلول آماده ی تزریق موجود می باشد.
در برخی عفونت های چشمی قطره ی سیپروفلوکساسین را تجویزمی کنند.منع مصرف سیپروفلوکساسین در فاوویسمپیش از مصرف سیپروفلوکساسین -در صورت بارداری یا اقدام به بارداری، شیردهی، مشکلات عضلانی،التهاب و یا کشیدگی تاندون ها، مشکل کلیوی، قلبی،بیماری صرع و سایر موارد پزشک خود را مطلع نمایید.
-در صورتی که مبتلا به فاویسم می باشید مصرف این دارو برای شما مناسب نیست.
-مصرف این دارو در افراد زیر ۱۸ سال تنها در شرایط خاص و با تجویز پزشک متخصص توصیه می شود.
-از آنجا که این دارو می تواند در عملکرد داروهای دیگر در بدن اختلال ایجاد کند لازم است پیش از شروع مصرف لیستی از کلیه ی داروهای مصرفی خود در اختیار پزشک یا داروسازتان قرار دهید.
-در صورت سابقه ی هرگونه حساسیت دارویی خصوصا حساسیت به آنتی بیوتک هایی مانند افلوکساسین، نورفلوکساسین، لووفلوکساسین، موکسی فلوکساسین و نالیدیکسیک اسید ،حتما به پزشک خود اطلاع دهید.نحوه ی مصرف سیپروفلوکساسینآنتی بیوتیک ها را دقیقا مطابق دستور پزشک مصرف کنید و دوره ی درمان را حتی اگر احساس بهبودی میکنید و علائمتان برطرف شده است کامل کنید زیرا در این زمان ممکن است هنوز باکتری بصورت کامل ریشه کن نشده باشد و این کار احتمال بروز مقاومت ميكروبی را افزایش می دهد.
مقاومت میکروبی یکی از مشکلات جهانی می باشد که با سرعت زیادی رو به افزایش است ودر صورتی که مصرف بی رویه و ناسب آنتی بیوتیک ها در دنیا ادامه یابد با مشکلات تهدید کننده ی حیات مواجه خواهیم شد.زماني كه اين داروها بدون تجويزپزشك ،با مقدار ناسب يا طول درمان ناسب مصرف شوند،نه تنها اثرات مطلوب براي خود فرد ندارند بلكه منجر به عدم ريشه كن شدن باكتري هاي موجود در بدن آن فرد مي شوند و علاوه بر اين،باكتري هايي كه در معرض دارو قرار گرفته اند اما از بين نرفته اند، نسبت به اين دارو مقاومت پيدا مي كنند.اين مسأله منجر به ايجاد نسل جديد و مقاومي از ميكروب ها مي شود كه ديگر به سادگي به داروهاي آنتي بيوتيكي موجود، پاسخ نمي دهند.
از آنجا كه عموماً عفونت ها مسری می باشند مصرف بي رويه ی آنتی بیوتیک ها نه تنها براي خود فرد بيمار بلكه براي ساير افراد جامعه نیز مشکل آفرین می باشد.
-قرص خوراکی این دارو باید حتما بطور کامل بلعیده شود لذا از خرد کردن یا جویدن آن بپرهیزید. از آنجایی که این قرص دارای طعم طبوعی می باشد می توانید آن را همراه با یک لیوان آب میل نمایید.
– مصرف شیر و لبنیات، آب پرتقال و نوشیدنی های انرژی زا همراه با این دارو منجر به کاهش اثربخشی آن می شود.
-درمان ا این دارو معمولا به صورت دوبار در روز به مدت یک هفته یا می باشد. با این وجود برای برخی عفونت ها ممکن است حتی به صورت یک قرص تکی تجویز شود.به همین دلیل طول درمان و مقدار مصرف را به طور دقیق از پزشک خود سوال بفرمایید.
-این دارو با غذا تداخل خاصی ندارد و می توان آن را قبل یا بعد از غذا مصرف کرد. اگر قرص به صورت دو نوبت در روز تجویز گردد، بهتر است فاصله ی بین دو نوبت 12 ساعت باشد.
-در مدت درمان با این دارو مصرف آب و مایعات به مقدار کافی احتمال بروز عوارض را کاهش می دهد.
-در مدت درمان با این دارو مصرف شیر ولبنیات، شربت های ضداسید معده و مکمل های حاوی آهن یا روی را حداقل ۲ ساعت با مصرف این دارو فاصله دهید.
-در مدت درمان با این دارو حساسیت بدن شما به نور خواهد شد. لذا تا حد ممکن از قرارگرفتن در معرض نور مستقیم خودداری کنید و از کرم ضدافتاب، پوشش مناسب و عینک آفتابی استفاده کنید.
-در صورت اقدام به هرگونه واكسيناسيون پزشك خود را از مصرف اين دارو مطلع نماييد.
-در برخی افراد با مصرف آنتی بیوتیک ها ضایعات قرمز همراه با خارش در دهان یا واژن ایجاد می شود.در صورت بروز این علائم به پزشک خود مراجعه نمایید.
-مصرف این دارو سرگیجه ی مختصری ایجاد می کند. لذا از رانندگی و فعالیت هایی که نیاز به تمرکز بیشتری دارند تا زمانی که اثر دارو برطرف نشده است، خودداری نمایید.
-از آنجا که سیپروفلوکساسین می تواند بر روی سطح قند خون موثر باشد، در افراد دیابتی کنترل قند خون روزانه در مدت درمان با این دارو ضروری می باشد.عوارض شایع سیپروفلوکساسین -احساس خستگی، تهوع یا استفراغ از عوارض شایع مصرف سیپروفلوکساسین می باشد که با مصرف وعده های غذایی سبک و همچنین مصرف دارو پس از غذا می توان آن را کنترل نمود.
-اسهال خفیف و درد حین ادرار کردن نیز از عوارض شایع سیپروفلوکساسین می باشد که با مصرف مایعات بمقدار کافی، می توان آنها را برطرف کرد با این حال اگر اسهال ادامه دار شد و یا حاوی خون بود، حتما به پزشک مراجعه نمایید.عوارض خاص اما مهم این دارو می تواند عوارض نادر اما مهمی داشته باشد که علی رغم اینکه احتمال وقوع آنها کم می باشد اما پیگیری و توجه به آنها بسیار مهم می باشد.لذا در صورت داشتن علائم سرفه همراه با گلودرد ،خشکی و التهاب چشم و. بروز لکه های قرمز پوستی فوراًبه پزشک خود یا مرکز درمانی مراجعه کنید.
-در موارد کمی مصرف این آنتی بیوتیک کینولینی منجر به انقباضات و کشیدگی عضلات و آسیب تاندون ها ومفاصل می شود. در صورت احساس درد و کشیدگی در عضلات و مفاصل در مدت درمان با این دارو، در اولین فرصت پیش از مصرف نوبت بعدی دارو به پزشک مراجعه نمایید.مطالب ویژه با همکاری آقای دکتر مهدی شاهمیرانیبهترین آنتی بیوتیک برای درمان عفونت ادراری تحتانی بدون عارضه کدام است؟ این مقاله، یکی از 2 مطالعه پژوهشی برتر سال 213 است که براساس پایش منظم مقالات توسط جمعی از اعضای انجمن پزشکی کانادا انتخاب گردیده است. این مطالعات که بعنوان شواهد بیمار-محور ارزشمند شناخته می شوند، امتیاز بالایی را بعلت مرتبط بودن و توانایی تغییر در طبابت را به دست آورده اند. این مقاله در گایدلاین کالج پزشکان خانواده آمریکا ( aafp ) هم به ثبت رسیده است. با وجود اینکه مقاله های بسیار زیادی در مجلات پژوهشی انگلیسی زبان در سال 213 منتشر گردیدند ولی فقط تعداد کمی مورد معیارهای شواهد مهم مبتنی بر بیمار ( POEM ) را از نظر روایی، مرتبط بودن، استفاده از پیامدهای بیمار محور و تغییر در طبابت دارا بودند و 2 مطالعه از این مطالعات جز مطالعات برتر پژوهشی شناخته شدند:
– مطالعه 15 (از 2 مطالعه ) زنان مبتلا به سوزش ادرار مراجعه کننده به مطبهای مراقبت اولیه را تحت پیگیری قرار داد تا بهترین سوالها را برای تشخیص عفونت ادراری تحتانی مشخص کند. مهمترین سوالاتی که پاسخ مثبت به آنها احتمال عفونت ادراری تحتانی را افزایش میداد عبارت بودند از:
– آیا خودتان فکر می کنید که عفونت ادراری تحتانی ( عفونت مثانه و پیشابراه ) دارید؟
– آیا سوزش ادراری شما واقعا شدید است؟ و علائم تحریک واژن ندارید؟
– در مجموع، ده مطالعه به بررسی 8 آنتی بیوتیک برای عفونت ادراری تحتانی پرداخته بودند و محققان مطالعه 16 ( از 2 مطالعه ) با استفاده از روشی موسوم به فرابررسی شبکه ای سعی کردند تا تمامی این داروها را باهم مقایسه کنند. آنها دریافتند که سیپروفلوکساسین و گاتی فلوکساسین در کوتاه مدت تا حدی موثرتر هستند و آموکسی سیلین-کلاوونیک اسید ( کوآموکسی کلاو) نسبت به بقیه اثربخشی کمتری دارد ولی زیان داروهای مختلف، مشابه بود.
 مطالعه 16: بهترین آنتی بیوتیک برای درمان عفونت ادراری تحتانی بدون عارضه کدام است؟
این فرابررسی شبکه ای نشان داد که اثربخشی آنتی بیوتیکهای مورد استفاده رایج برای عفونت ادراری تحتانی مشابه است و فقط یک استثنا وجود دارد؛ اثربخشی کوآموکسی کلاو به صورت معنی داری کمتر از بقیه می باشد.
Ebell MH, Grad R. Top 2 Research Studies of 213 for Primary Care Physician. American Academy Family Physician (aafp) September 15, 214 9: 397-42.آیا مصرف فلوروکینولونها در کودکان جایز است؟- تجویز سیستمیک فلوروکینولونها در کودکان زیر 18 سال توصیه نمی شود، زیرا مطالعات در حیوانات نابالغ نشان دادند که این داروها باعث افزایش خطر آتروپاتی همراه با ضایعات غضروف در مفاصل می شوند.
– یک وجود دارد که در غیاب آرتروپاتی ناشی از این داروها در انسان که در طی دهه های گذشته دیده شده است، مزایای فلوروکینولونها، مخصوصا در کودکان دچار سیستیک فیبروز، نسبت به خطر سمیت مفصلی کوتاه مدت و اندک این داروها ارجح می باشد.
– این از یک مطالعه حمایت می کند که در این مطالعه به ارزیابی خطرات و سمیت اسکلتی- عضلانی در طول پنج سال پیگیری در کودکان مبتلا به اوتیت میانی حاد یا پنومونی اکتسابی از جامعه که برای درمان از لووفلوکساسین یا مقایسه کننده استفاده کرده بودند، پرداخته بود. کودکانی که در سال اول پیگیری، دچار عوارض اسکلتی_عضلانی شدند به مدت چهار سال دیگر ( در مجموع پنج سال) پیگیری شدند. از بین کودکانی که در سالهای دوم تا پنجم پیگیری، با عوارض اسکلتی-عضلانی شناسایی شدند تعداد آنهایی که این عارضه، احتمالا مربوط به دارو بود در هر دو گروه ( لووفلوکساسین و مقایسه کننده) مساوی بود ( 1 از 134 در گروه مصرف کننده لووفلوکساسین، 1 از 893 در گروه مقایسه کننده) و در نهایت هیچ عوارضی جانبی اسکلتی- عضلانی به لووفلوکساسین احتمال داده نشد.
– سیپروفلوکساسین توسط سازمان غذاوداروی آمریکا در درمان عفونت ادراری پیچیده و پیلونفریت مرتبط با اشرشیا. کلی در کودکان، تایید شده است.
– سیپروفلوکساسین و لووفلوکساسین توسط سازمان غذاوداروی آمریکا در پروفیلاکسی بعد از تماس آنتراکس ( سیاه زخم ) استنشاقی، درمان و پیشگیری از طاعون ( plague ) تایید شده اند.
– آکادمی متخصصین کودکان آمریکا ( AAP ) توصیه می کند که استفاده از فلوروکینولونهای سیستمیک در کودکان باید به درمان عفونتهایی محدود شود که هیچ آنتی بیوتیک موثر و ایمن دیگر وجود نداشته باشد و یا در مواردی که استفاده از فلوروکینولونهای خوراکی، جایگزین منطقی به جای درمان تزریقی آنتی بیوتیکهایی از گروه دیگر باشد.دکتر مهدی شاهمیرانی

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با خواندن این مطلب هر آنچه لازم است در مورد قرص سیپروفلوکساسین را یاد می گیرید. ممکن است سوالات بسیار زیادی در رابطه با داروی سیپروفلوکساسین در ذهن شما باشد به منظور پاسخگویی به تمام سوالاتتان این مقاله ی جامع را در مورد قرص سیپروفلوکساسین تهیه کرده ایم.

قرص سیپروفلوکساسین جهت درمان انواع عفونت های باکتریایی تجویز می گردد. سیپروفلوکساسین متعلق به آن دسته از داروها به آنتی بیوتیک کینولون است. که با متوقف کردن رشد باکتری عمل میکند.

