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قرص euthyrox چیست
قرص euthyrox چیست

قرص یوتیروکس (Euthyrox) با نام ژنریک لووتیروکسین سدیم برای تشخیص و درمان کم کاری تیروئید، پیشگیری و درمان گواتر و سرطان تیروئید و نیز بررسی عملکرد تیروئید به کار می رود.

طبقه‌بندي فارماكولوژيك: هورمون تيروئيدي.


طبقه‌بندي درماني: جانشين هورمون تيروئيد.


طبقه‌بندي مصرف در بارداري: رده A

قرص euthyrox چیست


نام‌هاي تجاري: Euthyrox, Synox, T4

یوتیروکس جانشين هورمون تيروئيد است و بر متابوليسم پروتئين و كربوهيدرات تأثير مي‌گذارد، گلوكونئوژنز را پيش مي‌برد، مصرف و انتقال از ذخاير گليكوژن را افزايش مي‌دهد، ساخت پروتئين را تحريك مي‌كند، و رشد و افتراق سلولي را تنظيم مي‌كند. اثر عمده لووتيروكسين یا یوتیروکس افزايش سرعت متابوليك بافتها است.


یوتیروکس را صبح با معده خالي، حداقل نيم ساعت قبل از صبحانه تجويز كنيد. قرص را مي‌توان خرد كرد و با يك يا دو قاشق چايخوري آب حل كرد كه بلافاصله بايد مصرف شود.

الف) هايپوتروئيديسم:

بزرگسالان با بیش از 65 سال: 12.5 تا 50 ميكرو ‌گرم خوراكي روزانه بسته به پاسخ مي‌توان دوز را هر 6 تا 8 هفته 12.5 الي 25 ميكرو گرم افزايش داد.

بزرگسالان: ابتدا 50-25 ميكروگرم خوراكي روزانه، سپس هر 8-4 هفته 25 ميكرو گرم اضافه كنيد تا به پاسخ دلخواه برسيد. دوز نگهدارنده 75 تا 200 ميكرو گرم روزانه است.

كودكان بزرگتر از 12 سال (رشد و بلوغ ناكافي) : 1.7-1.6 میکروگرم بر کیلوگرم خوراكي روزانه.

كودكان 6 تا 12 ساله: 100 تا 150 ميكروگرم يا 5-4 میکروگرم بر کیلوگرم خوراكي روزانه.

كودكان 1 تا 5 ساله: 75 تا 100 ميكروگرم يا 6-5 میکروگرم بر کیلوگرم خوراكي روزانه.

كودكان 6 تا يك سال: 50 تا 75 ميكرو گرم يا 8-6 میکروگرم بر کیلوگرم خوراكي روزانه.

كودكان 3 تا 6 ماهه: 25 تا 50 ميكرو گرم يا 10-8 میکروگرم بر کیلوگرم خوراكي روزانه.

كودكان كوچكتر از سه ماه: 15-10 میکروگرم بر کیلوگرم خوراكي روزانه.

ب) کوماي ميگزدم

یوتیروکس برداشت يد راديواكتيو (I131) توسط تيروئيد، غلظت يد پيوند يافته به پروتئين و برداشت ليوتيرونين را تغيير مي‌دهد.


توجه: در صورت بروز واكنشهاي آلرژيك يا علائم پر‌كاري تيروئيد، بايد مصرف دارو قطع شود.

تظاهرات باليني مسمومیت با یوتیروکس عبارتند از كاهش وزن، افزايش اشتها، طپش قلب، عصبانيت، اسهال، كرامپهاي شكمي، تعريق، تاكيكاردي، افزايش فشار خون، زياد شدن فشار نبض، آنژين، آريتمي قلبي، لرزش، سردرد، بي خوابي، عدم تحمل گرما، تب، بي نظمي قاعدگي.

درمان مسمومیت با یوتیروکس شامل كاهش جذب گوارش و خنثي كردن اثرات مركزي و محيطي دارو و عمدتاً فعاليت سمپاتيك آن مي‌شود. معده را شستشو داده يا ايجاد استفراغ مي‌كنند و به دنبال آن تا چهار ساعت بعد از بلع دارو به بيمار ذغال فعال مي‌دهند. در صورت بيهوش بودن بيمار، يا بروز حملات تشنجي، بايد از بروز آسپيراسيون جلوگيري كرد. براي حمايت تنفسي مي‌توان از اكسيژن يا تنفس مصنوعي استفاده كرد. همچنين، نارسايي احتقاني قلب و تب و زيادي قند خون را درمان، و كاهش مايعات بدن را جبران كرد. پروپرانولول (يا مهار كننده ديگر گيرنده بتا) ممكن است براي مقابله با بسياري از اثرات ناشي از افزايش فعاليت سمپاتيك به كار رود. مصرف یوتیروکس بايد طي 6-2 روز به تدريج كاهش يابد و سپس با مقدار كمتري مجدداً شروع مي‌شود.



بیشتر بخوانید:


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تیروئید همراه با یک رژیم غذایی مناسب و تاثیر گذار

با رعایت این نکات دیگر نیازی به عمل تیروئید نیست




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© تمامی حقوق این سایت برای شرکت آرادپرداز محفوظ است ؛ هر گونه استفاده از مطالب دلگرم با رعایت شرایط بازنشر امکان پذیر است.

