Active Ingredient: Azithromycin
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General: Fatigue. Allergic: Rash, photosensitivity, and angioedema. Chronic therapy with 1200 mg weekly regimen The nature of adverse reactions seen with the 1200 mg weekly dosing regimen for the prevention of Mycobacterium avium infection in severely immunocompromised HIV-infected patients were similar to those seen with short-term dosing regimens.
Five percent of patients experienced reversible hearing impairment in the pivotal clinical trial for the treatment of disseminated MAC in patients with AIDS.
Hearing impairment has been reported with macrolide antibiotics, especially at higher doses. Discontinuations from treatment due to laboratory abnormalities or adverse reactions considered related to study drug occurred in 8 of 88 9.
Single 1 gram dose regimen Overall, the most common adverse reactions in patients receiving a single-dose regimen of 1 gram of Zithromax were related to the gastrointestinal system and were more frequently reported than in patients receiving the multiple-dose regimen.
Postmarketing Experience The following adverse reactions have been identified during post approval use of azithromycin.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular: Arrhythmias, including ventricular tachycardia, and hypotension. There have been reports of QT prolongation and torsades de pointes. General: Asthenia, paresthesia, fatigue, malaise, and anaphylaxis.
Genitourinary: Interstitial nephritis, acute renal failure, and vaginitis. Hematopoietic: Thrombocytopenia.
Psychiatric: Aggressive reaction and anxiety. When follow-up was provided, changes in laboratory tests appeared to be reversible.
In multiple-dose clinical trials involving more than 3000 patients, 3 patients discontinued therapy because of treatment-related liver enzyme abnormalities and 1 because of a renal function abnormality. Laboratory abnormalities seen in clinical trials for the prevention of disseminated Mycobacterium avium disease in severely immunocompromised HIV-infected patients.