CIMETIDINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

CIMETIDINE

Composition:

CIMETIDINE 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Cimetidine tablets USP, 300 mg are dark-green, oval-shaped, film-coated tablets, debossed with N192 on one side and 300 on the reverse. They are supplied as follows: NDC 0093-8192-01 bottles of 100 NDC 0093-8192-05 bottles of 500 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 0093-8204-01 bottles of 100 NDC 0093-8204-05 bottles of 500 Cimetidine tablets USP, 800 mg are white, oval-shaped, film-coated tablets, debossed with N vertical bisect 305 on one side and partial bisect 800 on the reverse. They are supplied as follows: NDC 0093-8305-01 bottles of 100 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). Keep this and all medications out of the reach of children. Brands listed are the trademarks of their respective owners. Manufactured In Canada By: Teva Canada Limited Toronto, Canada M1B 2K9 Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. F 11/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CIMETIDINE- CIMETIDINE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
----------
CIMETIDINE TABLETS, USP
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.
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_
2
10
16
6
2
2
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