Azithromycin - Zithromax ® |
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| The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. | |||||||||||||||||||||||||||||||
Usual Diluents |
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| D5W, NS Other (0.45% sodium chloride, LR, D5LR). | |||||||||||||||||||||||||||||||
Standard Dilution [Amount of drug] [Infusion volume] [Infusion rate] |
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| [500 mg] [250 ml] [1 hour] [1000mg] [500ml] [2 hours] ---------- The package insert also includes guidelines for a 1 mg/mL solution with a longer infusion time compared to the 2 mg/mL solution: [ 500mg ] [ 500 mL ] [ 3 hours ]
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Stability / Miscellaneous |
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INDICATIONS AND USAGE 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. Microbiology Azithromycin concentrates in phagocytes and fibroblasts as demonstrated by in vitro incubation techniques. Using such methodology, the ratio of intracellular to extra-cellular concentration was >30 after one hour incubation. In vivo studies suggest that concentration in phagocytes may contribute to drug distribution to inflamed tissues. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section of the package insert for ZITHROMAX (azithromycin for injection). Aerobic and facultative gram-positive microorganisms NOTE: Azithromycin demonstrates cross-resistance with erythromycin-resistant gram-positive strains. Most strains of Enterococcus faecalis and methicillin-resistant staphylococci are resistant to azithromycin. Aerobic and facultative gram-negative microorganisms "Other" microorganisms Beta-lactamase production should have no effect on azithromycin activity. Azithromycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section of the package insert for ZITHROMAX (azithromycin tablets) and ZITHROMAX (azithromycin for oral suspension). Aerobic and facultative gram-positive microorganisms Aerobic and facultative gram-negative microorganisms "Other" microorganisms Beta-lactamase production should have no effect on azithromycin activity. The following in vitro data are available, but their clinical significance is unknown. At least 90% of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoints for azithromycin. However, the safety and effectiveness of azithromycin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials. Aerobic and facultative gram-positive microorganisms Aerobic and facultative gram-negative microorganisms Anaerobic microorganisms "Other" microorganisms DOSAGE AND ADMINISTRATION 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. Preparation of the solution for intravenous administration is as follows: 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. Normal Saline (0.9% sodium chloride) 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/Stability ---- 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). HOW SUPPLIED These are packaged as follows: Renal dosing: |
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Reference(s) |
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| Package insert data: Revised: 05/2006 |
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Zithromax ® – Azithromycin
