Cimetidine Injection (Cimetidine Injection) - Summary

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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NEWS HIGHLIGHTS

Published Studies Related to Cimetidine Injection

A comparison of oral omeprazole and intravenous cimetidine in reducing complications of duodenal peptic ulcer. [2006.01.11]
BACKGROUND: Gastrointestinal bleeding is a common problem and its most common etiology is peptic ulcer disease. Ulcer rebleeding is considered a perilous complication for patients. To reduce the rate of rebleeding and to fasten the improvement of patients' general conditions, most emergency departments in Iran use H2-blockers before endoscopic procedures (i.e. intravenous omeprazole is not available in Iran). The aim of this study was to compare therapeutic effects of oral omeprazole and intravenous cimetidine on reducing rebleeding rates, duration of hospitalization, and the need for blood transfusion in duodenal ulcer patients... CONCLUSION: This study demonstrated that oral omeprazole significantly excels intravenous cimetidine in reducing the need for blood transfusion and lowering rebleeding rates in patients with upper gastrointestinal bleeding. Though not statistically significant (p = 0.074), shorter periods of hospitalization were found for omeprazole group which merits consideration for cost minimization.

Feasibility of biowaiver extension to biopharmaceutics classification system class III drug products: cimetidine. [2006]
BACKGROUND: The extension of biowaivers (drug product approval without a pharmacokinetic bioequivalence study) to drugs belonging to Class III of the Biopharmaceutics Classification System (BCS) is currently a subject of much discussion. OBJECTIVES: To assess the relationship between in vitro dissolution characteristics and in vivo absorption performance of immediate-release (IR) products containing cimetidine, a BCS Class III compound, in human subjects. To evaluate the feasibility and appropriateness of an extension of the biowaiver concept to BCS Class III compounds... CONCLUSION: The results of the present study indicated that the absorption of cimetidine from IR tablets is, in general, limited by permeability rather than dissolution. IVIVC analysis demonstrated that only when the release was deliberately retarded (tablets containing 26% methacrylate copolymer), did the dissolution represent the rate-limiting step to drug absorption. On the in vitro side, it seems that 85% dissolution within 30 minutes, as currently required by the US FDA Guidance, is more than sufficient to guarantee bioequivalence of IR cimetidine products. For cimetidine and other BCS Class III drugs with a similar intestinal absorption pattern, application of the biowaiver concept seems to present little risk of an inappropriate bioequivalence decision.

Randomized, double-blind study comparing postoperative effects of treatment timing with histamine H-receptor antagonist cimetidine. [2005.07]
BACKGROUND: The purpose of this study was to evaluate the effect of timing of preoperative, postoperative, and placebo administration of the H(2)-antagonist cimetidine on postoperative pain management and the incidence of side-effects... CONCLUSIONS: Our results suggested that neither preoperative nor postoperative administration of cimetidine 4 mg kg(-1) provided a pre-emptive or preventive analgesic advantage for postoperative pain or morphine consumption, and that the use of cimetidine failed to reduce the incidence of nausea or vomiting.

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Clinical Trials Related to Cimetidine Injection

Performance of Cimetidine-Corrected MDRD Equation in Renal Transplant Patients [Completed]
Among the different creatinine-based GFR predicting equations, the MDRD equation gives the best prediction in renal transplantation but does not provide the level of accuracy usually seen in renal patients with native kidneys.

Blocking the tubular secretion of creatinine with an oral administration of cimetidine is likely to make creatinine a more accurate marker of GFR.

We will test the hypothesis that the accuracy of the MDRD equation will be improved in renal transplant patients by incorporating into the equation a cimetidine-corrected serum creatinine value.

A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection [Completed]
To determine the change in CD4 count after 4 and 8 weeks in HIV-infected patients treated with cimetidine compared to placebo. To observe time-associated trends at weeks 4, 8, 12, and 16 in the change of CD4 counts for patients taking cimetidine for the full 16 weeks. To establish a safety record for cimetidine use in HIV-positive patients.

Biomet Humeral Stem Data Collection [Recruiting]

Lumbar Spinal Fusion System [Recruiting]

Oxford Partial Knee Replacement. A Randomized Clinical Trial of Three Implant Types [Recruiting]
The purpose of this scientific study is to clarify whether there is a relationship between the appearance of radiolucent lines in bone-cement interphase of the tibial component of the different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses. This will be accomplished in a se-ries of three different Oxford Uni Knees.

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