TAPAZOLE- methimazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pfizer Laboratories Div Pfizer Inc

INN (International Name):

METHIMAZOLE

Composition:

METHIMAZOLE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

TAPAZOLE Tablets are available in: The 5-mg tablets are round, white to off-white, bisected on one side and the other side debossed with "J94". They are available as follows: Bottles of 100 NDC 60793-104-01 The 10-mg tablets are round, white to off-white, bisected on one side and the other side debossed with "J95". They are available as follows: Bottles of 100 NDC 60793-105-01 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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TAPAZOLE- METHIMAZOLE TABLET
PFIZER LABORATORIES DIV PFIZER INC
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TAPAZOLE
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,
starch (corn), pregelatinized starch
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
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.
WARNINGS
FIRST TRIMESTER USE OF METHIMAZOLE AND CONGENITAL MALFORMATIONS
®
4
6
2
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), omph