Composition: Oral Suspension Reconstituted suspension contains 200 mg of azithromycin base per 5ml. Therapeutic Category: Antibiotic, macrolide.
Use
Treatment of acute otitis media due to H. influenzae. M. catarrhalis. or S. pneumoniae.
Pharyngitis/tonsillitis due to S. pyogenes.
Treatment of mild to moderate upper and lower respiratory tract infections.
Infections of the skin and skin structure.
Community-acquired pneumonia.
pharyngitis/tonsillitis (alternative to first-line therapy).
genital ulcer disease (chancroid) due to susceptible strains of C. trachomatis. M. catarrhal’s. ff. influenzae. S. aureus. S. pneumoniae, Alycoplasma pneumoniae. and C. psittaci.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (COPE)) due to H. influercae. M. catarrhal’s. or S. pneumoniae.
Unlabeled/Investigational Use
Prevention of (or to delay onset of) or treatment of MAC in patients with advanced HIV infection.
Prophylaxis of bacterial endocarditis in patients who are allergic to penicillin and undergoing surgical or dental procedures.
Contraindications
Hypersensitivity to azithromycin, other macrolide antibiotics. or any component of the formulation.
Warnings/Precautions
Use with caution in patients with hepatic dysfunction; hepatic impairment with or without jaundice has occurred chiefly in older children and adults; it may be accompanied by malaise, nausea, vomiting, abdominal colic. and fever; discontinue use if these occur.
May mask or delay symptoms of incubating gonorrhea or syphilis, so appropriate culture and susceptibility tests should be performed prior to initiating azithromycin.
Pseudomembranous colitis has been reported with use of macrolide antibiotics.
Use with caution with renal dysfunction.
Safety and efficacy have not been established in children less than 6 months of age with acute otitis media or community-acquired pneumonia, or in children less than 2 years of age with pharyngitis:tonsillitis.
Dosage
Children > 6 months Dosage in Community-acquired pneumonia
10 mg/kg on day 1 (maximum: 500 mg/day) followed by 5 mg/kg/day once daily on days 2 to 5 (maximum: 250 mg/day).
Children > 6 months Dosage in Otitis media
1-day regimen: 30 mg/kg as a single dose (maximum dose: 1500 mg).
3-days regimen: 10 mg/kg once daily for 3 days (maximum: 500 mg/day).
5-days regimen: 10 mg/kg on day 1 (maximum: 500 mg/day) followed by 5 mg/kg/day once daily on days 2 to 5 (maximum: 250 mg/day).
Children > 2 years Dosage in Pharyngitis, tonsillitis
12 mg/kg/day once daily for 5 days (maximum: 500 mg/day) .
Children > 2 years Dosage in Prophylaxis for bacterial endocarditis (unlabeled use)
15 mg/kg 1 hour before the procedure.
Instructions For Use
Shake the bottle containing powder before adding water.
Before using the suspension, always shake the bottle well.
Discard after 5 days of reconstitution.
Xithrone: Arabic Information
Xithrone: Arabic Information
Categories and tags: J01FA10, Azithromycin, Macrolides, MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS, ANTIBACTERIALS FOR SYSTEMIC USE, ANTIINFECTIVES FOR SYSTEMIC USE.
