Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
Cimetidine (UNII: 80061L1WGD) (Cimetidine - UNII:80061L1WGD)
Dispensing Solutions, Inc.
Cimetidine
Cimetidine 400 mg
ORAL
PRESCRIPTION DRUG
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
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 bottles of 100, 500 and 1000 tablets. 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 bottles of 60, 100 and 500 tablets. 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 bottles of 30, 100 and 500 tablets. 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
Abbreviated New Drug Application
CIMETIDINE - CIMETIDINE TABLET, FILM COATED DISPENSING SOLUTIONS, INC. ---------- 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 peri Przeczytaj cały dokument