قرص mobic meloxicam

خواص دارویی و گیاهی

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ملوکسیکام (به انگلیسی: Meloxicam) یک داروی ضدالتهاب غیراستروئیدی (NSAID) است. این دارو به صورت قرص‌های ۷٫۵ و ۱۵ میلی گرمی ارائه می‌شود. اثر این دارو ۳۰ تا ۶۰ دقیقه پس از مصرف آغاز می‌شود.

ملوکسیکام در درمان علائم بیماری‌های روماتیسم، پوکی استخوان، اسپوندیلیت انکیلوزان مورد استفاده قرار می‌گیرد.

ملوکسیکام از طریق مهار تولید ترکیبات شیمیایی که موجب درد و التهاب بدن می‌شوند عمل می‌کند. التهاب به علل مختلفی می‌تواند در مفصل، تاندون، عضله یا بافت‌های دیگر بدن بوجود آمده و موجب تورم و درد می‌شود. ملوکسیکام مانند دیگر داروهای ضد التهابی غیر استروئیدی آنزیم سیکلواکسیژناز cyclooxygenase را مهار کرده و مانع فعالیت آن می‌شود. این آنزیم مسئول ساخت پروستاگلاندین‌ها prostaglandins هستند و پروستاگلاندین‌ها مواد شیمیایی در بدن هستند که موجب التهاب مشوند. داروهای ضد التهابی غیر استروئیدی از جمله ملوکسیکام با مهار این آنزیم موجب کاهش التهاب و علائم ناشی از آن مثل درد می‌شوند.

مقدار مصرف ملوکسیکام معمولاً یک قرص ۷٫۵ میلیگرمی در روز است ولی تحت نظر پزشک می‌توان استفاده از آن را تا ۱۵ میلیگرم در روز هم رساند. این دارو را می‌توان در دمای اتاق و هوای خشک نگهداری کرد.

ملوکسیکام می‌تواند با داروهای کاپتوپریل و لازیکس (فورزماید) تداخل اثر کرده و با کاهش اثر آن‌ها موجب افزایش فشار خون شود. بیماران مبتلا به آسم یا دارای حساسیت به آسپرین یا دیگر داروهای ضد التهابی غیر استروئیدی نباید از این دارو استفاده کنند. خطر مرگ و همچنین مصرف همزمان ملوکسیکام با داروهای رقیق‌کننده خون مانند وارفارین باید با احتیاط و با نظر پزشک باشد. از مصرف ملوکسیکام در سه‌ماهه اول و دوم بارداری باید اجتناب کرد.
توجه : قبل از تجویز ملوکسیکام در صورتی که هرگونه داروی مسکن و آنتی هیستامین مصرف می‌کنید به پزشک خود اطلاع دهید.ملوکسیکام با داروهایی مانند آسپرین، ایبوپروفن، ناپروکسن و داروهای مشابه تداخل شدید دارد.

http://shahredaru.com/fa/node/110

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کربن عنصری شیمیائی در جدول تناوبی با نشان C و عدد اتمی ۶ است. عنصری غیر فلزی و فراوان، چهارظرفیتی و دارای چندین دگرشکل است. چنین کربنی همسانگرد و مانند شیشه محکم است. لایه‌های گرافیت آن مانند کتاب مرتب نشده‌اند، بلکه مانند کاغذ خرد شده می‌باشند. نوع خالص و متراکم آن الماس و نوع نرم و غیر متراکم آن گرافیت است.

الیاف کربن شبیه کربن شیشه‌ای هستند. تحت مراقبت‌های ویژه‌ای؛ (کشیدن الیاف آلی و کربنی کردن)، می‌توان لایه‌های صاف کربن را در جهت الیاف مرتب کرد. هیچ لایهٔ کربنی در جهت عمود بر محور الیاف قرار نمی‌گیرد. نتیجه الیافی با استحکام بیشتر از فولاد است.
کربن در ساختار بدنی تمامی جانداران وجود داشته و پایهٔ [شیمی آلی] را تشکیل می‌دهد. همچنین این غیر فلز ویژگی جالبی دارد که می‌تواند با خودش و انواع زیادی از عناصر دیگر پیوند برقرار کند؛ (تشکیل دهندهٔ بیش از ده میلیون ترکیب). در صورت ترکیب با اکسیژن تولید دی‌اکسید کربن می‌کند که برای رویش گیاهان، حیاتی است. در صورت ترکیب با هیدروژن ترکیبات مختلفی بنام هیدرو کربن‌ها را به‌وجود می‌آورد که به شکل سوخت‌های فسیلی، در صنعت بسیار بنیادی هستند. وقتی هم با اکسیژن و هم با هیدروژن ترکیب گردد، گروه زیادی از ترکیبات را از جمله اسیدهای چرب را می‌سازد که برای حیات و استر، که طعم دهنده بسیاری از میوه‌ها است، ضروری است. ایزوتوپ C-۱۴ به‌طور متداول در تاریخ‌گذاری رادیوکربن کاربرد دارد.

دوده چراغ از سطوح کوچک گرافیت تشکیل شده. این سطوح به صورت تصادفی توزیع شده، به همین دلیل کل ساختمان آن همسانگرد (ایزوتروپ) است.

کربن به عنوان یک ماده الکتریکی شناخته می‌شود. کربن می‌تواند به شکل‌های مختلفی باشد: یک رسانای خوب به شکل گرافیت، یک‌نیمه‌رسانای خیلی سخت با فاصله زیاد به شکل الماس، یک ابر رسانا هنگامی که با یک جزء مناسب مخلوط شود. به علاوه؛ مواد الکتریکی بر پایه کربن نمونه‌هایی از مواد را عرضه می‌کنند که مجموعهٔ به هم پیوسته‌ای از ابعاد را نشان می‌دهند از فلورن‌ها که نقاط ذره‌ای صفر بعدی هستند، تا نانولوله‌های کربنی که لوله‌های کوانتومی ۱ بعدی هستند، تا گرافیت که ماده غیر همسان لایه‌ای ۲ بعدی است و سرانجام تا الماس، یک‌نیمه‌رسانا با فاصلهٔ عریض ۳ بعدی.[۹]

قرص mobic meloxicam

کربن به دلایل زیادی قابل توجه‌است. اشکال مختلف آن شامل یکی از نرم‌ترین (گرافیت) و یکی از سخت‌ترین (الماس) مواد شناخته شده توسط انسان است. افزون بر این، کربن میل زیادی به پیوند با اتمهای کوچک دیگر از جمله اتمهای دیگر کربن، داشته و اندازهٔ بسیار کوچک آن امکان پیوندهای متعدد را به‌وجود می‌آورد. این خصوصیات باعث شکل‌گیری ده میلیون ترکیبات کربنی شده‌است. ترکیبات کربن زیر بنای حیات را در زمین می‌سازند و چرخهٔ کربن – نیتروژن قسمتی از انرژی تولید شده توسط خورشید و ستارگان دیگر را تأمین می‌کند.

