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:

AvKARE, Inc.

INN (International Name):

CIMETIDINE

Composition:

CIMETIDINE 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cimetidine tablets 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

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 42291-217-90 bottles of 90 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 42291-218-01 bottles of 100 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. 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 For: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. D 10/10 AV Rev. 01/16 (P)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CIMETIDINE- CIMETIDINE TABLET, FILM COATED
AVKARE, 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. 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_
Cimetidine 800 mg orally at bedtime reduces mean hourly H
activity by greater than 85% over an
2
10
16
6
2
2
+
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 hourly H
acti