METHIMAZOLE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Algemene Internationale Benaming):

METHIMAZOLE

Samenstelling:

METHIMAZOLE 5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 samenvatting:

Methimazole Tablets are available in: The 5 mg tablets are white, round, biconvex, beveled tablets, scored on one side and imprinted “E” over “205” on the other. They are available as follows: Blistercards of 30 tablets. 10 mg: White, round, biconvex, beveled tablets, scored on one side and debossed “E” over “210” on the other side and supplied as: Blistercards of 30 tablets Store at 20°-25°C (68°- 77°F)[see USP Controlled Room Temperature]. Dispense contents in a tight, light resistant container as defined in the USP with a child-resistant closure, as required. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

METHIMAZOLE- METHIMAZOLE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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METHIMAZOLE TABLETS
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 or 10 mg (43.8 or 87.6 μmol) methimazole, an
orally administered antithyroid
drug.
Each tablet also contains lactose monohydrate, NF, colloidal silicon
dioxide, NF, talc, USP,
pregelatinized starch, NF,
anhydrous lactose, NF, and magnesium stearate, NF. The molecular
weight is 114.16, and the molecular
formula
is C4H6N2S. 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 medi