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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.

Cimetidine Biowaivers [Recruiting]
The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.

A Prospective Clinical Registry to Collect Patient Outcome Date for the BIOMET´┐Ż Stimulator Systems [Recruiting]
The purpose of this open prospective patient registry is to capture data on an ongoing basis from a population of patients who will use any of Biomet's BHS, OrthoPak and SpinalPak devices. While electrical stimulation has been utilized increasingly by physicians since the first FDA approved unit came to market in 1979, questions remain regarding patient outcomes and the health economics associated with this technology as a class. A recent burden of illness study showed strong cost efficiency data for the electrical stimulators, but did not address clinical or patient outcomes.

Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty [Recruiting]

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Page last updated: 2006-11-04

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