مسئله‌ی مهم آن است که هرگز از سؤال‌کردن دست برندارید. برای هر حس کنجکاوی، یک پاسخ وجود دارد.

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لیست کامل

قرص euthyrox چیست

© Porseshkadeh.com

 

Euthyrox،
ساخت کشور آلمان، شرکت Merck

 

قرص لوتیروکسین سدیم با نام تجاری  Euthyrox برای تشخیص و درمان کم کاری تیروئید، پیشگیری و درمان گواتر و
سرطان تیروئید و نیز بررسی عملکرد تیروئید به کار می رود

قرص euthyrox چیست

موارد منع مصرف

این دارو در تیروتوکسیکوز، سابقه
پرکاری تیروئید، حساسیت به هورمون های تیروئیدی و بیماری های قلبی-عروقی( آنژین
صدری، آترواسکلروزیس، بیماری سرخک کرونر، زیادی فشار خون و انفارکتوس میوکارد)
نباید مصرف شود.

عوارض جانبی

معمولاً با مصرف مقادیر زیاد دارو
ایجاد شده و به صورت درد آنژینی، آریتمی قلبی، طپش قلب،
کرامپ های عضلانی، تاکی کاردی، اسهال، استفراغ، لرزش، بی قراری، تحریک
پذیری، بی خوابی، سردرد، گرگرفتگی، تعریق، کاهش وزن و ضعف عضلانی بروز می
نماید.

موارد احتیاط

در صورت تجویز
همزمان با داروهای ضد انعقاد، تنظیم مقدار مصرف آنها بر اساس زمان
پروترومبین لازم است. کلستیرامین سبب تأخیر و جلوگیری از جذب دارو می شود،
بنابراین بین تجویز دو دارو باید 5-4 ساعت فاصله باشد. مصرف همزمان با
داروهای مقلد سمپاتیک اثر دارو را زیاد می کند و در افراد مبتلا به بیماری
سرخگ کرونر که داروی مقلد سمپاتیک دریافت میکنند، خطر تشدید بیماری کرونر
وجود دارد.

اشکال دارویی

قرص 75،100،125،150، 50 میکروگرم

 

سلام من کم داری تیروئید دارم و دکتر
حدود سه ماه است برای من  Euthyrox100 تجویز
کرده هفته ای دو روز نصف و بقیه 
روزها رو یک عدد می خورم. مدتی هست که دچار خارش بدن شدم آیا می تواند
حساسیت به این دارو باشد؟

سلام

من این دارو رو برای لاغری میخورم ایا اثر داره یا نه ؟

Generic Name: levothyroxine (LEE voe thye ROX een)Brand Names: Euthyrox

Medically reviewed by Drugs.com. Last updated on Sep 26, 2018.

Euthyrox (levothyroxine) is a replacement for a hormone normally produced by your thyroid gland to regulate the body’s energy and metabolism. Levothyroxine is given when the thyroid does not produce enough of this hormone on its own.

Euthyrox treats hypothyroidism (low thyroid hormone).

Euthyrox is also used to treat or prevent goiter (enlarged thyroid gland), which can be caused by hormone imbalances, radiation treatment, surgery, or cancer.

قرص euthyrox چیست

You may not be able to take Euthyrox if you have certain medical conditions. Tell your doctor if you have an untreated or uncontrolled adrenal gland disorder, a thyroid disorder called thyrotoxicosis, or if you have any recent or current symptoms of a heart attack.

Euthyrox should not be used to treat obesity or weight problems. Dangerous side effects or death can occur from the misuse of levothyroxine, especially if you are taking any other weight-loss medications or appetite suppressants.

Since thyroid hormone occurs naturally in the body, almost anyone can take levothyroxine. However, you may not be able to take Euthyrox if you have certain medical conditions. Tell your doctor if you have:

an untreated or uncontrolled adrenal gland disorder;

a thyroid disorder called thyrotoxicosis; or

symptoms of a heart attack (chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling).

To make sure Euthyrox is safe for you, tell your doctor if you have ever had:

a thyroid nodule;

heart disease, a blood clot, or a blood-clotting disorder;

diabetes (insulin or oral diabetes medication doses may need to be changed when you start taking Euthyrox);

kidney disease;

anemia (lack of red blood cells);

osteoporosis, or low bone mineral density;

problems with your pituitary gland; or

any food or drug allergies.

Tell your doctor if you have recently received radiation therapy with iodine (such as I-131).

If you become pregnant while taking Euthyrox, do not stop taking the medicine without your doctor’s advice. Having low thyroid hormone levels during pregnancy could harm both mother and baby. Your dose needs may be different during pregnancy.

Tell your doctor if you are breast-feeding. Your dose needs may be different while you are nursing.

Do not give Euthyrox to a child without medical advice. Tirosint is not approved for use by anyone younger than 6 years old.

Take Euthyrox exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Euthyrox works best if you take it on an empty stomach, at least 30 minutes before breakfast. Follow your doctor’s dosing instructions and try to take the medicine at the same time each day.

Swallow the tablet whole, with a full glass (8 ounces) of water. The tablet may dissolve very quickly and could swell in your throat.

