CIMETIDINE tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD)

Доступна з:

Proficient Rx LP

ІПН (Міжнародна Ім'я):

CIMETIDINE

Склад:

CIMETIDINE 400 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Cimetidine tablets are indicated in: Cimetidine is contraindicated for patients known to have hypersensitivity to the product.

Огляд продуктів:

Cimetidine tablets USP, 400 mg are dark-green, oval-shaped, film-coated tablets, debossed with N vertical bisect 204 on one side and partial bisect 400 on the reverse. They are supplied as follows: NDC 63187-333-30 bottles of 30. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure (as required). * Theo-Dur® is a registered trademark of Key Pharmaceuticals Inc. Manufactured In Canada By: NOVOPHARM LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Rev. D 10/2010

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

CIMETIDINE- CIMETIDINE TABLET, FILM COATED
PROFICIENT RX LP
----------
CIMETIDINE TABLETS USP
8192
8204
8305
RX ONLY
DESCRIPTION
Cimetidine is a histamine H -receptor antagonist. Chemically it is
_N”_-cyano-_N_-methyl-_N’_-[2-[[(5-
methyl-1_H_-imidazol-4-yl)methyl]thio]-ethyl], guanidine.
The molecular formula for cimetidine is C
H N S; and the molecular weight is 252.35. The
structural formula for cimetidine is:
Cimetidine contains an imidazole ring, and is chemically related to
histamine. Cimetidine has a bitter
taste and characteristic odor.
SOLUBILITY CHARACTERISTICS
Cimetidine is soluble in alcohol, slightly soluble in water, very
slightly soluble in chloroform and
insoluble in ether.
Each tablet, for oral administration, contains 300 mg, 400 mg, or 800
mg cimetidine. In addition, each
tablet contains the following inactive ingredients: corn starch,
magnesium stearate, microcrystalline
cellulose, povidone, sodium lauryl sulfate and sodium starch
glycolate. The coating for the tablets
contains: carnauba wax, hypromellose, polyethylene glycol, polysorbate
80, talc, titanium dioxide, and
triethyl citrate. The coating for the 300 mg and 400 mg tablets also
contains D&C Yellow No. 10
Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and FD&C Yellow No. 6
Aluminum Lake.
CLINICAL PHARMACOLOGY
Cimetidine competitively inhibits the action of histamine at the
histamine H receptors of the parietal
cells and thus is a histamine H -receptor antagonist.
Cimetidine is not an anticholinergic agent. Studies have shown that
cimetidine inhibits both daytime and
nocturnal basal gastric acid secretion. Cimetidine also inhibits
gastric acid secretion stimulated by food,
histamine, pentagastrin, caffeine and insulin.
ANTISECRETORY ACTIVITY
1) ACID SECRETION
2
10
16
6
2
2
_NOCTURNAL_
Cimetidine 800 mg orally at bedtime reduces mean hourly H activity by
greater than 85% over an
eight-hour period in duodenal ulcer patients, with no effect on
daytime acid secretion. Cimetidine 1600
mg orally at bedtime produces 100% inhibition of mean