Vaxcel Azithromycin Dosage/Direction for Use

Adults: For the treatment of adult patients with CAP due to the indicated organisms, the recommended dose of intravenous azithromycin is 500mg as a single dose by the IV route for one or two days. Intravenous therapy should be followed by oral azithromycin as a single daily dose of 500mg 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 500mg as a single 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 250mg 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.
Children: The safety and efficacy of intravenous azithromycin for the treatment of infections in children has not been established.
Elderly: The same dosage as in adult patients is used in the elderly.
Patients with Renal Impairment: No dosage adjustment is necessary in patients with mild to moderate renal impairment (GFR10 - 80ml/min). Caution should be exercised when azithromycin is administered to patients with severe renal impairment (GFR < 10ml/min).
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.
Route of administration: 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. The infusate concentration and rate of infusion for azithromycin intravenous (IV) should be either 1 mg/ml over 3 hours or 2mg/ml over 1 hour. An intravenous dose of 500mg azithromycin should be infused for a minimum duration of one (1) hour.
Intravenous (IV) solution preparation: Reconstitution: Prepare the initial IV solution for infusion by adding 4.8ml of sterilized Water for Injection to the vial and shake the vial until all of the drug is dissolved. Each ml of reconstituted solution contains 100mg azithromycin. Chemical and physical in-use stability of the reconstituted product has been demonstrated for 24 hours at 25±2°C. When diluted according to the instructions the diluted solution is chemically and physically stable for 24 hours at or below 25°C or for 7 days if stored under refrigeration 2-8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally be no longer than 24 hours at 2 to 8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.
Dilute this solution further prior to administration as instructed as follows: Dilution: To provide azithromycin over a concentration range of 1.0 - 2.0mg/ml, transfer 5ml of the 100mg/ml azithromycin solution into the appropriate amount of any of the diluents listed as follows: (see table).

Click on icon to see table/diagram/image

The reconstituted solution can be diluted with: Normal Saline (0.9% sodium chloride); ¹/₂ Normal Saline (0.45% sodium chloride); 5% Dextrose in Water; Lactated Ringer's Solution; 5% Dextrose in ¹/₂ Normal Saline (0.45% sodium chloride) with 20mEq KCl; 5% Dextrose in Lactated Ringer's Solution; 5% Dextrose in ¹/₃ Normal Saline (0.3% sodium chloride); 5% Dextrose in ¹/₂ Normal Saline (0.45% sodium chloride).
Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.