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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

Overview

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.

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

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/06
Phase 4
Not yet recruiting
Armed Forces Hospital, Pakistan
2025/04/10
Phase 1
Not yet recruiting
Ehab Mohamed Elsayed Mohamed Saad
2024/10/01
Phase 2
Recruiting
2024/09/20
Phase 3
Recruiting
The George Washington University Biostatistics Center
2024/08/27
N/A
Not yet recruiting
2024/08/09
Phase 1
Recruiting
2024/07/05
Phase 2
Recruiting
2024/06/17
Not Applicable
Not yet recruiting
2024/05/10
Phase 3
Not yet recruiting
2024/05/02
Phase 4
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Unit Dose Services
50436-2852
ORAL
500 mg in 1 1
4/28/2017
NuCare Pharmaceuticals,Inc.
68071-2507
ORAL
500 mg in 1 1
8/20/2021
Dispensing Solutions, Inc.
55045-3693
ORAL
500 mg in 1 1
9/6/2011
Proficient Rx LP
71205-021
ORAL
250 mg in 1 1
11/1/2018
RPK Pharmaceuticals, Inc.
53002-5221
ORAL
500 mg in 1 1
12/19/2019
Proficient Rx LP
63187-604
ORAL
250 mg in 1 1
1/1/2021
Cardinal Health 107, LLC
55154-3374
ORAL
250 mg in 1 1
5/19/2025
RPK Pharmaceuticals, Inc.
53002-0473
ORAL
500 mg in 1 1
12/10/2021
NuCare Pharmaceuticals,Inc.
68071-5238
ORAL
250 mg in 1 1
2/7/2022
RPK Pharmaceuticals, Inc.
53002-2221
ORAL
500 mg in 1 1
4/28/2017

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
AZITHROMYCIN KERN PHARMA 200MG/5ML POWDER FOR ORAL SUSPENSION
SIN13977P
POWDER, FOR SUSPENSION
200 mg/5 ml
6/20/2011
Binozyt Powder for Oral Suspension 200mg/5ml
SIN13742P
POWDER, FOR SUSPENSION
200mg/5ml
12/1/2009
AZIMAX-250 TABLET 250MG
SIN15065P
TABLET, FILM COATED
250mg
8/8/2016
AZITHROMYCIN MEVON POWDER FOR SOLUTION FOR INFUSION 500 mg/vial
SIN14490P
INJECTION, POWDER, FOR SOLUTION
500.00mg
1/20/2014
ZITHROMAX POWDER FOR ORAL SUSPENSION 200 mg/5 ml
SIN07863P
POWDER, FOR SUSPENSION
200 mg/5 ml
10/5/1994
Azithromycin powder for oral suspension 200mg/5ml
SIN14141P
POWDER, FOR SUSPENSION
200 mg/5 ml
4/30/2012
AZITHROMYCIN-AFT POWDER FOR SOLUTION FOR INFUSION 500MG/VIAL
SIN16605P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
500MG/VIAL
9/21/2022
Imexa Film-Coated Tablet 250mg
SIN14281P
TABLET, FILM COATED
250.00mg
12/31/2012
AZITHROMYCIN KERN PHARMA 500MG FILM-COATED TABLETS
SIN13976P
TABLET, FILM COATED
500MG
6/20/2011
AZmycin Tablet 500mg
SIN14040P
TABLET, FILM COATED
500mg
10/27/2011

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Azithromycin Dihydrochloride for Injection
国药准字H20030626
化学药品
注射剂
6/5/2020
Azithromycin Dihydrochloride for Injection
国药准字H20060400
化学药品
注射剂
12/25/2020
Azithromycin Sulfate for Injection
国药准字H20000728
化学药品
注射剂
4/1/2020
Azithromycin Sulfate for Injection
国药准字H20000729
化学药品
注射剂
4/1/2020
Azithromycin Maleate for Injection
国药准字H20041920
化学药品
注射剂
9/5/2020
Azithromycin Maleate for Injection
国药准字H20020293
化学药品
注射剂
9/5/2020
Azithromycin Maleate for Injection
国药准字H20041921
化学药品
注射剂
9/5/2020
Azithromycin Soft Capsules
国药准字H20061229
化学药品
胶囊剂
7/4/2024
Azithromycin Soft Capsules
国药准字H20052637
化学药品
胶囊剂
8/3/2020
Azithromycin Soft Capsules
国药准字H20070301
化学药品
胶囊剂
6/23/2022

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
ZIROMIN TABLETS 500MG
N/A
N/A
N/A
5/2/2023
AZITHROCIN 500 TAB 500MG
N/A
N/A
N/A
3/25/2007
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