قرص levonorgestrel

خواص دارویی و گیاهی

قرص levonorgestrel
قرص levonorgestrel

مدپلاس

 

وونورژسترل یا  لوونورژسترول (Levonorgestrel) یک داروی پیشگیری از بارداری بعد از مقاربت جنسی، و یا مشکوک به بارداری می باشد.
لوونورژسترول یک پروژسترون است و اینکه دقیقا چگونه کار می کند شناخته شده نیست.

این دارو از بارداری با مهار تخمک گذاری، یا تغییر پوشش رحم برای جلوگیری از لانه گزینی اگر لقاح اتفاق می افتد جلوگیری می کند.

لوونورژسترل برای پیشگیری از بارداری اضطراری و مقاربت محافظت نشده و یا شکست های پیشگیری از بارداری شناخته شده و یا مشکوک به کار می رود؛ برای به دست آوردن کارآیی، قرص باید در اسرع وقت ظرف 72 ساعت پس از مقاربت مصرف گردد.

قرص levonorgestrel

قرص لوونورژسترول تنها با نسخه پزشک برای زنان جوان تر از سن 17 سال و بالاتر در دسترس می باشد؛ قرص لوونورژسترول برای استفاده روزمره به عنوان پیشگیری از بارداری تجویز می گردد.

نام ژنریک: لوونورژسترل یا  لوونورژسترول (Levonorgestrel)

نام تجاری:  My Way٬Next Choice٬Plan B٬Plan B One-Step

کلاس درمانی: پیشگیری از بارداری، پروژسترون

کلاس دارویی: پروژستین

 

مطمئن شوید که شما با خیال آسوده می ​​توانید این دارو را استفاده نمایید، اگر شما دارای هر یک از شرایط زیر می باشید با پزشک خود در جریان بگذارید :

شما به هر عنصر در لوونورژسترول حساسیت دارند
شما گمان می کنید که حامله هستید
شما خونریزی غیر طبیعی واژینال دارید
شما در حال استفاده nevirapine، ریفامپین، و یا مخمر سنت جان هستید
شما یک سکته مغزی و یا سابقه خونریزی از مغز، شناخته شده و یا سرطان پستان مشکوک، و یا یک اختلال لخته شدن خون داشته اید

اگر شما سابقه حاملگی خارج رحمی و قبل از قاعدگی داشته اید
اگر شما مبتلا به دیابت می باشید

اگر شما باردار هستید، قصد باردار شدن دارید ، یا در حال تغذیه کودک با شیر خود می باشید

اگر شما باردار هستید نباید از این دارو استفاده نمایید زیر لوونورژسترل میتواند به جنین شما آسیب برسانند و یا حتی ممکن است باعث نقض در هنگام تولد شود

هورمون های موجود در داروهای ضد بارداری می تواند به شیر مادر منتقل شود و به کودک شیرخوار آسیب برساند. این دارو همچنین ممکن است باعث کاهش تولید شیر مادر شود.

اگر شما پس از مصرف این دارو دچار هر یک از عارضه های جدی زیر شدید٬ با پزشک خود تماس گرفته و او را در جریان قرار دهید .

خونریزی قاعدگی سنگین یا نور
گرفتگی
قاعدگی نامنظم
درد
درد در لگن
توقف خونریزی قاعدگی

درد شکم یا معده
سرگیجه
سردرد
تهوع
حساسیت به لمس پستانها
خستگی یا ضعف غیر معمول
اسهال و استفراغ

داروهای دیگر ممکن است توسط این دارو تحت تاثیر قرار گیرند٬ قبل از استفاده از این دارو، با دکتر خود در مورد تمام نسخه ها و داروهایی که استفاده می کنید بگویید٬ به ویژه داروهای زیر. این شامل ویتامین ها، مواد معدنی، داروهای گیاهی و داروهای تجویز شده توسط پزشکان دیگر و … است .

ترانس امیک اسید
کاربامازپین
Dabrafenib
فنتانیل
ایزوترتینوئین
Mitotane
Piperaquine
تئوفیلین
تیزانیدین

فرمول شیمیایی:

مطلب قبلی

داروی اپری Apri

مطلب بعدی

اویان Aviane

سوماتروپین

آلپرازولام Alprazolam

آمپی سیلین

جنتامایسین

کلرامفنيکل | Chloramphenicol

تهیه روغن گل سرخ در خانه

عالی بود این قرص شگقت انگیزه

سلام من این قرص رو روز 3 عید خوردم، 12 پریود شدن در صورتی که وقت پریودم نبود، بعد 3_4 روز پاک شدم،امروز یعنی 19 باز به خونریزی افتادم، در صورتی که تایم پریود هام دقیق و 25 هر ماه بود، درد سینه هم دارم، امکان مراجعه به پزشک هم ندارم، لطفا راهنماییم کنید

سلام من روز ٦پريودم نزديكي داشتم بعد از ١٠ساعت دو عدد قرص لونژيل خوردم،ميخوام بدونم اگه من يه هفته بعد روز تخمك گذاريم نزديكي داشته باشم امكان حاملگي وجود داره يا اثر قرص هنوز تو بدنم وجود داره و حامله نميشم؟

سلام دوستان من با نامزدم روز22ام سیکل ماهانه ام بدون اینکه دخول کند مایع منی شو روی واژنم ریخت حدود 4روز بعد دوتا قرص لوونوژسترول باهم خوردم آیا احتمال بارداری هست؟؟ تورو خدا جواب بدید استرس دارم.

دوست عزیززمان دقیق تخمک گذاری میشه(سیکل بارداری/2)+-2
یعنی دوره ات رو تقسیم بر دو کن جواب رو باضافه و منهای دو کن.توی این مدت زمان تخمک آزاد میشه.
البته باید حتما دوره ات تنظیم باشه.

