CIMETIDINE tablet film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

REMEDYREPACK INC.

INN（国际名称）:

CIMETIDINE

组成:

CIMETIDINE 300 mg

处方类型:

PRESCRIPTION DRUG

授权状态:

Abbreviated New Drug Application

产品特点

CIMETIDINE- CIMETIDINE TABLET, FILM COATED
REMEDYREPACK INC.
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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, USP. 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.
2
10
16
6
2
2
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_
_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% inhibit