این آنتی بیوتیک فقط عفونت های باکتریایی را درمان میکند، و برای عفونت های ناشی از ویروس (مانند سرماخوردگی) استفاده نمیگردد. استفاده های غیر ضروری یا کاربرد نادرست هر آنتی بیوتیک میتواند بهکاهش اثربخشی آن منجر گردد.

چنانچه دستورالعمل استفاده از دارو وجود دارد قبل از شروع مصرف سیپروفلوکساسین با دقت مطالعه کنید، و در صورت در دسترس بودن اطلاعات بیمار پیش از تجویز به بیمار آن را با داروساز خود در میان گذارید. بیمار هنگام دریافت دارو باید از پزشک و داروساز هر سوالی را درباره نحوه استفاده از دارو بپرسد.

این دارو خوراکی است و مصرف با غذا یا بدون غذا را پزشک میبایست تشخیص دهد و معمولا دو بار در روز و در وعده های صبح و شام تجویز میگردد.

این قرص ممکن است طعم تلخی داشته باشد پس شما نمیتوانید آن را قسمت کنید، بجوید، و یا آن را خرد نموده سپس مصرف کنید. به همین دلیل شرکت داروسازی آن را به صورت بلعیدن تجویز میکند.

دوز و طول درمان بر اساس وضعیت پزشکی و سلامت بیمار و واکنش بیمار به دارو تعیین میگردد. هنگام مصرف سیپروفلوکساسین مایعات فراوان بنوشید مگر اینکه دکتر خلاف آن را تجویز نماید.

این دارو بایستی حداقل ۲ ساعت قبل یا ۶ ساعت پس از مصرف سایر داروها مصرف گردد که ممکن است با آن ترکیب شود، و اثربخشی آن را کاهش دهد. از داروساز خود در مورد سایر داروهایی که میتوانید با آن مصرف نموده و ممنوعیتی ندارد کسب اطلاع نمایید.

این نمونه ها عبارتند از : کوئیناپریل، سولامر، سوکرالفات، ویتامین ها / مواد معدنی (از جمله آهن و روی، مکمل ها) و محصولات حاوی منیزیم، آلومینیوم، یا کلسیم (مانند آنتی اسیدها، محلول دیدانوزین، مکملهای کلسیم).

غذاهای سرشار از کلسیم، من جمله فراورده های لبنی (مانند شیر، ماست) و یا آب میوه های غنی شده با کلسیم میتوانند اثر این دارو را کاهش دهند. این دارو را باید حداقل ۲ ساعت قبل یا ۶ ساعت پس از خوردن غذاهای غنی از کلسیم مصرف گردد، مگر اینکه شما این غذاها را به عنوان بخشی از یک وعده غذایی اصلی میل کنید که شامل غذاهای دیگر (غنی شده با موادی غیر کلسیم) میباشد. این غذاها باعث کاهش اثر کلسیم مورد نیاز میگردد.

از دکتر یا داروساز خود بپرسید که از چه مکمل های تغذیه ای و یا جایگزین آن با خیال راحت میتوانید استفاده نمایید.

دوره کامل این دارو را طبق تجویز پزشک استفاده نمایید. حتی اگر علایم بیماری پس از چند روز در شما کمرنگ شود و یا شما اثری از بیماری را در خود مشاهده نکنید. توقف دارو ممکن است خیلی زود موجب بازگشت عفونت گردد.

اگر وضعیت شما همچنان ادامه دارد و یا بدتر میشود حتما به پزشک خود اطلاع دهید.

تهوع، اسهال، سرگیجه، سبکی در سر، سردرد، و مشکلات خواب ممکن است در هنگام مصرف دارو رخ دهد. اگر هر یک از این اثرات در شما باقی بماند یا وخیم تر شود، دکتر یا داروساز خود را بی درنگ مطلع کنید.

به یاد داشته باشید که چون دکتر این دارو را تجویز کرده است پس او بهتر میتواند عوارض جانبی دارو را برای شما تشخیص دهد. ممکن است بسیاری از مردم در هنگام استفاده از این دارو دچار عوارض جانبی جدی نگردند. اگر شما هر گونه عوارض جانبی جدی را در خود مشاهده نمودید بلافاصله به دکتر خود اطلاع دهید، من جمله: زمانی که پوست شما وقتی در معرض آفتاب قرار میگیرید به راحتی دچار سوختگی میشود (حساسیت شدید پوستی به نور خورشید)، کبودی / خونریزی غیر معمول، نشانه هایی از عفونت جدید (مانند تب مداوم، گلو درد مداوم)، نشانه هایی از مشکلات کلیوی (مانند تغییر در میزان ادرار، و ادرار به رنگ قرمز / صورتی)، نشانه هایی از مشکلات کبدی (مانند خستگی غیر معمول، درد شکم / معده، تهوع / استفراغ مداوم، زردی چشم / پوست، ادرار تیره).

چنانچه شما هر گونه از این عوارض جانبی را در خود مشاهده نمودید بلافاصله کمک پزشکی دریافت کنید: از جمله: سردرد شدید / مداوم، تغییرات بینایی، لرزیدن اعضا بدن (لرزش)، تشنج، سرگیجه شدید، غش، ضربان قلب سریع / نظم، تغییرات خلق و خوی (مانند اضطراب، سردرگمی، توهم، افسردگی، و در موارد نادر افکار خودکشی).

این دارو به ندرت ممکن است باعث مشکلات عصبی دائمی (نوروپاتی محیطی) شود. در صورت بروز هر یک از علائم زیر مصرف سیپروفلوکساسین را قطع نموده و مشکل را با پزشک خود در میان گذارید:

درد، بی حسی، سوختگی، سوزن سوزن شدن، ضعف در بازوها، دست ها، پاها، یا انگشتان، تغییرات در چگونگی حس های لمسی درد / دما / ارتعاش / موقعیت بدن.

این دارو به ندرت ممکن است باعث یک بیماری شدید در روده (کلستریدیوم سخت مربوط به اسهال) به دلیل یک نوع باکتری مقاوم گردد. این وضعیت ممکن است در طول درمان یا به طور هفتگی یا ماه ها پس از درمان ٬ رخ دهد. چنانچه این علائم پیشرفت کرد به پزشک خود اطلاع دهید: اسهال مداوم، شکم یا درد / گرفتگی معده، خون / مخاط در مدفوع خود.

حتی اگر شما هر یک از این علائم را داشتید از محصولات ضد اسهال یا داروهای ضد درد مخدر استفاده نکنید زیرا این محصولات ممکن است شرایط شما را وخیم تر کند.

استفاده از این دارو برای دوره های طولانی مدت یا مکرر ممکن است موجب بروز برفک دهان یا عفونت جدید گردد. بعد از مشاهده تکه های سفید رنگی در دهان، تغییر در تخلیه واژن و یا سایر علائم جدید با دکتر خود تماس بگیرید.

واکنش آلرژیک جدی به این دارو نادر است. با این حال، در هنگام بروز این موارد، کمک پزشکی دریافت نمایید. از جمله: جوش، خارش / تورم (به خصوص در چهره / زبان / گلو)، سرگیجه شدید، مشکل تنفسی.

مواردی که در این مقاله اشاره شد ٬ یک فهرست کامل از عوارض جانبی است که امکان دارد رخ دهد. چنانچه شما متوجه عوارض دیگری شدید که در این فهرست به آن اشاره نشده است، با پزشک یا داروساز خود تماس بگیرید.

قبل از مصرف سیپروفلوکساسین، درصورت حساسیت داشتن به این دارو یا دیگر آنتی بیوتیک های کینولونمانند نورفلاکسسین، ژمیفلاکسسین، لوفلاکسسین، موکسیفلاکسسین، یا افلاکسسین جریان را با دکتر خود و یا داروساز در میان بگذارید؛ یا اگر هر حساسیت دیگری هم دارد با پزشک خود مطرح کنید. این محصول ممکن است شامل عناصر غیرفعال باشد که میتوانند موجب حساسیت و یا مشکلات دیگر شوند. برای جزئیات با داروساز صحبت کنید.

پیش از استفاده از این دارو، تاریخچه مصرف داروی خود را با پزشک و یا داروساز در میان بگذارید، مخصوصا مواردی از قبیل: دیابت، مشکلات قلبی (مانند حمله قلبی که اخیرا داشتید)، مشکلات تاندون یا مفصل (مانند التهاب تاندون و بورسیت)، مینیسک زانو، عارضه کبد، میاستنی گراویس، مشکلات عصبی (مانند نروپاتی محیطی)، تشنج و شرایطی که خطر تشنجتان را افزایش میدهند (مانند آسیب سر یا مغز، تومورهای مغزی، تصلب شرایین مغزی).

سیپروفلوکساسین ممکن است موجب ایجاد شرایطی شود که ریتم قلب را تحت تاثیر قرار دهند ( طولانی شدن زمان QT). طولانی شدن زمان QT بندرت میتواند موجب مشکل جدی ضربان قلب نظم یا سریع (بندرت کشنده) و دیگر علائم (مانند سرگیجه شدید، غش کردن) شود که نیاز به مراقبت های پزشکیدارد.

خطر طولانی شدن زمان QT درصورت وجود شرایط پزشکی معین یا در صورت استفاده همزمان از داروهای دیگری که موجب طولانی شدن زمان QT میشوند، ممکن است افزایش پیدا کند. پیش از استفاده از سیپروفلوکساسین، در مورد تمام داروهایی استفاده میکنید با پزشک و یا داروساز صبحت کنید و همچنین اگر هریک از شرایط زیر را داشتید با پزشک و یا داروساز در میان بگذارید: مشکلات قلبی معین ( نارسایی قلبی، ضربان قلب کند، طولانی شدن زمان QT در نوار قلب)، تاریخچه خانوادگیِ مشکلات قلبی معین (طولانی شدن زمان QT در نوار قلب، مرگ ناگهانی قلبی (ایست قلبی)).

میزان پایین پتاسیم یا منیزیم در خون هم ممکن است خطر طولانی شدن زمان QT را افزایش دهد. این خطر ممکن است در صورت استفاده از داروهای معینی (مانند دیورتیک یا «قرص های آبی») و یا در صورت داشتنشرایطی مانند عرق زیاد، اسهال یا استفراغ، افزایش یابد. در مورد استفاده صحیح از داروی سیپروفلوکساسین با پزشک خود مشورت کنید.

این دارو درمانی ممکن است به ندرت موجب تغییرات جدی در سطح قند خون شود، مخصوصا اگر شما دیابت دارید. مراقب علائم قند خون بالا شامل افزایش تشنگی و میزان دفعات ادرار باشید. سیپروفلوکساسین همچنین ممکن است اثرات کاهنده قندِ خونِ داروی glyburide را هم افزایش دهد. پس همچنین باید مراقب علائم کاهش قند خون مانند عرق ناگهانی، لرزش، ضربان بالای قلب، گرسنگی، دید تار، سرگیجه، یا سوزن سوزن شدن دست هم باشید. قند خون خود را به صورت منظم با بره ای که پزشکتان مشخص میکند، چک کنید. اگر علائم قند خون پایین را مشاهده کردید، باید قند خون خود را با استفاده از قرص ها یا ژلِ گلوکز یا خوردن مواردی مانند قند، عسل، یا شیرینی، یا نوشیدن آبمیوه یا نوشابه غیر رژیمی افزایش دهید و بلافاصله با پزشک خود درباره واکنش بدنتان به این دارو مشورت کنید. برای جلوگیری از کاهش قند خون، در وعده های غذایی منظمی غذا بخورید، و هیچ وعده ای را رها نکنید. پزشکتان ممکن است آنتی بیوتیک دیگری را برایتان تجویز کند و یا داروهای دیابتی را برای رفع این مشکل تجویز کند.

این دارو ممکن است باعث گیجی شما شود. پس از مصرف دارو، رانندگی نکنید، از دستگاه ها و ماشین آلات استفاده نکنید، یا از هر فعالیتی که نیازمند هوشیاری است تا زمانیکه مطمئن نشدید که میتوانید بطور امن انجامش دهید، اجتناب کنید. از مصرف نوشیدنی های الکلی دوری کنید.

این دارو ممکن است شما را به نور حساس کند. از قرار گرفتن طولانی تحت نور آفتاب،حمام های برنزه و لامپ های خورشیدی اجتناب کنید. زمانیکه خارج از منزل هستید، از کرم های ضد آفتاب و البسه محافظ در برابر نور آفتاب استفاده کنید. دیگر داروها (مانند ترتینون مکونیول) ممکن است حساسیت شما به آفتاب را افزایش دهند. برای جزئیات با پزشک و یا داروساز صحبت کنید.

سیپروفلوکساسین ممکن است موجب شود تا واکسن های باکتریایی زنده مانند واکسن حصبه بخوبی عمل نکنند. بنابراین، هیچ واکسیناسیونی در زمان استفاده از این دارو را بدون رضایت پزشک انجام ندهید.

پیش از داشتن عمل جراحی، در مورد مصرف محصولاتی که استفاده میکنید (شامل داروهای تجویزی، داروهای بدون نسخه و محصولات گیاهی) با پزشک یا دندانپزشک خود مشورت کنید.

کودکان ممکن است به عوارض جانبی این دارو حساس تر باشند، مخصوصا از نظر مشکلات تاندونی یا مفصلی.

