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.
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
Research Report
Azithromycin (DB00207): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Safety Profile
Executive Summary
Azithromycin is a semi-synthetic, second-generation macrolide antibiotic belonging to the azalide subclass, distinguished by a 15-membered macrocyclic lactone ring. Since its discovery in 1980 and subsequent US FDA approval in 1991, it has become one of the most widely prescribed antibiotics globally, valued for its broad spectrum of activity, unique pharmacokinetic profile, and convenient dosing regimens.[1] Its mechanism of action involves the inhibition of bacterial protein synthesis via binding to the 50S ribosomal subunit, effectively halting bacterial growth.[1] Beyond this primary antibacterial effect, azithromycin exhibits significant immunomodulatory and anti-inflammatory properties, which contribute to its efficacy in chronic inflammatory airway diseases.[2]
The drug's defining characteristic is its pharmacokinetic profile, marked by rapid absorption, extensive tissue distribution, and profound intracellular accumulation, particularly within phagocytic cells. This "ion-trapping" phenomenon, coupled with a long terminal elimination half-life of approximately 68 hours, allows for short-course therapeutic regimens (e.g., 3-5 days) that maintain effective drug concentrations at the site of infection for a prolonged period.[5] This profile, combined with minimal interaction with the cytochrome P450 system, distinguishes it from older macrolides like erythromycin.[7]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/08 | Not Applicable | Not yet recruiting | |||
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 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ZITHROMAX | 02247748 | Tablet - Oral | 500 MG | N/A | |
| ZITHROMAX FOR INTRAVENOUS INJECTION | 02239952 | Powder For Solution - Intravenous | 500 MG / VIAL | 8/27/1999 | |
| AZASITE | InSite Vision Incorporated | 02321661 | Solution - Ophthalmic | 1 % / W/W | N/A |
| ZITHROMAX 600MG | 02231143 | Tablet - Oral | 600 MG | 7/18/1997 | |
| PMS-AZITHROMYCIN | 02418452 | Powder For Suspension - Oral | 100 MG / 5 ML | 3/19/2014 | |
| ZITHROMAX CAP 250MG | 02091291 | Capsule - Oral | 250 MG | 12/31/1994 | |
| PMS-AZITHROMYCIN | 02418460 | Powder For Suspension - Oral | 200 MG / 5 ML | 3/19/2014 | |
| PMS-AZITHROMYCIN | 02261634 | Tablet - Oral | 250 MG | 1/4/2006 | |
| AZITHROMYCIN | dominion pharmacal | 02418371 | Powder For Solution - Oral | 200 MG / 5 ML | N/A |
| GD-AZITHROMYCIN | genmed a division of pfizer canada ulc | 02274574 | Powder For Suspension - Oral | 200 MG / 5 ML | 11/4/2013 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| AZITROMICINA SANDOZ 500 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Sandoz Farmaceutica S.A. | 65638 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| AZITROMICINA ADVENTIA 200 mg/5 ml POLVO PARA SUSPENSION ORAL EFG | Adventia Pharma S.L. | 65611 | POLVO PARA SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ZITROMAX 200 mg/5 ml POLVO PARA SUSPENSION ORAL EN FRASCO | Pfizer S.L. | 59615 | POLVO PARA SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ZITROMAX 1000 mg POLVO PARA SUSPENSION ORAL EN SOBRE | Pfizer S.L. | 60065 | POLVO PARA SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ZITROMAX 500 mg POLVO PARA SUSPENSION ORAL EN SOBRE | Pfizer S.L. | 60066 | POLVO PARA SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| AZITROMICINA SANDOZ 250 MG POLVO PARA SUSPENSIÓN ORAL EN SOBRE EFG | Sandoz Farmaceutica S.A. | 65637 | POLVO PARA SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| AZITROMICINA SANDOZ 500 MG POLVO PARA SUSPENSIÓN ORAL EN SOBRE EFG | Sandoz Farmaceutica S.A. | 65636 | POLVO PARA SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| AZITROMICINA KERN PHARMA 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 65546 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| AZITROMICINA ALTAN 500 mg POLVO PARA SOLUCION PARA PERFUSION EFG | Altan Pharmaceuticals Sa | 73962 | POLVO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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