کربن در اثر مهبانگ (انفجار بزرگ آغازین) حاصل نشده، چون این عنصر برای تولید نیاز به یک برخورد سه مرحله‌ای ذرات آلفا (هسته اتم هلیم) دارد. جهان در ابتدا گسترش یافت و چنان به سرعت سرد شد که امکان تولید آن غیرممکن بود. به هر حال، کربن درون ستارگانی که در رده افقی نمودار H-R قرار دارند، یعنی جایی که ستارگان هسته هلیم را با فرایند سه‌گانه آلفا به کربن تبدیل می‌کنند، تولید شد.

کربن بخش بسیار مهمی در تمامی موجودات زنده‌است و تا آنجا که می‌دانیم بدون این عنصر زندگی وجود نخواهد داشت (به برتر پنداری کربن مراجعه کنید). عمده‌ترین کاربرد اقتصادی کربن، فرم هیدروکربنها می‌باشد که قابل توجه‌ترین آن‌ها سوختهای فسیلی، گاز متان و نفت خام است. نفت خام در صنعت پتروشیمی برای تولید محصولات زیادی از جمله مهم‌ترین آن‌ها بنزین، گازوئیل و نفت سفید بکار می‌رود که از طریق فرایند تقطیر در پالایشگاه‌ها بدست می‌آیند. از نفت خام مواد اولیه بسیاری از مواد مصنوعی، که بسیاری از آن‌ها در مجموع پلاستیک نامیده می‌شوند، شکل می‌گیرد.

کربن در میله کنترل در واکنشگاه‌های اتمی بکار می‌رود.

خصوصیات ساختمانی و شیمیایی فولرن به شکل ریزتیوب کربن، کاربردهای بالقوه امیدوارکننده‌ای در رشته در حال شکل‌گیری نانوتکنولوژی دارد.

کربن (واژه لاتین carbo به معنی زغال چوب) در دوران پیشاتاریخ کشف شد و برای مردم باستان که آن را از سوختن مواد آلی در اکسیژن ضعیف تولید می‌کردند، آشنا بود. (تولید زغال چوب). مدت طولانی است که الماس به‌عنوان ماده‌ای زیبا و کمیاب به حساب می‌آید. فولرن، آخرین آلوتروپ شناخته شده کربن در دهه ۸۰ به‌عنوان محصولات جانبی آزمایش‌های پرتو مولکولی کشف شدند.

تاکنون چهار شکل گوناگون از کربن شناخته شده‌است: غیر متبلور، گرافیت، الماس و فولرن.

کربن در نوع غیر بلورین آن اساساً گرافیت است اما به صورت ساختارهای بزرگ بلورین وجود ندارد. این شکل کربن، بیشتر به صورت پودر است که بخش اصلی موادی مثل زغال چوب و سیاهی چراغ (دوده) را تشکیل می‌دهد.
در فشار و دمای اتاق کربن به شکل گرافیت پایدارتر است که در آن هر اتم با سه اتم دیگر به صورت حلقه‌های شش وجهی- درست مثل هیدروکربن‌های معطر – به هم متصل شده‌اند. هردو گونه شناخته شده از گرافیت، آلفا (شش ضلعی) و بتا (منشور شش وجهی که سطوح آن لوزی است) خصوصیات فیزیکی همانند دارند تنها تفاوت آن‌ها در ساختار بلوری آن‌ها است. گرافیت‌های طبیعی شامل بیش از ۳۰٪ نوع بتا هستند در حالی‌که گرافیت‌های مصنوعی تنها حاوی نوع آلفا می‌باشند. نوع آلفا از طریق فرآوری مکانیکی می‌تواند به بتا تبدیل شود و نوع بتا نیز بر اثر دمای بالای ۱۰۰۰ درجه سانتیگراد دوباره به صورت آلفا بر می‌گردد.

گرافیت به سبب پراکندگی ابر pi هادی الکتریسیته است. این ماده نرم بوده و ورقه‌های آن که اغلب به‌وسیله اتم‌های دیگر تفکیک شده‌اند، تنها به‌وسیلهٔ نیروهای وان در والس به هم چسبیده‌اند به گونه‌ای که به راحتی یکدیگر را کنار می‌زنند.

در دما و فشارهای خیلی بالا کربن به صورت الماس پایدار است که در آن هر اتم با چهار اتم دیگر پیوند دارد. الماس ساختار مکعبی همانند سیلسیم و ژرمانیم دارد و (به سبب نیروی پیوندهای کربن – کربن) با نیترید بور هم‌الکترون(BN) در کنار هم بوده و سخت‌ترین جسم از نظر مقاومت در برابر سایش به‌شمار می‌رود. تبدیل الماس به گرافیت در حرارت اتاق به اندازه‌ای کند است که محسوس نیست. در برخی شرایط کربن به شکل لونسدالیت (lonsdalite) متبلور می‌شود که مشابه الماس ولی شش ضلعی است.
فولرین ساختاری مثل گرافیت دارد اما به‌جای بخش‌های تماماً شش ضلعی، حاوی پنج ضلعی‌ها (یا احتمالاً هفت ضلعی‌های) اتم‌های کربن نیز می‌باشند که ورقه را به‌شکل کره، بیضی یا استوانه به‌وجود می‌آورند. ویژگی‌هایی از فولرین با نام فولرین باکمینستر (buckminsterfullerene) هم نامیده می‌شوند هنوز به خوبی بررسی نشده‌اند. اینگونه ساختار را به گونهٔ کوتاه شده، گلوله‌های باکی (buckyballs) هم نامیده‌اند. کل نامگان فولرین برگرفته از نام باکمینستر فولر (Buckminster Fuller)، توسعه دهندهٔ گنبد میله‌ای است که از ساختار گلوله‌های باکی تقلید کرد.

