AZITHROMYCIN MEVON POWDER FOR SOLUTION FOR INFUSION 500 MG/VIAL [SIN14490P]

Product Info

AZITHROMYCIN MEVON POWDER FOR SOLUTION FOR INFUSION 500 MG/VIAL

[SIN14490P]

Indication

4.1 Therapeutic indications

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

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

Dosing

4.2 Posology and method of administration

For the treatment of adult patients with (CAP) due to the indicated organisms, the recommended dose of intravenous azithromycin is 500 mg as a single daily dose by the IV route for at least two days. Intravenous 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 intravenous azithromycin is 500 mg as a single daily dose by the IV route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route 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 agent with anaerobic activity should be administered in combination with azithromycin.

Intravenous Administration: After reconstitution and dilution, the recommended route of administration for intravenous azithromycin is by IV infusion only. Do not administer as an intravenous bolus or an intramuscular injection (see Section 4.4 Special warnings and precautions for use and section 6.6 Special precautions for disposal and other handling – 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 intravenous (IV) should be either 1mg/ml over 3 hours or 2 mg/ml over 1 hour. An intravenous dose of 500 mg azithromycin should be infused for a minimum duration of one (1) hour.

SPECIAL POPULATIONS:
Children
The safety and efficacy of azithromycin powder for solution for infusion in the treatment of infections in children have not been established.

Elderly patients
The same dosage as in adult patients is used in the elderly. Elderly patients may be more susceptible to development of torsades de pointes arrhythmia than younger patients (see Section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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) (see Section 4.4 Special warnings and precautions for use and Section 5.2 Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with hepatic impairment
In patients with mild to moderate hepatic impairment, the same dosage as in patients with normal hepatic functions may be used (see Section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

4.3 Contraindications
Azithromycin powder for solution for infusion is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any excipient listed in section 6.1 (List of excipients) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.