Drug Catalog - Product Detail
METHIMAZOLE TB 5MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 64980-0260-01 | RISING PHARMACEUTICALS | 100 | 5MG | TABLET |
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Description
DESCRIPTION Methimazole (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, corn 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: Methimazole Structural Formula
How Supplied
HOW SUPPLIED Methimazole tablets, USP are available in: Methimazole Tablets, USP 5 mg - white to off-white, round, flat-faced, bevelled-edged tablets, scored with “EM/5” on one side and plain on the other. Bottles of 100 NDC 64980-260-01 Methimazole Tablets, USP 10 mg - white to off-white, round, flat-faced, bevelled-edged tablets, scored with “EM/10” on one side and plain on the other. Bottles of 100 NDC 64980-261-01 STORAGE Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container. Manufactured by: Appco Pharma LLC Piscataway, NJ 08854 Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Revised. Jan 2020
Indications & Usage
INDICATIONS AND USAGE Methimazole tablets are 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 tablets are 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.