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:

Physicians Total Care, Inc.

INN (International Name):

CIMETIDINE

Composition:

CIMETIDINE 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cimetidine tablets are indicated in: 1) 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. 2) 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. 3) Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than eight weeks. 4) Erosive gastroesophageal reflux disease (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for twelve weeks for healin

Product summary:

Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. *Theo-Dur® is a registered trademark of Key Pharmaceuticals, Inc. Iss. 3/2009 Manufactured in Ireland By: IVAX PHARMACEUTICALS IRELAND Waterford, Ireland Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CIMETIDINE - CIMETIDINE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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CIMETIDINE TABLETS USP
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. Its
structural formula is:
C
H N S M.W. 252.34
Cimetidine contains an imidazole ring, and is chemically related to
histamine.
Cimetidine has a bitter taste and characteristic odor.
Cimetidine is soluble in alcohol, slightly soluble in water, very
slightly soluble in chloroform and
insoluble in ether.
Each film-coated tablet, for oral administration, contains 300 mg, 400
mg or 800 mg of cimetidine. In
addition, each tablet contains the following inactive ingredients:
corn starch, hydroxypropyl cellulose,
hypromellose, magnesium stearate, polyethylene glycol, povidone,
sodium starch glycolate, and
titanium dioxide.
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
+
An 800 mg oral dose of cimetidine 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. A 1600
mg oral dose of cimetidine at bedtime produces 100% inhibition of mean
hourly H activity over an
eight-hour period in duodenal ulcer patients, but also reduces H
activity by 35% for an additional five
hours into the following morning. Cimetidine given as 400 mg twice
daily and 300 mg four times daily
decreases nocturnal acid secretion in a dose-related manner, i.e., 47%
to 83% over a six- to eight-hour
period and 54% over a nine-hour per