سلام..من 6ساله ک ازدواج کردم و راه جلوگیریم طبیعی تقویمی بوده..4سال اول با این روش پیش رفتم خیلی خوب بود فقط مواقعی ک حس میکردم لازمه همین قرص مصرف میکردم.بعداز بارداری دوره ام تنظیم هس ولی بخاطر بارداری کمی عفونت دارم خیلی کم..اما هنوزم ازهمین روش استفاده میکن..سوالم اینه آیا با این وضعیت بعدازمصرف این قرص مطمئن باشم ک بار دار نمیشم

لطفا زمان دقیق تخمک گذاری رو بگید؟

قرص levonorgestrel

خیلی عالی بود

سلام خسته نباشین…
عذر میخوام من بعد ارضا سدن مایع منی رو داخل واژن خالی شد..
الان چه دارویی برای باردار نشدن استفاده بشه؟

همین “لوونورژسترل” جواب گو هست ؟

سلام…من با همسرم امیزش بدون روش جلوگیری داشتم ک منی داخل واژنم ریخت.بعدهم من ۸عدد قرصLDخوردم و ۱۲ساعت بعد هم۱عدد قرص لوژسترول خوردم اما صبح ک بیدارشدم دردشکم و حالت تهوع داشتم.تا بعدازظهر ک بهتر شدم..نمیدونم الان احتمال بارداریم هس.دوره عادت من۲۸ روزه است.و۱۵فروردین پاک شدم

سلام من با نامزدم رابطه داشتم و منی ایشون وارد بدنم شد ده ساعت بعد دو تا قرص لونوژسترول ۱/۵ خوردم امکان داره حامله بشم لطفا جواب بدید

د از رابطه قرص لونورژسترول خوردم امکانش هست حامله بشم.یا رو بچم تاثیر بذاره برای همین یه بار؟

سلام من سکس بدون جلوگیری داشتم وهمه منی داخل واژنم ریخت بعدش که رفتم دستشویی یه عالمه بود که بیرون ریخت 6 ساعت بعدش قرص لونورژسترول 1.5 درصد خوردم، میخوام بدونم دیگه چه کاری میتونم انجام بدم که احتمال بارداریم صفر بشه، درضمن سکس در روزهفتم پریودیم بود که پاک شده بودم، خواهش میکنم زودتر جوابمو بدین، خیلی دلشوره دارم، بگین دیگه چیکار کنم؟

با سلام
در زمان تخمک گذاری ام (یکی دو روز بعد پریودم) با کاندوم نزدیکی داشتیم . چهل و هشت ساعت بعد حدودا دوتا قرص لونو ژستریل استفاده کردم . سه روز بعد دستا و پاهام لمس بودن که معمولا وقتی خیلی کم خونم این اتفاق میفته بعد از ۵ روز حدودا الان خونریزی خفیف دارم . باید چه کنم از عوارض داروست؟

من بعد از قرص اول یادم رفت قرص دوم رو بخورم. مشکلی نداره؟

با سلام من دختری باکره هستم،با نامزدم رابطه برقرار کردیم اما دخول سطحی صورت گرفت،من سریعا خود را شستشو دادم اما مقدار کمی خون مشاهده کردم،بنابراین سریعا دو قرص لوونورژسترل را طی دو ساعت همزمان مصرف کردم،اما احساس کمردرد و دلدرد زمان پریود را دارم،میخواستم بدانم آیا من هنوز باکره هستم و امکان بارداری تا چه حد است؟خواهشا به سوالم جواب بدین،واقعا فوری هست،با تشکر

من با همسرم رابطه ی مقعدی داشتم و منی ایشون داخل مقعد من ریخته شد ولی من این قرص رو بعد از 15 ساعت مصرف کردم احتمال بارداری وجود داره یا نه

خیر

سلام من بانامزدم نزدیکی سطحی داشتم باکره هستم ودخولی انجام نشد.روزپنجم پریودم بودوقتی رابطه داشتیم نامزدم انزال کمی داشت که روی نواربهداشتی من ریخت و متاسفانه من ازهمون نواراستفاده کردم.روزپنجم و ششم و هفتم مثل هرماه خونریزیمو داشتم وامروز ب خاطرنگرانی ب متخصص مراجعه کردم و دوعدد قرص اووسیز۱/۵ همون لوونورژسترل بهم داد با فاصله ۱۲ساعت مصرف کنم این قرصو زمانی مصرف کردم که هنوز ۴۸ساعت از رابطمون نگذشته بود به نظر شما خطری هست؟خواهش میکنم سریعتر جواب بدید

سلام .مریم عزیز با اوضاعی که توضیح دادین احتمال حاملگی در حد صفر هستش

سلام من با همسرم رابطه داشتم که دخول صورت نگرفت اما مقداری از مایع منی ایشان ریخته شد جلوی بدنم نزدیک قسمتی که خانمها زایمان میکنن و خون قادگی ازانجامیاد قرص لونورژسترول 1ونیم را خوردم ایا باز باردار میشم یاخیر . یا بستگی به قاعده شدنم داره

سلام.
ببینید احتمال بارداری رو نمیشه دقیق اندازه گرفت . ولی با وضعیت شما بعیده منجر به بارداری بشه . تست های خانگی رو برای مطمعن شدن استفاده کنید . و در نهایت در صورتی که مشکوک شدین حتما به دکتر زنان مراجعه بفرمایید .

سلام من با نامزدم رابطه نزدیک داشتم اما نزدیکی ازجلو صورت نگرفته اما فقط مقداری از منی ایشان درجلوی بدنم ریخته شد که من این قرص را یک ونیم این دارو را مصرف کردم بنظر شما باردارمیشم یانه سریعا راهنمایی کنید نگرانم

سلام ن تاثیری نداره
منم بک سوال داشتم
من باکره هستم و با نامزدم رابطه سطحی داشتم ک هیچ دخولی صورت نگرفت .در روز 7ام عادت ماهیانه بودم.اصولا تا روز 4-5عادتم خونریزی دارم و تا روز 10لکه بینی.برای احتیاط حدود18ساعت بعد دو قرص لوونورژسترون0/75یک جا و 12ساعت بعد یکی دیگه خوردم ایا با این شرح احتمال بارداری در من هست؟

سلام.
خیر احتمال بارداری نزدیک به صفره .