انسان های پیر و سالخورده هم ممکن است به عوارض جانبی این دارو بخصوص مشکلات تاندونی (بویژه اگر آن ها در حال مصرف همزمان کورتیکواستروئیدهایی مانند پردنیزول یا هیدروکورتیزون باشند) و طولانی شدن زمان QT حساس تر باشند.

در طول بارداری، این دارو باید تنها زمانیکه واقعا مورد نیاز باشد، استفاده شود. در مورد خطرات این دارو با پزشک خود مشورت کنید.

این دارو وارد شیر مادر میشود ! با پزشک خود قبل از شیر دادن به نوزادتان مشورت کنید.

فعل و انفعالات دارویی ممکن است اثر داروهای شما را بهبود دهند و یا خطر عوارض جانبی جدی را افزایش دهند. این مطلب شامل همه فعل و انفعالات ممکن نمیباشد. لیستی از تمام محصولاتی که مصرف میکنید را تهیه و با پزشک خود و یا داروساز در میان بگذارید. میزان مصرف هیچ دارویی را بدون نظر پزشک خود تغییر ندهید و قطع نکنین و یا اینکه بدون اطلاع پزشک مصرف هیچ دارویی را آغاز نکنید.

برخی محصولات که ممکن است با این دارو فعل و انفعالاتی داشته باشند عبارتند از: رقیق کننده های خون (مانند آسنوکومورال، وارفارین) و استرانسیوم.

علاوه بر سیپروفلوکساسین، بسیاری از داروهایی که ممکن است بر ریتم قلبی (طولانی شدن زمان QT) اثر بگذارند، عبارتند از: آمیودارون، دوفتیلید، کوئینیدین، پروکینآمید، سوتالول.

این دارو میتواند خروج دیگر داروها از بدن شما را کُند کنَد که ممکن است بر نحوه تاثیر این داروها اثر داشته باشد. مثال هایی از داروهایی که تحت تاثیر قرار میگیرند عبارتند از: دولکستین،پیرفنیدون، تاسیملتئون،تیزانیدین.

از نوشیدن مقدار زیادی از نوشیدنی های کافئین دار (قهوه، چای، کولا)، خوردن مقدار بالای شکلات، یا مصرف زیاد داروهای کافئین دار، اجتناب کنید. این دارو ممکن است اثرات کافئین را افزایش دهد و یا زمان اثر آن را کند.

اگرچه آنتی بیوتیک ها مانند قرص ها، پچ، یا حلقه، بعید است که بر کنترل بارداری هورمونی اثری داشته باشند، تعدادی از آنتی بیوتیک ها (مانند ریفامپین، ریفابوتین) میتوانند تاثیر آنها را کاهش دهند. این امر ممکن است در بارداری تاثیرگذار باشد، اگر شما تحت کنترل بارداری هورمونی هستید، از پزشک خود و یا داروساز بخواهید تا جزئیات بیشتری را در اختیارتان بگذارند.

در صورتی که دوز بالایی مصرف گردد با مرکز مسمومیت یا اورژانس تماس گیرید. در تهران میتوان با مرکز مسمومیت با شماره تلفن ۱۴۹۰ تماس بگیرید. ساکنان دیگر شهر ها میتوانند با مرکز کنترل مسمومیت استانی یا اورژانس ۱۱۵ تماس بگیرند.

سیپروفلوکساسین را به بقیه افراد جهت مصرف ندهید. این برخلاف قانون است. تست های آزمایشگاهی و یا پزشکی (مانند فشار خون، ضربان قلب، رشد در کودکان) ممکن است به صورت دوره ای برای نشان دادن پیشرفت شما و یا کنترل عوارض جانبی انجام شود. برای جزئیات با پزشک خود مشورت کنید.

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POM: Preion only medicine

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet.
The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD.
For further information call RNIB Medicine Leaflet Line on 8 198 5.
The product code(s) for this leaflet is: PL 8553/174.

Ciprofloxacin 5mg Film-Coated Tablets

Package leaflet: Information for the user

Ciprofloxacin 5 mg Film-Coated Tablets

Ciprofloxacin hydrochloride

Read all of this leaflet carefully before taking this medicine because it contains important information for you:

What is in this leaflet:

1. What Ciprofloxacin 5mg Tablets are and what they are used for2. What you need to know before you take Ciprofloxacin 5mg Tablets3. How to take Ciprofloxacin 5mg Tablets4. Possible side effects5. How to store your Ciprofloxacin 5mg Tablets6. Contents of the pack and other information

1. What Ciprofloxacin 5mg Tablets are and what they are used for

Ciprofloxacin 5mg Tablets are an antibiotic belonging to the fluoroquinolone family.

Ciprofloxacin Tablets are used for the treatment of severe bacterial infections. They only work with specific strains of bacteria.

Adults

Ciprofloxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection.

If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciprofloxacin Tablets.

Children and adolescents

Ciprofloxacin Tablets are used in children and adolescents, under specialist medical supervision to treat the following bacterial infections:

Ciprofloxacin Tablets may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.

2. What you need to know before you take Ciprofloxacin 5mg Tablets

Do NOT take Ciprofloxacin 5mg Tablets if you or your child:

Warnings and precautions

Talk to your doctor before taking Ciprofloxacin 5mg Tablets

For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor

While taking Ciprofloxacin 5mg Tablets

Tell your doctor immediately if any of the following occurs while taking Ciprofloxacin 5mg Tablets. Your doctor will decide whether treatment with Ciprofloxacin 5mg Tablets needs to be stopped.

Other medicines and Ciprofloxacin 5mg Tablets.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Ciprofloxacin can increase the level of the following substances in the blood:

Do not take Ciprofloxacin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see section 2: “Do not take Ciprofloxacin”).

If Ciprofloxacin 5mg Tablets and one of the following medicines are given at the same time, special care must be taken:

Tell your doctor if you are taking:

Ciprofloxacin may increase the levels of the following medicines in your blood:

Some medicines reduce the effect of Ciprofloxacin. Tell your doctor if you take or wish to take:.

If these preparations are essential, take Ciprofloxacin about two hours before or no sooner than four hours after taking them.

Ciprofloxacin 5mg Tablets with food and drink

Large amounts of dairy products particularly milk or yoghurt may slow down ciprofloxacin uptake, therefore ciprofloxacin should be taken 1 to 2 hours before or at least 4 hours after these products.

Surgical procedures

Tell your doctor that you are taking ciprofloxacin because pain relief and sedative medicines administered prior to surgery can also be affected by ciprofloxacin.

If one of the above-mentioned situations is applicable to you, your doctor may decide to prescribe another medicine or to adjust the dose of Ciprofloxacin 5mg Tablets or the other medicine.

It is advisable never to use several medicines at the same time without consulting your doctor first.

Pregnancy

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is preferable to avoid the use of Ciprofloxacin during pregnancy.

Breast-feeding

Ciprofloxacin is passed into human breast milk. You must not breast-feed your child during treatment with ciprofloxacin, due to the risk of malformation of joint cartilage and other harmful effects in the breast-fed infant.

Driving and using machines

Ciprofloxacin can reduce your attention. If you suffer from dizziness, do not drive or operate machines, which require your full concentration.

3. How to take Ciprofloxacin 5mg Tablets

You should follow your doctor’s instructions and check the pharmacist’s label for how many tablets to take, and when. The usual doses for different types of infections treated with Ciprofloxacin 5mg Tablets are given below as a guide:

Respiratory tract infections 1 tablet twice a day for 7 to 14 days.

Pyelonephritis 1 tablet twice a day for 7 to 14 days.

Prostatitis 1 tablet twice a day for up to 28 days

Severe gastroenteritis 1 tablet twice a day for 3 to 7 days.

Skin and soft tissue infections 1 tablet twice a day for 5 to 1 days.

Bone and joint infections 1 tablet twice a day for 4 to 6 weeks or longer.

Severe systemic infections 1 tablet twice a day.

Acute, uncomplicated gonorrhea a single dose of 1 tablet.

The actual dose may be adjusted to take into account your age, severity of infection and how well your kidneys are working. If you have a severe infection and serious kidney problems your doctor may take regular blood samples to check your recovery and ensure you are receiving the correct dose. Ideally these tablets should be swallowed whole with a glass of water. These tablets can be taken at any time, with or without food. Taking the tablets on an empty stomach will speed up the uptake, whilst dairy products such as milk or yoghurt may slow down the uptake of ciprofloxacin in the stomach.

If you take more Ciprofloxacin 5mg Tablets than you should

If you take more than you should, or in the event of an overdose, seek medical advice immediately and, if possible, take any remaining tablets or this leaflet with you to show the doctor.

If you forget to take Ciprofloxacin 5mg Tablets

If you forget to take your medicine take the missed dose as soon as possible and then continue as normal. However, if it is almost time for your next dose, do not take the missed dose and continue as usual. Do not take a double dose to make up for the forgotten one.

If you stop taking Ciprofloxacin 5mg Tablets

You should continue to take these tablets for as long as directed by your doctor. It is important that you complete the course of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may .

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side-effects although not everybody gets them.

Common side effects (may affect up to 1 in 1 people):

Uncommon side effects (may affect up to 1 in 1 people):

Rare side effects (may affect up to 1 in 1, people):

Very rare side effects (may affect up to 1 in 1, people):

Frequency not known (cannot be estimated from the available data)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ciprofloxacin 5mg Tablets

Keep this medicine out of the sight and reach of children. Do not store above 25°C and keep in the original container. Do not use this medicine after the expiry date which is stated on the label after ‘Exp (MM/YY)’. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ciprofloxacin 5mg Tablets contain:

Each tablet contains ciprofloxacin hydrochloride equivalent to 5mg ciprofloxacin. The other ingredients are maize starch, microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol 4 and titanium dioxide (E171).

What Ciprofloxacin 5mg Tablets looks like and contents of the pack:

Ciprofloxacin 5mg Tablets are white, oval shaped film-coated tablets debossed ‘C5’ on one side with a breakline on the other. They are packaged in blister packs of 1, 12, 2 or 1 tablets or also in high-density polyethylene containers of 5, 1 or 5 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

UK:

Manufacturer:

Ciprofloxacin 5mg Tablets PL8553/174

Date of preparation 11/215

6 Riverview Road, Beverley, Hull, HU17 LD

+44 ()1482 86228

+44 ()1748 828873

+44 ()1482 389858

http://www.drreddys.com/united-kingdom

+44 ()1482 8624

DrReddys@professionalinformation.co.uk

+44 ()1748 82881

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Ciprofloxacin is an antibiotic used to treat a number of bacterial infections.[2] This includes bone and joint infections, intra abdominal infections, certain type of infectious diarrhea, respiratory tract infections, skin infections, typhoid fever, and urinary tract infections, among others.[2] For some infections it is used in addition to other antibiotics.[2] It can be taken by mouth, in eye drops, or intravenously.[2][3]

Common side effects include nausea, vomiting, diarrhea and rash.[2] Ciprofloxacin increases the risk of tendon rupture.[2] In people with myasthenia gravis, there is worsening muscle weakness.[2] Rates of side effects appear to be higher than some groups of antibiotics such as cephalosporins but lower than others such as clindamycin.[4] Studies in other animals raise concerns regarding use in pregnancy.[5] No problems were identified, however, in the children of a small number of women who took the medication.[5] It appears to be safe during breastfeeding.[2] It is a second-generation fluoroquinolone with a broad spectrum of activity that usually results in the death of the bacteria.[2][6][7]

Ciprofloxacin was introduced in 1987.[8] It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system.[9] It is available as a generic medication and not very expensive.[2][1] The wholesale cost in the developing world is between .3 and .13 USD a dose.[11] In the United States it is sold for about .4 USD per dose.[2]

Ciprofloxacin is used to treat a wide iety of infections, including infections of bones and joints, endocarditis, gastroenteritis, malignant otitis externa, respiratory tract infections, cellulitis, urinary tract infections, prostatitis, anthrax, and chancroid.[2]

Ciprofloxacin only treats bacterial infections it does not treat viral infections such as the common cold. For certain uses including acute sinusitis, lower respiratory tract infections and uncomplicated gonorrhea, ciprofloxacin is not considered a first-line agent.

