Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD)
Blenheim Pharmacal, Inc.
CIMETIDINE
CIMETIDINE 300 mg
ORAL
PRESCRIPTION DRUG
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
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). * Theo-Dur ® is a registered trademark of Key Pharmaceuticals Inc. Manufactured In Canada By: NOVOPHARM LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. D 10/2010
Abbreviated New Drug Application
CIMETIDINE- CIMETIDINE TABLET, FILM COATED BLENHEIM PHARMACAL, INC. ---------- CIMETIDINE TABLETS USP 8192 8204 8305 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 2 10 16 6 2 2 1) Acid Secretion _Nocturnal_ 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% inhibit read_full_document