METHIMAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHIMAZOLE (UNII: 554Z48XN5E) (METHIMAZOLE - UNII:554Z48XN5E)

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

METHIMAZOLE

Composition:

METHIMAZOLE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Methimazole is contraindicated in the presence of hypersensitivity to the drug or any of the other product components.

Product summary:

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. They are available in: Bottles of 100         NDC 49884-640-01 Bottles of 500         NDC 49884-640-05 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. They are available in: Bottles of 100         NDC 49884-641-01 Bottles of 500         NDC 49884-641-05 Store at controlled room temperature 15° to 30°C (59° to 86°F). Dispense in tight, light-resistant container. Manufactured and distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 Revised: 01/16 OS640-01-1-11

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHIMAZOLE- METHIMAZOLE TABLET
PAR PHARMACEUTICAL, INC.
----------
METHIMAZOLE TABLETS USP
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 114.17, and the molecular formula is C H N S.
The structural
formula is as follows:
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
triiodothyronine 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.
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
CONTRAINDICATIONS
Methimazole is contraindicated in the presence of hypersensitivity to
the drug or any of
the other product components.
4
6
2
WARNINGS
FIRST TRIMESTER USE OF METHIMAZOLE AND CONGENITAL MALFORMATIONS
Methimazole crosses the placental membranes and can cause fetal harm
when
administered in the first trimester of pregnancy. Rare instances of
congenital defects,
including aplasia cutis, craniofacial malformations (facial
dysmorphism; choanal atresia),
gastrointestinal malformations (esophageal atresia with or without
tracheoesophageal
fistula), omphalocele and abnormalities of the omphalom