Ciprofloxacin occupies an important role in treatment guidelines issued by major medical societies for the treatment of serious infections, especially those likely to be caused by Gram-negative bacteria, including Pseudomonas aeruginosa. For example, ciprofloxacin in combination with metronidazole is one of several first-line antibiotic regimens recommended by the Infectious Diseases Society of America for the treatment of community-acquired abdominal infections in adults.[12] It also features prominently in treatment guidelines for acute pyelonephritis, complicated or hospital-acquired urinary tract infection, acute or chronic prostatitis,[13] certain types of endocarditis,[14] certain skin infections,[15] and prosthetic joint infections.[16]

In other cases, treatment guidelines are more restrictive, recommending in most cases that older, narrower-spectrum drugs be used as first-line therapy for less severe infections to minimize fluoroquinolone-resistance development. For example, the Infectious Diseases Society of America recommends the use of ciprofloxacin and other fluoroquinolones in urinary tract infections be reserved to cases of proven or expected resistance to narrower-spectrum drugs such as nitrofurantoin or trimethoprim/sulfamethoxazole.[17] The European Association of Urology recommends ciprofloxacin as an alternative regimen for the treatment of uncomplicated urinary tract infections, but cautions that the potential for “adverse events have to be considered”.[13]

Although approved by regulatory authorities for the treatment of respiratory infections, ciprofloxacin is not recommended for respiratory infections by most treatment guidelines due in part to its modest activity against the common respiratory pathogen Streptococcus pneumoniae.[18][19][2] “Respiratory quinolones” such as levofloxacin, having greater activity against this pathogen, are recommended as first line agents for the treatment of community-acquired pneumonia in patients with important co-morbidities and in patients requiring hospitalization (Infectious Diseases Society of America 27). Similarly, ciprofloxacin is not recommended as a first-line treatment for acute sinusitis.[21][22]

Ciprofloxacin is approved for the treatment of gonorrhea in many countries, but this recommendation is widely regarded as obsolete due to resistance development.[23][24][25]

In the United States ciprofloxacin is pregnancy category C.[26] This category includes drugs for which no adequate and well-controlled studies in human pregnancy exist, and for which animal studies have suggested the potential for harm to the fetus, but potential benefits may warrant use of the drug in pregnant women
despite potential risks. An expert review of published data on experiences with ciprofloxacin use during pregnancy by the Teratogen Information System concluded therapeutic doses during
pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of datafair), but the data are insufficient to state no risk exists.[27]

Two small post-marketing epidemiology studies of mostly short-term, first-trimester exposure found that fluoroquinolones did not increase risk of major malformations, spontaneous abortions, premature birth, or low birth weight.[28][29] The label notes, however, that these studies are insufficient to reliably evaluate the definitive safety or risk of less common defects by ciprofloxacin in pregnant women and their developing fetuses.

Fluoroquinolones have been reported as present in a mother’s milk and thus passed on to the nursing child.[3][31] The U.S. FDA recommends that because of the risk of serious adverse reactions (including articular damage) in infants nursing from mothers taking ciprofloxacin, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Oral and intravenous ciprofloxacin are approved by the FDA for use in children for only two indications due to the risk of permanent injury to the musculoskeletal system:

1) Inhalational anthrax (postexposure)[32]

2) Complicated urinary tract infections and pyelonephritis due to Escherichia coli,[33] but never as first-line agents. Current recommendations by the American Academy of Pediatrics note the systemic use of ciprofloxacin in children should be restricted to infections caused by multidrug-resistant pathogens or when no safe or effective alternatives are available.[34]

Its spectrum of activity includes most strains of bacterial pathogens responsible for community-acquired pneumonias, bronchitis, urinary tract infections, and gastroenteritis.[35] Ciprofloxacin is particularly effective against Gram-negative bacteria (such as Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Legionella pneumophila, Moraxella catarrhalis, Proteus mirabilis, and Pseudomonas aeruginosa), but is less effective against Gram-positive bacteria (such as methicillin-sensitive Staphylococcus aureus, Streptococcus pneumoniae, and Enterococcus faecalis) than newer fluoroquinolones.[36]

As a result of its widespread use to treat minor infections readily treatable with older, narrower spectrum antibiotics, many bacteria have developed resistance to this drug in recent years, leaving it significantly less effective than it would have been otherwise.[37][38]

Resistance to ciprofloxacin and other fluoroquinolones may evolve rapidly, even during a course of treatment. Numerous pathogens, including enterococci, Streptococcus pyogenes and Klebsiella pneumoniae (quinolone-resistant) now exhibit resistance.[39] Widespread veterinary usage of the fluoroquinolones, particularly in Europe, has been implicated.[4] Meanwhile, some Burkholderia cepacia, Clostridium innocuum and Enterococcus faecium strains have developed resistance to ciprofloxacin to ying degrees.[41]

Fluoroquinolones had become the class of antibiotics most commonly prescribed to adults in 22.[42] Nearly half (42%) of those preions in the U.S. were for conditions not approved by the FDA, such as acute bronchitis, otitis media, and acute upper respiratory tract infection, according to a study supported in part by the Agency for Healthcare Research and Quality.[42] Additionally, they were commonly prescribed for medical conditions that were not even bacterial to begin with, such as viral infections, or those to which no proven benefit existed.

Contraindications include:[43]

Ciprofloxacin is also considered to be contraindicated in children (except for the indications outlined above), in pregnancy, to nursing mothers, and in people with epilepsy or other seizure disorders.

Side effects can involve the tendons, muscles, joints, nerves, and the central nervous system.[44]

Rates of side effects appear to be higher than with some groups of antibiotics such as cephalosporins but lower than with others such as clindamycin.[4] Compared to other antibiotics some studies find a higher rate of side effects[45][46] while others find no difference.[47]

In trials most of the adverse events were described as mild or moderate in severity, abated soon after the drug was discontinued, and required no treatment.[26] Some side effects may be permanent.[44] Ciprofloxacin was stopped because of an adverse event in 1% of people treated with the medication by mouth. The most frequently reported drug-related events, from trials of all formulations, all dosages, all drug-therapy durations, and for all indications, were nausea (2.5%), diarrhea (1.6%), abnormal liver tests (1.3%), vomiting (1%), and rash (1%). Other adverse events occurred at rates of &lt1%.

The black box warning on the U.S. FDA-approved ciprofloxacin label warns of an increased risk of tendinitis and tendon rupture, especially in people who are older than 6 years, people who also use corticosteroids, and people with kidney, lung, or heart transplants. Tendon rupture can occur during therapy or even months after discontinuation of the medication.[48] A case-control study[49] performed using a UK medical care database found that fluoroquinolone use was associated with a 1.9-fold increase in tendon problems. The relative risk increased to 3.2 in those over 6 years of age and to 6.2 in those over the age of 6 who were also taking corticosteroids. Among the 46,766 quinolone users in the study, 38 (.1%) cases of Achilles tendon rupture were identified. A study performed using an Italian healthcare database reached qualitatively similar conclusions.[5]

The 213 FDA label warns of nervous system effects. Ciprofloxacin, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold, and may cause other central nervous system side effects. Headache, dizziness, and insomnia have been reported as occurring fairly commonly in postapproval review articles, along with a much lower incidence of serious CNS side effects such as tremors, psychosis, anxiety, hallucinations, paranoia, and suicide attempts, especially at higher doses.[4] Like other fluoroquinolones, it is also known to cause peripheral neuropathy that may be irreversible, such as weakness, burning pain, tingling or numbness.[51]

Ciprofloxacin is active in six of eight in vitro assays used as rapid screens for the detection of genotoxic effects, but is not active in in vivo assays of genotoxicity.[26] Long-term carcinogenicity studies in rats and mice resulted in no carcinogenic or tumorigenic effects due to ciprofloxacin at daily oral dose levels up to 25 and 75 mg/kg to rats and mice, respectively (about 1.7 and 2.5 times the highest recommended therapeutic dose based upon mg/m2). Results from photo co-carcinogenicity testing indicate ciprofloxacin does not reduce the time to appearance of UV-induced skin tumors as compared to vehicle control.[citation needed]

The other black box warning is that ciprofloxacin should not be used in people with myasthenia gravis due to possible exacerbation of muscle weakness which may lead to breathing problems resulting in death or ventilator support. Fluoroquinolones are known to block neuromuscular transmission.[26]

Clostridium difficile-associated diarrhea is a serious adverse effect of ciprofloxacin and other fluoroquinolones it is unclear whether the risk is higher than with other broad-spectrum antibiotics.[52]

A wide range of rare but potentially fatal side effects spontaneously reported to the U.S. FDA or the subject of case reports published in medical journals includes, but is not limited to, toxic epidermal necrolysis, Stevens-Johnson syndrome, abnormal heart rhythms (torsades de pointes or QT prolongation), low blood pressure, allergic pneumonitis, bone marrow suppression, hepatitis or liver failure, and sensitivity to light.[26][53] The medication should be discontinued if a rash, jaundice, or other sign of hypersensitivity occurs.[26]

Children and the elderly are at a much greater risk of experiencing adverse reactions.[54][55]

Overdose of ciprofloxacin may result in reversible renal toxicity. Treatment of overdose includes emptying of the stomach by induced vomiting or gastric lavage, as well as administration of antacids containing magnesium, aluminum, or calcium to reduce drug absorption. Renal and urinary pH should be monitored. Important support includes adequate hydration and urine acidification if necessary to prevent crystalluria. Hemodialysis or peritoneal dialysis can only remove less than 1% of ciprofloxacin.[56] Ciprofloxacin may be quantified in plasma or serum to monitor for drug accumulation in patients with hepatic dys or to confirm a diagnosis of poisoning in acute overdose victims.[57]

Ciprofloxacin interacts with certain foods and several other drugs leading to undesirable increases or decreases in the serum levels or distribution of one or both drugs.

Ciprofloxacin should not be taken with antacids containing magnesium or aluminum, highly buffered drugs (sevelamer, lanthanum carbonate, sucralfate, didanosine), or with supplements containing calcium, iron, or zinc. It should be taken two hours before or six hours after these products. Magnesium or aluminum antacids turn ciprofloxacin into insoluble salts that are not readily absorbed by the intestinal tract, reducing peak serum concentrations by 9% or more, leading to therapeutic failure. Additionally, it should not be taken with dairy products or calcium-fortified juices alone, as peak serum concentration and the area under the serum concentration-time curve can be reduced up to 4%. However, ciprofloxacin may be taken with dairy products or calcium-fortified juices as part of a meal.[56][58][59]

Ciprofloxacin inhibits the drug-metabolizing enzyme CYP1A2 and thereby can reduce the clearance of drugs metabolized by that enzyme. CYP1A2 substrates that exhibit increased serum levels in ciprofloxacin-treated patients include tizanidine, theophylline, caffeine, methylxanthines, clozapine, olanzapine, and ropinirole. Co-administration of ciprofloxacin with the CYP1A2 substrate tizanidine (Zanaflex) is contraindicated due to a 583% increase in the peak serum concentrations of tizanidine when administered with ciprofloxacin as compared to administration of tizanidine alone. Use of ciprofloxacin is cautioned in patients on theophylline due to its narrow therapeutic index. The authors of one review recommended that patients being treated with ciprofloxacin reduce their caffeine intake. Evidence for significant interactions with several other CYP1A2 substrates such as cyclosporine is equivocal or conflicting.[59][6][61]

The Committee on Safety of Medicines and the FDA warn that central nervous system adverse effects, including seizure risk, may be increased when NSAIDs are combined with quinolones.[6][62] The mechanism for this interaction may involve a synergistic increased antagonism of GABA neurotransmission.[63][64]

Altered serum levels of the antiepileptic drugs phenytoin and carbamazepine (increased and decreased) have been reported in patients receiving concomitant ciprofloxacin.[6][65][66]

Ciprofloxacin is a potent inhibitor of CYP1A2, CYP2D6, and CYP3A4.[67]

Ciprofloxacin is a broad-spectrum antibiotic of the fluoroquinolone class. It is active against both Gram-positive and Gram-negative bacteria. It s by inhibiting DNA gyrase, and a type II topoisomerase, topoisomerase IV,[68][69] necessary to separate bacterial DNA, thereby inhibiting cell division.

Ciprofloxacin for systemic administration is available as immediate-release tablets, extended-release tablets, an oral suspension, and as a solution for intravenous administration.
When administered over one hour as an intravenous infusion,[26] ciprofloxacin rapidly distributes into the tissues, with levels in some tissues exceeding those in the serum. Penetration into the central nervous system is relatively modest, with cerebrospinal fluid levels normally less than 1% of peak serum concentrations. The serum half-life of ciprofloxacin is about 4–6 hours, with 5-7% of an administered dose being excreted in the urine as unmetabolized drug. An additional 1% is excreted in urine as metabolites. Urinary excretion is virtually complete 24 hours after administration. Dose adjustment is required in the elderly and in those with renal impairment.[citation needed]

Ciprofloxacin is weakly bound to serum proteins (2-4%), but is an inhibitor of the drug-metabolizing enzyme cytochrome P45 1A2, which leads to the potential for clinically important drug interactions with drugs metabolized by that enzyme.[medical citation needed]

Ciprofloxacin is about 7% orally available when administered orally, so a slightly higher dose is needed to achieve the same exposure when switching from IV to oral administration[26]

The extended release oral tablets[7] allow once-daily administration by releasing the drug more slowly in the gastrointestinal tract. These tablets contain 35% of the administered dose in an immediate-release form and 65% in a slow-release matrix. Maximum serum concentrations are achieved between 1 and 4 hours after administration. Compared to the 25- and 5-mg immediate-release tablets, the 5-mg and 1-mg XR tablets provide higher Cmax, but the 24‑hour AUCs are equivalent.

Ciprofloxacin immediate-release tablets contain ciprofloxacin as the hydrochloride salt, and the XR tablets contain a mixture of the hydrochloride salt as the free base.[citation needed]

Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4 g/mol. It is a faintly yellowish to light yellow crystalline substance.[56]

Ciprofloxacin hydrochloride (USP) is the monohydrochloride monohydrate salt of ciprofloxacin. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8 g/mol. Its empirical formula is C17H18FN3O3HCl•H2O.[56]

Ciprofloxacin is the most widely used of the second-generation quinolones.[71][72] In 21, over 2 million preions were written, making it the 35th-most commonly prescribed generic drug and the 5th-most commonly prescribed antibacterial in the U.S.[73]

The first members of the quinolone antibacterial class were relatively low-potency drugs such as nalidixic acid, used mainly in the treatment of urinary tract infections owing to their renal excretion and propensity to be concentrated in urine.[74] In 1979, the publication of a patent[75] filed by the pharmaceutical arm of Kyorin Seiyaku Kabushiki Kaisha disclosed the discovery of norfloxacin, and the demonstration that certain structural modifications including the attachment of a fluorine atom to the quinolone ring leads to dramatically enhanced antibacterial potency.[76] In the aftermath of this disclosure, several other pharmaceutical companies initiated research and development programs with the goal of discovering additional antibacterial agents of the fluoroquinolone class.