Levothyroxine doses are based on weight in children. Your dose needs may change if you gain or lose weight.

It may take several weeks before your body starts to respond to levothyroxine. Keep using Euthyrox even if you feel well. You may need to use Euthyrox for the rest of your life.

You may need frequent medical tests. Tell any doctor, dentist, or surgeon who treats you that you are using levothyroxine.

Store at room temperature away from moisture and heat.

Do not share Euthyrox with another person, even if they have the same symptoms you have.

Usual Adult Dose of Euthyrox for Hypothyroidism:

-HYPOTHYROIDISM IN ADULTS AND IN CHILDREN IN WHOM GROWTH AND PUBERTY ARE COMPLETE:
Therapy may begin at full replacement doses in otherwise healthy individuals less than 50 years old and in those older than 50 years who have been recently treated for hyperthyroidism or who have been hypothyroid for only a short time (such as a few months):
Average full replacement dose: 1.7 mcg/kg/day (e.g., 100 to 125 mcg/day for a 70 kg adult) orally
Older patients may require less than 1 mcg/kg/day
Doses greater than 200 mcg/day orally are seldom required
An inadequate response to oral daily doses of 300 mcg/day or greater is rare and may indicate poor compliance, malabsorption, and/or drug interactions
-FOR MOST PATIENTS OLDER THAN 50 YEARS OR FOR PATIENTS UNDER 50 YEARS OF AGE WITH UNDERLYING CARDIAC DISEASE:
-Initial dose: 25 to 50 mcg/day, with gradual increments in dose at 6 to 8 week intervals, as needed
-PATIENTS WITH SEVERE HYPOTHYROIDISM:
-Initial dose: 12.5 to 50 mcg orally once a day; dosage can be increased in 12.5 to 25 mcg/day increments every 2 to 4 weeks (accompanied by clinical and laboratory assessment, until the TSH level is normalized)
-PATIENTS WITH SECONDARY (PITUITARY) OR TERTIARY (HYPOTHALAMIC) HYPOTHYROIDISM: The oral dose should be titrated until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.

Usual Adult Dose of Euthyrox for Myxedema Coma:

Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of the oral dosage form of this drug from the GI. Only the IV dosage form should be used for this condition:
IV:
-Initial loading dose: 300 to 500 mcg IV
-Maintenance dose: 50 and 100 mcg IV, until the patient can tolerate oral therapy.

Usual Geriatric Dose of Euthyrox for Hypothyroidism:

ELDERLY PATIENTS WITH CARDIAC DISEASE:
-Initial dose: 12.5 to 25 mcg orally per day, with gradual dose increments at 4 to 6 week intervals
-The dose is generally adjusted in 12.5 to 25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.

Usual Pediatric Dose of Euthyrox for Hypothyroidism:

CONGENITAL OR ACQUIRED HYPOTHYROIDISM:
-Neonatal: 10 to 15 mcg/kg/day; if patient is at risk for development of cardiac failure, begin with a lower dose. In severe cases of hypothyroidism (T4 less than 5 mcg/dL), a higher initial dose of 12 to 17 mcg/kg/day may be considered.
-Age 0 to 3 months: 10 to 15 mcg/kg orally once per day; if the infant is at risk for development of cardiac failure use a lower starting dose of approximately 25 mcg per day; if the initial serum T4 is very low (less than 5 mcg/dL) begin treatment at a higher dosage of approximately 50 mcg per day
-Age 3 to 6 months: 8 to 10 mcg/kg/day
-Age 6 to 12 months: 6 to 8 mcg/kg/day
-Age 1 to 5 years: 5 to 6 mcg/kg/day
-Age 6 to 12 years: 4 to 5 mcg/kg/day
-Age 12 years and older: 2 to 3 mcg/kg/day
-Patients in which growth and puberty are complete: 1.7 mcg/kg/day

For chronic or severe hypothyroidism: 25 mcg orally once per day and increase dosage as needed in increments of 25 mcg every 2 to 4 weeks until the desired effect is achieved.

قرص euthyrox چیست

Euthyrox dosage information (in more detail)

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, leg cramps, tremors, feeling nervous or irritable, chest pain, shortness of breath, and fast or pounding heartbeats.

Avoid the following food products, which can make your body absorb less levothyroxine: grapefruit juice, infant soy formula, soybean flour, cotton seed meal, walnuts, and high-fiber foods.

Get emergency medical help if you have signs of an allergic reaction to Euthyrox: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

irregular heart rate;

chest pain, feeling short breath;

fever, hot flashes, sweating;

feeling unusually cold;

weakness, tiredness, sleep problems (insomnia);

memory problems, feeling depressed or irritable;

headache, leg cramps, muscle aches;

feeling nervous or irritable;

dryness of your skin or hair, hair loss;

changes in your menstrual periods; or

vomiting, diarrhea, appetite changes, weight changes.

Certain side effects may be more likely in older adults.

Common Euthyrox side effects may include:

muscle weakness;

headache, leg cramps;

tremors, nervousness, trouble sleeping;

diarrhea; or

skin rash, mild hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Euthyrox side effects (in more detail)

Many other medicines can be affected by your thyroid hormone levels. Certain other medicines may also increase or decrease the effects of Euthyrox.

