ZITHROMAX (azithromycin for injection) is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. As recommended dosages, durations of therapy, and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for dosing recommendations.

Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy.

Pelvic inflammatory disease 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 (azithromycin for injection) should be followed by ZITHROMAX by the oral route as required. (See DOSAGE AND ADMINISTRATION.)

Appropriate culture and susceptibility tests should be performed before treatment to determine the causative microorganism and its susceptibility to azithromycin. Therapy with ZITHROMAX may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.

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 or prevent 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 CLINICAL PHARMACOLOGY.)

The recommended dose of ZITHROMAX (azithromycin 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 (azithromycin) 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. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with ZITHROMAX.

Renal Insufficiency

No dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)

Hepatic Insufficiency

The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)

No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)

The infusate concentration and rate of infusion for ZITHROMAX (azithromycin for injection) should be either 1 mg/mL over 3 hours or 2 mg/mL over 1 hour. ZITHROMAX (azithromycin for injection) should not be given as a bolus or as an intramuscular injection.

Preparation of the solution for intravenous administration is as follows: Reconstitution

Prepare the initial solution of ZITHROMAX (azithromycin 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 (azithromycin 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 hours when stored below 30°C or 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.

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:

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 20 mEq 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)

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.

It is recommended that a 500-mg dose of ZITHROMAX (azithromycin for injection), diluted as above, be infused over a period of not less than 60 minutes.

ZITHROMAX (azithromycin for injection) should not be given as a bolus or as an intramuscular injection.

Other intravenous substances, additives, or medications should not be added to ZITHROMAX (azithromycin for injection), or infused simultaneously through the same intravenous line.

Storage

When diluted according to the instructions (1.0 mg/mL to 2.0 mg/mL), ZITHROMAX (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).

ZITHROMAX (azithromycin for injection) is supplied in lyophilized form under a vacuum in a 10-mL vial equivalent to 500 mg of azithromycin for intravenous administration. Each vial also contains sodium hydroxide and 413.6 mg citric acid.

These are packaged as follows:

10 vials of 500 mg...... ..........................................NDC 0069-3150-83

10 vials of 500 mg with 1 Vial-Mate™ Adaptor each..................NDC 0069-3150-14

Licensed from Pliva. Vial-Mate is a trademark of Baxter International Inc., Reg. U.S. Pat and TM Off. Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. Revised August 2007. FDA Rev date: 10/25/2007

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