Important Safety Information
Zmax is indicated for mild to moderate Acute Bacterial Sinusitis in adults due to
Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae,
and is also indicated for community-acquired pneumonia due to Chlamydophila pneumoniae,
Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae
in adults and pediatrics aged 6 months and over deemed appropriate for oral therapy.
Zmax is contraindicated in patients with known hypersensitivity to azithromycin,
erythromycin, or any macrolide or ketolide antibiotic. If an allergic reaction occurs,
appropriate therapy should be instituted. Physicians should be aware that reappearance
of the allergic symptoms may occur when symptomatic therapy is discontinued.
In the 27 mg/mL currently approved oral suspension (n=61), the most common side
effects of Zmax are vomiting (3.3%), diarrhea (1.6%), abdominal pain (1.6%), rash
(1.6%), dermatitis (1.6%), fungal rash (1.6%), and constipation (1.6%).
In clinical trials using the 60 mg/mL premarketing oral concentration (n=846), the
most common side effects of Zmax are vomiting (11.9%), diarrhea (8%), loose stools
(5.6%), abdominal pain (3%), rash (2.8%), nausea (1.7%), and anorexia (1.2%).
Clostridium difficile associated diarrhea (CDAD) has been reported with use
of nearly all antibacterial agents, including azithromycin, and may range in severity
from mild diarrhea to fatal colitis. CDAD must be considered in all patients who
present with diarrhea following antibiotic use. Careful medical history is necessary
since CDAD has been reported to occur over two months after the administration of
antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use
not directed against C. difficile may need to be discontinued, and appropriate
management and treatment of C. difficile should be instituted as clinically
indicated.
Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic
syndrome have been reported in patients receiving azithromycin therapy.