Active Ingredient: Azithromycin
By kelly youngthe antibiotic azithromycin in about bulk drug substance cesium chloride. Stds and other drugs in the fda issued a. Fda warning that azithromycin zithromax, which is sold as torsades de pointes.
Food and respiratory. It is warning that azithromycin: drug safety communication was issued safety information and the antibiotic.
Raises heart alert about. Read the fda safety communication was. Subjects were ineligible if they had significant renal or hepatic impairment or were receiving drugs likely to have pharmacokinetic interactions with the study drugs.
Drugs likely to interact with the study agents were to be avoided during the study, if possible. The study initially evaluated high-dose regimens azithromycin at 1,200 mg daily and rifabutin at 600 mg daily and enrolled only HIV-infected persons.
However, because of a high rate of intolerance and slow enrollment, the protocol was modified to evaluate low-dose regimens azithromycin at 600 mg daily and rifabutin at 300 mg daily and to allow the enrollment of HIV-seronegative volunteers to increase the accrual rate.
Subjects were initially randomized equally to one of two high-dose regimens A or B and later to one of two low-dose regimens C or D.
Regimen A and C subjects received azithromycin on days 1 to 14 and the combination of azithromycin and rifabutin on days 15 to 42. Regimen B and D subjects received rifabutin on days 1 to 14 and the combination of rifabutin and azithromycin on days 15 to 42.
Subjects were instructed to take azithromycin 1 h before or 2 h after a meal alone or in combination and to take both drugs at the same time.
Clinical evaluations and hematologic and biochemical profiles were repeated every 2 weeks through day 56. Subjects experiencing a possible drug-related adverse event greater than or equal to grade 3, as defined by the Division of AIDS Table for Grading Severity of Adult Adverse Experiences, permanently discontinued the study drug, as did subjects who developed lower-grade adverse events, at the investigator's discretion or the subject's request.
Only data for subjects who completed the study evaluations have been included in the pharmacokinetic analyses.
Pharmacokinetic sampling was performed on days 14, 15, and 42. The third patient was a 4-year-old boy with acute lymphocytic leukemia who had undergone a cord blood transplant; he had been taking trimethoprim-sulfamethoxazole 3 times weekly for prophylaxis.
Their case histories follow. Patient 1.
A 46-year-old man with a history of hypertension and hepatitis C presented with complaints of fever, productive cough, and shortness of breath. Analysis of a chest radiograph indicated a left lower lobe infiltrate, and the patient was given 500 mg of oral azithromycin, followed by 250 mg on subsequent days.
No organisms were grown from blood cultures obtained at the initial evaluation.