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Zithromax Injection (Azithromycin Injection) - Summary



ZITHROMAX (azithromycin for injection) contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for intravenous injection.

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.

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Published Studies Related to Zithromax Injection (Azithromycin Injection)

[Efficacy assessment of azithromycin 1.5% eye drops versus tobramycin 0.3% on clinical signs of purulent bacterial conjunctivitis] [2010.04]
INTRODUCTION: Bacterial conjunctivitis is characterized by hyperemia and discharge of one or both eyes. These clinical signs appear quickly and are contagious. This study compares the clinical efficacy (signs and symptoms) and safety of azithromycin 1.5% eye drops with tobramycin 0.3%... CONCLUSIONS: Azithromycin 1.5% for 3 days (six drops) was as effective as tobramycin for 7 days (36 drops). Furthermore, patients on azithromycin presented earlier clinical cure on Day 3 than patients on tobramycin. Azyter, with its convenient dosing (bid for 3 days), is a step forward in the management of purulent bacterial conjunctivitis. Copyright 2010 Elsevier Masson SAS. All rights reserved.

Efficacy and safety of azithromycin 1.5% eye drops for purulent bacterial conjunctivitis in pediatric patients. [2010.03]
BACKGROUND: Purulent bacterial conjunctivitis affects all ages with high frequency in newborns and children. In a subset of 150 children included in a large study having enrolled 1043 patients, our aim was to analyze in children, the efficacy and safety of azithromycin 1.5% eye-drops in the treatment of this disease... CONCLUSIONS: Azithromycin 1.5% eye drops leads to a rapid clinical and microbiological cure.

Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial. [2008.06]
PURPOSE: To analyze the effect of azithromycin 1% ophthalmic solution in DuraSite (InSite Vision, Inc, Alameda, California, USA) on bacterial conjunctivitis. DESIGN: Prospective, randomized, vehicle-controlled, parallel-group, double-masked multicenter clinical study... CONCLUSIONS: Azithromycin 1% ophthalmic solution in DuraSite showed statistically significant differences in clinical resolution and bacterial eradication rates when compared with vehicle. Because it was well tolerated in this population, it may be a viable treatment option for children and adults with bacterial conjunctivitis.

The comparison of single-dose ceftriaxone, five-day azithromycin, and ten-day amoxicillin/clavulanate for the treatment of children with acute otitis media. [2007.10]
The aim of the study was to evaluate the efficacy of short-course antimicrobial therapies [single intramuscular dose of ceftriaxone (50 mg/kg, not exceeding 1 g), 5 days of azithromycin (10 mg/kg on day 1, then 5 mg/kg daily on days 2-5) and the traditional 10-day course of amoxicillin/clavulanate (90/6.4 mg/kg/day in 2 doses)] in children with acute otitis media (AOM)...

Correlation between In vitro susceptibility and treatment outcome with azithromycin in gonorrhoea: A prospective study. [2007.10]
Purpose: This prospective study was carried out to determine the antimicrobial susceptibility of Neisseria gonorrhoeae isolates by disc diffusion method and minimum inhibitory concentration (MIC) by E -test with special reference to azithromycin. Also, the correlation between in vitro susceptibility and treatment outcome with single 2 g oral dose azithromycin was assessed...

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Clinical Trials Related to Zithromax Injection (Azithromycin Injection)

Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan) [Completed]

Fed Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600 mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg) dose administered under fed conditions.

Fasting Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600 mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg) dose administered under fasting conditions.

Comparative Bioavailability Study of 600mg Azithromycin Monohydrate Tablets Under Fasting Conditions [Completed]

A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions [Completed]
The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX oral suspension distributed by Pfizer labs, a division of Pfizer Inc. following a single oral 10 mL dose (400 mg) in healthy adult subjects administered under non-fasting conditions.

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Page last updated: 2010-10-05

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