Powder for Oral Suspension: Tap the bottle to loosen the powder. To the 600-mg bottle, add 9 mL of water. Shake well. Shake prior to use everytime .
For children weighing less than 15 kg, the suspension should be measured as closely as possible. For children weighing 15 kg or more, the suspension should be administered using an appropriate measuring spoon.
Sachets: Empty the contents of each sachet into 4 mL of water (the total volume of suspension will be 5 mL) or empty the contents of each sachet into 5 mL of water (the total volume of suspension will be 6 mL) and stir thoroughly before taking.
Powder for Intravenous Solution: Reconstitution: Prepare the initial IV solution for infusion by adding 4.8 mL of sterilized Water for Injection 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 sterilized Water for Injection is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin.
Chemical and physical in-use stability of the reconstituted product has been demonstrated for 24 hours below 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.
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°C 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: Dilution: To provide azithromycin over a concentration range of 1.0 mg/mL to 2.0 mg/mL, transfer 5 mL of the 100 mg/mL azithromycin solution into the appropriate amount of any of the diluents listed in table 6:
Click on icon to see table/diagram/imageThe 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% Dextrose in ½ Normal Saline (0.45% sodium chloride) with 20 mEq KCl, 5% Dextrose in Lactated Ringer's Solution, 5% Dextrose in ⅓ Normal Saline (0.3% sodium chloride), 5% Dextrose in ½ Normal Saline (0.45% sodium chloride), Normosol-M in 5% Dextrose, Normosol-R in 5% Dextrose.
Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution shou ld be discarded.
Incompatibilities: Intravenous: Other IV substances, additives or medications should not be added to IV azithromycin, or infused simultaneously through the same IV line.
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