تقریباً ده میلیون ترکیبات کربنی که برای دانش شناخته شده‌اند وجود دارد که هزاران نوع آن‌ها در فرایندهای حیاتی و واکنش‌های آلی بسیار مهم اقتصادی، ضروری هستند. این عنصر به مقدار فراوان در خورشید، ستارگان، دنباله دارها و نیز در جو بیشتر سیارات یافت می‌شود. بعضی از شهابسنگها حاوی الماس‌های میکروسکپی هستند که در زمانیکه منظومه شمسی هنوز یک دیسک گازی شکل بود شکل گرفته‌اند. کربن به صورت ترکیب با سایر عناصر در جو زمین وجود دارد و در همه گونه آب حل می‌شود. کربن به همراه مقادیر کمتر کلسیم، منیزیم و آهن، عنصر اصلی سازنده جرم زیادی از سنگ کربنات (سنگ آهک، دولمیت، سنگ مرمر و…) است. این عنصر در صورت ترکیب با هیدروژن تولید زغال سنگ، نفت خام و گاز طبیعی می‌کند که آن‌ها را هیدرو کربن می‌نامند.
گرافیت به مقدار فراوان در نیویورک و تکزاس، آمریکا، روسیه، مکزیک، گرینلند و هند یافت می‌شود.
الماس طبیعی در کیمبرلیت معدنی موجود درچینه‌ها یا ستون‌های سنگ‌های آذرین یافت می‌شوند. بیشترین الماس در آفریقا به ویژه آفریقای جنوبی، نامیبیا، بوتسوانا، جمهوری کنگو و سیرالئون وجود دارد. همچنین کانادا، قسمت‌های قطبی روسیه، برزیل و بخش‌های غربی و شرقی استرالیا دارای الماس می‌باشد.

(به شیمی آلی هم مراجعه کنید)

معروف‌ترین اکسید کربن، دی‌اکسید کربن (CO2) است که به مقدار کمتری در اتمسفر زمین وجود دارد. این اکسید توسط موجودات زنده، و برخی موارد دیگر تولید شده و مورد استفاده قرار می‌گیرد. آب مقدار کمی اسید کربنیک تولید می‌کند اما دی‌اکسید کربن مانند بیشتر ترکیباتی که دارای پیوندهای ساده چندگانه با اکسیژن‌های روی یک کربن هستند، ناپایدار است. به هر حال، از طریق این واسطه، یونهای کربنات با تشدید تثبیت شده، به‌وجود می‌آیند. تعدادی از مواد معدنی مهم، کربنات‌ها هستند که معروف‌ترین آن‌ها کلسیت است. دی سولفید کربن، (۲ CS)، هم مانند آن است.

اکسیدهای دیگر آن، مونوکسید کربن (CO) و زیراکسید (suboxide) نادر C3O۲ هستند. مونوکسید کربن که گازی بی‌رنگ و بی‌بو است به‌وسیله اکسیده شدن ناقص به‌وجود می‌آید. هر یک از این مولکول‌ها دارای یک پیوند سه‌گانه و نسبتاً قطبی هستند که ناشی از تمایل به یک پیوند دائمی با مولکول‌های هموگلوبین می‌باشد به‌طوری‌که این گاز بسیار سمی است. سیانید (CN-) دارای ساختار و رفتاری بسیار شبیه به یون هالید بوده و نیترید سیانوژن (CN2) نیز به آن مربوط است.

کربن با فلزات قوی، کاربید C-، یا استیلید C22-؛ به‌وجود می‌آورد که با متان و استیلن همراه بوده و هر دوی آن‌ها اسیدهای به‌طور باور نکردنی پائتیک اسید هستند. در کل، کربن با الکترو نگاتیوی ۵/۲ به تشکیل پیوندهای کووالانسی تمایل دارد. تعداد کمی از کاربیدها مثل کربوراندوم و Sic، که شبیه الماس می‌باشند، به صورت شبکه‌های کووالانسی هستند.

در ساختار اتمی هیدروکربن‌ها، گروهی از اتم‌های کربن (اشباع شده با اتم‌های هیدروژن) تشکیل یک زنجیره می‌دهند. روغن‌های فرار زنجیره‌های کوچک‌تری دارند. چربی‌ها دارای زنجیره‌های بلندتر و پارافین‌ها زنجیره‌هایی بی‌اندازه بلند دارند.

فرایند مداوم ترکیب و آزادسازی کربن و اکسیژن که در آن انرژی و حرارت ذخیره و دفع می‌شود را چرخه کربن می‌گویند. فروگشت (کاتابولیسم) + فراگشت (آنابولیسم) = دگرگشت (متابولیسم). (واژه‌ها از فرهنگستان زبان و ادب فارسی). به چرخه کربن مراجعه کنید

اتحادیه بین‌المللی شیمی کاربردی و محض در سال ۱۹۶۱ ایزوتوپ کربن- ۱۲ را برای اوزان اتمی اتخاذ کرد. کربن- ۱۴ رادیوایزوتوپی است با نیمه عمر ۵۷۱۵ سال و برای تاریخ یابی رادیو کربن چوب، نقاط باستان‌شناسی و نمونه‌ها کاربرد بسیار زیادی دارد.
کربن دارای دو ایزوتوپ پایدار طبیعی می‌باشد: (C-۱۲(۹۸٫۸۹٪ و C-۱۳(۱٫۱۱٪). نسبت این ایزوتوپ‌ها در؟ به نسبت الگوی VPDB (Vienna Pee Dee Belemnite from the Peedee Formation of South Carolina).
d C-۱۳ در اتمسفر ۷ -؟ است است. هنگام فتوسنتز، کربنی که در بافت گیاه تثبیت می‌شود، به‌طور قابل ملاحظه‌ای به C-۱۳ موجود در جو بستگی دارد.

دو حالت برای توزیع مقادیر dC-۱۳ در گیاهان خشکی وجود دارد که ناشی از تفاوت‌هایی است که گیاهان در واکنش‌های فتوسنتز بکار می‌برند. بیشتر گیاهان خشکی، گیاهان مسیر C۳ هستند و دارای ارزش‌های dC-۱۳ بوده که بین ۲۴- و ۳۴- قرار دارند(؟). دومین گروه از گیاهان (گیاهان مسیر C۴) می‌باشند که ترکیبی از گیاهان آبی، صحرایی، شوراب زار و مرغزارهای استوایی هستند، و دارای ارزش‌های dC-۱۳ بین ۶- و ۱۹- می‌باشند. یک گروه واسطه (گیاهان کم)، متشکل از جلبک و گلسنگ، دارای ارزش‌های dC-۱۳ می‌باشد که بین ۱۲- و ۲۳-؟ هستند. dC-۱۳ گیاهان و موجودات زنده داده‌های سودمندی دربارهٔ مواد مغذی و ارتباطات شبکه غذایی ارائه می‌کند.