The fluoroquinolone program at Bayer focused on examining the effects of very minor changes to the norfloxacin structure.[77][78] In 1983, the company published in vitro potency data for ciprofloxacin, a fluoroquinolone antibacterial having a chemical structure differing from that of norfloxacin by the presence of a single carbon atom.[79] This small change led to a two- to 1-fold increase in potency against most strains of Gram-negative bacteria. Importantly, this structural change led to a four-fold improvement in activity against the important Gram-negative pathogen Pseudomonas aeruginosa, making ciprofloxacin one of the most potent known drugs for the treatment of this intrinsically antibiotic-resistant pathogen.[medical citation needed]

The oral tablet form of ciprofloxacin was approved in October 1987,[8] just one year after the approval of norfloxacin.[81] In 1991, the intravenous formulation was introduced. Ciprofloxacin sales reached a peak of about 2 billion euros in 21, before Bayer’s patent expired in 24, after which annual sales have averaged around €2 million.[82][83]

The name probably originates from the International Scientific Nomenclature: ci- (alteration of cycl-) + propyl + fluor- + ox- + az- + -mycin.[84]

It is available as a generic medication and not very expensive.[2][1] Wholesale it costs between .3 and .13 USD a dose.[11] In the United States it is sold for about .4 USD per dose.[2]

On 24 October 21, the Preion Access Litigation (PAL) project filed suit to dissolve an agreement between Bayer and three of its competitors which produced generic versions of drugs (Barr Laboratories, Rugby Laboratories, and Hoechst-Marion-Roussel) that PAL claimed was blocking access to adequate supplies and cheaper, generic versions of ciprofloxacin. The plaintiffs charged that Bayer Corporation, a unit of Bayer AG, had unlawfully paid the three competing companies a total of $2 million to prevent cheaper, generic versions of ciprofloxacin from being brought to the market, as well as manipulating its price and supply. Numerous other consumer advocacy groups joined the lawsuit. On 15 October 28, five years after Bayer’s patent had expired, the United States District Court for the Eastern District of New York granted Bayer’s and the other defendants’ motion for summary judgment, holding that any anticompetitive effects caused by the settlement agreements between Bayer and its codefendants were within the exclusionary zone of the patent and thus could not be redressed by federal antitrust law,[85] in effect upholding Bayer’s agreement with its competitors.

Ciprofloxacin for systemic administration is available as immediate-release tablets, as extended-release tablets, as an oral suspension, and as a solution for intravenous infusion. It is also available for local administration as eye drops and ear drops.

A class action was filed against Bayer AG on behalf of employees of the Brentwood Post Office in Washington, D.C., and workers at the U.S. Capitol, along with employees of American Media, Inc. in Florida and postal workers in general who alleged they suffered serious adverse effects from taking ciprofloxacin (Cipro) in the aftermath of the anthrax attacks in 21. The action alleged Bayer failed to warn class members of the potential side effects of the drug, thereby violating the Pennsylvania Unfair Trade Practices and Consumer Protection Laws. The class action was defeated and the litigation abandoned by the plaintiffs.[86]
A similar action was filed in 23 in New Jersey by four New Jersey postal workers but was withdrawn for lack of grounds, as workers had been informed of the risks of cipro when they were given the option of taking the drug.[87][88]

As resistance to ciprofloxacin has grown, research has been conducted to discover and develop analogs that can be effective against resistant bacteria some have been looked at in antiviral models as well.[89]

ciprofloxacin

Molecular Weight: 331.3452

ciprofloxacin hydrochloride

Molecular Weight: 385.821

Several FDA-approved drug labels may be available for ciprofloxacin. AIDSinfo provides the following drug label solely as an example of the labels available for ciprofloxacin. Inclusion or absence of a drug label on the AIDSinfo site does not imply endorsement or lack thereof by AIDSinfo. Search Drugs@FDA to access more information on ciprofloxacin, including additional drug labels and any generic equivalents.

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

See full prescribing information for complete boxed warning.

CIPRO XR is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria:

The most common adverse reactions ≥2% were nausea, ache, dizziness, diarrhea, vomiting, and vaginal moniliasis. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-8-FDA-188 or www.fda.gov/medwatch.

Interacting Drug

Interaction

Theophylline

Serious and fatal reactions. Avoid concomitant use. Monitor serum level. (5.9, 7)

Warfarin

Anticoagulant effect enhanced. Monitor prothrombin time, INR, and bleeding. (7)

Antidiabetic agents

Hypoglycemia including fatal outcomes have been reported. Monitor blood glucose. (7)

Phenytoin

Monitor phenytoin level (7)

Methotrexate

Monitor for methotrexate toxicity (7)

Cyclosporine

May increase serum creatinine. Monitor serum creatinine. (7)

Multivalent cation-containing products including antacids, metal cations or didanosine

Decreased CIPRO absorption. Take 2 hours before or 6 hours after CIPRO (2.2, 7)

Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions (5.1-5.15), reserve CIPRO XR for use in patients who have no alternative treatment options for uncomplicated urinary tract infections (1.1)

CIPRO XR is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below.

 CIPRO XR is indicated for the treatment of uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticus.

 Because fluoroquinolones, including CIPRO XR, have been associated with serious adverse reactions [see Warnings and Precautions (5.1–5.15)] and for some patients uncomplicated UTI (acute cystitis) is self-limiting, reserve CIPRO XR for treatment of uncomplicated UTIs (acute cystitis) in patients who have no alternative treatment options.

CIPRO XR is indicated for the treatment of complicated urinary tract infections (cUTI) caused by Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, Proteus mirabilis, or Pseudomonas aeruginosa and acute uncomplicated pyelonephritis (AUP) caused by Escherichia coli.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO XR and other antibacterial drugs, CIPROXR should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with CIPRO XR may be initiated before results of these tests are known once results become available appropriate therapy should be continued.

As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.

CIPRO XR and ciprofloxacin immediate-release tablets are not interchangeable. Cipro XR should be administered orally once daily (Table 1).

Indication

Dose

Frequency

Usual Duration

Uncomplicated Urinary Tract Infection (Acute Cystitis)

5 mg

every 24 hours

3 Days

Complicated Urinary Tract Infection and Acute Uncomplicated Pyelonephritis

1 mg

every 24 hours

7–14 Days

Patients whose therapy is started with CIPRO IV for UTIs may be switched to CIPRO XR when clinically indicated at the discretion of the physician.

CIPRO XR is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components [see Warnings and Precautions (5.7)].

Concomitant administration with tizanidine is contraindicated [see Drug Interactions (7)].

 Fluoroquinolones, including CIPRO XR, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe aches, and confusion). These reactions can occur within hours to weeks after starting CIPRO XR. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions (5.2, 5.3, 5.4)].

 Discontinue CIPRO XR immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including CIPRO XR, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

Fluoroquinolones, including CIPRO XR, have been associated with an increased risk of tendinitis and tendon rupture in all ages [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)]. This adverse reaction most frequently involves the Achilles tendon, and also been reported in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis and tendon rupture can occur within hours or days of starting CIPRO XR, or as long as several months after completion of fluoroquinolone therapy. Tendinitis and tendon rupture can occur bilaterally.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in patients over 6 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors.

Discontinue CIPRO XR immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including CIPRO XR, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture [see Adverse Reactions (6.2)].

Fluoroquinolones, including CIPRO XR, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including CIPRO XR. Symptoms may occur soon after initiation of CIPRO XR and may be irreversible in some patients [see Warnings and Precautions (5.1) and Adverse Reactions (6.1, 6.2)].

Discontinue CIPRO XR immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light touch, pain, temperature, position sense and vibratory sensation and/or motor strength in order to minimize the development of an irreversible condition. Avoid fluoroquinolones, including CIPRO, in patients who have previously experienced peripheral neuropathy [see Adverse Reactions (6.1, 6.2).]

Fluoroquinolones, including CIPRO XR, have been associated with an increased risk of central nervous system (CNS) effects, including convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis. CIPRO XR may also cause central nervous system (CNS) events including: nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and psychotic reactions that have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide. These reactions may occur following the first dose. Advise patients receiving ciprofloxacin to inform their healthcare provider immediately if these reactions occur, discontinue the drug, and institute appropriate care. CIPRO XR, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold. As with all fluoroquinolones, use CIPRO XR with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (for example, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (for example., certain drug therapy, renal dys). Use CIPRO XR when the benefits of treatment exceed the risks, since these patients are endangered because of possible undesirable CNS side effects. Cases of status epilepticus have been reported. If seizures occur, discontinue CIPRO XR [see Adverse Reactions (6.1, 6.2) and Drug Interactions (7)].

Fluoroquinolones, including CIPRO XR, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Postmarketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Avoid CIPRO XR in patients with known history of myasthenia gravis [see Adverse Reactions (6.3) and Patient Counseling Information (17)].

Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported in patients receiving therapy with quinolones, including ciprofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

Discontinue CIPRO XR immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted [see Adverse Reactions (6.1, 6.2)].

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy, including CIPRO XR. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, including intubation, as indicated [see Contraindications (4.1), Adverse Reactions (6.1) and Patient Counseling Information (17)].

Cases of severe hepatotoxicity, including hepatic necrosis, life-threatening hepatic failure, and fatal events, have been reported with CIPRO XR. Acute liver injury is rapid in onset (range 1–39 days), and is often associated with hypersensitivity. The pattern of injury can be hepatocellular, cholestatic or mixed. Most patients with fatal outcomes were older than 55 years old. In the event of any signs and symptoms of hepatitis (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), discontinue treatment immediately.

There can be a temporary increase in transaminases, alkaline phosphatase, or cholestatic jaundice, especially in patients with previous liver damage, who are treated with CIPRO XR [see Adverse Reactions (6.1, 6.2, 6.3)].

Serious and fatal reactions have been reported in patients receiving concurrent administration of CIPRO XR and theophylline. These reactions have included cardiac arrest, seizure, status epilepticus, and respiratory failure. Instances of nausea, vomiting, tremor, irritability, or palpitation have also occurred.

Although similar serious adverse reactions have been reported in patients receiving theophylline alone, the possibility that these reactions may be potentiated by CIPRO XR cannot be eliminated. If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate [see Drug Interactions (7)].

Clostridium difficile (C. difficile)-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CIPRO XR, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and institute surgical evaluation as clinically indicated [see Adverse Reactions (6.2)].

Some fluoroquinolones, including CIPRO XR have been associated with prolongation of the QT interval on the electrocardiogram and cases of arrhythmia. Cases of torsade de pointes have been reported during postmarketing surveillance in patients receiving fluoroquinolones, including CIPRO XR.

Avoid CIPRO XR in patients with known prolongation of the QT interval, risk factors for QT prolongation or torsade de pointes (for example, congenital long QT syndrome, uncorrected electrolyte imbalance, such as hypokalemia or hypomagnesemia and cardiac disease, such as heart failure, myocardial infarction, or bradycardia), and patients receiving Class IA antiarrhythmic agents (quinidine, procainamide), or Class III antiarrhythmic agents (amiodarone, sotalol), tricyclic antidepressants, macrolides, and antipsychotics. Elderly patients may also be more susceptible to drug-associated effects on the QT interval [see Adverse Reactions (6.2) and Use in Specific Populations (8.5)].

An increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues, has been observed [see Adverse Reactions (6.2)].

In pre-clinical studies, oral administration of CIPRO XR caused lameness in immature dogs. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of ious species [see Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)].

Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolones including CIPRO XR after sun or UV light exposure. Therefore, avoid excessive exposure to these sources of light. Discontinue CIPRO XR if phototoxicity occurs [see Adverse Reactions (6.1)].

Prescribing CIPRO XR Tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Ciprofloxacin is an inhibitor of the hepatic CYP1A2 enzyme pathway. Co-administration of ciprofloxacin and other drugs primarily metabolized by CYP1A2 (for example, theophylline, methylxanthines, caffeine, tizanidine, ropinirole, clozapine, olanzapine) results in increased plasma concentrations of the co-administered drug and could lead to clinically significant pharmacodynamic adverse reactions of the co-administered drug [see Drug Interactions (7) and Clinical Pharmacology (12.3)].

Ciprofloxacin has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high dose for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. Perform a serologic test for syphilis in all patients with gonorrhea at the time of diagnosis. Perform follow-up serologic test for syphilis three months after CIPRO XR treatment.

Crystals of ciprofloxacin have been observed rarely in the urine of human subjects but more frequently in the urine of laboratory animals, which is usually alkaline [see Nonclinical Toxicology (13.2)]. Crystalluria related to ciprofloxacin has been reported only rarely in humans because human urine is usually acidic. Avoid alkalinity of the urine in patients receiving CIPRO XR. Hydrate patients well to prevent the formation of highly concentrated urine [see Dosage and Administration (2.2)].