دیروز بخاطر اصرار همسرم بعد از تقریبا72 ساعت از نزدیکی دو قرص لوونورژسترل خوردم. ولی خیلی نگران هستم که اگر حامله بشوم این دارو بر روی بچه تاثیر گذاشته باشد.. لطفا راهنماییم کنید..

سلام دوستان اگر تجربه ای دارید در اختیار سارا خانوم قرار بدید
سارا خانوم بهترین راه ممکن کمک و مشاوره از یک ماما یا دکتر می باشد
با تشکر

سلام دوستان اگر تجربه ای دارید در اختیار سارا خانوم قرار بدید
سارا خانوم بهترین راه ممکن کمک و مشاوره از یک ماما یا دکتر می باشد
با تشکر

ایمیل شما نمایش داده نخواهد شد

مشخصات من را ذخیره کن

کد کپچا *

دریافت مطالب جدید , اخبار و اطلاعیه ها در ایمیل شما

 

از عضویت شما سپاسگذاریم . ایمیل خود را جهت تایید بررسی کنید

مطالب تصادفی


محافظت از کودکان در برابر گرما


برقرای یک رابطه جنسی خوب با همسر


15روش جلوگیری از بیماری قلبی

آیا مادران زمان کافی برای فرزندانشان می گذرانند؟


کاهش وزن با رعایت این نکات کاربردی


درمان کم خونی و پلاکت پایین با گیاه شبدر


داروخانه ها در بريتانيا


همه مواد گیاهی لزوما بی خطر نیستند


کاهش خطر بیماری قلبی با رژیم گیاه خواری


تاثیر اندازه آلت تناسلی در رابطه جنسی


از نوزادتان عروسکی ناتوان نسازید

آشنایی با خواص زعفران یک معجزه گر در زیبایی


گلاب،معجون سلامتی ایرانی


زعفران | طلای قرمز


تسکین دردهای مفصلی با طب سنتی


عوامل موثر در کاهش لذت جنسی در بانوان


سرنخ هایی جدید از بیماری اوتیسم


تـراژدی مرگ کودک


عوارض استفاده از لنز رنگی

زمانی که سیســتم ایمنی پیام هــای غلطی را به پوســت می فرســتد و باعث رشــد بیشتر ســلول های آن می شــود؛ چندین لایه ســلول مرده به شکل پوســته های ســفید رنگ در سطح پوست تجمع پیدا می کنند.

(بیشتر بخوانید : پسوریازیس )

پذیرش و چاپ تضمینی در معتبرترین مجلات تماس

به گزارش سایت خبری ساعد نیوز و به نقل از مردمان، قرص جـدیـد جلوگیری از بارداری و حاملگی بـه روش اورژانـس (ECP)، لـوونـورجسـتـرل (LEVONORGESTREL) میباشد، که (به غلط) لوونورجسترول نیز نامیده میشود. این قرص با برندهای (PLAN B)  ،(POSTINOR-2) ،(LEVONELLE ONE STEP) عرضه گردیده است. این قرص از ابتدای سال آینده نیز در داروخانه های ایران دردسترس عموم قرار خواهد گرفت. این قرص بمنظور جلوگیری از بارداری پس از تماس جنسی حفاظت نشده و یا هنگام شکست در سایر روشهای جلوگیری از بارداری (پاره شدن کاندوم)، مورد استفاده قرار میگیرد. پیشتر از قرصهای LD و HD برای مواقع اورژانس پیشگیری استفاده میگردید. مزیت این قرصهای جدید، کاهش عوارض و افزایش ضریب موفقیت میباشد.

نحوه عملکرد:

لوونورجسترول یک هورمون زنانه است که از تخمک گذاری جلوگیری بعمل آورده و با ایجاد تغییرات در مخاط گردن رحم و پوشش رحم حرکت اسپرم را به سمت رحم، و لانه گزینی تخم بارورشده در دیواره رحم  را دشوار میسازد. این هورمون در سایر روشهای جلوگیری از بارداری نظیر قرصهای ضد بارداری متداول و یا کپسول های کاشتنی(نورپلانت) نیز یافت میشود. اما این هورمون در قرصهای جدید در دوز بالاتر و بصورت مجزا عرضه گردیده است.

شکل دارویی:

قرص levonorgestrel

این قرص سفید رنگ در بسته های دو عددی عرضه میگردد. هر کدام از قرصها حاوی ۷۵۰ میکروگرم لوونورجسترول میباشد.

میزان اثر بخشی:

اثر بخشی آن ۶۰ تا ۹۵ درصد، و بطور میانگین ۸۹ درصد است. از هر ۱۰۰ زن، ۲ نفر ممکن است پس از مصرف این قرصها باردار شود.

نکته: قرصها هر چه زودتر پس از تماس جنسی حفاظت نشده مصرف گردند، اثر بخشی شان بیشتر گردیده و شانس حاملگی ناخواسته کمتر میشود. در صورتی که این قرص ها ظرف ۲۴ ساعت پس از تماس جنسی حفاظت نشده مصرف گردند، ۹۵ درصد از حاملگی جلوگیری میکند. اما چنانچه ظرف ۴۸ تا ۷۲ ساعت پس از تماس جنسی مصرف گردند، ۶۰ درصد از حاملگی جلوگیری میکنند.

نحوه مصرف:

۱- یک قرص بسته را پس از رابطه جنسی حفاظت نشده مصرف کنید. این زمان نباید از ۷۲ ساعت (۳ روز) پس از تماس جنسی فراتر رود.

۲-قرص دوم را ۱۲ ساعت بعد از قرص نخست مصرف کنید.

نکته:زمانبندی مصرف قرصها در میزان اثر بخشی آنها بسیار مهم است.

نکته: هر چه زودتر قرصها را مورد استفاده قرار دهید، اثر بخشی شان افزایش می یابد.

نکته:قرص نخست را بایستی ظرف ۷۲ ساعت پس از تماس جنسی حفاظت نشده مصرف کنید.