Certain medicines can make levothyroxine less effective if taken at the same time. If you use any of the following drugs, avoid taking them within 4 hours before or 4 hours after you take Euthyrox:

calcium carbonate (Alka-Mints, Caltrate, Os-Cal, Oyster Shell Calcium, Rolaids Soft Chew, Tums, and others);

cholestyramine, colesevelam, colestipol;

ferrous sulfate iron supplement;

sucralfate;

sodium polystyrene sulfonate (Kalexate, Kayexalate, Kionex);

stomach acid reducers – esomeprazole, lansoprazole, omeprazole, rabeprazole, Nexium, Prilosec, Prevacid, Protonix, Zegerid, and others; or

antacids that contain aluminum or magnesium – Gaviscon, Maalox, Milk of Magnesia, Mintox, Mylanta, Pepcid Complete, and others.

Many drugs can interact with levothyroxine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Euthyrox drug interactions (in more detail)

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Euthyrox only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2019 Cerner Multum, Inc. Version: 12.04.

Medical Disclaimer

Other brands: Synthroid, Tirosint, Levoxyl, Levothroid, … +2 more

levothyroxine, Synthroid, Armour Thyroid, Tirosint, liothyronine, Levoxyl, Cytomel, NP Thyroid


Euthyrox reviews

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Updated

December 7, 2018

If you are a consumer or patient please visit this version.

EUTHYROX is L-thyroxine (T4) indicated in pediatric and adult patients for:

Limitations of Use:

قرص euthyrox چیست

– Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. (1)

– Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. (1)

Tablets: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg (3)

Adverse reactions associated with EUTHYROX are primarily those of hyperthyroidism due to therapeutic overdosage: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Provell Pharmaceuticals, LLC at 1-888-899-7041 or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.

See full prescribing information for drugs that affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to EUTHYROX. (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2018

Hypothyroidism

EUTHYROX is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression

EUTHYROX is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Limitations of Use:

Administer EUTHYROX tablets orally as a single daily dose, on an empty stomach, one-half to one hour before breakfast.

Administer EUTHYROX at least 4 hours before or after drugs known to interfere with EUTHYROX absorption [see Drug Interactions (7.1)].

Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect EUTHYROX absorption [see Drug Interactions (7.9), Clinical Pharmacology (12.3)].

Administer EUTHYROX to infants and children who cannot swallow intact tablets by crushing the tablet, suspending the freshly crushed tablet in a small amount (5 mL to 10 mL or 1 teaspoon to 2 teaspoons) of water and immediately administering the suspension by spoon or dropper. Do not store the suspension. Do not administer in foods that decrease absorption of EUTHYROX, such as soybean-based infant formula [see Drug Interactions (7.9)].

The dose of EUTHYROX for hypothyroidism or pituitary TSH suppression depends on a variety of factors including: the patient’s age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food and the specific nature of the condition being treated [see Dosage and Administration (2.3), Warnings and Precautions (5), Drug Interactions (7)]. Dosing must be individualized to account for these factors and dose adjustments made based on periodic assessment of the patient’s clinical response and laboratory parameters [see Dosage and Administration (2.4)].

The peak therapeutic effect of a given dose of EUTHYROX may not be attained for 4 to 6 weeks.

Primary Hypothyroidism in Adults and in Adolescents in Whom Growth and Puberty Are Complete

Start EUTHYROX at the full replacement dose in otherwise healthy, non-elderly individuals who have been hypothyroid for only a short time (such as a few months). The average full replacement dose of EUTHYROX is approximately 1.6 mcg per kg per day (for example: 100 mcg per day to 125 mcg per day for a 70 kg adult).

Adjust the dose by 12.5 mcg to 25 mcg increments every 4 to 6 weeks until the patient is clinically euthyroid and the serum TSH returns to normal. Doses greater than 200 mcg per day are seldom required. An inadequate response to daily doses of greater than 300 mcg per day is rare and may indicate poor compliance, malabsorption, drug interactions, or a combination of these factors.

For elderly patients or patients with underlying cardiac disease, start with a dose of 12.5 mcg per day to 25 mcg per day. Increase the dose every 6 to 8 weeks, as needed until the patient is clinically euthyroid and the serum TSH returns to normal. The full replacement dose of EUTHYROX may be less than 1 mcg per kg per day in elderly patients.

In patients with severe longstanding hypothyroidism, start with a dose of 12.5 mcg per day to 25 mcg per day. Adjust the dose in 12.5 mcg to 25 mcg increments every 2 to 4 weeks until the patient is clinically euthyroid and the serum TSH level is normalized.

Secondary or Tertiary Hypothyroidism

قرص euthyrox چیست

Start EUTHYROX at the full replacement dose in otherwise healthy, non-elderly individuals. Start with a lower dose in elderly patients, patients with underlying cardiovascular disease or patients with severe longstanding hypothyroidism as described above. Serum TSH is not a reliable measure of EUTHYROX dose adequacy in patients with secondary or tertiary hypothyroidism and should not be used to monitor therapy. Use the serum free-T4 (L-thyroxine) level to monitor adequacy of therapy in this patient population. Titrate EUTHYROX dosing per above instructions until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.

