AZITHROMYCIN-AFT POWDER FOR SOLUTION FOR INFUSION 500MG/VIAL [SIN16605P]

Product Info

AZITHROMYCIN-AFT POWDER FOR SOLUTION FOR INFUSION 500MG/VIAL

[SIN16605P]

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 community acquired pneumonia (CAP) caused by susceptible organisms including Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophilia, 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 Dose and method of administration
Azithromycin tablets, capsules and powder for oral suspension are unavailable in the AZITHROMYCIN-AFT brand. Information obtained using azithromycin tablets, capsules and powder for oral suspension formulations have been retained throughout the PI, where appropriate, for continuity and prescriber information.

Dose

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 IV dose for at least two days. IV therapy should be followed by oral therapy of 500 mg azithromycin administered as a single daily dose to complete a 7- to 10-day course of therapy. The timing of the conversion to oral azithromycin 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.

Special populations

Use in elderly
No dose adjustment is necessary in elderly patients requiring azithromycin therapy. Elderly patients may be more susceptible to the 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).

Use in patients with renal impairment
No dose adjustment is needed in patients with mild or moderate renal impairment (GFR 10 – 80 mL/min). After oral administration of a single dose of azithromycin 1 g in subjects with severe renal impairment (GFR < 10 mL/min), mean AUC_0–120h and mean C_max were increased by approximately 30% and 60%, respectively when compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to patients with severe renal impairment (see Section 4.4 Special warnings and precautions for use and Section 5.2 Pharmacokinetic properties, Pharmacokinetics in special patient groups – renal impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use 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 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in children
The safety and effectiveness of IV azithromycin powder for solution for infusion for the treatment of infections in children have not been established.

AZITHROMYCIN-AFT after reconstitution and dilution is for administration by IV infusion only. Not to be given as a bolus or as an intramuscular injection.

The infusate concentration and rate of infusion for azithromycin powder for solution for infusion 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.

Method of administration
Preparation of the solution for IV administration is as follows:

Reconstitution
Prepare the initial solution of azithromycin powder for solution for infusion by adding 4.8 mL of sterile Water for Injections to the 500 mg vial and shaking the vial until all of the drug is dissolved. Since azithromycin IV is supplied under vacuum, it is recommended that a standard 5 mL (non-automated) syringe be used to ensure that the exact amount of 4.8 mL of sterile Water for Injections is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin.

Dilute this solution further prior to administration as instructed below.

Dilution
To provide azithromycin over a concentration range of 1.0 – 2.0 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed below.

It is recommended that a 500 mg dose of azithromycin powder for solution for infusion, diluted as above, be infused over a period of not less than 60 minutes.

AZITHROMYCIN-AFT is supplied in single use vials. The vial contents are reconstituted with 4.8 mL sterile Water for Injections (azithromycin 100 mg/mL). For administration, the required volume of the reconstituted solution is added to a compatible infusion solution to produce a final azithromycin solution of 1.0 – 2.0 mg/mL.

Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident, the drug solution should be discarded.

Chemical and physical in-use stability of the reconstituted product has been demonstrated for 24 hours at 30 °C. When diluted according to the instructions the diluted solution is chemically and physically stable for 24 hours at or below 30 °C or for 7 days if stored under refrigeration at 5 °C.

However, as this product contains no antimicrobial agent, to reduce microbiological hazard, use as soon as practicable after reconstitution/preparation. If storage is necessary, hold at 2 – 8 °C for not more than 24 hours.

This product is for single use in one patient on one occasion only. Discard any residue.

The reconstituted solution can be diluted with:

• Normal saline (0.9% sodium chloride)

• ½ Normal saline (0.45% sodium chloride)

• 5% Dextrose in Water

• Lactated Ringer’s solution

• 5% Glucose in ½ normal saline (0.45% sodium chloride) with 20 mEq KCl

• 5% Glucose in Lactated Ringer’s solution

• 5% Glucose in ⅓ normal saline (0.3% sodium chloride)

• 5% Glucose in ½ normal saline (0.45% sodium chloride)

• Normosol®-M in 5% Dextrose

• Normosol®-R in 5% Dextrose

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