Source: FDA, National Drug Code (US) Revision Year: 2020
ZITHROMAX (azithromycin) for injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
due to Chlamydophila pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy.
due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with ZITHROMAX.
ZITHROMAX for injection should be followed by ZITHROMAX by the oral route as required [see Dosage and Administration (2)].
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin) should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
[see Indications and Usage (1) and Clinical Pharmacology (12.3)]
The recommended dose of ZITHROMAX for injection 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 ZITHROMAX for injection 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 ZITHROMAX for injection should be either 1 mg/mL over 3 hr or 2 mg/mL over 1 hr. ZITHROMAX for injection should not be given as a bolus or as an intramuscular injection.
Prepare the initial solution of ZITHROMAX for injection by adding 4.8 mL of Sterile Water for Injection to the 500 mg vial, and shaking the vial until all of the drug is dissolved. Since ZITHROMAX for injection 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 is dispensed. Each mL of reconstituted solution contains 100 mg azithromycin. Reconstituted solution is stable for 24 hr when stored below 30°C (86°F).
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.
Dilute this solution further prior to administration as instructed below.
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:
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
When used with the Vial-Mate drug reconstitution device, please reference the Vial-Mate instructions for assembly and reconstitution.
| Final Infusion Solution Concentration (mg/mL) | Amount of Diluent (mL) |
|---|---|
| 1.0 mg/mL | 500 mL |
| 2.0 mg/mL | 250 mL |
Other intravenous substances, additives, or medications should not be added to ZITHROMAX for injection, or infused simultaneously through the same intravenous line.
When diluted according to the instructions (1.0 mg/mL to 2.0 mg/mL), ZITHROMAX for injection is stable for 24 hr at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F).
Adverse reactions experienced in higher than recommended doses were similar to those seen at normal doses particularly nausea, diarrhea, and vomiting. In the event of overdosage, general symptomatic and supportive measures are indicated as required.
Before reconstitution, store vials at or below 30°C (86°F) [see Dosage and Administration (2.3)].
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