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

Because clinical trials are conducted under widely ying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical trials in patients with urinary tract infections enrolled 961 patients treated with 5 mg or 1 mg CIPRO XR. The overall incidence, type and distribution of adverse reactions were similar in patients receiving both 5 mg and 1 mg of CIPRO XR. The adverse reaction information from clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

In the clinical trial of uncomplicated UTIs, CIPRO XR (5 mg once daily) in 444 patients was compared to ciprofloxacin immediate-release tablets (25 mg twice daily) in 447 patients for 3 days. Discontinuations due to adverse reactions thought to be drug-related occurred in .2% (1/444) of patients in the CIPRO XR arm and in % (/447) of patients in the control arm.

In the clinical trial of cUTI and acute uncomplicated pyelonephritis (AUP) defined as infections occurring in premenopausal, non-pregnant women with no known urological abnormalities or comorbidities, CIPRO XR (1 mg once daily) in 517 patients was compared to ciprofloxacin immediate-release tablets (5 mg twice daily) in 518 patients for 7 to 14 days. Discontinuations due to adverse reactions thought to be drug-related occurred in 3.1% (16/517) of patients in the CIPRO XR arm and in 2.3% (12/518) of patients in the control arm. The most common reasons for discontinuation in the CIPRO XR arm were nausea/vomiting (4 patients) and dizziness (3 patients). In the control arm the most common reason for discontinuation was nausea/vomiting (3 patients).

In these clinical trials, the following events occurred in ≥ 2% of all CIPRO XR patients: nausea (4%), ache (3%), dizziness (2%), diarrhea (2%), vomiting (2%) and vaginal moniliasis (2%).

Adverse reactions, judged by investigators to be at least possibly drug-related, occurring in greater than or equal to 1% of all CIPRO XR treated patients were: nausea (3%), diarrhea (2%), ache (1%), dyspepsia (1%), dizziness (1%), and vaginal moniliasis (1%). Vomiting (1%) occurred in the 1 mg group.

System Organ Class

Adverse Reactions

Body as a Whole

Abdominal pain

Asthenia

Malaise

Cardiovascular

Bradycardia

Migraine

Syncope

Central Nervous System

Abnormal dreams

Convulsive seizures (including status epilepticus) Depersonalization

Depression (potentially culminating in self-injurious behavior, such as suicidal ideations/thoughts and attempted or completed suicide)

Hypertonia

Incoordination

Insomnia

Somnolence

Tremor

Vertigo

Gastrointestinal

Constipation

Dry mouth

Flatulence

Thirst

Hepatobiliary Disorders

Liver tests abnormal

Investigations

Prothrombin decrease

Metabolic

Hyperglycemia

Hypoglycemia

Psychiatric Disorders

Anorexia

Skin/Hypersensitivity

Dry skin

Maculopapular rash

Photosensitivity/phototoxicity reactions

Pruritus

Rash

Skin disorder

Urticarial

Vesiculobullous rash

Special Senses

Diplopia

Taste perversion

Urogenital

Dysmenorrhea

Hematuria

Kidney abnormalVaginitis

The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including CIPRO XR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure (Table 3).

System Organ Class

Adverse Reactions

Cardiovascular

QT prolongation

Torsade de Pointes

Vasculitis and ventricular arrhythmia

Central Nervous System

Hypertonia

Myasthenia

Exacerbation of myasthenia gravis

Peripheral neuropathy

Polyneuropathy

Twitching

Eye Disorders

Nystagmus

Gastrointestinal

Pseudomembranous colitis

Hemic/Lymphatic

Pancytopenia (life threatening or fatal outcome)

Methemoglobinemia

Hepatobiliary

Hepatic failure (including fatal cases)

Infections and Infestations

Candidiasis (oral, gastrointestinal, vaginal)

Investigations

Prothrombin time prolongation or decrease

Cholesterol elevation (serum)

Potassium elevation (serum)

Musculoskeletal

Myalgia

Myoclonus

Tendinitis

Tendon rupture

Psychiatric Disorders

Agitation

Confusion

Delirium

Psychosis (toxic)

Skin/Hypersensitivity

Acute generalized exanthematous pustulosis (AGEP)

Fixed eruption

Serum sickness-like reaction

Special Senses

Anosmia

Hyperesthesia

Hypesthesia

Taste loss

Changes in laboratory parameters while on CIPRO are listed below:

Hepatic–Elevations of ALT (SGPT), AST (SGOT), alkaline phosphatase, LDH, serum bilirubin.

Hematologic–Eosinophilia, leukopenia, decreased blood platelets, elevated blood platelets, pancytopenia.

Renal–Elevations of serum creatinine, BUN, crystalluria, cylindruria, and hematuria have been reported.

Other changes occurring were: elevation of serum gammaglutamyl transferase, elevation of serum amylase, reduction in blood glucose, elevated uric acid, decrease in hemoglobin, anemia, bleeding diathesis, increase in blood monocytes, and leukocytosis.

Ciprofloxacin is an inhibitor of human cytochrome P45 1A2 (CYP1A2) mediated metabolism. Co-administration of CIPRO XR with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the co-administered drug.

Drugs That are Affected by CIPRO

Drug(s)

Recommendation

Comments

Tizanidine

Concomitant administration of tizanidine and CIPRO XR is contraindicated due to the potentiation of hypotensive and sedative effects of tizanidine [see Contraindications (4.2)].

Theophylline

Avoid Use

(Plasma Exposure Likely to be Increased and Prolonged)

Concurrent administration of CIPRO XR with theophylline may result in increased risk of a patient developing central nervous system (CNS) or other adverse reactions. If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate [see Warnings and Precautions (5.9)].

Drugs Known to Prolong QT Interval

Cipro XR may further prolong the QT interval in patients receiving drugs known to prolong the QT interval (for example, class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) [see Warnings and Precautions (5.11) and Use in Specific Populations (8.5)].

Oral antidiabetic drugs

Use with caution

Glucose-lowering effect potentiated

Hypoglycemia sometimes severe has been reported when CIPRO XR and oral antidiabetic agents, mainly sulfonylureas (for example, glyburide, glimepiride), were co-administered, presumably by intensifying the action of the oral antidiabetic agent. Fatalities have been reported. Monitor blood glucose when CIPRO XR is co-administered with oral antidiabetic drugs [see Adverse Reactions (6.1)].

Phenytoin

Use with caution

Altered serum levels of phenytoin (increased and decreased)

To avoid the loss of seizure control associated with decreased phenytoin levels and to prevent phenytoin overdose-related adverse reactions upon CIPRO XR discontinuation in patients receiving both agents, monitor phenytoin therapy, including phenytoin serum concentration during and shortly after co-administration of CIPRO XR with phenytoin.

Cyclosporine

Use with caution

(transient elevations in serum creatinine)

Monitor renal (in particular serum creatinine) when CIPRO XR is co-administered with cyclosporine.

Anti-coagulant drugs

Use with caution

(Increase in anticoagulant effect)

The risk may y with the underlying infection, age and general status of the patient so that the contribution of CIPRO XR to the increase in INR (international normalized ratio) is difficult to assess. Monitor prothrombin time and INR frequently during and shortly after co-administration of CIPRO XR with an oral anti-coagulant (for example, warfarin).

Methotrexate

Use with caution

Inhibition of methotrexate renal tubular transport potentially leading to increased methotrexate plasma levels

Potential increase in the risk of methotrexate associated toxic reactions. Therefore, carefully monitor patients under methotrexate therapy when concomitant CIPRO XR therapy is indicated.

Ropinirole

Monitoring for ropinirole-related adverse reactions and appropriate dose adjustment of ropinirole is recommended during and shortly after co-administration with CIPRO XR [see Warnings and Precautions (5.15)].

Clozapine

Careful monitoring of clozapine associated adverse reactions and appropriate adjustment of clozapine dosage during and shortly after co-administration with CIPRO XR are advised.

NSAIDs

Non-steroidal anti-inflammatory drugs (but not acetyl salicylic acid) in combination of very high doses of quinolones have been shown to provoke convulsions in pre-clinical studies and in postmarketing.

Sildenafil

Use with caution

Two-fold increase in exposure

Monitor for sildenafil toxicity [see Clinical Pharmacology (12.3)]..

Duloxetine

Avoid Use

Five-fold increase in duloxetine exposure

If unavoidable monitor, for duloxetine toxicity

Caffeine/Xanthine Derivatives

Use with caution

Reduced clearance resulting in elevated levels and prolongation of serum half-life

CIPRO XR inhibits the formation of paraxanthine after caffeine administration (or pentoxifylline containing products). Monitor for xanthine toxicity and adjust dose as necessary.

Drug(s) Affecting Pharmacokinetics of CIPRO XR

Antacids, Sucralfate, Multivitamins and Other Products Containing Multivalent Cations (magnesium/aluminum antacids polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) sucralfate Videx® (didanosine) chewable/buffered tablets or pediatric powder other highly buffered drugs or products containing calcium, iron, or zinc and dairy products)

CIPRO XR should be taken at least two hours before or six hours after Multivalent cation-containing products administration [see Dosage and Administration ( 2)].

Decrease CIPRO XR absorption, resulting in lower serum and urine levels considerably lower than desired for concurrent administration of these agents with CIPRO XR

Probenecid

Use with caution

(interferes with renal tubular secretion of CIPRO XR and increases CIPRO XR serum levels)

Potentiation of CIPRO XR toxicity may occur.

There are no adequate and well-controlled studies in pregnant women. CIPRO XR should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother.An expert review of published data on experiences with ciprofloxacin use during pregnancy by TERIS–the Teratogen Information System concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of datafair), but the data are insufficient to state that there is no risk.

A controlled prospective observational study followed 2 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures) during gestation. In utero exposure to fluoroquinolones during embryogenesis was not associated with increased risk of major malformations. The reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% for the control group (background incidence of major malformations is 1–5%). Rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dyss up to one year of age in the ciprofloxacin exposed children.

Another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures). There were 7 ciprofloxacin exposures, all within the first trimester. The malformation rates among live-born babies exposed to ciprofloxacin and to fluoroquinolones overall were both within background incidence ranges. No specific patterns of congenital abnormalities were found. The study did not reveal any clear adverse reactions due to in utero exposure to ciprofloxacin.

No differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to ciprofloxacin during pregnancy. However, these small postmarketing epidemiology studies, of which most experience is from short term, first trimester exposure, are insufficient to evaluate the risk for the less common defects or to permit reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and their developing fetuses.

Reproduction studies have been performed in rats and mice using oral doses up to 1 mg/kg (.6 and .3 times the maximum daily human dose of 1 mg based upon body surface area, respectively) and have revealed no evidence of harm to the fetus due to ciprofloxacin. In rabbits, oral ciprofloxacin dose levels of 3 and 1 mg/kg (approximately .4- and 1.3-times the highest recommended therapeutic dose based upon body surface area) produced gastrointestinal toxicity resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose level. After intravenous administration of doses up to 2 mg/kg (approximately .3-times the highest recommended therapeutic dose based upon body surface area), no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed.

Ciprofloxacin is excreted in human milk. The amount of ciprofloxacin absorbed by the nursing infant is unknown. Because of the potential risk of serious adverse reactions (including articular damage) in infants nursing from mothers taking CIPRO XR, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness of CIPRO XR in pediatric patients and adolescents less than 18 years of age have not been established. Ciprofloxacin causes arthropathy in juvenile animals [see Nonclinical Toxicology (13.2)]. CIPRO XR is not indicated for pediatric patients [see Indications and Usage (1.3)].

Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as CIPRO XR. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing CIPRO XR to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue CIPRO XR and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur [see Boxed Warning, Warnings and Precautions (5.2), and Adverse Reactions (6.2)].

In a large, prospective, randomized CIPRO XR clinical trial in cUTI, 49% (59/135) of the patients were 65 and over, while 3% (38/135) were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. Ciprofloxacin is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal . No alteration of dosage is necessary for patients greater than 65 years of age with normal renal . However, since some older individuals experience reduced renal by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal monitoring may be useful in these patients [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using CIPRO XR with concomitant drugs that can result in prolongation of the QT interval (for example, class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known QT prolongation, uncorrected hypokalemia) [see Warnings and Precautions (5.11)].

Ciprofloxacin is eliminated primarily by renal excretion however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternate pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. No dosage adjustment is required for patients with uncomplicated UTIs receiving 5 mg CIPRO XR. Dosing in children (less than 18 years of age) with impaired renal has not been studied [see Clinical Pharmacology (12.3)].

In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. The pharmacokinetics of ciprofloxacin in patients with acute hepatic insufficiency, have not been studied.

In the event of acute overdosage, reversible renal toxicity has been reported in some cases. Empty the stomach by inducing vomiting or by gastric lavage. Observe the patient carefully and give supportive treatment, including monitoring of renal , urinary pH and acidify, if required, to prevent crystalluria and administration of magnesium, aluminum or calcium containing antacids, which can reduce the absorption of ciprofloxacin. Adequate hydration must be maintained. Only a small amount of ciprofloxacin (less than 1%) is removed from the body after hemodialysis or peritoneal dialysis.

