METHIMAZOLE- methimazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

METHIMAZOLE

Composition:

METHIMAZOLE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Methimazole Tablets, USP, for oral administration, are available as 5 mg White, round, biconvex, beveled tablets, scored on one side and debossed “E” over “205” on the other side and supplied as: Unit dose packages of 100 (10 x 10) NDC 68084-275-01 10 mg White, round, biconvex, beveled tablets, scored on one side and debossed “E” over “210” on the other side and supplied as: Unit dose packages of 100 (10 x 10) NDC 68084-276-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. KEEP THIS ANDALL MEDICATION OUT OF THE REACH OF CHILDREN. WARNING – This drug may cause toxic reaction. If such reactions occur, discontinue the drug. Constant supervision of patient is essential. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHIMAZOLE- METHIMAZOLE TABLET
AMERICAN HEALTH PACKAGING
----------
METHIMAZOLE TABLETS, USP
8227601/1215OS
RX ONLY
DESCRIPTION
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 mg or 10 mg (43.8 mcmol or 87.6 mcmol)
methimazole USP, an orally
administered antithyroid drug.
Each tablet also contains anhydrous lactose, colloidal silicon
dioxide, lactose monohydrate, magnesium
stearate, pregelatinized starch (corn) and talc.
The molecular weight is 114.16, 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
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.
INDICATIONS AND USAGE
Methimazole tablets, USP 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
CONTRAINDICATIONS
Methimazole is contraindicated in the presence of hypersensitivity to
the drug or any of the other
product components.
WARNINGS
4
6
2
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) gastrointes