HIV-related use for antibiotic - in Jun 1996, the FDA approved the drug Zithromax for use in HIV-patients suffering from mycobacterium avium complex - Updates - Brief Article

FDA Consumer, Nov, 1996

Previously approved to treat other bacterial infections, the antibiotic Zithromax (azithromycin) has been approved by FDA to prevent or delay infection with mycobacterium avium complex, or MAC, which can be fatal in AIDS patients.

MAC causes chronic, weakening symptoms such as fever, weight loss, fatigue, and gastrointestinal problems. To prevent or delay MAC symptoms, the new use approved last June, Zithromax is given in one weekly dose of 1,200 milligrams. Alternatively, the single weekly dose may be given in combination with daily doses of Mycobutin (rifabutin), the first drug approved to prevent MAC in patients with advanced HIV infection. (See "Mycobutin Approved to Prevent MAC," in the Updates section of the April 1993 FDA Consumer.) Biaxin (clarithromycin) also is approved to treat MAC.

Zithromax is not for use in patients highly sensitive to other macrolide antibiotics, such as erythromycin and clarithromycin.

In clinical trials, Zithromax caused mild to moderately severe side effects, mainly nausea, vomiting, diarrhea, and abdominal pain. Rare but potentially serious side effects were localized swelling and jaundice. Studied both alone and in combination with other AIDS treatments, the drug showed very little interaction with the other therapies. It was not studied with the newest class of AIDS drugs, protease inhibitors. (See "Free Backgrounder on Protease Inhibitors" in the Updates section of the October 1996 FDA Consumer.)