CIMETIDINE tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Carilion Materials Management

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Cimetidine tablets are indicated in: Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks (see ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. (1) Short-term treatment of active duodenal ulcer. DOSAGE AND ADMINISTRATION: Duodenal Ulcer Patients have been maintained on continued treatment with cimetidine tablets 400 mg at bedtime for periods of up to 5 years. (2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks. (3) Short-term treatment of active benign gastric ulcer. Erosive esophagitis diagnosed by endoscopy. Treatment is

Resumen del producto:

NDC:68151-1497-0 in a PACKAGE of 1 TABLET, FILM COATEDS

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CIMETIDINE- CIMETIDINE TABLET, FILM COATED
CARILION MATERIALS MANAGEMENT
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DESCRIPTION
Cimetidine is a histamine H -receptor antagonist. Chemically it is
-cyano- -methyl- -[2-[[(5-methyl-1 -
imidazol-4-yl)methyl]thio]-ethyl]guanidine. Its structural formula is:
_N"NN'H_
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 200 mg, 300 mg, 400 mg
or 800 mg cimetidine, USP.
Inactive ingredients are: croscarmellose sodium, crospovidone,
hypromellose, lecithin, magnesium
stearate, microcrystalline cellulose, polydextrose, polyethylene
glycol, povidone, pregelatinized
starch, sodium alginate, sodium lauryl sulfate, titanium dioxide,
triacetin, vanillin, FD&C Blue No. 1
Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10
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
_NOCTURNAL_
An 800 mg oral dose of cimetidine at bedtime reduces mean hourly H
activity by greater than 85% over
an 8-hour period in duodenal ulcer patients, with no effect on daytime
acid secretion. A 1600 mg oral
dose of cimetidine at bedtime produces 100% inhibition of mean hourly
H activity over an 8-hour
period in duodenal ulcer patients, but also reduces H activity by 35%
for an additional 5 hours into the
following morning. Cimetidine given as 400 mg twice daily and 300 mg 4
times daily decreases
nocturnal acid sec