Manufacturer
- Manufacturer Registraction Number ingredient, MAL, manufacture in 3 bullet sentence content, indications, instructions
Registraction Number
- MAL09051572AZ
Content:
- Each 5 mL of the reconstituted suspension contains 204.8 mg of azithromycin monohydrate, equivalent to 200 mg of azithromycin.
Indications:
- Binozyt is indicated for the treatment of infections caused by susceptible organisms, including:
Upper respiratory tract infections: Sinusitis, pharyngitis, tonsillitis
Acute otitis media
Lower respiratory tract infections: Acute bronchitis, mild to moderately severe community-acquired pneumonia
Skin and soft tissue infections
Uncomplicated genital infections due to Chlamydia trachomatis
Note: Penicillin is the usual drug of choice for the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. Azithromycin is generally effective in the eradication of streptococci from the oropharynx; however, data establishing the efficacy of azithromycin and the subsequent prevention of rheumatic fever are not available at present
Instructions:
Adults:
For uncomplicated Chlamydia trachomatis urethritis and cervicitis: 1,000 mg as a single oral dose.
For other infections: The total dose should not exceed 1,500 mg/day, divided into 500 mg/day for 3 days, or use for 5 days with a dose of 500 mg on the first day and 250 mg from day 2–5.
Children and Adolescents under 18 years:
The total dose is 30 mg/kg/day, divided into 10 mg/kg/day for 3 days. Alternatively, treat for 5 days with a single dose of 10 mg/kg on the first day, then 5 mg/kg on the next 4 days.
Administration:
Add water to the powder and shake well to obtain 15 mL of oral suspension.
Take at least 1 hour before meals or 2 hours after meals.
Shake the vial well just before drinking.
Do not use the suspension after the expiration date.
Storage Instructions:
Store at room temperature, away from light and moisture.
Keep out of reach of children.
After reconstitution, the suspension can be kept stable at temperatures below 25°C for 10 days.
Malaysia
