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Safety and tolerability of multiple doses of imipenem/cilastatin
Author(s) -
Drusano George L,
Standiford Harold C,
Bustamante Carlos I,
Rivera Giselle,
Forrest Alan,
Leslie James,
Tatem Beverly,
Delaportas Dino,
Schimpff Stephen C
Publication year - 1985
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.1985.85
Subject(s) - imipenem/cilastatin , cilastatin , tolerability , medicine , placebo , renal function , urinalysis , imipenem , dosing , urinary system , nausea , anesthesia , adverse effect , pharmacology , urology , antibiotics , chemistry , pathology , biochemistry , alternative medicine , antibiotic resistance
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 β 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‐β‐glucosaminidase or β 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. Clinical Pharmacology and Therapeutics (1985) 37, 539–543; doi: 10.1038/clpt.1985.85