ترکیبات کربن گستره وسیعی از آثار سمی دارند. مونوکسید کربن (C O) موجود در اگزوز موتورهای درون‌سوز و سیانید (CN) که گاهی اوقات در آلودگی‌های معدنی وجود دارد برای پستانداران بسیار سمی هستند. بسیاری از ترکیبات دیگر کربن نه تنها سمی نیستند بلکه در واقع برای زیست ضروری می‌باشند. گازهای آلی مثل اتیلن (H2C=CH2) و اتان و (HCCH)، و متان (CH4) در صورت مخلوط شدن با هوا قابلیت انفجار و اشتعال خطرناکی پیدا می‌کنند.

۱_کربن به دلیل ۴ ظرفیت که دارد می‌تواند چهار پیوند کوالانسی دهد.

۲_کربن می‌تواند با تمام عناصر پیوند دهد

۳_می‌تواند هم پیوند یگانه هم دوگانه هم سه‌گانه دهد

Benutzername

Passwort

Angemeldet bleiben

Technisches Hilfswerk Bad Staffelstein: Inhaltsübersicht unseres Online-Auftritts

oben

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the symptoms of arthritis, primary dysmenorrhea, fever; and as an analgesic, especially where there is an inflammatory component. It is closely related to piroxicam. In Europe it is marketed under the brand names Movalis, Melox, and Recoxa. In North America it is generally marketed under the brand name Mobic. In Latin America, the drug is marketed as Tenaron.

A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

قرص mobic meloxicam

For symptomatic treatment of arthritis and osteoarthritis.

Meloxicam is an nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. Prostaglandins are substances that contribute to inflammation of joints. Meloxicam inhibits prostaglandin synthetase (cylooxygenase 1 and 2) and leads to a decrease of the synthesis of prostaglandins, therefore, inflammation is reduced.

Anti-inflammatory effects of meloxicam are believed to be due to inhibition of prostaglandin synthetase (cylooxygenase), leading to the inhibition of prostaglandin synthesis. As prostaglandins sensitize pain receptors, inhibition of their synthesis may be associated with the analgesic and antipyretic effects of meloxicam.

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

Absolute bioavailability = 89%

99.4% bound, primarily to albumin

Meloxicam is almost completely metabolized into inactive metabolites by the cytochrome P450 (CYP450) isozymes. CYP2C9 is primarily responsible for metabolism of meloxicam while CYP3A4 plays a minor role. An intermediate metabolite, 5′-hydroxymethyl meloxicam, is further metabolized to 5′-carboxy meloxicam, the major metabolite. Peroxidase activity is thought to produce the two other inactive metabolites of meloxicam.

Meloxicam is almost completely metabolized to four pharmacologically inactive metabolites. Meloxicam excretion is predominantly in the form of metabolites, and occurs to equal extents in the urine and feces. Only traces of the unchanged parent compound are excreted in the urine (0.2%) and feces (1.6%). The extent of the urinary excretion was confirmed for unlabeled multiple 7.5 mg doses: 0.5%, 6% and 13% of the dose were found in urine in the form of meloxicam, and the 5′-hydroxymethyl and 5′-carboxy metabolites, respectively.

15-20 hours

LD50, Acute: 84 mg/kg (Rat); Oral 470 mg/kg (Mouse); Oral 320 mg/kg (Rabbit)

Extended description of the mechanism of action and particular properties of each drug interaction.

A severity rating for each drug interaction, from minor to major.

A rating for the strength of the evidence supporting each drug interaction.

An effect category for each drug interaction. Know how this interaction affects the subject drug.

Laura Coppi, “Crystalline forms of meloxicam and processes for their preparation and interconversion.” U.S. Patent US20030109701, issued June 12, 2003.

The date on which a patent was filed with the relevant government.

There is additional data available for commercial users including Adverse Effects, Contraindications, and Blackbox Warnings. Contact us to learn more about these and other features.

Drug created on June 13, 2005 07:24 / Updated on August 21, 2019 22:17

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قرص mobic meloxicam

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Cardiovascular Thrombotic Events

Gastrointestinal Bleeding, Ulceration, and Perforation

قرص mobic meloxicam

MOBIC is a non-steroidal anti-inflammatory drug indicated for:

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (2.1)

To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906 TTY or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 10/2018

MOBIC is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].

MOBIC is indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].

MOBIC is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2)].

Carefully consider the potential benefits and risks of MOBIC and other treatment options before deciding to use MOBIC. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].

After observing the response to initial therapy with MOBIC, adjust the dose to suit an individual patient’s needs.

In adults, the maximum recommended daily oral dose of MOBIC is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

MOBIC may be taken without regard to timing of meals.

For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of MOBIC is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of MOBIC is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of MOBIC is 7.5 mg once daily in children who weigh ≥60 kg. There was no additional benefit demonstrated by increasing the dose above 7.5 mg in clinical trials.

MOBIC tablets should not be used in children who weigh <60 kg.

The use of MOBIC in subjects with severe renal impairment is not recommended.

In patients on hemodialysis, the maximum dosage of MOBIC is 7.5 mg per day [see Clinical Pharmacology (12.3)].

MOBIC Tablets have not shown equivalent systemic exposure to other approved formulations of oral meloxicam. Therefore, MOBIC Tablets are not interchangeable with other formulations of oral meloxicam product even if the total milligram strength is the same. Do not substitute similar dose strengths of MOBIC Tablets with other formulations of oral meloxicam product.

MOBIC (meloxicam) Tablets:

MOBIC is contraindicated in the following patients:

قرص mobic meloxicam

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as meloxicam, increases the risk of serious gastrointestinal (GI) events [see Warnings and Precautions (5.2)].

Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG [see Contraindications (4)].

Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.

Avoid the use of MOBIC in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If MOBIC is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

NSAIDs, including meloxicam, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. However, even short-term NSAID therapy is not without risk.

Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10‑fold increased risk for developing a GI bleed compared to patients without these risk factors. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status. Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients. Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.

Strategies to Minimize the GI Risks in NSAID-treated patients:

Elevations of ALT or AST (three or more times the upper limit of normal [ULN]) have been reported in approximately 1% of NSAID-treated patients in clinical trials. In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported.

Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs including meloxicam.

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue MOBIC immediately, and perform a clinical evaluation of the patient [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

NSAIDs, including MOBIC, can lead to new onset or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs [see Drug Interactions (7)].

Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy.

The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.

Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of meloxicam may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]) [see Drug Interactions (7)].

Avoid the use of MOBIC in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If MOBIC is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

Renal Toxicity

Long-term administration of NSAIDs, including MOBIC, has resulted in renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury.

Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors or ARBs, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

The renal effects of MOBIC may hasten the progression of renal dysfunction in patients with preexisting renal disease. Because some MOBIC metabolites are excreted by the kidney, monitor patients for signs of worsening renal function.

Correct volume status in dehydrated or hypovolemic patients prior to initiating MOBIC. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia during use of MOBIC [see Drug Interactions (7)].

No information is available from controlled clinical studies regarding the use of MOBIC in patients with advanced renal disease. Avoid the use of MOBIC in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function. If MOBIC is used in patients with advanced renal disease, monitor patients for signs of worsening renal function [see Clinical Pharmacology (12.3)].

Hyperkalemia

Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state.

Meloxicam has been associated with anaphylactic reactions in patients with and without known hypersensitivity to meloxicam and in patients with aspirin-sensitive asthma [see Contraindications (4) and Warnings and Precautions (5.8)].

Seek emergency help if an anaphylactic reaction occurs.

A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, MOBIC is contraindicated in patients with this form of aspirin sensitivity [see Contraindications (4)]. When MOBIC is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.

NSAIDs, including meloxicam, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of MOBIC at the first appearance of skin rash or any other sign of hypersensitivity. MOBIC is contraindicated in patients with previous serious skin reactions to NSAIDs [see Contraindications (4)].

Meloxicam may cause premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including MOBIC, in pregnant women starting at 30 weeks of gestation (third trimester) [see Use in Specific Populations (8.1)].

Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. If a patient treated with MOBIC has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.

NSAIDs, including MOBIC, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients for signs of bleeding [see Drug Interactions (7)].

The pharmacological activity of MOBIC in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically [see Warnings and Precautions (5.2, 5.3, 5.6)].

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Because clinical trials are conducted under widely varying 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.

Adults

Osteoarthritis and Rheumatoid Arthritis

The MOBIC Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with MOBIC 7.5 mg/day, 3505 OA patients and 1351 RA patients treated with MOBIC 15 mg/day. MOBIC at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year. Approximately 10,500 of these patients were treated in ten placebo- and/or active-controlled osteoarthritis trials and 2363 of these patients were treated in ten placebo- and/or active-controlled rheumatoid arthritis trials. Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across MOBIC trials.

A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of MOBIC with placebo and with an active control. Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of MOBIC with placebo.

Table 1a depicts adverse events that occurred in ≥2% of the MOBIC treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial.

Table 1b depicts adverse events that occurred in ≥2% of the MOBIC treatment groups in two 12-week placebo-controlled rheumatoid arthritis trials.

The adverse events that occurred with MOBIC in ≥2% of patients treated short-term (4 to 6 weeks) and long-term (6 months) in active-controlled osteoarthritis trials are presented in Table 2.

Higher doses of MOBIC (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore, the daily dose of MOBIC should not exceed 15 mg.

Pediatrics

Pauciarticular and Polyarticular Course Juvenile Rheumatoid Arthritis (JRA)

Three hundred and eighty-seven patients with pauciarticular and polyarticular course JRA were exposed to MOBIC with doses ranging from 0.125 to 0.375 mg/kg per day in three clinical trials. These studies consisted of two 12-week multicenter, double-blind, randomized trials (one with a 12-week open-label extension and one with a 40-week extension) and one 1-year open-label PK study. The adverse events observed in these pediatric studies with MOBIC were similar in nature to the adult clinical trial experience, although there were differences in frequency. In particular, the following most common adverse events, abdominal pain, vomiting, diarrhea, headache, and pyrexia, were more common in the pediatric than in the adult trials. Rash was reported in seven (<2%) patients receiving MOBIC. No unexpected adverse events were identified during the course of the trials. The adverse events did not demonstrate an age or gender-specific subgroup effect.

The following is a list of adverse drug reactions occurring in <2% of patients receiving MOBIC in clinical trials involving approximately 16,200 patients.

The following adverse reactions have been identified during post approval use of MOBIC. 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. Decisions about whether to include an adverse event from spontaneous reports in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug. Adverse reactions reported in worldwide post marketing experience or the literature include: acute urinary retention; agranulocytosis; alterations in mood (such as mood elevation); anaphylactoid reactions including shock; erythema multiforme; exfoliative dermatitis; interstitial nephritis; jaundice; liver failure; Stevens-Johnson syndrome; toxic epidermal necrolysis, and infertility female.

See Table 3 for clinically significant drug interactions with meloxicam. See also Warnings and Precautions (5.2, 5.6, 5.11) and Clinical Pharmacology (12.3).

Risk Summary

Use of NSAIDs, including MOBIC, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including MOBIC, in pregnant women starting at 30 weeks of gestation (third trimester) [see Warnings and Precautions (5.10)].

There are no adequate and well-controlled studies of MOBIC in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss.

In animal reproduction studies, embryofetal death was observed in rats and rabbits treated during the period of organogenesis with meloxicam at oral doses equivalent to 0.65- and 6.5-times the maximum recommended human dose (MRHD) of MOBIC. Increased incidence of septal heart defects were observed in rabbits treated throughout embryogenesis with meloxicam at an oral dose equivalent to 78-times the MRHD. In pre- and post-natal reproduction studies, there was an increased incidence of dystocia, delayed parturition, and decreased offspring survival at 0.08-times MRHD of meloxicam. No teratogenic effects were observed in rats and rabbits treated with meloxicam during organogenesis at an oral dose equivalent to 2.6 and 26-times the MRHD [see Data].

Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors, such as meloxicam, resulted in increased pre- and post-implantation loss.

