Abstract
Azithromycin (AZM), a new macrolide antibiotic, in fine granules and in capsules was studied for pharmacokinetic and clinical evaluations.
1. Antibacterial activities MIC profile of AZM was as follows: 0.78-1.56 μg/ml against Staphylococcus aureus, ≤0.025-0.10 μg/ml against Streptococcus pyogenes, 0.10-0.39 and 6.25 μg/ml against Streptococcus pneumoniae, 0.025-0.39μg/ml against Moraxella (Branhamella) catarrhalis, 0.39-3.13 μg/ml against Haemophilus influenzae, and 0.20-6.25μg/ml against Haemophilus parainfluenzae.
2. Absorption and excretion The elimination half-life of AZM after its administration at 10 mg/kg/day for three days was 28.1-46.1 hours. The cumulative urinary excretion rate in the first 120 hours after start of treatment was 4.01-8.47%.
3. Clinical evaluation
AZM was given to 76 pediatric patients to treat following infections: pharyngitis in seven, tonsillitis in 11, bronchitis in 11, pneumonia in 19, Mycoplasma pneumonia in eight, scarlet fever in 13, infective enteritis in one, SSTI in four, and otitis media in two. Effectiveness of AZM was assessed in 75 patients and the drug was rated “excellent” or “good” in 71 resulting in an efficacy rate of 94.7%. 87.0% of the 46 cases indicated that AZM had eradicated bacteria identified before the treatment.
One patient complained of moderate diarrhea which disappeared after treatment of antidiarrheic. Abnormal laboratory changes were reported in 12 patients in the following: decreased leukocytes in eight, increased eosinophils in two, increased platelet count in one, and increased GPT in one. All cases of abnormality was deemed mild in severity and clinically insignificant.
