TAPAZOLE- methimazole tablet
King Pharmaceuticals, Inc.
DESCRIPTION
TAPAZOLE� (Methimazole Tablets, 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 �mol) methimazole, an orally administered antithyroid drug.
Each tablet also contains lactose monohydrate, magnesium stearate, starch (corn), pregelatinized starch and talc.
The molecular weight is 114.16, and the molecular formula is C4 H6 N2
CLINICAL PHARMACOLOGY
Methimazole inhibits the synthesis of thyroid hormones and thus is effective in the treatment of hyperthyroidism. The drug does not inactivate existing thyroxine and tri-iodothyronine 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.
Methimazole is readily absorbed in the gastrointestinal tract, metabolized in the liver, and excreted in the urine.
TAPAZOLE Indications and Usage
TAPAZOLE 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.
CONTRAINDICATIONS
TAPAZOLE is contraindicated in the presence of hypersensitivity to the drug or any of the other product components.
DOSAGE AND ADMINISTRATION
TAPAZOLE 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.