METHIMAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

METHIMAZOLE

Composition:

METHIMAZOLE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methimazole is indicated in the medical treatment of hyperthyroidism. Long-term therapy may lead to remission of the disease. Methimazole may be used to ameliorate hyperthyroidism in preparation for subtotal thyroidectomy or radioactive iodine therapy. Methimazole is also used when thyroidectomy is contraindicated or not advisable. Methimazole is contraindicated in the presence of hypersensitivity to the drug and in nursing mothers because the drug is excreted in milk.

Product summary:

Methimazole Tablets, USP 5 mg - round, white to off white bi-convex tablet. Debossed HP bisect 70 on one side and plain on the reverse side. Methimazole Tablets, USP 10 mg - round, white to off white bi-convex tablet. Debossed HP bisect 71 on one side and plain on the reverse side. They are supplied by State of Florida DOH Central Pharmacy as follows: 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]. Manufactured for: Heritage Pharmaceuticals Inc. Edison, NJ 08837 1.866.901.DRUG (3784) This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHIMAZOLE - METHIMAZOLE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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METHIMAZOLE TABLETS, USP
RX ONLY
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, pregelatinized 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.
The actions and use of methimazole are similar to those of
propylthiouracil. On a weight basis, the drug
is at least 10 times as potent as propylthiouracil, but methimazole
may be less consistent in action.
Methimazole is readily absorbed from the gastrointestinal tract. It is
metabolized rapidly and requires
frequent administration. Methimazole is excreted in the urine.
In laboratory animals, various regimens that continuously suppress
thyroid function and thereby increase
TSH secretion result in thyroid tissue hypertrophy. Under such
conditions, the appearance of thyroid
and pituitary neoplasms has also been reported. Regimens that have
been studied in this regard include
antithyroid agents as well as dietary iodine deficiency, subtotal
thyroidectomy, implantation of
autonomous thyrotropic hormone-secreting pituitary tumors, and
administration of chemical goitrogens.
INDICATIONS AND USAGE
Methimazole is indicated in the medical treatment of hyperthyroidism.
Long-term therapy may lead to
remission of