Clinical Considerations

Labor or Delivery

There are no studies on the effects of MOBIC during labor or delivery. In animal studies, NSAIDs, including meloxicam, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

Data

Animal Data

Meloxicam was not teratogenic when administered to pregnant rats during fetal organogenesis at oral doses up to 4 mg/kg/day (2.6-fold greater than the MRHD of 15 mg of MOBIC based on BSA comparison). Administration of meloxicam to pregnant rabbits throughout embryogenesis produced an increased incidence of septal defects of the heart at an oral dose of 60 mg/kg/day (78-fold greater than the MRHD based on BSA comparison). The no effect level was 20 mg/kg/day (26-fold greater than the MRHD based on BSA conversion). In rats and rabbits, embryolethality occurred at oral meloxicam doses of 1 mg/kg/day and 5 mg/kg/day, respectively (0.65- and 6.5-fold greater, respectively, than the MRHD based on BSA comparison) when administered throughout organogenesis.

Oral administration of meloxicam to pregnant rats during late gestation through lactation increased the incidence of dystocia, delayed parturition, and decreased offspring survival at meloxicam doses of 0.125 mg/kg/day or greater (0.08-times MRHD based on BSA comparison).

Risk Summary

There are no human data available on whether meloxicam is present in human milk, or on the effects on breastfed infants, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MOBIC and any potential adverse effects on the breastfed infant from the MOBIC or from the underlying maternal condition.

Data

Animal Data

Meloxicam was present in the milk of lactating rats at concentrations higher than those in plasma.

Infertility

Females

Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including MOBIC, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation. Consider withdrawal of NSAIDs, including MOBIC, in women who have difficulties conceiving or who are undergoing investigation of infertility.

The safety and effectiveness of meloxicam in pediatric JRA patients from 2 to 17 years of age has been evaluated in three clinical trials [see Dosage and Administration (2.3), Adverse Reactions (6.1) and Clinical Studies (14.2)].

Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see Warnings and Precautions (5.1, 5.2, 5.3, 5.6, 5.13)].

No dose adjustment is necessary in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment have not been adequately studied. Since meloxicam is significantly metabolized in the liver and hepatotoxicity may occur, use meloxicam with caution in patients with hepatic impairment [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

No dose adjustment is necessary in patients with mild to moderate renal impairment. Patients with severe renal impairment have not been studied. The use of MOBIC in subjects with severe renal impairment is not recommended. In patients on hemodialysis, meloxicam should not exceed 7.5 mg per day. Meloxicam is not dialyzable [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)].

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see Warnings and Precautions (5.1, 5.2, 5.4, 5.6)].

Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

There is limited experience with meloxicam overdosage. Cholestyramine is known to accelerate the clearance of meloxicam. Accelerated removal of meloxicam by 4 g oral doses of cholestyramine given three times a day was demonstrated in a clinical trial. Administration of cholestyramine may be useful following an overdosage.

For additional information about overdosage treatment, call a poison control center (1-800-222-1222).

MOBIC (meloxicam) is a nonsteroidal anti-inflammatory drug (NSAID). Each pastel yellow MOBIC tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5‑methyl‑2‑thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula:

Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2.

MOBIC is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam.

The inactive ingredients in MOBIC tablets include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium citrate dihydrate.

Meloxicam has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of MOBIC, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Meloxicam is a potent inhibitor of prostaglandin synthesis in vitro. Meloxicam concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because meloxicam is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Absorption

The absolute bioavailability of meloxicam capsules was 89% following a single oral dose of 30 mg compared with 30 mg IV bolus injection. Following single intravenous doses, dose-proportional pharmacokinetics were shown in the range of 5 mg to 60 mg. After multiple oral doses the pharmacokinetics of meloxicam capsules were dose-proportional over the range of 7.5 mg to 15 mg. Mean Cmax was achieved within four to five hours after a 7.5 mg meloxicam tablet was taken under fasted conditions, indicating a prolonged drug absorption. With multiple dosing, steady-state concentrations were reached by Day 5. A second meloxicam concentration peak occurs around 12 to 14 hours post-dose suggesting biliary recycling.

Meloxicam oral suspension doses of 7.5 mg/5 mL and 15 mg/10 mL have been found to be bioequivalent to meloxicam 7.5 mg and 15 mg capsules, respectively. Meloxicam capsules have been shown to be bioequivalent to MOBIC tablets.

Food and Antacid Effects

Administration of meloxicam capsules following a high fat breakfast (75 g of fat) resulted in mean peak drug levels (i.e., Cmax) being increased by approximately 22% while the extent of absorption (AUC) was unchanged. The time to maximum concentration (Tmax) was achieved between 5 and 6 hours. In comparison, neither the AUC nor the Cmax values for meloxicam suspension were affected following a similar high fat meal, while mean Tmax values were increased to approximately 7 hours. No pharmacokinetic interaction was detected with concomitant administration of antacids. Based on these results, MOBIC can be administered without regard to timing of meals or concomitant administration of antacids.

Distribution

The mean volume of distribution (Vss) of meloxicam is approximately 10 L. Meloxicam is ~99.4% bound to human plasma proteins (primarily albumin) within the therapeutic dose range. The fraction of protein binding is independent of drug concentration, over the clinically relevant concentration range, but decreases to ~99% in patients with renal disease. Meloxicam penetration into human red blood cells, after oral dosing, is less than 10%. Following a radiolabeled dose, over 90% of the radioactivity detected in the plasma was present as unchanged meloxicam.

Meloxicam concentrations in synovial fluid, after a single oral dose, range from 40% to 50% of those in plasma. The free fraction in synovial fluid is 2.5 times higher than in plasma, due to the lower albumin content in synovial fluid as compared to plasma. The significance of this penetration is unknown.

Elimination

Metabolism

Meloxicam is extensively metabolized in the liver. Meloxicam metabolites include 5′-carboxy meloxicam (60% of dose), from P-450 mediated metabolism formed by oxidation of an intermediate metabolite 5’‑hydroxymethyl meloxicam which is also excreted to a lesser extent (9% of dose). In vitro studies indicate that CYP2C9 (cytochrome P450 metabolizing enzyme) plays an important role in this metabolic pathway with a minor contribution of the CYP3A4 isozyme. Patients’ peroxidase activity is probably responsible for the other two metabolites which account for 16% and 4% of the administered dose, respectively. All the four metabolites are not known to have any in vivo pharmacological activity.

