RVP

Drug Catalog - Product Detail

METHIMAZOLE 5MG TB 100

NDC Mfr Size Str Form
51293-0820-01 ECI PHARMACEUTICALS 100 5MG TABLET
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Description
DESCRIPTION Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 or 10 mg (43.8 or 87.6 μmol) methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, potato starch and talc. The molecular weight is 114.16, and the molecular formula is C 4 H 6 N 2 S. The structural formula is as follows: Chemical Structure
How Supplied
HOW SUPPLIED Methimazole Tablets, USP 5 mg white, round, flat-faced, beveled-edged tablets with “VM” on one side and scored on the other. They are available in: Bottles of 100 NDC 51293-820-01 Methimazole Tablets, USP 10 mg white, round, flat-faced, beveled-edged tablets with “XM” on one side and scored on the other. They are available in: Bottles of 100 NDC 51293-821-01 Store at controlled room temperature, 20°- 25°C (68°- 77°F). Dispense in a tight, light-resistant container. To report suspected adverse event: contact ECI Pharmaceuticals LLC at 1-888-514-4727. Manufactured for ECI Pharmaceuticals, LLC Fort Lauderdale, FL 33309 REV 07/16
Indications & Usage
INDICATIONS AND USAGE Methimazole is indicated: In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter 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
Dosage and Administration
DOSAGE AND ADMINISTRATION Methimazole is administered orally. The total daily dosage is usually given in 3 divided doses at approximately 8-hour intervals. Adult - The initial daily dosage is 15 mg for mild hyperthyroidism, 30 to 40 mg for moderately severe hyperthyroidism, and 60 mg for severe hyperthyroidism, divided into 3 doses at 8-hour intervals. The maintenance dosage is 5 to 15 mg daily. Pediatric - Initially, the daily dosage is 0.4 mg/kg of body weight divided into 3 doses and given at 8-hour intervals. The maintenance dosage is approximately 1/2 of the initial dose.