Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD)
Mylan Pharmaceuticals Inc.
CIMETIDINE
CIMETIDINE 200 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 tablets 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 cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of 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 tablets 400 mg at bedtime for periods of up to 5 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 lesions and control of symptoms. The use of cimetidine tablets beyond 12 weeks has not been established (see DOSAGE AND ADMINISTRATION: GERD). 5. The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas). Cimetidine tablets are contraindicated for patients known to have hypersensitivity to the product.
Cimetidine Tablets, USP are available containing 200 mg, 300 mg, 400 mg or 800 mg of cimetidine, USP. The 200 mg tablets are green, film-coated, 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 green, film-coated, 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 The 400 mg tablets are green, film-coated, 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 The 800 mg tablets are green, film-coated, 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 Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75069095 Revised: 8/2019 MXA:CIM:R1
Abbreviated New Drug Application
CIMETIDINE- CIMETIDINE TABLET, FILM COATED MYLAN PHARMACEUTICALS INC. ---------- 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, USP. Inactive ingredients are: croscarmellose sodium, crospovidone, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch (corn), sodium alginate, sodium lauryl sulfate, titanium dioxide, triacetin, vanillin, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. CLINICAL PHARMACOLOGY Cimetidine tablets 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 tablets inhibit both daytime and nocturnal basal gastric acid secretion. Cimetidine tablets also inhibit gastric acid secretion stimulated by food, histamine, pentagastrin, caffeine and insulin. ANTISECRETORY ACTIVITY _1) ACID SECRETION_ _Nocturnal_ An 800 mg oral dose of cimetidine tablets at bedtime reduces mean hourly H activity by 2 2 2 + greater than 85% over an 8-hour period in duodenal ulcer patients, with no effect on daytime acid secretion. A 1,600 mg oral dose of cimetidine tablets at bedtime produces 100% inhibition of mean hourly H activity over an 8-hour period in duodenal ulcer patients, but also reduces H activity by 35% for an additional 5 hours into the following morning. Cimetidine tablets given as 400 mg tw সম্পূর্ণ নথি পড়ুন