Pediatric Dosage – Congenital or Acquired Hypothyroidism

The recommended daily dose of EUTHYROX in pediatric patients with hypothyroidism is based on body weight and changes with age as described in Table 1. Start EUTHYROX at the full daily dose in most pediatric patients. Start at a lower starting dose in newborns (0 to 3 months) at risk for cardiac failure and in children at risk for hyperactivity (see below). Monitor for clinical and laboratory response [see Dosage and Administration (2.4)].

Newborns (0 to 3 months) at Risk for Cardiac Failure:

Consider a lower starting dose in newborns at risk for cardiac failure. Increase the dose every 4 to 6 weeks as needed based on clinical and laboratory response.

Pediatric Patients at Risk for Hyperactivity:

To minimize the risk of hyperactivity in pediatric patients, start at one-fourth the recommended full replacement dose, and increase on a weekly basis by one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.

Pregnancy

Pre-existing Hypothyroidism: EUTHYROX dose requirements may increase during pregnancy. Measure serum TSH and free-T4 as soon as pregnancy is confirmed and, at a minimum, during each trimester of pregnancy. In patients with primary hypothyroidism, maintain serum TSH in the trimester-specific reference range. For patients with serum TSH above the normal trimester-specific range, increase the dose of EUTHYROX by 12.5 mcg daily to 25 mcg daily and measure TSH every 4 weeks until a stable EUTHYROX dose is reached and serum TSH is within the normal trimester-specific range. Reduce EUTHYROX dosage to pre-pregnancy levels immediately after delivery and measure serum TSH levels 4 to 8 weeks postpartum to ensure EUTHYROX dose is appropriate.

New Onset Hypothyroidism: Normalize thyroid function as rapidly as possible. In patients with moderate to severe signs and symptoms of hypothyroidism, start EUTHYROX at the full replacement dose (1.6 mcg per kg body weight per day). In patients with mild hypothyroidism (TSH less than 10 mIU per liter) start EUTHYROX at 1 mcg per kg body weight per day. Evaluate serum TSH every 4 weeks and adjust EUTHYROX dosage until a serum TSH is within the normal trimester-specific range [see Use in Specific Populations (8.1)].

TSH Suppression in Well-Differentiated Thyroid Cancer

The dose of EUTHYROX should target TSH levels within the desired therapeutic range. This may require a EUTHYROX dose of greater than 2 mcg per kg per day, depending on the target level for TSH suppression.

Assess the adequacy of therapy by periodic assessment of laboratory tests and clinical evaluation. Persistent clinical and laboratory evidence of hypothyroidism despite an apparent adequate replacement dose of EUTHYROX may be evidence of inadequate absorption, poor compliance, drug interactions, or a combination of these factors.

Adults

In adult patients with primary hypothyroidism, monitor serum TSH levels after an interval of 6 to 8 weeks after any change in dose. In patients on a stable and appropriate replacement dose, evaluate clinical and biochemical response every 6 to 12 months and whenever there is a change in the patient’s clinical status.

Pediatrics

In patients with congenital hypothyroidism, assess the adequacy of replacement therapy by measuring both serum TSH and total or free-T4. Monitor TSH and total or free-T4 in children as follows: 2 and 4 weeks after the initiation of treatment, 2 weeks after any change in dosage, and then every 3 to 12 months thereafter following dose stabilization until growth is completed. Poor compliance or abnormal values may necessitate more frequent monitoring. Perform routine clinical examination, including assessment of development, mental and physical growth, and bone maturation, at regular intervals.

While the general aim of therapy is to normalize the serum TSH level, TSH may not normalize in some patients due to in utero hypothyroidism causing a resetting of pituitary-thyroid feedback. Failure of the serum T4 to increase into the upper half of the normal range within 2 weeks of initiation of EUTHYROX therapy and/or of the serum TSH to decrease below 20 mIU per liter within 4 weeks may indicate the child is not receiving adequate therapy. Assess compliance, dose of medication administered, and method of administration prior to increasing the dose of EUTHYROX [see Warnings and Precautions (5.4) and Use in Specific Populations (8.4)])].

Secondary and Tertiary Hypothyroidism

Monitor serum free-T4 levels and maintain in the upper half of the normal range in these patients.

EUTHYROX tablets are uncoated, off-white, round and flat on both sides with a beveled edge, and a dividing score on both sides available as:

EUTHYROX is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)].

Overtreatment with levothyroxine may cause an increase in heart rate, cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias, particularly in patients with cardiovascular disease and in elderly patients. Initiate EUTHYROX therapy in this population at lower doses than those recommended in younger individuals or in patients without cardiac disease [see Dosage and Administration (2.3), Use in Specific Populations (8.5)].

Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive EUTHYROX therapy. Monitor patients receiving concomitant EUTHYROX and sympathomimetic agents for signs and symptoms of coronary insufficiency. If cardiovascular symptoms develop or worsen, reduce or withhold the EUTHYROX dose for one week and restart at a lower dose.

Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Use of oral thyroid hormone drug products is not recommended to treat myxedema coma. Administer thyroid hormone products formulated for intravenous administration to treat myxedema coma.

Thyroid hormone increases metabolic clearance of glucocorticoids. Initiation of thyroid hormone therapy prior to initiating glucocorticoid therapy may precipitate an acute adrenal crisis in patients with adrenal insufficiency. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with EUTHYROX [see Contraindications (4)].

