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.
Sotalol is a pure beta-adrenergic receptor antagonist. The present study was divided into a first and second therapy period. A total of 38 patients with atrial or ventricular arrhythmias were included in the first therapy period. After a drug-free period of approximately two months, 14 of the 38 patients entered the second therapy period and were given oral sotalol. During the two treatment periods, oral sotalol was given in doses ranging from 40 to 480 mg/day for 0.5 to 11 months in the first period and for four to nine months in the second period. Oral sotalol decreased or abolished arrhythmias in 92 per cent of the patients in the first therapy period and in all the patients in the second therapy period. Minor side effects occurred in two patients. Sotalol possesses a unique class III antiarrhythmic action. The electrophysiological profile is different from other beta-adrenergic blocking agents in that sotalol prolongs the duration of the intracellularly recorded action potential. This property may contribute to the antiarrhythmic efficacy demonstrated with sotalol.
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