CIPRO XR (ciprofloxacin*) extended-release tablets contain ciprofloxacin, a synthetic antimicrobial agent for oral administration. CIPRO XR tablets are coated, bilayer tablets consisting of an immediate-release layer and an erosion-matrix type controlled-release layer. The tablets contain a combination of two types of ciprofloxacin drug substance, ciprofloxacin hydrochloride and ciprofloxacin betaine (base). Ciprofloxacin hydrochloride is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7- (1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride. It is provided as a mixture of the monohydrate and the sesquihydrate. The empirical formula of the monohydrate is C17H18FN3O3 • HCl • H2O and its molecular weight is 385.8. The empirical formula of the sesquihydrate is C17H18FN3O3 • HCl • 1.5 H2O and its molecular weight is 394.8. The drug substance is a faintly yellowish to light yellow crystalline substance. The chemical structure of the monohydrate is as follows:

Ciprofloxacin betaine is 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. As a hydrate, its empirical formula is C17H18FN3O3 • 3.5 H2O and its molecular weight is 394.3. It is a pale yellowish to light yellow crystalline substance and its chemical structure is as follows:

CIPRO XR is available in 5 mg and 1 mg (ciprofloxacin equivalent) tablet strengths. CIPRO XR tablets are nearly white to slightly yellowish, film-coated, oblong-shaped tablets. Each CIPRO XR 5 mg tablet contains 5 mg of ciprofloxacin as ciprofloxacin HCl (287.5 mg, calculated as ciprofloxacin on the dried basis) and ciprofloxacin† (212.6 mg, calculated on the dried basis). Each CIPRO XR 1 mg tablet contains 1 mg of ciprofloxacin as ciprofloxacin HCl (574.9 mg, calculated as ciprofloxacin on the dried basis) and ciprofloxacin† (425.2 mg, calculated on the dried basis). The inactive ingredients are crospovidone, hypromellose, magnesium stearate, polyethylene glycol, silica colloidal anhydrous, succinic acid, and titanium dioxide.

* as ciprofloxacin† and ciprofloxacin hydrochloride

† does not comply with the loss on drying test and residue on ignition test of the USP monograph.

Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4)].

CIPRO XR tablets are formulated to release drug at a slower rate compared to immediate-release tablets. Approximately 35% of the dose is contained within an immediate-release component, while the remaining 65% is contained in a slow-release matrix.

Maximum plasma ciprofloxacin concentrations are attained between 1 and 4 hours after dosing with CIPRO XR. In comparison to the 25 mg and 5 mg ciprofloxacin immediate-release twice a day (BID) treatment, the Cmax of CIPRO XR 5 mg and 1 mg once daily are higher than the corresponding BID doses, while the AUCs over 24 hours are equivalent.

The following table compares the pharmacokinetic parameters obtained at steady state for these four treatment regimens (5 mg once a day (QD) CIPRO XR versus 25 mg BID ciprofloxacin immediate-release tablets and 1 mg QD CIPRO XR versus 5 mg BID ciprofloxacin immediate-release).

Cmax

(mg/L)

AUC–24h

(mg•h/L)

T1/2 (hr)

Tmax (hr) 1

1.59 ± .43

7.97 ± 1.87

6.6 ± 1.4

1.5 (1 – 2.5)

1.14 ± .23

8.25 ± 2.15

4.8 ± .6

1 (.5 – 2.5)

3.11 ± 1.8

16.83 ± 5.65

6.31 ± .72

2 (1 – 4)

2.6 ± .41

17.4 ± 4.79

5.66 ± .89

2 (.5 – 3.5)

1 median (range)

Results of the pharmacokinetic studies demonstrate that CIPRO XR may be administered with or without food (for example, high-fat and low-fat meals or under fasted conditions).

The volume of distribution calculated for intravenous ciprofloxacin is approximately 2.1–2.7 L/kg. Studies with the oral and intravenous forms of ciprofloxacin have demonstrated penetration of ciprofloxacin into a iety of tissues. The binding of ciprofloxacin to serum proteins is 2% to 4%, which is not likely to be high enough to cause significant protein binding interactions with other drugs. Following administration of a single dose of CIPRO XR, ciprofloxacin concentrations in urine collected up to 4 hours after dosing averaged over 3 mg/L for both the 5 mg and 1 mg tablets in urine excreted from 12 to 24 hours after dosing, ciprofloxacin concentration averaged 27 mg/L for the 5 mg tablet, and 58 mg/L for the 1 mg tablet.

Four metabolites of ciprofloxacin were identified in human urine. The metabolites have antimicrobial activity, but are less active than unchanged ciprofloxacin. The primary metabolites are oxociprofloxacin (M3) and sulfociprofloxacin (M2), each accounting for roughly 3% to 8% of the total dose. Other minor metabolites are desethylene ciprofloxacin (M1), and formylciprofloxacin (M4). The relative proportion of drug and metabolite in serum corresponds to the composition found in urine. Excretion of these metabolites was essentially complete by 24 hours after dosing. Ciprofloxacin is an inhibitor of CYP1A2 mediated metabolism. Co-administration of ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the co-administered drug [see Contraindications (4.2), Warnings and Precautions (5.9, 5.15) and Drug Interactions (7)].

The elimination kinetics of ciprofloxacin are similar for the immediate-release and the CIPRO XR tablet. In studies comparing the CIPRO XR and immediate-release ciprofloxacin, approximately 35% of an orally administered dose was excreted in the urine as unchanged drug for both formulations. The urinary excretion of ciprofloxacin is virtually complete within 24 hours after dosing. The renal clearance of ciprofloxacin, which is approximately 3 mL/minute, exceeds the normal glomerular filtration rate of 12 mL/minute. Thus, active tubular secretion would seem to play a significant role in its elimination. Co-administration of probenecid with immediate-release ciprofloxacin results in about a 5% reduction in the ciprofloxacin renal clearance and a 5% increase in its concentration in the systemic circulation. Although bile concentrations of ciprofloxacin are several fold higher than serum concentrations after oral dosing with the immediate-release tablet, only a small amount of the dose administered is recovered from the bile as unchanged drug. An additional 1 to 2% of the dose is recovered from the bile in the form of metabolites. Approximately 2 to 35% of an oral dose of immediate-release ciprofloxacin is recovered from the feces within 5 days after dosing. This may arise from either biliary clearance or transintestinal elimination.

Pharmacokinetic studies of the immediate-release oral tablet (single dose) and intravenous (single and multiple dose) forms of ciprofloxacin indicate that plasma concentrations of ciprofloxacin are higher in elderly subjects (&gt 65 years) as compared to young adults. Cmax is increased 16 to 4%, and mean AUC is increased approximately 3%, which can be at least partially ibuted to decreased renal clearance in the elderly. Elimination half-life is only slightly (~2%) prolonged in the elderly. These differences are not considered clinically significant [see Use in Specific Populations (8.5)].

In patients with reduced renal , the half-life of ciprofloxacin is slightly prolonged. No dose adjustment is required for patients with uncomplicated UTIs receiving 5 mg CIPRO XR. For cUTI and AUP, where 1 mg is the appropriate dose, the dosage of CIPRO XR should be reduced to CIPRO XR 5 mg q24h in patients with creatinine clearance equal to or below 3 mL/min [see Dosage and Administration (2.3)].

In preliminary studies in patients with stable chronic cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. The kinetics of ciprofloxacin in patients with acute hepatic insufficiency, however, have not been fully elucidated [see Use in Specific Populations (8.7)].

Concurrent administration of antacids containing magnesium hydroxide or aluminum hydroxide may reduce the bioavailability of CIPRO by as much as 9% [see Dosage and Administration (2.2) and Drug Interactions (7)].

Histamine H2-receptor antagonists appear to have no significant effect on the bioavailability of CIPRO.

The serum concentrations of CIPRO and metronidazole were not altered when these two drugs were given concomitantly.

In a pharmacokinetic study, systemic exposure of tizanidine (4 mg single dose) was significantly increased (Cmax 7-fold, AUC 1-fold) when the drug was given concomitantly with CIPRO (5 mg twice a day for 3 days). Concomitant administration of tizanidine and CIPRO XR is contraindicated due to the potentiation of hypotensive and sedative effects of tizanidine [see Contraindications (4.2)].

In a study conducted in 12 patients with Parkinson’s disease who were administered 6 mg ropinirole once daily with 5 mg CIPRO twice-daily, the mean Cmax and mean AUC of ropinirole were increased by 6% and 84%, respectively. Monitoring for ropinirole-related adverse reactions and appropriate dose adjustment of ropinirole is recommended during and shortly after co-administration with CIPRO XR [see Warnings and Precautions (5.15)].

Following concomitant administration of 25 mg CIPRO with 34 mg clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Careful monitoring of clozapine associated adverse reactions and appropriate adjustment of clozapine dosage during and shortly after co-administration with CIPRO XR are advised.

Following concomitant administration of a single oral dose of 5 mg sildenafil with 5 mg CIPRO to healthy subjects, the mean Cmax and mean AUC of sildenafil were both increased approximately two-fold. Use sildenafil with caution when co-administered with CIPRO XR due to the expected two-fold increase in the exposure of sildenafil upon co-administration of CIPRO [see Drug Interactions (7)].

In clinical studies it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP45 1A2 isozyme such as fluvoxamine, may result in a 5-fold increase in mean AUC and a 2.5-fold increase in mean Cmax of duloxetine.

In a study conducted in 9 healthy volunteers, concomitant use of 1.5 mg/kg IV lidocaine with 5 mg ciprofloxacin twice daily resulted in an increase of lidocaine Cmax and AUC by 12% and 26%, respectively. Although lidocaine treatment was well tolerated at this elevated exposure, a possible interaction with CIPRO XR and an increase in adverse reactions related to lidocaine may occur upon concomitant administration.

Metoclopramide significantly accelerates the absorption of oral ciprofloxacin resulting in a shorter time to reach maximum plasma concentrations. No significant effect was observed on the bioavailability of ciprofloxacin.

When CIPRO XR was administered as a single 1 mg dose concomitantly with omeprazole (4 mg once daily for three days) to 18 healthy volunteers, the mean AUC and Cmax of ciprofloxacin were reduced by 2% and 23%, respectively. The clinical significance of this interaction has not been determined.

The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, tranion, repair, and recombination.

The mechanism of action of fluoroquinolones, including ciprofloxacin, is different from that of other antimicrobial agents such as beta-lactams, macrolides, tetracyclines, or aminoglycosides therefore, microorganisms resistant to these classes of drugs may be susceptible to ciprofloxacin. Resistance to fluoroquinolones occurs primarily by either mutations in the DNA gyrases, decreased outer membrane permeability, or drug efflux. In vitro resistance to ciprofloxacin develops slowly by multiple step mutations. Resistance to ciprofloxacin due to spontaneous mutations occurs at a general frequency of between &lt 1-9 to 1×1-6.

There is no known cross-resistance between ciprofloxacin and other classes of antimicrobials.

Ciprofloxacin has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections ciprofloxacin [see Indications and Usage (1)].

Enterococcus faecalis

Staphylococcus saprophyticus

Escherichia coli

Klebsiella pneumoniae

Proteus mirabilis

Pseudomonas aeruginosa

The following in vitro data are available, but their clinical significance is unknown. At least 9 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for ciprofloxacin (&lt1 mcg/mL). However, the efficacy of ciprofloxacin in treating clinical infections due to these bacteria has not beenestablished in adequate and well-controlled clinical trials.

Citrobacter koseri

Citrobacter freundii

Edwardsiella tarda

Enterobacter aerogenes

Enterobacter cloacae

Klebsiella oxytoca

Morganella morganii

Proteus vulgaris

Providencia rettgeri

Providencia stuartii

Serratia marcescens

When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drug products used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug product for treatment.

Bacteria

MIC(mcg/mL)

Zone Diameter(mm)

S

I

R

S

I

R

Enterobacteriaceae

≤1

2

≥4

≥21

16–2

≤15

Enterococcus faecalis

≤1

2

≥4

≥21

16–2

≤15

Pseudomonas aeruginosa

≤1

2

≥4

≥21

16–2

≤15

Staphylococcus saprophyticus

≤1

2

≥4

≥21

16–2

≤15

SSusceptible, IIntermediate, and RResistant.

A report of “Susceptible indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations at the site of infection necessary to inhibit growth of the pathogen. A report of “Intermediate indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site other therapy should be selected.

Bacteria

MIC range (mcg/mL)

Zone Diameter (mm)

Enterococcus faecalis ATCC 29212

.25–2

–

Escherichia coli ATCC 25922

.4–.15

3–4

Pseudomonas aeruginosa ATCC 27853

.25–1

25–33

Staphylococcus aureus ATCC 29213

.12–.5

–

Staphylococcus aureus ATCC 25923

–

22–3

Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below:

Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results:

Ciprofloxacin was not carcinogenic or tumorigenic in 2-year carcinogenicity studies with rats and mice at daily oral dose levels of 25 mg/kg and 75 mg/kg, respectively (approximately 2 and 3 -fold greater than the 1 mg daily human dose based upon body surface area).

Results from photo co-carcinogenicity testing indicate that ciprofloxacin does not reduce the time to appearance of UV-induced skin tumors as compared to vehicle control. Hairless (Skh-1) mice were exposed to UVA light for 3.5 hours five times every two weeks for up to 78 weeks while concurrently being administered ciprofloxacin. The time to development of the first skin tumors was 5 weeks in mice treated concomitantly with UVA and ciprofloxacin (mouse dose approximately equal to the maximum recommended daily human dose of 1 mg based upon body surface area), as opposed to 34 weeks when animals were treated with both UVA and vehicle. The times to development of skin tumors ranged from 16–32 weeks in mice treated concomitantly with UVA and other quinolones.