EUTHYROX has a narrow therapeutic index. Over- or under-treatment with EUTHYROX may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and on glucose and lipid metabolism. Titrate the dose of EUTHYROX carefully and monitor response to titration to avoid these effects [see Dosage and Administration (2.4)]. Monitor for the presence of drug or food interactions when using EUTHYROX and adjust the dose as necessary [see Drug Interactions (7), Clinical Pharmacology (12.3)].

Addition of levothyroxine therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing EUTHYROX [see Drug Interactions (7.2)].

Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in post-menopausal women. The increased bone resorption may be associated with increased serum levels and urinary excretion of calcium and phosphorous, elevations in bone alkaline phosphatase, and suppressed serum parathyroid hormone levels. Administer the minimum dose of EUTHYROX that achieves the desired clinical and biochemical response to mitigate against this risk.

Adverse reactions associated with EUTHYROX therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5), Overdosage (10)]. They include the following:

Seizures have been reported rarely with levothyroxine therapy.

Adverse Reactions in Pediatric Patients

Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in pediatric patients receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in pediatric patients with resultant compromised adult height.

Hypersensitivity Reactions

Hypersensitivity reactions to inactive ingredients have occurred in patients treated with thyroid hormone products. These include urticaria, pruritus, skin rash, flushing, angioedema, various gastrointestinal symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness and wheezing. Hypersensitivity to levothyroxine itself is not known to occur.

Many drugs can exert effects on thyroid hormone pharmacokinetics (e.g. absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to EUTHYROX (see Tables 2 – 5).

Addition of EUTHYROX therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control, especially when EUTHYROX is started, changed, or discontinued [see Warnings and Precautions (5.5)].

EUTHYROX increases the response to oral anticoagulant therapy. Therefore, a decrease in the dose of anticoagulant may be warranted with correction of the hypothyroid state or when the EUTHYROX dose is increased. Closely monitor coagulation tests to permit appropriate and timely dosage adjustments.

EUTHYROX may reduce the therapeutic effects of digitalis glycosides. Serum digitalis glycoside levels may decrease when a hypothyroid patient becomes euthyroid, necessitating an increase in the dose of digitalis glycosides.

Concurrent use of tricyclic (e.g., amitriptyline) or tetracyclic (e.g., maprotiline) antidepressants and EUTHYROX may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines. Toxic effects may include increased risk of cardiac arrhythmias and central nervous system stimulation. EUTHYROX may accelerate the onset of action of tricyclics. Administration of sertraline in patients stabilized on EUTHYROX may result in increased EUTHYROX requirements.

Concurrent use of ketamine and EUTHYROX may produce marked hypertension and tachycardia. Closely monitor blood pressure and heart rate in these patients.

Concurrent use of sympathomimetics and EUTHYROX may increase the effects of sympathomimetics or thyroid hormone. Thyroid hormones may increase the risk of coronary insufficiency when sympathomimetic agents are administered to patients with coronary artery disease.

Concurrent use of tyrosine-kinase inhibitors such as imatinib may cause hypothyroidism. Closely monitor TSH levels in such patients.

Consumption of certain foods may affect EUTHYROX absorption thereby necessitating adjustments in dosing [see Dosage and Administration (2.1)]. Soybean flour (infant formula), cottonseed meal, walnuts, and dietary fiber may bind and decrease the absorption of EUTHYROX from the gastrointestinal tract. Grapefruit juice may delay the absorption of levothyroxine and reduce its bioavailability.

Consider changes in TBG concentration when interpreting T4 and T3 values. Measure and evaluate unbound (free) hormone and/or determine the free-T4 index (FT4I) in this circumstance. Pregnancy, infectious hepatitis, estrogens, estrogen containing oral contraceptives, and acute intermittent porphyria increase TBG concentrations. Nephrosis, severe hypoproteinemia, severe liver disease, acromegaly, androgens and corticosteroids decrease TBG concentration. Familial hyper- or hypo-thyroxine binding globulinemias have been described, with the incidence of TBG deficiency approximating 1 in 9000.

Risk Summary

Experience with levothyroxine use in pregnant women, including data from post-marketing studies, have not reported increased rates of major birth defects or miscarriages (see Data). There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. Since thyroid-stimulating hormone (TSH) levels may increase during pregnancy, TSH should be monitored and EUTHYROX dosage adjusted during pregnancy (see Clinical Considerations). There are no animal studies conducted with levothyroxine during pregnancy. EUTHYROX should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

Maternal hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, gestational hypertension, pre-eclampsia, stillbirth, and premature delivery. Untreated maternal hypothyroidism may have an adverse effect on fetal neurocognitive development.

Dose Adjustments During Pregnancy and Postpartum Period

Pregnancy may increase EUTHYROX requirements. Serum TSH level should be monitored and the EUTHYROX dosage adjusted during pregnancy. Since postpartum TSH levels are similar to preconception values, the EUTHYROX dosage should return to the pre-pregnancy dose immediately after delivery [see Dosage and Administration (2.3)].

Data

Human Data

Levothyroxine is approved for use as a replacement therapy for hypothyroidism. There is a long experience of levothyroxine use in pregnant women, including data from post-marketing studies that have not reported increased rates of fetal malformations, miscarriages or other adverse maternal or fetal outcomes associated with levothyroxine use in pregnant women.

