ZYNOMAX FILM-COATED TABLET 250 MG [SIN16423P]

Product Info

ZYNOMAX FILM-COATED TABLET 250 MG

[SIN16423P]

I. INDICATIONS
Zynomax is indicated for infections caused by susceptible organisms; in lower respiratory tract infections including bronchitis and pneumonia, in skin and soft tissue infections, in acute otitis media and in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis. (Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. Zynomax is generally effective in the eradication of streptococci from the oropharynx, however, data establishing the efficacy of Zynomax and the subsequent prevention of rheumatic fever are not available at present.) In sexually transmitted diseases in men and women, Zynomax is indicated in the treatment of uncomplicated genital infections due to Chlamydia trachomatis. It is also indicated in the treatment of chancroid due to Haemophilus ducreyi and uncomplicated genital infection due to non- multiresistant Neisseria gonorrhoea; concurrent infection with Treponema pallidum should be excluded.

II. DOSAGE AND ADMINISTRATION
Oral Zynomax should be administered as a single daily dose. The period of dosing with regard to infection is given below. Zynomax can be taken with or without food.

In Adults:
For the treatment of sexually transmitted disease caused by Chlamydia trachomatis, or non-multiresistant Neisseria gonorrhea, the dose is 1000 mg as a single oral dose.

For all other indications in which the oral formulation is administered, the total dosage of 1500 mg should be given as 500 mg daily for 3 days. As an alternative, the same total dose can be given 5 days with 500 mg given on day 1, then 250 mg daily on days 2 to 5.

In Children:
The maximum recommended total dose for any treatment is 1500 mg for children.
In general, the total dose in children is 30 mg/kg. Treatment for pediatric streptococcal pharyngitis should be dosed at a different regimen (see below).
The total dose 30 mg/kg should be given as single daily dose of 10 mg/kg daily for 3 day, or given over 5 days with a single daily dose of 10 mg/kg on day 1, then 5 mg/kg on days 2–5.
As an alternative to the above dosing, treatment for children with acute otitis media can be given as a single dose of 30 mg/kg.

For pediatric streptococcal pharyngitis, azithromycin given as a single dose of 10 mg/kg or 20 mg/kg for 3 days has been shown to be effective; however, a daily dose of 500 mg must not be exceeded. In clinical trials comparing these two dosage regimens, similar clinical efficacy was observed but greater bacteriologic eradication was evident at the 20 mg/kg/day dose.

However, penicillin is the usual drug of choice for the treatment of Streptococcus pyogenes pharyngitis, including prophylaxis of rheumatic fever.
For children weighing less than 15 kg, Zynomax should be measured as closely as possible. For children weighing 15 kg or more, Zynomax should be administered according to the guide provided below:

Zynomax tablets should only be administered to children weighing more than 45kg.

Special populations:
Elderly:
The same dosage as in adult patients is used in the elderly. Elderly patients may be more susceptible to the development of torsades de pointes arrhythmia than younger patients.
Patients with Renal Impairment:
No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10 – 80 ml/min). Caution should be exercised when azithromycin is administered to patients with severe renal impairment (GFR < 10 ml/min).
Patients with Hepatic Impairment
The same dosage as in patients with normal hepatic function may used in patients with mild to moderate hepatic impairment.

III. CONTRAINDICATIONS
The use of azithromycin is contraindicated in patients with hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any excipient used in the product.