[see Indications and Usage (1) and Clinical Pharmacology (12.3)].
The recommended dose of Azithromycin for Injection, USP for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for Injection, USP for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is 500 mg as a single daily dose by the intravenous 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 switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The infusate concentration and rate of infusion for Azithromycin for Injection, USP should be 2 mg/mL over 1 hour. Azithromycin for Injection, USP should not be given as a bolus or as an intramuscular injection.
Instructions for Use
These instructions for use should be made available to the individuals who perform the reconstitution steps.
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.
Peel overwrap at corner and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Assemble Vial and Flexible Diluent Container:
(Use Aseptic Technique)
To Reconstitute the Drug
If the rubber stopper is not removed from the vial and medication is not released on the first attempt, the inner cap may be manipulated back into the rubber stopper without removing the drug vial from the diluent container. Repeat steps 3 through 5.
Dilute this solution further prior to administration as instructed below.
Azithromycin for Injection, USP ADD-Vantage vials must be diluted prior to IV administration with the ADD-Vantage diluent container [see Dosage and Administration (2.3)]. The ADD-Vantage vial should be joined with a 250 mL ADD-Vantage flexible diluent container (5% dextrose injection, 0.9% sodium chloride injection or 0.45% sodium chloride injection).
It is recommended that a 500-mg dose of Azithromycin for Injection, diluted as above, be infused over a period of not less than 60 minutes.
Other intravenous substances, additives, or medications should not be added to Azithromycin for Injection, or infused simultaneously through the same intravenous line.
Preparation for Administration
WARNING: Do not use flexible container in series connections.
When diluted according to the instructions (2 mg/mL), Azithromycin for Injection is stable for 24 hours at or below room temperature (30°C or 86°F), or for 7 days if stored under refrigeration (5°C or 41°F).
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.
*Contact Medical Information. 8AM-9PM ET Monday to Friday; excluding holidays.
Submit a medical question for Pfizer prescription products.
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are
not part of a clinical trial* for this product, click the link below to submit your
*If you are involved in a clinical trial for this product, adverse
events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related
to a different Pfizer product, please call Pfizer Safety at
You may also contact the U.S. Food and Drug Administration (FDA) directly to report
adverse events or product quality concerns either online at