Indication

Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy. Pelvic inflammatory disease due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with ZIBAC. ZIBAC INJECTION SHOULD BE FOLLOWED BY ZIBAC BY THE ORAL ROUTE AS REQUIRED.


Dosage & Administration

Community-acquired pneumonia: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. Pelvic inflammatory disease: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with ZIBAC. Renal Insufficiency: No dosage adjustment is recommended for subjects with renal impairment (GFR<80 mL/min). Caution should be exercised when Azithromycin is administered to subjects with severe renal impairment. Hepatic Insufficiency: No dose adjustment recommendations can be made in patients with impaired hepatic function. No dosage adjustment is recommended based on age or gender. THE INFUSATE CONCENTRATION AND RATE OF INFUSION FOR ZIBAC INJECTION SHOULD BE EITHER 1 mg/mL OVER 3 HOURS OR 2 mg/mL OVER 1 HOUR. ZIBAC INJECTION SHOULD NOT BE GIVEN AS A BOLUS OR AS AN INTRAMUSCULAR INJECTION.


Precautions

Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis have been reported rarely in patients on Azithromycin therapy. Although rare, fatalities have been reported. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ZIBAC injection, and may range in severity from mild diarrhea to fatal colitis. Because Azithromycin is principally eliminated via the liver, caution should be exercised when Azithromycin is administered to patients with impaired hepatic function. Due to the limited data in subjects with GFR <10 mL/min, caution should be exercised when prescribing Azithromycin in these patients. ZIBAC INJECTION SHOULD BE RECONSTITUTED AND DILUTED AS DIRECTED AND ADMINISTERED AS AN INTRAVENOUS INFUSION OVER NOT LESS THAN 60 MINUTES. Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with other macrolides. A caution should be exercised when prescribing Azithromycin in these patients.


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