Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
PROPYLTHIOURACIL (UNII: 721M9407IY) (PROPYLTHIOURACIL - UNII:721M9407IY)
Rebel Distributors Corp.
PROPYLTHIOURACIL
PROPYLTHIOURACIL 50 mg
ORAL
PRESCRIPTION DRUG
Propylthiouracil is indicated: - in patients with Graves' disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option. - to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole. Propylthiouracil is contraindicated in patients who have demonstrated hypersensitivity to the drug or any of the other product components.
Propylthiouracil Tablets, USP, 50 mg: White, Round, Scored Tablet, Debossed “West-ward 480”. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Reference: Manufactured By: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised August 2011 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
Abbreviated New Drug Application
Rebel Distributors Corp. ---------- MEDICATION GUIDE PROPYLTHIOURACIL TABLETS, USP (Pro-pil-thi-o-ur-a-sil) Read this Medication Guide before you start taking Propylthiouracil and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. What is the most important information I should know about Propylthiouracil? Propythiouracil can cause serious side effects, including: Severe liver problems. In some cases, these liver problems can lead to liver failure, the need for liver transplant, or death. Stop taking Propylthiouracil and call your doctor right away if you have: • fever • loss of appetite • nausea • vomiting • tiredness • itchiness • pain or tenderness in your right upper stomach area (abdomen) • dark (tea colored) urine • pale or light colored bowel movements (stools) • yellowing of your skin or whites of your eyes What is Propylthiouracil? Propylthiouracil is a prescription medicine used to treat people who have Graves' disease with hyperthyroidism or toxic multinodular goiter. Propylthiouracil is used when: • certain other antithyroid medicines do not work well. • thyroid surgery or radioactive iodine therapy is not a treatment option. • to decrease symptoms of hyperthyroidism in preparation for a thyroidectomy (removal of the thyroid gland) or radioactive iodine therapy. Propylthiouracil is not recommended for use in children. Propylthiouracil may be used when an antithyroid drug is needed during or just before the first trimester of pregnancy. Who should not take Propylthiouracil? Do not take Propylthiouracil if you are allergic to Propylthiouracil or any of its ingredients. See the end of this Medication Guide for a complete list of ingredients in Propylthiouracil. What should I tell my doctor before taking Propylthiouracil? Before you take Propylthiouracil, tell your doctor if you: • plan to have surgery. • have any other medical conditions. • are pregnant Přečtěte si celý dokument
PROPYLTHIOURACIL- PROPYLTHIOURACIL TABLET REBEL DISTRIBUTORS CORP. ---------- PROPYLTHIOURACIL TABLETS, USP Rev. 08/11 RX ONLY BOXED WARNING WARNING: Severe liver injury and acute liver failure, in some cases fatal, have been reported in patients treated with propylthiouracil. These reports of hepatic reactions include cases requiring liver transplantation in adult and pediatric patients. Propylthiouracil should be reserved for patients who can not tolerate methimazole and in whom radioactive iodine therapy or surgery are not appropriate treatments for the management of hyperthyroidism. Because of the risk of fetal abnormalities associated with methimazole, proplythiouracil may be the treatment of choice when an antithyroid drug is indicated during or just prior to the first trimester of pregnancy (see WARNINGS AND PRECAUTIONS). DESCRIPTION: Propylthiouracil (6-propyl-2-thiouracil) is one of the thiocarbamide compounds. It is a white, crystalline substance that has a bitter taste and is very slightly soluble in water. Propylthiouracil is an antithyroid drug administered orally. The structural formula is: Each tablet contains propylthiouracil 50 mg and the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. CLINICAL PHARMACOLOGY: Propylthiouracil inhibits the synthesis of thyroid hormones and thus is effective in the treatment of hyperthyroidism. The drug does not inactivate existing thyroxine and triodothyronine that are stored in the thyroid or circulating in the blood, nor does it interfere with the effectiveness of thyroid hormones given by mouth or by injection. Propylthiouracil inhibits the conversation of thyroxine to triiodothyronine to peripheral tissues and may therefore be an effective treatment for thyroid storm. Propylthiouracil is readily absorbed and is extensively metabolized. Approximately 35% of the drug is excreted in the urine, in intact and in conjugated forms, within 24 hours. INDICATIONS AND US Přečtěte si celý dokument