CIMETIDINE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

A-S Medication Solutions

INN (International namn):

CIMETIDINE

Sammansättning:

CIMETIDINE 300 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Cimetidine tablets USP are indicated in: - Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION , Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. - Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg at bedtime for periods of up to five years. - Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks. - Erosive gastroesophageal reflux disease (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of

Produktsammanfattning:

Product: 50090-0499 NDC: 50090-0499-0 30 TABLET, FILM COATED in a BOTTLE Product: 50090-0500 NDC: 50090-0500-0 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-0500-1 60 TABLET, FILM COATED in a BOTTLE

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CIMETIDINE- CIMETIDINE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
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%
inh