METHIMAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Pharmaceuticals, Inc.

INN (International Name):

METHIMAZOLE

Composition:

METHIMAZOLE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methimazole tablets are indicated: Methimazole tablets are contraindicated in the presence of hypersensitivity to the drug or any of the other product components.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHIMAZOLE - METHIMAZOLE TABLET
RISING PHARMACEUTICALS, INC.
----------
METHIMAZOLE- METHIMAZOLE TABLET
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 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 are indicated:
•
•
4
6
2
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 tablets are 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_
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),