چه زمان به پزشک مراجعه کنید؟

۱-چنانچه ظرف ۳ ساعت پس از مصرف قرص نخست، دچاراستفراغ شدید، بلافاصله قرص دوم را مصرف کرده و فورا به پزشک مراجعه کنید.

۲-چنانچه (پس از مصرف قرصها) عادت ماهانه شما یک هفته از زمان معمول خود به تاخیر افتاد، احتمال باردار بودن شما وجود دارد، بنابراین تست بارداری بدهید.

۳-چنانچه پس از گذشت ۳ هفته از مصرف قرصها عادت ماهانه در شما ایجاد نگردید(پریود نشدید)، نزد پزشک بروید و تست بارداری بدهید.

۴-در صورت بروز سردرد شدید، شکم درد شدید، اختلال در بینایی، حالت تهوع و استفراغ شدید، علایم واکنش آلرژیک شدید به پزشک مراجعه کنید.

نکات مهم در رابطه با قرصهای لوونورجسترول:

۱-مصرف این قرصها شما را در برابر بیماریهای منتقله از راه تماس جنسی از جمله HIV محافظت نمیکند.

۲-نبایستی از این قرصها به عنوان یک روش روتین جلوگیری از بارداری استفاده گردد.

۳-این قرصها را نبایستی همراه با سایر روشهای جلوگیری از بارداری به روش اورژانس مصرف کرد.

موارد منع مصرف:

۱-مصرف این قرصها برای دختران زیر ۱۷ سال ممنوع است. (مگر با صلاحدید پزشک)

۲-چنانچه احتمال می دهید باردار هستید، از مصرف آنها خودداری کنید. این قرصها قادر به خاتمه بارداری نمیباشند.

۳-چنانچه مبتلا به دیابت میباشید و یا نسبت به داروهای جلوگیری از بارداری آلرژی دارید، قبل از مصرف این قرصها، با پزشک خود مشورت کنید.

۴-در دوران شیردهی از مصرف این قرصها خودداری ورزید، چراکه میتوانند وارد شیر مادر گردیده و به نوزاد آسیب برسانند.

۵-در صورت وجود خونریزی تشخیص داده نشده مهبلی (واژینال)، از مصرف این قرصها خودداری ورزید.

۶-در صورت ابتلا به بیماریهای کبدی، مشکلات انعقاد خون، بیماریهای قلبی و سرطان پستان از مصرف آن قبل از مشورت با پزشک خودداری کنید.

۷- ابتلا به برخی اختلالات روده ای، در جذب دارو تداخل ایجاد میکنند، بنابراین آنها را با پزشک خود در میان بگذارید.

عوارض احتمالی مصرف لوونورجسترول:

عوارض جانبی معمولا مشابه مصرف سایر قرصهای جلوگیری از بارداری است.

۱-آلرژی: کهیر- تنفس دشوار- تورم در ناحیه صورت، لب ها، زبان و یا گلو.

۲-درد شدید در ناحیه تحتانی شکم و یا پهلوها که میتواند نشانه حاملگی خارج رحمی باشد و بایستی فوراً به پزشک مراجعه کنید.

۳-تهوع، اسهال، درد خفیف شکم، حساس شدن سینه ها، سرگیجه، احساس خستگی، سردرد، تغییر در الگوی عادت ماهانه، آکنه.

تداخلات دارویی:

۱-برخی داروهای ضد تشنـج نظیر کاربامازپین (CARBAMAZEPINE)، فنیتوئین (PHENYTOIN)، پریمیدون (PRIMIDONE)

۲-برخی آنتی بیوتیک ها نظیر ریفامپین  (RIFAMPIN)

قرص levonorgestrel

۲-برخی از باربیتوراتها (BARBITURATE)

۳-داروی درمان ایدز: ریتوناویر(RITONAVIR)

۴-داروی ضد قارچ: گریزئوفولوین (GRISEOFULVIN)

۵-داروی سرکوب کننده سیستم ایمنی: سیکلوسپورین (CYCLOSPORIN)

۶-سایر داروهای ضد بارداری.

نکته: در صورت مصرف داروهای مذکور آن را با پزشک خود در میان بگذارید. ۵ مورد نخست از اثر بخشی قرصها کاسته و در عملکرد آنها ایجاد تداخل میکنند.

نحوه نگهداری:

۱-قرصهای لوونورجسترول را به دور از رطوبت و گرما نگهداری کنید. در دمای بین ۱۵ تا ۲۵ درجه سانتی گراد.

۲-آن را دور از دسترس کودکان و حیوانات خانگی قرار دهید.

۳-به تاریخ انقضای دارو دقت کنید.

1Shanghai Institute of Planned Parenthood Research, Shanghai, PR China

2Family Planning Research Institute, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, PR China

3Department of Gynecology and Obstetrics, The Sixth Affiliated Hospital of SUN YAT-SEN University, Guangzhou, PR China

4Family Planning Institute of Hunan Province, Changsha, PR China

5Jilin Hospital of Reproductive Health, Changchun, PR China

قرص levonorgestrel

6International Peace Maternity and Child Health Hospital, Shanghai Jiaotong University, Shanghai, PR China

1Shanghai Institute of Planned Parenthood Research, Shanghai, PR China

An enteric-coated levonorgestrel emergency contraceptive pill (E-LNG-ECP) is an improved formulation, in terms of side effects, which both dissolves and is absorbed in the intestine. Our aim was to evaluate the efficacy and safety of E-LNG-ECP as an over-the-counter (OTC) drug for emergency contraception (EC) in Chinese women.

A Phase IV clinical trial was conducted in five family planning clinics in China. Women seeking EC within 72 h after unprotected sexual intercourse or contraceptive failure who met the inclusion criteria were recruited. The efficacy of contraception (primary end-point was pregnancy rate), side effects (i.e. safety) and the value of E-LNG-ECP for EC were investigated.