Risk Summary

Limited published studies report that levothyroxine is present in human milk. However, there is insufficient information to determine the effects of levothyroxine on the breastfed infant and no available information on the effects of levothyroxine on milk production. Adequate levothyroxine treatment during lactation may normalize milk production in hypothyroid lactating mothers. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EUTHYROX and any potential adverse effects on the breastfed infant from EUTHYROX or from the underlying maternal condition.

The initial dose of EUTHYROX varies with age and body weight. Dosing adjustments are based on an assessment of the individual patient’s clinical and laboratory parameters [see Dosage and Administration (2.3,2.4)].

In children in whom a diagnosis of permanent hypothyroidism has not been established, discontinue EUTHYROX administration for a trial period, but only after the child is at least 3 years of age. Obtain serum T4 and TSH levels at the end of the trial period, and use laboratory test results and clinical assessment to guide diagnosis and treatment, if warranted.

Congenital Hypothyroidism [see Dosage and Administration (2.3,2.4)]

Rapid restoration of normal serum T4 concentrations is essential for preventing the adverse effects of congenital hypothyroidism on intellectual development as well as on overall physical growth and maturation. Therefore, initiate EUTHYROX therapy immediately upon diagnosis. Levothyroxine is generally continued for life in these patients.

Closely monitor infants during the first 2 weeks of EUTHYROX therapy for cardiac overload, arrhythmias, and aspiration from avid suckling.

Closely monitor patients to avoid undertreatment or overtreatment. Undertreatment may have deleterious effects on intellectual development and linear growth. Overtreatment has been associated with craniosynostosis in infants, may adversely affect the tempo of brain maturation, and accelerate the bone age, with resultant premature closure of the epiphyses and compromised adult stature.

Acquired Hypothyroidism in Pediatric Patients

Closely monitor patients to avoid undertreatment and overtreatment. Undertreatment may result in poor school performance due to impaired concentration and slowed mentation and in reduced adult height. Overtreatment may accelerate the bone age and result in premature epiphyseal closure and compromised adult stature.

Treated children may manifest a period of catch-up growth, which may be adequate in some cases to normalize adult height. In children with severe or prolonged hypothyroidism, catch-up growth may not be adequate to normalize adult height.

Because of the increased prevalence of cardiovascular disease among the elderly, initiate EUTHYROX at less than the full replacement dose [see Warnings and Precautions (5.1) and Dosage and Administration (2.3)]. Atrial arrhythmias can occur in elderly patients. Atrial fibrillation is the most common of the arrhythmias observed with levothyroxine overtreatment in the elderly.

The signs and symptoms of overdosage are those of hyperthyroidism [See Warnings and Precautions (5.4) and Adverse Reactions (6)]. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported. Seizures occurred in a 3 year-old child ingesting 3.6 mg levothyroxine. Symptoms may not necessarily be evident or may not appear until several days after ingestion of levothyroxine sodium.

Reduce the EUTHYROX dose or discontinue temporarily if signs or symptoms of overdosage occur. Initiate appropriate supportive treatment as dictated by the patient’s medical status.

For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.

EUTHYROX contains the active ingredient, levothyroxine, a synthetic crystalline levothyroxine (T4) in sodium salt form. It is chemically designated as L-3,3′,5,5′-tetraiodothyronine monosodium hydrate. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine sodium has the molecular formula C15H10I4NNaO4 ∙ xH2O, molecular weight of 798.85 (anhydrous), and structural formula as shown:

EUTHYROX tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, and 200 mcg. Inactive ingredients citric acid anhydrous, corn starch, gelatin, magnesium stearate, mannitol, sodium croscarmellose.

Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins.

The physiological actions of thyroid hormones are produced predominantly by T3, the majority of which (approximately 80%) is derived from T4 by deiodination in peripheral tissues.

Oral levothyroxine sodium is a synthetic T4 hormone that exerts the same physiologic effect as endogenous T4, thereby maintaining normal T4 levels when a deficiency is present.

Absorption

Absorption of orally administered T4 from the gastrointestinal tract ranges from 40% to 80%. The majority of the levothyroxine dose is absorbed from the jejunum and upper ileum. The relative bioavailability of EUTHYROX tablets, compared to an equal nominal dose of oral levothyroxine sodium solution, is approximately 99%. T4 absorption is increased by fasting, and decreased in malabsorption syndromes and by certain foods such as soybeans. Dietary fiber decreases bioavailability of T4. Absorption may also decrease with age. In addition, many drugs and foods affect T4 absorption [see Drug Interactions (7)].

Distribution

Circulating thyroid hormones are greater than 99% bound to plasma proteins, including thyroxine-binding globulin (TBG), thyroxine-binding prealbumin (TBPA), and thyroxine-binding albumin (TBA), whose capacities and affinities vary for each hormone. The higher affinity of both TBG and TBPA for T4 partially explains the higher serum levels, slower metabolic clearance, and longer half-life of T4 compared to T3. Protein-bound thyroid hormones exist in reverse equilibrium with small amounts of free hormone. Only unbound hormone is metabolically active. Many drugs and physiologic conditions affect the binding of thyroid hormones to serum proteins [see Drug Interactions (7)]. Thyroid hormones do not readily cross the placental barrier [see Use in Specific Populations (8.1)].

