A review of results of clinical trials with amikacin.
Case records of 1,098 patients treated with amikacin at 79 research centers in 10 countries in a program of worldwide clinical trials were reviewed. Of the 697 patients eligible for use in evaluation of efficacy of the drug, 81% were cured, as evidenced by clinical remission and eradication of the infecting pathogen. The usual dosage was 7.5 mg/kg administered intramuscularly at 12-hr intervals. This dosage was modified in patients with renal impairment. Amikacin was effective in 90% of 322 patients with genitourinary infections, 85% of 97 patients with septicemia, 70% of 73 patients with infections of skin, soft tissue, or bone (excluding burns), and 69% of 68 patients with infections of the lower respiratory tract. Amikacin was effective in treatment of 88% of 85 infections due to gentamicin-resistant pathogens. The drug was generally well tolerated, and no side effects were reported in 80.6% of the 1,098 patients evaluated. Amikacin shares with other aminoglycosides the risk of ototoxicity and nephtotoxicity; previous exposure to gentamicin was a major factor in the development of such adverse effects. Other adverse reactions were relatively infrequent and in most cases were characterized as mild and transient.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000583:Amikacin / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D001847:Bone Diseases / Q000188:drug therapy; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004352:Drug Resistance, Microbial; D004756:Enterobacteriaceae Infections / Q000188:drug therapy; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007612:Kanamycin / Q000031:analogs & derivatives*; D008875:Middle Aged; D011552:Pseudomonas Infections / Q000188:drug therapy; D012141:Respiratory Tract Infections / Q000188:drug therapy; D018805:Sepsis / Q000188:drug therapy; D012874:Skin Diseases, Infectious / Q000188:drug therapy; D014552:Urinary Tract Infections / Q000188:drug therapy
D007612:Kanamycin; D000583:Amikacin