METHIMAZOLE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Eon Labs, Inc.

INN (International Adı):

METHIMAZOLE

Kompozisyon:

METHIMAZOLE 5 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

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: NDC 0185-0205-01 bottles of 100 NDC 0185-0205-10 bottles of 1000 10 mg White, round, biconvex, beveled tablets, scored on one side and debossed “E” over “210” on the other side and supplied as: NDC 0185-0210-01 bottles of 100 NDC 0185-0210-10 bottles of 1000 Store at 20° to 25°C (68° to 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 TIGHTLY CLOSED. KEEP THIS AND ALL 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. Distributed by Sandoz Inc. Princeton, NJ 08540 Rev. February 2019 MF0205REV02/19

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

METHIMAZOLE- METHIMAZOLE TABLET
EON LABS, INC.
----------
METHIMAZOLE TABLETS, USP
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:
•
•
CONTRAINDICATIONS
Methimazole is contraindicated in the presence of hypersensitivity to
the drug or any of the other
product components.
WARNINGS
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
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 (esoph