Excretion

Meloxicam excretion is predominantly in the form of metabolites, and occurs to equal extents in the urine and feces. Only traces of the unchanged parent compound are excreted in the urine (0.2%) and feces (1.6%). The extent of the urinary excretion was confirmed for unlabeled multiple 7.5 mg doses: 0.5%, 6%, and 13% of the dose were found in urine in the form of meloxicam, and the 5’‑hydroxymethyl and 5’‑carboxy metabolites, respectively. There is significant biliary and/or enteral secretion of the drug. This was demonstrated when oral administration of cholestyramine following a single IV dose of meloxicam decreased the AUC of meloxicam by 50%.

The mean elimination half-life (t1/2) ranges from 15 hours to 20 hours. The elimination half-life is constant across dose levels indicating linear metabolism within the therapeutic dose range. Plasma clearance ranges from 7 to 9 mL/min.

Specific Populations

Pediatric

After single (0.25 mg/kg) dose administration and after achieving steady state (0.375 mg/kg/day), there was a general trend of approximately 30% lower exposure in younger patients (2 to 6 years old) as compared to the older patients (7 to 16 years old). The older patients had meloxicam exposures similar (single dose) or slightly reduced (steady state) to those in the adult patients, when using AUC values normalized to a dose of 0.25 mg/kg [see Dosage and Administration (2.4)]. The meloxicam mean (SD) elimination half-life was 15.2 (10.1) and 13.0 hours (3.0) for the 2 to 6 year old patients, and 7 to 16 year old patients, respectively.

In a covariate analysis, utilizing population pharmacokinetics body-weight, but not age, was the single predictive covariate for differences in the meloxicam apparent oral plasma clearance. The body-weight normalized apparent oral clearance values were adequate predictors of meloxicam exposure in pediatric patients.

The pharmacokinetics of MOBIC in pediatric patients under 2 years of age have not been investigated.

Geriatric

Elderly males (≥65 years of age) exhibited meloxicam plasma concentrations and steady-state pharmacokinetics similar to young males. Elderly females (≥65 years of age) had a 47% higher AUCss and 32% higher Cmax,ss as compared to younger females (≤55 years of age) after body weight normalization. Despite the increased total concentrations in the elderly females, the adverse event profile was comparable for both elderly patient populations. A smaller free fraction was found in elderly female patients in comparison to elderly male patients.

Sex

Young females exhibited slightly lower plasma concentrations relative to young males. After single doses of 7.5 mg MOBIC, the mean elimination half-life was 19.5 hours for the female group as compared to 23.4 hours for the male group. At steady state, the data were similar (17.9 hours vs 21.4 hours). This pharmacokinetic difference due to gender is likely to be of little clinical importance. There was linearity of pharmacokinetics and no appreciable difference in the Cmax or Tmax across genders.

Hepatic Impairment

Following a single 15 mg dose of meloxicam there was no marked difference in plasma concentrations in patients with mild (Child-Pugh Class I) or moderate (Child-Pugh Class II) hepatic impairment compared to healthy volunteers. Protein binding of meloxicam was not affected by hepatic impairment. No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment (Child-Pugh Class III) have not been adequately studied [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)].

Renal Impairment

Meloxicam pharmacokinetics have been investigated in subjects with mild and moderate renal impairment. Total drug plasma concentrations of meloxicam decreased and total clearance of meloxicam increased with the degree of renal impairment while free AUC values were similar in all groups. The higher meloxicam clearance in subjects with renal impairment may be due to increased fraction of unbound meloxicam which is available for hepatic metabolism and subsequent excretion. No dosage adjustment is necessary in patients with mild to moderate renal impairment. Patients with severe renal impairment have not been adequately studied. The use of MOBIC in subjects with severe renal impairment is not recommended [see Dosage and Administration (2.5), Warnings and Precautions (5.6) and Use in Specific Populations (8.7)].

Hemodialysis

Following a single dose of meloxicam, the free Cmax plasma concentrations were higher in patients with renal failure on chronic hemodialysis (1% free fraction) in comparison to healthy volunteers (0.3% free fraction). Hemodialysis did not lower the total drug concentration in plasma; therefore, additional doses are not necessary after hemodialysis. Meloxicam is not dialyzable [see Dosage and Administration (2.1) and Use in Specific Populations (8.7)].

Drug Interaction Studies

Aspirin: When NSAIDs were administered with aspirin, the protein binding of NSAIDs were reduced, although the clearance of free NSAID was not altered. When MOBIC is administered with aspirin (1000 mg three times daily) to healthy volunteers, it tended to increase the AUC (10%) and Cmax (24%) of meloxicam. The clinical significance of this interaction is not known. See Table 3 for clinically significant drug interactions of NSAIDs with aspirin [see Drug Interactions (7)].

Cholestyramine: Pretreatment for four days with cholestyramine significantly increased the clearance of meloxicam by 50%. This resulted in a decrease in t1/2, from 19.2 hours to 12.5 hours, and a 35% reduction in AUC. This suggests the existence of a recirculation pathway for meloxicam in the gastrointestinal tract. The clinical relevance of this interaction has not been established.

Cimetidine: Concomitant administration of 200 mg cimetidine four times daily did not alter the single-dose pharmacokinetics of 30 mg meloxicam.

Digoxin: Meloxicam 15 mg once daily for 7 days did not alter the plasma concentration profile of digoxin after β-acetyldigoxin administration for 7 days at clinical doses. In vitro testing found no protein binding drug interaction between digoxin and meloxicam.

Lithium: In a study conducted in healthy subjects, mean pre-dose lithium concentration and AUC were increased by 21% in subjects receiving lithium doses ranging from 804 to 1072 mg twice daily with meloxicam 15 mg QD every day as compared to subjects receiving lithium alone [see Drug Interactions (7)].

Methotrexate: A study in 13 rheumatoid arthritis (RA) patients evaluated the effects of multiple doses of meloxicam on the pharmacokinetics of methotrexate taken once weekly. Meloxicam did not have a significant effect on the pharmacokinetics of single doses of methotrexate. In vitro, methotrexate did not displace meloxicam from its human serum binding sites [see Drug Interactions (7)].

