Azithromycin
Visa No.: VD-23220-15
Product: PymeAZI 500
API: Azithromycin
Product Category: Antibiotics
Version approved leaflet: 201/QĐ-QLD_20/04/2022_174.1
INDICATIONS
Treatment of infections caused by susceptible organisms:
- Lower respiratory tract infections, including bronchitis and pneumonia.
- Odontostomatological (oral and dental) infections.
- Skin and soft tissue infections.
- Acute otitis media and upper respiratory tract infections, including sinusitis, pharyngitis, and/or tonsillitis.
(Penicillin is generally the drug of choice for the treatment of pharyngitis caused by Streptococcus pyogenes, including the prevention of rheumatic fever. Azithromycin is generally effective in eradicating streptococci in pharyngitis; however, data demonstrating the efficacy of azithromycin in preventing subsequent rheumatic fever are currently lacking.)
- Uncomplicated genital infections caused by Chlamydia trachomatis; chancroid caused by Haemophilus ducreyi; and uncomplicated genital infections caused by non–multidrug-resistant Neisseria gonorrhoeae. Azithromycin is not indicated for the treatment of concomitant infection with Treponema pallidum.
- Azithromycin may be used alone or in combination with rifabutin for the prophylaxis of Mycobacterium avium complex (MAC) infection, an opportunistic infection commonly occurring in patients with advanced HIV infection.
- Azithromycin in combination with ethambutol is indicated for the treatment of disseminated MAC (DMAC) infection in patients with advanced HIV infection.
DOSAGE AND ADMINISTRATION
Azithromycin is administered as a single daily dose. It may be taken with or without food.
Adults:
For sexually transmitted infections caused by Chlamydia trachomatis or Haemophilus ducreyi, a single oral dose of 1,000 mg is recommended. For infections caused by susceptible Neisseria gonorrhoeae, the recommended dose is 1,000 mg or 2,000 mg azithromycin, administered concomitantly with ceftriaxone 250 mg or 500 mg, in accordance with current clinical treatment guidelines. For patients allergic to penicillins and/or cephalosporins, relevant treatment guidelines should be consulted.
Prophylaxis of MAC infection in HIV-infected patients: 1,200 mg once weekly.
Treatment of disseminated MAC (DMAC) infection in patients with advanced HIV infection: 600 mg once daily. Azithromycin should be used in combination with other antimycobacterial agents with in vitro activity against MAC, such as ethambutol at the approved dose.
Other indications suitable for oral therapy: A total dose of 1,500 mg, administered as 500 mg once daily for 3 days. Alternatively, the same total dose may be given over 5 days, with 500 mg on Day 1, followed by 250 mg once daily from Day 2 to Day 5.
Children: The maximum recommended total dose for any treatment course in children is 1,500 mg. The 3-day and 5-day monotherapy regimens are the same as those used in adults.. Azithromycin tablets should only be used in children weighing more than 45 kg.
Elderly patients: The same dosage as for adults is recommended. Elderly patients may be at increased risk of torsades de pointes arrhythmia compared with younger patients..
Renal impairment: No dose adjustment is required in patients with mild to moderate renal impairment. Caution is advised when azithromycin is used in patients with severe renal impairment.
Hepatic impairment: No dose adjustment is required in patients with mild to moderate hepatic impairment.
CONTRAINDICATIONS
Patients with hypersensitivity to any component of the product or to other antibiotics belonging to the macrolide or ketolide class.
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children