Of 2445 women (aged 15–48 years) who took E-LNG-ECP with follow-up to determine pregnancy, only five pregnancies (0.2%) occurred. The efficacy of contraception was 95.3%. In total, 6.5% of women reported at least one adverse event after taking E-LNG-ECP, and no serious adverse events were reported. Only four subjects (0.16%) reported vomiting. The incidence of menstrual cycle disturbance was 20.1% after taking E-LNG-ECP. Subjects who had previously taken ECPs (54.4% of these women) rated the acceptability of E-LNG-ECP at 9.36 (on a 10-point scale) higher (P<0.05) than the rating of other LNG-EC pills taken previously.

The study found that E-LNG-ECP was effective, safe and well tolerated as an OTC drug. However, an randomized controlled trial should be performed to compare standard LNG tablets with E-LNG-ECP.

Emergency contraception (EC) methods, available in oral and intrauterine forms, are used to prevent pregnancy after unprotected intercourse or contraceptive failure. The most widely used EC drug is levonorgestrel (LNG), taken orally in repeated doses (0.75 mg × 2) or as a single dose (1.5 mg) within 72 h of sexual intercourse (Trussell et al., 2010). LNG EC is more effective and has fewer side effects than the Yuzpe regimen, which contains both estrogen and progestin (Cheng et al., 2004).

Several studies have shown that LNG acts by inhibiting or postponing ovulation (Gemzell-Danielsson, 2010; Leung et al., 2010; Noé et al., 2010). Higher doses of LNG taken after ovulation, or LNG administered by the vaginal route, have no effect on endometrial development or function (Gemzell-Danielsson, 2010; Meng et al., 2010; Palomino et al., 2010).

In recent years, the use of LNG has increased and it is now available for women seeking EC without a doctor’s prescription in nearly 50 countries, including China (Pittrof et al., 2010; Trussell et al., 2010). However, extensive debate on overreliance on LNG as an over-the-counter (OTC) drug still occurs in many other countries, which is a barrier to switching the prescription status of LNG in these countries. As a result, prospective, multi-center, open-label clinical trials of LNG as an OTC drug are necessary to provide evidence to inform the discussion.

The LNG emergency contraceptive pill (ECP) was approved as an OTC drug by the State Food and Drug Administration (SFDA) in 1998 and has been widely available in China since that time. An enteric-coated LNG-ECP (E-LNG-ECP) is an improved formulation that both dissolves and is absorbed in the intestine rather than in the stomach so as to reduce the adverse events of nausea and vomiting. A pharmacokinetics study of E-LNG-ECP showed it to be bioequivalent with the previous, uncoated tablet with the use of the liquid chromatography–tandem mass spectrometry method, although the time to peak value in blood plasma was significantly longer than that for the previous tablet (Tmax: 3.4 versus 1.8 h) (Zhao et al., 2008). We conducted a Phase IV clinical trial in Chinese women to provide data on the efficacy and safety of the E-LNG-ECP as an OTC drug.

This study was conducted in five family-planning clinics (Shanghai, Guangzhou, Changsha, Changchun and Wuhan) in China from August 2009 to October 2010. Ethical approval was obtained from the Ethics Committee of the medical college of Huazhong University of Science and Technology. The study was performed in full compliance with the Declaration of Helsinki and Good Clinical Practice of China.

Subjects were healthy women who sought ECP to avoid unwanted pregnancy. According to drug law and regulations in China, the minimum number of enrolled women subjects required in a Phase IV clinical trial of contraceptives is 2000. Given the high loss of follow-up in clinical trials of OTC drugs (20%), we planned to include 2400 women. Inclusion criteria were the following: 15–49 years old, regular menstrual cycle of 21–35 days, a usually menstrual period duration of 3–7 days and seeking EC within 72 h of unprotected sexual intercourse or contraceptive failure. Subjects were excluded if they had a contraindication to LNG, chronic disease with prolonged medication, a known or suspected pregnancy or if they were current or recent users of hormonal methods of contraception. All participants signed informed consent forms.

The enteric-coated tablet contained 1.5 mg LNG (Nevenol®, Regenex Pharmaceutical Corporation, Guangzhou, China). Participants were told to take one tablet orally within 72 h of unprotected intercourse or contraceptive failure.

Participants filled in a registration form to provide basic information when they came to pharmacies to purchase emergency contraceptives. Throughout the study, participants were asked to keep a daily diary to record the time of sexual intercourse and administration of E-LNG-ECP, adverse effects, vaginal bleeding, concomitant medication and contraceptive use. A follow-up interview (either by telephone or in a clinic) was carried out within 3 days of the administration of E-LNG-ECP, with the content mainly focusing on adverse events. The second follow-up was 5–7 days after expected menses. If menses had occurred, the follow-up study ended. Women with negative pregnancy tests without menses on the expected date were contacted every 2 weeks, and periodic pregnancy testing was undertaken until menses resumed. Positive urinary pregnancy tests were confirmed by measurement of serum β-hCG and later by ultrasonography. The outcome of the pregnancies was obtained by further follow-ups.

The primary efficacy end-point was the rate of pregnancy in women who took E-LNG-ECP within 72 h of unprotected intercourse. The rate of side effects in women who received E-LNG-ECP within 72 h of unprotected intercourse was analyzed as a safety measurement. Serious side effects were defined in accordance with the female harmonization guidelines (Liao, 2004) and reported to the research center immediately by investigators. The principal investigator reviewed every pregnancy (enrolment and follow-up serum hCG concentrations, ultrasound dating, menstrual cycle and coital data) to establish whether conception clearly occurred before E-LNG-ECP was given or well after treatment (at least 10 days after treatment). Pregnancies that met these criteria were deemed to be incompatible with treatment failure. The efficacy of contraception (the fraction of expected pregnancies prevented) was estimated using the method of Trussell et al. (1998).

In addition, the subjects who had taken ECPs in the past rated E-LNG-ECP versus other ECPs on a scale ranging from 0 (poor) to 10 (excellent). The perceived advantages and disadvantages of E-LNG-ECP were also investigated in the follow-up interviews of participants.

