Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
CIMETIDINE HYDROCHLORIDE (UNII: WF10491673) (CIMETIDINE - UNII:80061L1WGD)
Akorn Operating Company LLC
CIMETIDINE HYDROCHLORIDE
CIMETIDINE 300 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Cimetidine Hydrochloride Oral Solution is 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 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 disease (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for hea
Cimetidine Hydrochloride Oral Solution is a clear yellow, orange flavored solution containing 300 mg of cimetidine per 5 mL (teaspoonful) supplied in 8 fl oz (237 mL) amber PET containers NDC 50383-050-08 and 16 fl oz (473 mL) amber PET containers NDC 50383-050-16. Store at controlled room temperature, 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container. Rx Only Distributed by: Akorn Operating Company LLC Gurnee, IL 60031
Abbreviated New Drug Application
CIMETIDINE HYDROCHLORIDE ORAL SOLUTION- CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION AKORN OPERATING COMPANY LLC ---------- CIMETIDINE HYDROCHLORIDE ORAL SOLUTION RX ONLY Rev. 050:05 08/22 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 hydrochloride is C H N S•HCI and the molecular weight is 288.80 the structural formula of cimetidine hydrochloride is: Cimetidine contains an imidazole ring, and is chemically related to histamine. Cimetidine has a bitter taste and characteristic odor. SOLUBILITY CHARACTERISTICS Cimetidine hydrochloride is freely soluble in water, soluble in alcohol, very slightly soluble in chloroform and practically insoluble in ether. Each 5 mL (1 teaspoonful), for oral administration, contains cimetidine hydrochloride equivalent to cimetidine, 300 mg; alcohol, 2.8%. In addition, the oral solution contains the following inactive ingredients: FD&C Yellow No. 6, hydrochloric acid, methylparaben, natural orange flavor, polyoxyethylene, polyoxypropylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium chloride, dibasic sodium phosphate anhydrous, and sorbitol. The pH range is 5.1 to 5.7. 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 2 10 16 6 2 2 acid secretion stimulated by food, histamine, pentagastrin, caffeine and insulin. ANTISECRETORY ACTIVITY 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 h.s. pr Læs hele dokumentet