Azithromycin

Generic Name
Azithromycin
Brand Names
Azasite, Zithromax, Zmax
Drug Type
Small Molecule
Chemical Formula
C38H72N2O12
CAS Number
83905-01-5
Unique Ingredient Identifier
J2KLZ20U1M
Background

Azithromycin is a broad-spectrum macrolide antibiotic with a long half-life and a high degree of tissue penetration . It was initially approved by the FDA in 1991 .

It is primarily used for the treatment of respiratory, enteric and genitourinary infections and may be used instead of other macrolides for some sexually transmitted and enteric infections. It is structurally related to erythromycin .

Azithromycin [9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin] is a part of the azalide subclass of macrolides, and contains a 15-membered ring, with a methyl-substituted nitrogen instead of a carbonyl group at the 9a position on the aglycone ring, which allows for the prevention of its metabolism. This differentiates azithromycin from other types of macrolides .

In March 2020, a small study was funded by the French government to investigate the treatment of COVID-19 with a combination of azithromycin and the anti-malaria drug hydroxychloroquine. The results were positive, all patients taking the combination were virologically cured within 6 days of treatment, however, larger studies are required.

Indication

Azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria in order to prevent the development antimicrobial resistance and maintain the efficacy of azithromycin .

Azithromycin is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the microorganisms listed in the specific conditions below. Recommended dosages, duration of therapy and considerations for various patient populations may vary among these infections. Refer to the FDA label and "Indications" section of this drug entry for detailed information .

Adults:

Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae

Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae

Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy

Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.

Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae. Abscesses usually require surgical drainage.

Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.

Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.

Pediatric Patients

Acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae

Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.

Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.

Associated Conditions
Acute Bacterial Sinusitis (ABS), Acute Otitis Media (AOM), Acute bacterial exacerbation of COPD caused by Haemophilus Influenza Infections, Moraxella Catarrhalis Infection, Streptococcus Pneumoniae Infections, Bacterial Conjunctivitis, Bacterial Sinusitis, Cervicitis, Chancroid, Community Acquired Pneumonia (CAP), Genital Ulcer Disease (GUD), Pelvic Inflammatory Disease (PID), Pharyngitis, Streptococcal Pharyngitis, Tonsillitis bacterial, Tonsillitis streptococcal, Traveler's Diarrhea, Uncomplicated Skin and Skin Structure Infections, Urethritis
Associated Therapies
-

A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media

First Posted Date
2008-03-27
Last Posted Date
2008-03-27
Lead Sponsor
Abbott
Target Recruit Count
357
Registration Number
NCT00645112

Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat

Phase 4
Completed
Conditions
Interventions
First Posted Date
2008-03-26
Last Posted Date
2008-03-26
Lead Sponsor
Pfizer
Target Recruit Count
360
Registration Number
NCT00643539
Locations
🇫🇷

Pfizer Investigational Site, Versailles, France

Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger

First Posted Date
2008-02-20
Last Posted Date
2012-05-08
Lead Sponsor
University of California, San Francisco
Target Recruit Count
1139
Registration Number
NCT00618449
Locations
🇺🇸

Chlamydia Research Laboratory, San Francisco, California, United States

🇳🇪

Programme National de Lutte Contre la Cécité, Niamey, Niger

Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia

First Posted Date
2008-02-08
Last Posted Date
2008-02-08
Lead Sponsor
Anbics Management-Services Ag
Target Recruit Count
92
Registration Number
NCT00610623
Locations
🇧🇪

Intensive Care Unit, Clinique Saint-Pierre, Ottignies, Louvain, Belgium

Surgical Intensive Care Unit, Clinical Center of Serbia, Belgrade, Former Serbia and Montenegro

Surgical Intensive Care Unit, Clinical Center of Serbia, Institut of Neurosurgery, Belgrade, Former Serbia and Montenegro

and more 16 locations

Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease

First Posted Date
2008-01-23
Last Posted Date
2017-05-23
Lead Sponsor
The University of Texas Health Science Center at Tyler
Target Recruit Count
58
Registration Number
NCT00598962
Locations
🇺🇸

The University of Texas Health Science Center at Tyler, Tyler, Texas, United States

Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates

First Posted Date
2008-01-23
Last Posted Date
2017-05-17
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
7
Registration Number
NCT00599053
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

Azithromycin in the Treatment of M. Avium Complex Lung Disease

Phase 4
Completed
Conditions
Interventions
First Posted Date
2008-01-23
Last Posted Date
2017-05-23
Lead Sponsor
The University of Texas Health Science Center at Tyler
Target Recruit Count
66
Registration Number
NCT00599079
Locations
🇺🇸

The University of Texas Health Science Center at Tyler, Tyler, Texas, United States

Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers

First Posted Date
2007-11-28
Last Posted Date
2011-09-22
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
48
Registration Number
NCT00564447

Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation

First Posted Date
2007-11-26
Last Posted Date
2011-06-16
Lead Sponsor
Hospital Authority, Hong Kong
Target Recruit Count
30
Registration Number
NCT00563251
Locations
🇨🇳

Queen Mary Hospital, Hong Kong, China

Effect of Macrolide Antibiotics on Airway Inflammation in People With Chronic Obstructive Pulmonary Disease (COPD)

First Posted Date
2007-10-25
Last Posted Date
2017-09-29
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
53
Registration Number
NCT00549445
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

© Copyright 2024. All Rights Reserved by MedPath