SUMMARY
CIMETIDINE
in 0.9% Sodium Chloride Injection, USP
Cimetidine in 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution of cimetidine hydrochloride in 0.9% sodium chloride injection. It is administered by the intravenous route. Each mL contains cimetidine HCl equivalent to 6 mg cimetidine and sodium chloride 9 mg in water for injection. The osmolar concentration is 356 mOsmol/L (calc.); pH is 6.0 (5.0 to 7.0). May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose administration. When smaller doses are required, the unused portion should be discarded. Cimetidine hydrochloride is a histamine H2-receptor antagonist.
Cimetidine hydrochloride injection 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 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) Prevention of upper gastrointestinal bleeding in critically ill patients.
(5) The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).
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