(Approval lapsed) Azithromycin powder for oral suspension, USP 200mg per 5 mL (600mg/15mL) (Zydus, USA)

Azithromycin is indicated for use in adults for the treatment of the following infections of mild to moderate severity:

Lower respiratory tract infections:
Acute bacterial bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis. Community acquired pneumonia due to Streptococcus pneumoniae or Haemophilus influenzae in patients suitable for outpatient oral treatment. Community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. In clinical studies efficacy has been demonstrated against Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophilia, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus and Streptococcus pneumoniae.

Upper respiratory tract infections:
Acute sinusitis due to Streptococcus pneumoniae or Haemphilus influenzae. Acute streptococcal pharyngitis. Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. Azithromycin appears to be almost as effective in the treatment of streptococcal pharyngitis. However, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present.

Uncomplicated skin and skin structure infections:
Uncomplicated infections due to Staphylococcus aureus, Streptococcus pyogenes or Streptococcus agalactiae. Abscesses usually require surgical drainage.

Sexually transmitted diseases:
Uncomplicated urethritis and cervicitis due to Chlamydia trachomatis. Note. At the recommended dose azithromycin cannot be relied upon to treat gonorrhoea or syphilis. As with other drugs for the treatment of non-gonococcal infections, it may mask or delay the symptoms of incubating gonorrhoea or syphilis. Appropriate tests should be performed for the detection of gonorrhoea or syphilis and treatment should be instituted as required.

Azithromycin is indicated for use in children for the treatment of the following infections:
Acute streptococcal pharyngitis/tonsillitis. Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. The 20mg/kg azithromycin dose appears to be almost as effective as penicillin in the treatment of streptococcal pharyngitis. However substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present.