In this model, mice treated with ciprofloxacin alone did not develop skin or systemic tumors. There are no data from similar models using pigmented mice and/or fully haired mice. The clinical significance of these findings to humans is unknown.

Fertility studies performed in rats at oral doses of ciprofloxacin up to 1 mg/kg (1 times the highest recommended daily human dose of 1 mg based upon body surface area) revealed no evidence of impairment.

Ciprofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested [see Warnings and Precautions (5.12)].Damage of weight bearing joints was observed in juvenile dogs and rats. In young beagles, 1 mg/kg ciprofloxacin, given daily for 4 weeks, caused degenerative articular changes of the knee joint. At 3 mg/kg, the effect on the joint was minimal. In a subsequent study in young beagle dogs, oral ciprofloxacin doses of 3 mg/kg and 9 mg/kg given daily for 2 weeks caused articular changes which were still observed by histopathology after a treatment-free period of 5 months. At 1 mg/kg no effects on joints were observed. This dose was also not associated with arthrotoxicity after an additional treatment-free period of 5 months. In another study, removal of weight bearing from the joint reduced the lesions but did not totally prevent them.

Crystalluria, sometimes associated with secondary nephropathy, occurs in laboratory animals dosed with ciprofloxacin. This is primarily related to the reduced solubility of ciprofloxacin under alkaline conditions, which predominate in the urine of test animals in man, crystalluria is rare since human urine is typically acidic. In rhesus monkeys, crystalluria without nephropathy has been noted after single oral doses as low as 5 mg/kg (approximately .1-times the highest recommended therapeutic dose based upon body surface area. After 6 months of intravenous dosing at 1 mg/kg/day, no nephropathological changes were noted however, nephropathy was observed after dosing at 2 mg/kg/day for the same duration (approximately .4 times the highest recommended therapeutic dose based upon body surface area).

In dogs, ciprof1oxacin administered at 3 and 1 mg/kg by rapid infusion injection (15 sec.) produces hypotensive effects. These effects are considered to be related to histamine release because they are partially antagonized by pyrilamine, an antihistamine. In rhesus monkeys, rapid infusion injection also produces hypotension. but the effect in this species is inconsistent and less pronounced.

In mice, concomitant administration of nonsteroidal anti-inflammatory drugs such as phenylbutazone and indomethacin with quinolones has been reported to enhance the CNS stimulatory effect of quinolones.

Ocular toxicity seen with some related drugs has not been observed in ciprofloxacin-treated animals.

CIPRO XR was evaluated for the treatment of uncomplicated UTIs (acute cystitis) in a randomized, double-blind, controlled clinical trial conducted in the US. This study compared CIPRO XR (5 mg once daily for three days) with ciprofloxacin immediate-release tablets (CIPRO® 25 mg two times a day (BID) for three days). Of the 95 patients enrolled, 452 were randomly assigned to the CIPRO XR treatment group and 453 were randomly assigned to the control group. The primary efficacy iable was bacteriologic eradication of the baseline organism(s) with no new infection or superinfection at test-of-cure (Day 4–11 Post-therapy).

The bacteriologic eradication and clinical success rates were similar between CIPRO XR and the control group. The eradication and clinical success rates and their corresponding 95% confidence intervals for the differences between rates (CIPRO XR minus control group) are given in Table 8:

CIPRO XR 5 mg

QD x 3 Days

452

199

188/199 (94.5%)

1 n/N patients with baseline organism(s) eradicated and no new infections or superinfections/ total number of patients

2 n/N patients with specified baseline organism eradicated/patients with specified baseline organism

3 n/N patients with clinical success /total number of patients

4 The presence of a pathogen at a level of ≥ 15 CFU/mL was required for microbiological evaluability criteria, except for S. saprophyticus (≥14 CFU/mL).

CIPRO XR was evaluated for the treatment of cUTI and acute uncomplicated pyelonephritis (AUP) in a randomized, double-blind, controlled clinical trial conducted in the US and Canada. The study enrolled 1,42 patients (521 patients per treatment arm) and compared CIPRO XR (1 mg once daily for 7 to 14 days) with immediate-release ciprofloxacin (5 mg BID for 7 to 14 days). The primary efficacy endpoint for this trial was bacteriologic eradication of the baseline organism(s) with no new infection or superinfection at 5 to 11 days post-therapy (test-of-cure or TOC) for the Per Protocol and Modified Intent-To-Treat (MITT) populations.

The Per Protocol population was defined as patients with a diagnosis of cUTI or AUP, a causative organism(s) at baseline present at ≥15 CFU/mL, no inclusion criteria violation, a valid test-of-cure urine culture within the TOC window, an organism susceptible to study drug, no premature discontinuation or loss to follow-up, and compliance with the dosage regimen (among other criteria). More patients in the CIPRO XR arm than in the control arm were excluded from the Per Protocol population and this should be considered in the interpretation of the study results. Reasons for exclusion with the greatest discrepancy between the two arms were no valid test-of-cure urine culture, an organism resistant to the study drug, and premature discontinuation due to adverse events.

An analysis of all patients with a causative organism(s) isolated at baseline and who received study medication, defined as the MITT population, included 342 patients in the CIPRO XR arm and 324 patients in the control arm. Patients with missing responses were counted as failures in this analysis. In the MITT analysis of cUTI patients, bacteriologic eradication was 16/271 (59%) versus 156/248 (62.9%) in CIPRO XR and control arm, respectively [97.5% CI* (-13.5%, 5.7%)]. Clinical cure was 184/271 (67.9%) for CIPRO XR and 182/248 (73.4%) for control arm, respectively [97.5% CI* (-14.4%, 3.5%)]. Bacterial eradication in the MITT analysis of patients with AUP at TOC was 47/71 (66.2%) and 58/76 (76.3%) for CIPRO XR and control arm, respectively [97.5% CI* (-26.8%, 6.5%)]. Clinical cure at TOC was 5/71 (7.4%) for CIPRO XR and 58/76 (76.3%) for the control arm [97.5% CI* (-22.%, 1.4%)].

* confidence interval of the difference in rates (CIPRO XR minus control).

In the Per Protocol population, the differences between CIPRO XR and the control arm in bacteriologic eradication rates at the TOC visit were not consistent between AUP and cUTI patients. The bacteriologic eradication rate for cUTI patients was higher in the CIPRO XR arm than in the control arm. For AUP patients, the bacteriologic eradication rate was lower in the CIPRO XR arm than in the control arm. This inconsistency was not observed between the two treatment groups for clinical cure rates. Clinical cure rates were 96.1% (198/26) and 92.1% (211/229) for CIPRO XR and the control arm, respectively [difference: 4.% with a two-sided 97.5% CI (-1.3%, 9.4%)].

The bacterial eradication and clinical cure rates by infection type for CIPRO XR and the control arm at the TOC visit and their corresponding 97.5% confidence intervals for the differences between rates (CIPRO XR minus control arm) are given in Table 9 for the Per Protocol population analysis.

CIPRO XR 1 mg QD

CIPRO 5 mg BID

521

521

26

229

CI [-.7%, 16.3%]

CI [-1.1%, 1.8%]

CI [-34.8%, 6.2%]

35/36 (97.2%)

39/4 (97.5%)

5/52 (96.2%)

CI [-15.3%, 21.1%]

2 n/N patients with baseline organism(s) eradicated and no new infections or superinfections/total number of patients

3 n/N patients with specified baseline organism eradicated/patients with specified baseline organism

4 n/N patients with clinical success /total number of patients

Of the 166 cUTI patients treated with CIPRO XR, 148 (89%) had the causative organism(s) eradicated, 8 (5%) had persistence, 5 (3%) patients developed superinfections and 5 (3%) developed new infections. Of the 177 cUTI patients treated in the control arm, 144 (81%) had the causative organism(s) eradicated, 16 (9%) patients had persistence, 3 (2%) developed superinfections and 14 (8%) developed new infections. Of the 4 patients with AUP treated with CIPRO XR, 35 (87.5%) had the causative organism(s) eradicated, 2 (5%) patients had persistence and 3 (7.5%) developed new infections. Of the 5 CIPRO XR AUP patients without eradication at TOC, 4 were considered clinical cures and did not receive alternative antibiotic therapy. Of the 52 patients with AUP treated in the control arm, 51 (98%) had the causative organism(s) eradicated. One patient (2%) had persistence.

CIPRO XR is available as nearly white to slightly yellowish, film-coated, oblong-shaped tablets containing 5 mg or 1 mg ciprofloxacin. The 5 mg tablet is coded with the word “BAYER on one side and “C5 QD on the reverse side. The 1 mg tablet is coded with the word “BAYER on one side and “C1 QD on the reverse side.

Strength NDC Code

Bottles of 5 5 mg 5419-788-1

Bottles of 5 1 mg 5419-789-1

Store at 25°C (77°F) excursions permitted to 15° to 3°C (59° to 86°F) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Serious Adverse Reactions

Advise patients to stop taking CIPRO XR if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug.

Inform patients of the following serious adverse reactions that have been associated with CIPRO XR or other fluoroquinolone use:

Antibacterial Resistance

Inform patients that antibacterial drugs including CIPRO XR, CIPRO Tablets, and CIPRO Oral Suspension should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When CIPRO XR, CIPRO Tablets, and CIPRO Oral Suspension are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by CIPRO XR, CIPRO Tablets, and CIPRO Oral Suspension or other antibacterial drugs in the future.

Administration with Food, Fluids, and Concomitant Medications

Inform patients that CIPRO XR may be taken with or without food.

Inform patients to drink fluids liberally while taking CIPRO XR to avoid formation of a highly concentrated urine and crystal formation in the urine.

Inform patients that antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine should be taken at least two hours before or six hours after CIPRO XR administration. CIPRO XR should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone since absorption of ciprofloxacin may be significantly reduced however, CIPRO XR may be taken with a meal that contains these products

Drug Interactions Oral Antidiabetic Agents

Inform patients that hypoglycemia has been reported when ciprofloxacin and oral antidiabetic agents were co-administered if low blood sugar occurs with CIPRO XR, instruct them to consult their physician and that their antibacterial medicine may need to be changed.

Medication Guide

CIPRO® (Sip-row)

(ciprofloxacin hydrochloride)

Tablets

for oral use

CIPRO® (Sip-row)

(ciprofloxacin hydrochloride)

for oral suspension

CIPRO® XR (Sip-row)

(ciprofloxacin hydrochloride)

Tablets

for oral use

CIPRO® IV (Sip-row)

(ciprofloxacin)

Injection

for intravenous infusion

Read this Medication Guide before you start taking CIPRO and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about CIPRO?

CIPRO, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death.

If you get any of the following serious side effects while you take CIPRO, you should stop taking CIPRO immediately and get medical help right away.

1. Tendon rupture or swelling of the tendon (tendinitis).

What is CIPRO?

CIPRO is a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:

Who should not take CIPRO?

Do not take CIPRO if you:

Ask your healthcare provider if you are not sure.

What should I tell my healthcare provider before taking CIPRO?

Before you take CIPRO, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including preion and over-the-counter medicines, vitamins, and herbal supplements.

Ask your healthcare provider for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take CIPRO?

What should I avoid while taking CIPRO?

What are the possible side effects of CIPRO?

CIPRO may cause serious side effects, including:

Stop taking CIPRO and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to CIPRO (a liver problem). Intestine infection(Pseudomembranous colitis). Pseudomembranous colitis can happen with many antibacterial medicines, including CIPRO. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibacterial medicine.

The most common side effects of CIPRO include:

Tell your healthcare provider about any side effect that bothers you, or that does not go away.

These are not all the possible side effects of CIPRO. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-8-FDA-188.

How should I store CIPRO?

CIPRO Oral Suspension

Keep CIPRO and all medicines out of the reach of children.

General Information about the safe and effective use of CIPRO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CIPRO for a condition for which it is not prescribed. Do not give CIPRO to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about CIPRO. If you would like more information about CIPRO, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CIPRO that is written for healthcare professionals.

For more information call 1-888-842-2937.

What are the ingredients in CIPRO?

CIPRO is a registered trademark of Bayer Aktiengesellschaft.

Rx Only

©1987 Bayer HealthCare Pharmaceuticals Inc.

CIPRO (ciprofloxacin*) 5% and 1% Oral Suspension Manufactured in Italy

CIPRO (ciprofloxacin HCl) Tablets Manufactured in Germany

Cipro XR 5 mg Tablets

NDC 5419-788-1

ONCE DAILYCipro XR(ciprofloxacin extended-release tablets)Rx Only

5 mg5 TABLETS

Manufactured forBayer HealthCare

Bayer HealthCare Pharmaceuticals Inc.Wayne, NJ 747Manufactured in Germany

Cipro XR 1 mg Tablets

NDC 5419-789-1

ONCE DAILYCipro XR(ciprofloxacin extended-release tablets)Rx Only

1 mg5 TABLETS

Manufactured forBayer HealthCare

Bayer HealthCare Pharmaceuticals Inc.Wayne, NJ 747Manufactured in Germany

Revised: 7/216 Bayer HealthCare Pharmaceuticals Inc.

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Site Updated: July 3, 218

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