Demographics, the efficacy of contraception and the frequency of adverse events in the observed cycle were described for the intention-to-treat population. The data were imputed and verified in two databases by two analyzers independently. Statistical analysis was performed using SAS version 9.0 (Cary, NC, USA). Statistical significance was set at P < 0.05.

A total of 2566 subjects were enrolled in the study, 45 of whom were excluded because they did not meet the eligibility requirements (these 45 subjects were given E-LNG-ECP and there were no pregnancies). A total of 2521 were therefore eligible and treated with E-LNG-ECP; these women were all contacted for the first follow-up interview and were therefore included in the safety analysis. Of these, 2445 finished the study and were included in the efficacy analysis, while 76 women (with characteristics similar to the others) [3.0%, 95% confidence interval (CI) 2.4–3.8] were lost to follow-up (Fig. 1, trial profile). The ages of the enrolled participants ranged from 14 to 48 years, with a mean age of 27.4 years. Other characteristics of the participants are presented in Table I. Among the 2445 subjects, 91.2% of the follow-up interviews were conducted by telephone and 8.8% were completed in a clinic.

Baseline characteristics of participants in a Phase IV clinical trial to study the efficacy and safety of an E-LNG-ECP as an OTC drug for emergency contraception in China (n= 2566).

Profile of a Phase IV clinical trial to investigate the efficacy and safety of a LNG enteric-coated tablet as an OTC drug for EC.

A total of 2021 subjects (82.7%) had taken the E-LNG-ECP within 24 h of unprotected intercourse, 361 subjects (14.8%) within 24–48 h and 38 (1.6%) within 48–72 h. The rest (25 women) did not provide the specific time between coitus and drug administration. Only five pregnancies (0.20%, 95% CI 0.07–0.48%) among 2445 women occurred during the study. Among the 2401 women who reported the cycle day on which intercourse occurred, the expected number of pregnancies was 106.8. The efficacy of contraception was 95.3% (95% CI 88.6–98.1%). All five pregnancies ended in abortion (four induced and one spontaneous). No ectopic pregnancy was observed. No pregnancy was deemed incompatible with contraceptive failure according to the estimated date of conception.

Women lost to follow-up in our trial were 76; these were excluded from the denominator in calculations, under the assumption that they would experience failure at the same rate as those with observed outcomes. If all became pregnant, the failure rate would be 3.21%. This is considered as the highest failure rate. On the other hand, if none became pregnant, the failure rate would be 0.20%.

No serious adverse events were reported. Among 2521 subjects with safety data, 178 (7.1%; 95% CI 6.1–8.1%) reported at least one adverse event after taking E-LNG-ECP. In total, 4.2% of women reported mild or medium nausea, which occurred usually within 60 min of treatment. The next most frequent adverse event was vaginal bleeding and spotting (2.0%), which usually occurred within 3 days of treatment. Only four subjects (0.2%) reported vomiting, one at 30 min after treatment and three at unspecified times. No one took more E-LNG-ECP because of vomiting. The presence of adverse events is detailed in Table II.

Incidence of side effects after treatment with E-LNG-ECP (n = 2521).

Disturbances of the menstrual cycle were common after the E-LNG-ECP. In total, 20.1% of women reported that their next menses did not occur when expected, including 4.7% whose menses started at least 7 days early and 15.4% whose menses were delayed by >7 days. The average duration of menses was 4.9 days, which was no different than the previous one. The menstrual bleeding volume and the degree of dysmenorrhoea were similar to those in the previous menstrual cycle.

Thousand three hundred seventy-two of 2521 women (54.4%) in this study had used LNG ECPs previously and 99.6% obtained them from community pharmacies. The participants’ average rating of the ECPs used previously was 7.96 compared with 9.36 for E-LNG-ECP, a difference that is significant (P < 0.05), using Student t-test.

The advantages and disadvantages of E-LNG-ECP were also investigated at the second follow-up. Among 2445 participants, 1363 women (55.7%) listed several advantages of E-LNG-ECP: fewer or no side effects (52.2%), contraceptive efficacy (27.7%), convenient to use (18.0%) and attractive packaging (0.7%). Only 207 women listed some disadvantages, which were: menses disturbance (45.9%), high cost (42.0%), side effects (9.2%), could not frequently use (1.9%), brand name is not well known (0.5%) and contraceptive failure (0.5%).

In addition, the subjects listed their source of ECP information at the first follow-up: community pharmacies (75.4%), papers or magazines (24.3%), relatives or friends (10.6%), counseling by doctors (9.6%), internet (8.3%), broadcasting (6.6%), community education (3.3%) and others (1.3%). It was an open question and the answer was not limited to one choice; so some women used more than one source of information. Higher-educated women were more likely to gain ECP knowledge from papers or magazines, broadcasting and internet, using correlation analysis.

The contraception methods used after E-LNG-ECP treatment were investigated at the first follow-up. A total of 559 women (22.2%) did not use any contraceptive methods after the treatment. Among 1962 women who used contraception, the methods reported were: condoms (66.3%), ECPs (8.45%), oral contraceptive pills (1.55%), intrauterine device (0.28%), fertility awareness methods (0.6%) and spermicides (0.16%).

LNG was approved as an OTC emergency contraceptive drug by SFDA in 1998 in China and is mainly sold by community pharmacies, which provides convenient access for women. According to the Good Clinical Practice guidelines of SFDA, the current study was a Phase IV clinical trial of a new tablet, E-LNG-ECP. A total of 2566 women who were seeking ECPs from community pharmacies in five cities were enrolled to assess the contraceptive efficacy, safety and acceptability of E-LNG-ECP. This was the first large-sample post-marketing study of an emergency contraceptive as an OTC drug in China.

