Generic Name:  Azithromycin

Regulatory Class: Rx

Formulations: Each 5 ml Powder for suspension contains: Azithromycin (as monohydrate).... 200mg

Indications or Uses: For the treatment of the following infections caused by microorganisms sensitive to azithromycin:
- Upper respiratory tract infections, including sinusitis, pharyngitis, tonsillitis
- Lower respiratory tract infections, including bronchitis and pneumonia
- Acute otitis media
- Skin and soft tissue infections
- Uncomplicated genital infections caused by Chlamydia trachomatis or Neisseria gonorrhoeae (non-multi-resistant strains)

Dosage or Directions for use:  The dosage in children and adolescents up to 45 kg body weight (KG) is based on the body weight (BW), taking either 10 mg once a day for 3 days in a 3-day regimen. Azithromycin per kg BW or alternatively in a 5-day therapy schedule on the first day 10 mg/kg BW and 5 mg/kg BW on days 2 to 5. Adults and adolescents over 45 kg body weight (KG) usually receive a total dose of 1500 mg azithromycin, which can be taken either according to the 3-day therapy schedule or the 5-day therapy schedule.

Administration: Shake well until a homogenous suspension is achieved. For administration the syringe adapter should be placed in the neck of the bottle and the stopper should be opened. Take w/ food. 

Contraindications: Hypersensitivity to the active substance, erythromycin, any macrolide or ketolide antibiotic, or to any of the excipients.

Special Precautions:  Hypersensitivity. Caution in patients with significant hepatic disease, patients receiving ergot derivatives, patients with severe renal impairment and patients with neurological and psychiatric disorders.Prolonged cardiac repolarization and QT interval.

Adverse Reaction:  Anorexia; dizziness, headache, paraesthesia, dysgeusia; visual impairment; deafness; diarrhoea, abdominal pain, nausea, flatulence, abdominal discomfort, loose stools; rash, pruritus and fatigue.

Interactions:  P-gycloprotein substrates such as digoxin and colchicine, has been reported to result in increased serum levels of P-glycoprotein substrates. Ergot derivatives possible of ergotism.

Presentation or Packaging:  Oral Suspension: 200mg/5ml in 60 mL HDPE Plastic Bottle; Box of 1's; Net content: 20ml

For more information on this product, please see the product insert.