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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

Phase 4
Not yet recruiting
Posted: 2025/05/06
Sponsor:
Armed Forces Hospita...
Phase 1
Not yet recruiting
Posted: 2025/04/10
Sponsor:
Ehab Mohamed Elsayed...
Phase 2
Recruiting
Posted: 2024/10/01
Phase 3
Recruiting
Posted: 2024/09/20
Sponsor:
The George Washingto...

FDA Approved Products

AZITHROMYCIN
Manufacturer:Alembic Pharmaceuticals Inc.
Route:ORAL
Strength:600 mg in 1 1
Approved: 2021/11/29
NDC:62332-253
Azithromycin
Manufacturer:Pharmasource Meds, LLC
Route:ORAL
Strength:500 mg in 1 1
Approved: 2023/04/04
NDC:82982-021
Azithromycin
Manufacturer:NuCare Pharmaceuticals,Inc,
Route:ORAL
Strength:900 mg in 22.5 mL
Approved: 2023/03/21
NDC:68071-2963
azithromycin
Manufacturer:Greenstone LLC
Route:ORAL
Strength:200 mg in 5 mL
Approved: 2021/11/15
NDC:59762-3120
AZITHROMYCIN
Manufacturer:Direct_Rx
Route:ORAL
Strength:500 mg in 1 1
Approved: 2022/09/29
NDC:72189-015

Singapore Approved Products

AZITHROMYCIN KERN PHARMA 200MG/5ML POWDER FOR ORAL SUSPENSION
Manufacturer:KERN PHARMA, S. L.
Form:POWDER, FOR SUSPENSION
Strength:200 mg/5 ml
Online:Yes
Approved: 2011/06/20
Approval:SIN13977P
Binozyt Powder for Oral Suspension 200mg/5ml
Manufacturer:Sandoz S.R.L.
Form:POWDER, FOR SUSPENSION
Strength:200mg/5ml
Online:Yes
Approved: 2009/12/01
Approval:SIN13742P
AZIMAX-250 TABLET 250MG
Manufacturer:Hovid Bhd
Form:TABLET, FILM COATED
Strength:250mg
Online:Yes
Approved: 2016/08/08
Approval:SIN15065P
AZITHROMYCIN MEVON POWDER FOR SOLUTION FOR INFUSION 500 mg/vial
Manufacturer:Laboratório Reig Jofré, S.A.
Form:INJECTION, POWDER, FOR SOLUTION
Strength:500.00mg
Online:Yes
Approved: 2014/01/20
Approval:SIN14490P
ZITHROMAX POWDER FOR ORAL SUSPENSION 200 mg/5 ml
Manufacturer:HAUPT PHARMA LATINA SRL
Form:POWDER, FOR SUSPENSION
Strength:200 mg/5 ml
Online:Yes
Approved: 1994/10/05
Approval:SIN07863P

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