Elimination

Metabolism

T4 is slowly eliminated (Table 6). The major pathway of thyroid hormone metabolism is through sequential deiodination. Approximately 80% of circulating T3 is derived from peripheral T4 by monodeiodination. The liver is the major site of degradation for both T4 and T3, with T4 deiodination also occurring at a number of additional sites, including the kidney and other tissues. Approximately 80% of the daily dose of T4 is deiodinated to yield equal amounts of T3 and reverse T3 (rT3). T3 and rT3 are further deiodinated to diiodothyronine. Thyroid hormones are also metabolized via conjugation with glucuronides and sulfates and excreted directly into the bile and gut where they undergo enterohepatic recirculation.

Excretion

Thyroid hormones are primarily eliminated by the kidneys. A portion of the conjugated hormone reaches the colon unchanged and is eliminated in the feces. Approximately 20% of T4 is eliminated in the stool. Urinary excretion of T4 decreases with age.

Animal studies have not been performed to evaluate the carcinogenic potential, mutagenic potential, or effects on fertility of levothyroxine.

EUTHYROX (levothyroxine sodium) tablets are uncoated, off-white, round and flat on both sides with a beveled edge, and a dividing score on both sides available as:

Each carton contains 30 tablets with 2 blister packs. Each blister pack contains 15 tablets placed in individual cavities.

Store between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light and moisture, avoid heat. Do not separate the individual cavities containing the tablet from the intact blister and do not remove the individual tablets from blister packaging until ready to use.

Inform the patient of the following information to aid in the safe and effective use of EUTHYROX:

Dosing and Administration

Important Information

Adverse Reactions

Rx Only

Manufactured by: Merck KGaAFrankfurter Straße 25064293 Darmstadt, Germany

Marketed by: Provell Pharmaceuticals, LLC1801 Horseshoe Pike – Suite 1Honey Brook, PA 19344 US

Revised: 09/2018

Euthyrox® (levothyroxine sodium) tablets25 mcg per tablet, USP

Rx only

NDC 72305-025-30

Do not remove individual tablets from blister packaging until ready to use.

30 Tablets (2 x 15 tablets per blister pack)

PROVELL PHARMACEUTICALS LLC

Euthyrox® (levothyroxine sodium) tablets 50 mcg per tablet, USP

Rx only

NDC 72305-050-30

Do not remove individual tablets from blister packaging until ready to use.

30 Tablets (2 x 15 tablets per blister pack)

PROVELL PHARMACEUTICALS LLC

Euthyrox® (levothyroxine sodium) tablets 75 mcg per tablet, USP

Rx only

NDC 72305-075-30

Do not remove individual tablets from blister packaging until ready to use.

30 Tablets (2 x 15 tablets per blister pack)

PROVELL PHARMACEUTICALS LLC

Euthyrox® (levothyroxine sodium) tablets 88 mcg per tablet, USP

Rx only

NDC 72305-088-30

Do not remove individual tablets from blister packaging until ready to use.

30 Tablets (2 x 15 tablets per blister pack)

PROVELL PHARMACEUTICALS LLC

Euthyrox® (levothyroxine sodium) tablets 100 mcg per tablet, USP

Rx only

NDC 72305-100-30

Do not remove individual tablets from blister packaging until ready to use.

30 Tablets (2 x 15 tablets per blister pack)

PROVELL PHARMACEUTICALS LLC

Euthyrox® (levothyroxine sodium) tablets 112 mcg per tablet, USP

Rx only

NDC 72305-112-30

Do not remove individual tablets from blister packaging until ready to use.

30 Tablets (2 x 15 tablets per blister pack)

PROVELL PHARMACEUTICALS LLC

Euthyrox® (levothyroxine sodium) tablets 125 mcg per tablet, USP

Rx only

NDC 72305-125-30

Do not remove individual tablets from blister packaging until ready to use.

30 Tablets (2 x 15 tablets per blister pack)

PROVELL PHARMACEUTICALS LLC

Euthyrox® (levothyroxine sodium) tablets 137 mcg per tablet, USP

Rx only

NDC 72305-137-30

Do not remove individual tablets from blister packaging until ready to use.

30 Tablets (2 x 15 tablets per blister pack)

PROVELL PHARMACEUTICALS LLC

Euthyrox® (levothyroxine sodium) tablets 150 mcg per tablet, USP

Rx only

NDC 72305-150-30

Do not remove individual tablets from blister packaging until ready to use.

30 Tablets (2 x 15 tablets per blister pack)

PROVELL PHARMACEUTICALS LLC

Euthyrox® (levothyroxine sodium) tablets 175 mcg per tablet, USP

Rx only

NDC 72305-175-30

Do not remove individual tablets from blister packaging until ready to use.

30 Tablets (2 x 15 tablets per blister pack)

PROVELL PHARMACEUTICALS LLC

Euthyrox® (levothyroxine sodium) tablets 200 mcg per tablet, USP

Rx only

NDC 72305-200-30

Do not remove individual tablets from blister packaging until ready to use.

30 Tablets (2 x 15 tablets per blister pack)

PROVELL PHARMACEUTICALS LLC

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