With both the LNG and Yuzpe regimens, the earlier the treatment begins the more effective it is. In a World Health Organization (WHO) large randomized controlled trial (RCT) of these methods, delaying the first dose by 12 h increased the odds of pregnancy by almost 50% (Piaggio et al., 1999). In our study, the contraceptive efficacy of E-LNG-ECP was 95.3%, and the failure rate was 0.2%, significantly lower than failure rates in the RCTs of LNG conducted by WHO and other researchers (Ho et al., 1993; Task Force on Post-ovulatory Methods of Fertility Regulation,1998; Piaggio et al., 1999; Wu et al., 1999; Arowojolu et al., 2002; von Hertzen H et al., 2002; Ngai et al., 2005) (see Supplementary data, Table SI) In our study, 82.7% of participants took the drug during the first 24 h after unprotected intercourse, while only 42–46% did so in the WHO RCT (von Hertzen H et al., 2002). Another study showed that the failure rates of ECPs during the first 24 h, 24–48 h and 48–72 h were 0.4, 1.2 and 2.7%, respectively (WHO, 1998). The superior efficacy of E-LNG-ECP found in this study might partially be related to the short interval between unprotected intercourse and taking the drug, and this short interval is good evidence of the easy accessibility of LNG ECP as an OTC drug. Subjects’ knowledge about ECP was also helpful in reducing the time required to obtain the ECP. It should be pointed out that the failure rates of ECPs might vary in different studies because of differences in characteristics among populations (such as age, reasons for requesting EC, the time between coitus and drug administration).

In our study, only 165 women (7.1%) reported a side effect, and 13 women reported more than one side effect. The presence of side effects is lower than in previous studies, except for a similar incidence of menstrual bleeding disturbances. One of the highlights in the present study is the significantly lower rate of nausea and vomiting compared with that in clinical trials conducted in different reports (WHO, 1998; Arowojolu et al., 2002; von Hertzen H et al., 2002). Decreased nausea and vomiting are probably primarily related to the enteric-coated tablet, which avoids irritation of the stomach. No pregnancy was observed among subjects who vomited, but very few vomited, precluding further investigation. Also, we could not differentiate method failure from subject failure. The main reason women chose E-LNG-ECP was that they thought it could have fewer gastrointestinal side effects. Therefore, the incidence of side effects, such as nausea and vomiting, may also depend on psychological factors. If women know that the drug is a new and improved preparation, they may feel more reassured and be less apprehensive, which might decrease the incidence of nausea and vomiting.

The influence of LNG on menstruation was previously found to depend on when LNG was taken in the menstrual cycle (Raymond et al., 2006). Taking the drug during the first 3 weeks of one’s cycle shortened the menstrual cycle and duration of menses, and this effect increased when it was taken even earlier in the 3-week period. In contrast, taking the LNG EC after ovulation had little influence on menstrual cycle length or duration of menses (Tirelli et al., 2008). In our study, nearly 80% of participants did not experience any menstrual change during the first cycle after treatment, while 20.1% experienced a change in timing of onset of the next menses of >7 days. The duration and volume of menses were not affected.

The E-LNG-ECP was found to be acceptable by women in our study. Advantages described by participants included few side effects, satisfactory efficacy and ease of use, while disadvantages included gastrointestinal side effects (nausea), menstrual disturbance and high cost. An estimated 19% to 22% of women were not using any contraceptive method after ECP treatment, while another 7.5% were relying on ECPs, which are not as effective as any ongoing method of contraception.

The present study also investigated the accessibility of ECPs: 99.6% of participants who had used ECPs in the past had obtained them from community pharmacies rather than clinics. Moreover, participants’ knowledge about EC mainly came from community pharmacies (75.4%), and only a small proportion of participants received counseling from clinicians (9.6%). The community pharmacy was not only a place for dispensing EC pills but also an important source of information about using the ECP correctly.

قرص levonorgestrel

In summary, this study suggested that an LNG enteric-coated tablet was safe and effective for use as an OTC EC drug. The E-LNG-ECP remarkably reduced the gastrointestinal side effects, such as nausea and vomiting. E-LNG-ECP should be available as an OTC drug in community pharmacies, while instructions on using ECPs that are dispensed by pharmacists or healthcare practitioners should be strengthened, particularly the importance of timing. Our findings provide convincing evidence for the safety, efficacy and accessibility of ECPs in an OTC setting; however, an RCT should be performed to compare results with the standard LNG treatment.

Supplementary data are available at http://humrep.oxfordjournals.org/.

L.C. supervised the whole study procedure, including conception, design and completion. Q.C., W.X., D.Z., R W., Y L. and J.K. were responsible for the collection of data. Q.C. and W.X. contributed to data analysis and drafting the manuscript. All seven authors participated in the ultimate interpretation of the study data and revision of the manuscript.

L.C. has received consulting fees from Regenex Corporation.

The study was funded by Regenex Corporation. Funding to pay the Open Access publication charges for this article was provided by Regenex Corporation.

We are grateful to Prof Naiqing Zhao for the statistical analysis of the study. We acknowledge Drs Chengliang Xiong, Shan Chen, Hongling Huang, Yujuan Jiang, and Ms. Huiying Li for their contributions to this study. Finally, we thank Prof James Trussell for his insightful comments and revisions of the manuscript.

National Center for
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USA

Levonorgestrel is used to prevent pregnancy after unprotected sexual intercourse (sex without any method of birth control or with a birth control method that failed or was not used properly [e.g., a condom that slipped or broke or birth control pills that were not taken as scheduled]). Levonorgestrel should not be used to prevent pregnancy on a regular basis. This medication is to be used as an emergency contraceptive or backup in case regular birth control fails or is used incorrectly. Levonorgestrel is in a class of medications called progestins. It works by preventing the release of an egg from the ovary or preventing fertilization of the egg by sperm (male reproductive cells). It also may work by changing the lining of the uterus (womb) to prevent development of a pregnancy. Levonorgestrel may prevent pregnancy, but it will not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.

Levonorgestrel comes as a tablet to take by mouth. If you are taking levonorgestrel as a single tablet product , take one tablet as soon as possible within 72 hours after unprotected sexual intercourse. If you are taking levonorgestrel as a two tablet product, take one tablet as soon as possible within 72 hours after unprotected sexual intercourse and take a second dose 12 hours later. Levonorgestrel works best if it is taken as soon as possible after unprotected sexual intercourse. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take levonorgestrel exactly as directed.

