| Safety and tolerability of multiple doses of imipenem/cilastatin. | |
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MedLine Citation:
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PMID: 3886256 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The safety and tolerability of 1 gm imipenem and cilastatin given together every 6 hours for 10 days was evaluated in a randomized, double-blind, placebo-controlled trial in normal subjects. Nausea was more common in the drug-treated group (five of six subjects) than in the control group (two of six subjects). No consistent changes in hepatic function indices were noted. Although beta 2-microglobulin excretion showed a significant trend of rising over time in the drug group, there were no differences between groups with regard to 24-hour urinary excretion of either N-acetyl-beta-glucosaminidase or beta 2-microglobulin. Urinalysis did not reveal any casts and serial creatinine clearance determinations showed no change in renal function in either the drug- or placebo-treated groups. Pure tone audiograms were performed before and after dosing in 11 of 12 subjects; no changes were noted. We conclude that the combination of imipenem and cilastatin was well tolerated and safe. |
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Authors:
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G L Drusano; H C Standiford; C I Bustamante; G Rivera; A Forrest; J Leslie; B Tatem; D Delaportas; S C Schimpff |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Clinical pharmacology and therapeutics Volume: 37 ISSN: 0009-9236 ISO Abbreviation: Clin. Pharmacol. Ther. Publication Date: 1985 May |
Date Detail:
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Created Date: 1985-06-06 Completed Date: 1985-06-06 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0372741 Medline TA: Clin Pharmacol Ther Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 539-43 Citation Subset: AIM; IM |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Acetylglucosaminidase
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urine Adult Alanine Transaminase / blood Analysis of Variance Aspartate Aminotransferases / blood Bilirubin / blood Blood Urea Nitrogen Cilastatin Creatinine / metabolism Cyclopropanes / adverse effects, pharmacology* Double-Blind Method Drug Evaluation Drug Therapy, Combination Humans Imipenem Kidney Function Tests Liver Function Tests Male Radioimmunoassay Random Allocation Serum Albumin Thienamycins / adverse effects, pharmacology* beta 2-Microglobulin / urine |
| Chemical | |
Reg. No./Substance:
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0/Cyclopropanes; 0/Serum Albumin; 0/Thienamycins; 0/beta 2-Microglobulin; 60-27-5/Creatinine; 635-65-4/Bilirubin; 74431-23-5/Imipenem; 82009-34-5/Cilastatin; EC 2.6.1.1/Aspartate Aminotransferases; EC 2.6.1.2/Alanine Transaminase; EC 3.2.1.52/Acetylglucosaminidase |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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