ZITHROMAX IV POWDER FOR SOLUTION FOR INFUSION 500 MG/VIAL [SIN12057P]

Product Info

ZITHROMAX IV POWDER FOR SOLUTION FOR INFUSION 500 MG/VIAL

[SIN12057P]

4.1 Therapeutic indications

Azithromycin is indicated for infections caused by susceptible organisms; in lower respiratory tract infections including bronchitis and pneumonia, in odontostomatological infections, 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. 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.)

In sexually transmitted diseases in men and women, azithromycin is indicated for the treatment of uncomplicated genital infections due to Chlamydia trachomatis. It is also indicated for the treatment of chancroid due to Haemophilus ducreyi and uncomplicated genital infections due to non-multiresistant Neisseria gonorrhoeae; concurrent infection with Treponema pallidum should be excluded.

Azithromycin is indicated, either alone or in combination with rifabutin, for prophylaxis against Mycobacterium avium-intracellulare complex (MAC) infection, an opportunistic infection prevalent in patients with advanced human immunodeficiency virus (HIV).

Azithromycin IV is indicated for the treatment of community-acquired pneumonia (CAP) caused by susceptible organisms, including Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae, in patients who require initial IV therapy.

Azithromycin IV is indicated for the treatment of pelvic inflammatory diseases (PID) caused by susceptible organisms, including Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis, in patients who require initial IV therapy.

4.2 Posology and method of administration

Oral azithromycin should be administered as a single daily dose. The period of dosing with regard to infection is given below.

Azithromycin tablets and powder for oral suspension can be taken with or without food.

In adults

For the treatment of sexually transmitted diseases caused by Chlamydia trachomatis, Haemophilus ducreyi, or susceptible Neisseria gonorrhoeae, the dose is 1000 mg as a single oral dose.

For prophylaxis against MAC infections in patients infected with the HIV, the dose is 1200 mg once per week.

For the treatment of adult patients with CAP due to the indicated organisms, the recommended dose of IV azithromycin is 500 mg as a single daily dose by the IV route for at least 2 days. IV therapy should be followed by oral azithromycin at a single daily dose of 500 mg to complete a 7- to 10-day course of therapy. The timing of the conversion to oral therapy should be done at the discretion of the physician and in accordance with clinical response.

For the treatment of adult patients with PID due to the indicated organisms, the recommended dose of IV azithromycin is 500 mg as a single daily dose by the IV route for 1 or 2 days. IV therapy should be followed by oral azithromycin at a single daily dose of 250 mg to complete a 7-day course of therapy. The timing of the conversion to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial anaerobic agent may be administered in combination with azithromycin.

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 over 5 days with 500 mg given on Day 1, then 250 mg daily on Days 2 to 5.

Intravenous Administration: After reconstitution and dilution, the recommended route of administration for IV azithromycin is by IV infusion only. Do not administer as an IV bolus or an intramuscular injection (see section 4.4 and section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The infusate concentration and rate of infusion for azithromycin IV should be either 1 mg/ml over 3 hours or 2 mg/ml over 1 hour. An IV dose of 500 mg azithromycin should be infused for a minimum duration of 1 hour.

In children

The maximum recommended total dose for any treatment is 1500 mg for children.

The total dose of 30 mg/kg should be given as a single daily dose of 10 mg/kg daily for 3 days, 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.

For children weighing less than 15 kg, azithromycin suspension should be measured as closely as possible. For children weighing 15 kg or more, azithromycin suspension should be administered according to the guide provided below:

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

The safety and efficacy of IV azithromycin for the treatment of infections in children have not been established.

Safety and efficacy for the prevention of MAC in children have not been established. Based on pediatric pharmacokinetic data, a dose of 20 mg/kg would be similar to the adult dose of 1200 mg but with a higher C_max.

Special populations

In the 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 (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In Patients with Renal Impairment: No dose adjustment is necessary in patients with GFR 10–80 ml/min. Caution should be exercised when azithromycin is administered to patients with GFR <10 ml/min (see section 4.4 and section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In Patients with Hepatic Impairment: The same dosage as in patients with normal hepatic function may be used in patients with mild to moderate hepatic impairment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

The use of this product is contraindicated in patients with a hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any excipient listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.