Warfarin: The effect of meloxicam on the anticoagulant effect of warfarin was studied in a group of healthy subjects receiving daily doses of warfarin that produced an INR (International Normalized Ratio) between 1.2 and 1.8. In these subjects, meloxicam did not alter warfarin pharmacokinetics and the average anticoagulant effect of warfarin as determined by prothrombin time. However, one subject showed an increase in INR from 1.5 to 2.1. Caution should be used when administering MOBIC with warfarin since patients on warfarin may experience changes in INR and an increased risk of bleeding complications when a new medication is introduced [see Drug Interactions (7)].

Carcinogenesis

There was no increase in tumor incidence in long-term carcinogenicity studies in rats (104 weeks) and mice (99 weeks) administered meloxicam at oral doses up to 0.8 mg/kg/day in rats and up to 8.0 mg/kg/day in mice (up to 0.5- and 2.6-times, respectively, the maximum recommended human dose [MRHD] of 15 mg/day MOBIC based on body surface area [BSA] comparison).

Mutagenesis

Meloxicam was not mutagenic in an Ames assay, or clastogenic in a chromosome aberration assay with human lymphocytes and an in vivo micronucleus test in mouse bone marrow.

Impairment of Fertility

Meloxicam did not impair male and female fertility in rats at oral doses up to 9 mg/kg/day in males and 5 mg/kg/day in females (up to 5.8- and 3.2-times greater, respectively, than the MRHD based on BSA comparison).

The use of MOBIC for the treatment of the signs and symptoms of osteoarthritis of the knee and hip was evaluated in a 12-week, double-blind, controlled trial. MOBIC (3.75 mg, 7.5 mg, and 15 mg daily) was compared to placebo. The four primary endpoints were investigator’s global assessment, patient global assessment, patient pain assessment, and total WOMAC score (a self-administered questionnaire addressing pain, function, and stiffness). Patients on MOBIC 7.5 mg daily and MOBIC 15 mg daily showed significant improvement in each of these endpoints compared with placebo.

The use of MOBIC for the management of signs and symptoms of osteoarthritis was evaluated in six double-blind, active-controlled trials outside the U.S. ranging from 4 weeks’ to 6 months’ duration. In these trials, the efficacy of MOBIC, in doses of 7.5 mg/day and 15 mg/day, was comparable to piroxicam 20 mg/day and diclofenac SR 100 mg/day and consistent with the efficacy seen in the U.S. trial.

The use of MOBIC for the treatment of the signs and symptoms of rheumatoid arthritis was evaluated in a 12-week, double-blind, controlled multinational trial. MOBIC (7.5 mg, 15 mg, and 22.5 mg daily) was compared to placebo. The primary endpoint in this study was the ACR20 response rate, a composite measure of clinical, laboratory, and functional measures of RA response. Patients receiving MOBIC 7.5 mg and 15 mg daily showed significant improvement in the primary endpoint compared with placebo. No incremental benefit was observed with the 22.5 mg dose compared to the 15 mg dose.

The use of MOBIC for the treatment of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older was evaluated in two 12-week, double-blind, parallel-arm, active-controlled trials.

Both studies included three arms: naproxen and two doses of meloxicam. In both studies, meloxicam dosing began at 0.125 mg/kg/day (7.5 mg maximum) or 0.25 mg/kg/day (15 mg maximum), and naproxen dosing began at 10 mg/kg/day. One study used these doses throughout the 12-week dosing period, while the other incorporated a titration after 4 weeks to doses of 0.25 mg/kg/day and 0.375 mg/kg/day (22.5 mg maximum) of meloxicam and 15 mg/kg/day of naproxen.

The efficacy analysis used the ACR Pediatric 30 responder definition, a composite of parent and investigator assessments, counts of active joints and joints with limited range of motion, and erythrocyte sedimentation rate. The proportion of responders were similar in all three groups in both studies, and no difference was observed between the meloxicam dose groups.

MOBIC is available as a pastel yellow, round, biconvex, uncoated tablet containing meloxicam 7.5 mg or as a pastel yellow, oblong, biconvex, uncoated tablet containing meloxicam 15 mg. The 7.5 mg tablet is impressed with the Boehringer Ingelheim logo on one side, and on the other side, the letter “M”. The 15 mg tablet is impressed with the tablet code “15” on one side and the letter “M” on the other.

MOBIC (meloxicam) tablets 7.5 mg: NDC 0597-0029-01; Bottles of 100

MOBIC (meloxicam) tablets 15 mg: NDC 0597-0030-01; Bottles of 100

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep MOBIC tablets in a dry place.

Dispense tablets in a tight container.

Keep this and all medications out of the reach of children.

Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed.

Inform patients, families or their caregivers of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy.

Cardiovascular Thrombotic Events

Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately [see Warnings and Precautions (5.1)].

Gastrointestinal Bleeding, Ulceration, and Perforation

Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their healthcare provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for the signs and symptoms of GI bleeding [see Warnings and Precautions (5.2)].

Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “flu‑like” symptoms). If these occur, instruct patients to stop MOBIC and seek immediate medical therapy [see Warnings and Precautions (5.3)].

Heart Failure and Edema

Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see Warnings and Precautions (5.5)].

Anaphylactic Reactions

Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see Contraindications (4) and Warnings and Precautions (5.7)].

Serious Skin Reactions

Advise patients to stop MOBIC immediately if they develop any type of rash and to contact their healthcare provider as soon as possible [see Warnings and Precautions (5.9)].

Female Fertility

Advise females of reproductive potential who desire pregnancy that NSAIDs, including MOBIC, may be associated with a reversible delay in ovulation [see Use in Specific Populations (8.3)].

Fetal Toxicity

Inform pregnant women to avoid use of MOBIC and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus [see Warnings and Precautions (5.10) and Use in Specific Populations (8.1)].

Avoid Concomitant Use of NSAIDs

Inform patients that the concomitant use of MOBIC with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see Warnings and Precautions (5.2) and Drug Interactions (7)]. Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia.

Use of NSAIDs and Low-Dose Aspirin

Inform patients not to use low-dose aspirin concomitantly with MOBIC until they talk to their healthcare provider [see Drug Interactions (7)].

For current prescribing information, scan the code below or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or TTY 1-800-459-9906.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

Licensed from: Boehringer Ingelheim International GmbH

090340141/11OT1407KF302016

The risk of getting an ulcer or bleeding increases with:

NSAIDs should only be used:

Mobic® (meloxicam) Tablets Label7.5 mg/100 TabletsNDC: 0597002901

Mobic® (meloxicam) Tablets Label15 mg/100 TabletsNDC: 0597003001

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