If you vomit less than 2 hours after you take a dose of levonorgestrel, call your doctor. You may need to take another dose of this medication.

Because you can become pregnant soon after treatment with levonorgestrel, you should continue using your regular method of birth control or begin using regular birth control immediately.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

قرص levonorgestrel

Unless your doctor tells you otherwise, continue your normal diet.

Levonorgestrel may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about levonorgestrel.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Patient Medication Information™. © Copyright, 2019. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

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Brand name

Levonorgestrel-1 AN Tablets

Active ingredient

Levonorgestrel

Schedule

S3

Please read this leaflet carefully before you start using LEVONORGESTREL-1 AN.

This leaflet answers some common questions about Levonorgestrel-1 AN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist will have discussed and considered the risks of you taking LEVONORGESTREL-1 AN against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Your doctor and pharmacist have more information.

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Keep this leaflet with the medicine.

You may need to read it again.

LEVONORGESTREL-1 AN is an emergency contraceptive only. LEVONORGESTREL-1 AN is not intended as a regular method of contraception.

It is used to prevent pregnancy when taken within 72 hours of unprotected intercourse. It is estimated that LEVONORGESTREL-1 AN will prevent 85% of expected pregnancies. The sooner that you take LEVONORGESTREL-1 AN after unprotected intercourse, the more likely it is that the medication will work.

LEVONORGESTREL-1 AN is most effective if taken within 72 hours of unprotected intercourse. But remember that the sooner you take it, the more likely it will work.

LEVONORGESTREL-1 AN will not prevent you from catching sexually transmitted diseases. Ask your doctor or pharmacist if you have any questions about why you are taking LEVONORGESTREL-1 AN.

Before you start treatment with Levonorgestrel-1 AN, your doctor or pharmacist should:

You should consult your doctor before you take it if:

If any of these conditions apply to you it may not be suitable for you to take LEVONORGESTREL-1 AN.

If these conditions apply to you your doctor may recommend a higher dose.

Do not take LEVONORGESTREL-1 AN if:

Do not take LEVONORGESTREL-1 AN after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

Tell your doctor or pharmacist if you are taking any other medicines, including those purchased from a supermarket or health food store. Some medicines may prevent LEVONORGESTREL-1 AN from working properly or LEVONORGESTREL-1 AN may affect the way other medicines work. Examples of medicines which may interfere with LEVONORGESTREL-1 AN are:

Take the tablet as soon as possible after unprotected intercourse. The sooner that you take the tablet, the more effective the treatment is likely to be. It is best to take it immediately after you receive it. The tablet should be taken no later than 72 hours after intercourse.

LEVONORGESTREL-1 AN is not recommended for children. There is only limited information available on LEVONORGESTREL-1 AN when taken by women aged 14-16 years and no information on its use in younger women or children.

If you vomit within 2 hours of taking the tablet you should return to your pharmacy, doctor or clinic as the tablet may not be absorbed and you will need to take an additional tablet.

Tell any doctor or pharmacist who are treating you that you have taken Levonorgestrel-1 AN.

Do not give LEVONORGESTREL-1 AN to anyone else.

If LEVONORGESTREL-1 AN makes you drowsy or dizzy, do not drive a car or operate machinery.

Tell your doctor or pharmacist as soon as possible if you do not feel well after you take Levonorgestrel-1 AN.

All medicines have side effects. Often they are not serious but sometimes they can be. You may need medical treatment if you get some side effects.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Common side effects are tiredness, nausea and vomiting. Some patients have also experienced stomach pain, diarrhoea, dizziness, headache, tender breasts, increased vaginal bleeding and skin reactions.

Other side effects not listed above may also occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

You should see your doctor within 3 weeks of taking Levonorgestrel-1 AN.

You may experience spotting or vaginal bleeding earlier than expected.

If you do not get your period within 3 weeks of taking the tablets you must see your doctor, as you may be pregnant. If LEVONORGESTREL-1 AN does not work, you could be pregnant. Your doctor will order a pregnancy test. If stomach pain is severe you should see your doctor immediately as on rare occasions a tubal pregnancy could occur.

LEVONORGESTREL-1 AN is only intended as an emergency measure. If you have not already done so you should discuss with your doctor other methods of long term contraception.

You should not breast feed within three days after taking Levonorgestrel-1 AN.

Telephone your doctor, or the Poisons Information Centre (13 11 26) if you take too many LEVONORGESTREL-1 AN tablets, or if a child has taken Levonorgestrel-1 AN.

LEVONORGESTREL-1 AN contains one blister sheet containing one tablet. Each white tablet contains 1.5 mg of levonorgestrel and the following excipients: lactose, maize starch, povidone, colloidal anhydrous silica and magnesium stearate.

Keep your tablet in the pack until it is time to take it. If you take the tablet out of the pack it will not keep well.

Keep your tablet in a cool, dry place where the temperature stays below 25°C. Protect from light.

Do not store LEVONORGESTREL-1 AN or any other medicine in the bathroom or near a sink.

Do not leave it in the car on hot days or on window sills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least 1½ metres above the ground is a good place to store medicines.

The expiry date is printed on the pack and the foil blister.

Do not use LEVONORGESTREL-1 AN after this expiry date.

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

Amneal Pharma Australia Pty Ltd 12 River StSouth Yarra VIC 3141

The AUST R for LEVONORGESTREL-1 AN is 231121.

This leaflet was prepared in December 2014.

Reasonable care is taken to provide accurate information at the time of creation. This information is not intended as a substitute for medical advice and should not be exclusively relied on to manage or diagnose a medical condition. NPS MedicineWise disclaims all liability (including for negligence) for any loss, damage or injury resulting from reliance on or use of this information. Read our full disclaimer. This website uses cookies. Read our privacy policy.

© 2019 NPS MedicineWise. Providing independent, evidence-based information about medicines, medical tests and other health technologies for all Australians.

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