Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD)
STAT RX USA LLC
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 h.s. 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 8 weeks. (4) Erosive gastroesophageal reflux (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of l
Cimetidine tablets are available containing 200 mg, 300 mg, 400 mg and 800 mg of cimetidine. The 200 mg tablets are film-coated green, five sided, house shaped, unscored tablets debossed with M on one side and 53 on the other side. They are available as follows: NDC 0378-0053-01 bottles of 100 tablets The 300 mg tablets are film-coated green, five sided, house shaped, unscored tablets debossed with M on one side and 317 on the other side. They are available as follows: NDC 0378-0317-01 bottles of 100 tablets NDC 0378-0317-05 bottles of 500 tablets The 400 mg tablets are film-coated green, five sided, house shaped, partially scored tablets debossed with M on one side and 372 on the other side. They are available as follows: NDC 0378-0372-01 bottles of 100 tablets NDC 0378-0372-05 bottles of 500 tablets The 800 mg tablets are film-coated green, oval, partially scored tablets debossed with M 541 across the partial score. They are available as follows: NDC 0378-0541-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED SEPTEMBER 2005 CIM:R12
Abbreviated New Drug Application
CIMETIDINE - CIMETIDINE TABLET, FILM COATED STAT RX USA LLC ---------- CIMETIDINE TABLETS, USP 200 MG, 300 MG, 400 MG AND 800 MG 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. Its structural formula 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 200 mg, 300 mg, 400 mg or 800 mg cimetidine. Inactive ingredients are: croscarmellose sodium, crospovidone, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium alginate, sodium lauryl sulfate, titanium dioxide, triacetin, vanillin, FD and C Blue #1 aluminum lake, FD and C Yellow #6 aluminum lake and D and C Yellow #10 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 SecretionNocturnal 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 h.s. 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 400 mg b.i.d. and 300 mg q.i.d. decrease no Aqra d-dokument sħiħ