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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/10/07 | Phase 3 | Completed | Lihir Medical Centre | ||
2013/08/13 | Phase 2 | Completed | |||
2013/08/09 | Phase 2 | Terminated | |||
2013/08/02 | Phase 4 | Completed | |||
2013/07/19 | Phase 4 | Withdrawn | |||
2013/04/05 | Phase 3 | Completed | Anna Griffiths, MRC | ||
2013/04/05 | Phase 4 | Completed | |||
2013/03/28 | Phase 4 | UNKNOWN | University of Roma La Sapienza | ||
2013/02/28 | Phase 3 | Completed | |||
2013/02/22 | Phase 2 | Withdrawn | Philadelphia Eye Associates |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| NuCare Pharmaceuticals, Inc. | 68071-3169 | ORAL | 500 mg in 1 1 | 2/11/2021 | |
| NuCare Pharmaceuticals,Inc, | 68071-2963 | ORAL | 900 mg in 22.5 mL | 3/21/2023 | |
| Asclemed USA, Inc. | 76420-589 | ORAL | 500 mg in 1 1 | 9/1/2023 | |
| Quality Care Products, LLC | 55700-859 | ORAL | 250 mg in 1 1 | 4/11/2023 | |
| Alembic Pharmaceuticals Limited | 46708-058 | ORAL | 500 mg in 1 1 | 1/13/2023 | |
| Alembic Pharmaceuticals Limited | 46708-253 | ORAL | 600 mg in 1 1 | 1/27/2023 | |
| MedVantx, Inc. | 66116-524 | ORAL | 200 mg in 5 mL | 5/16/2013 | |
| Wockhardt USA LLC. | 64679-961 | ORAL | 250 mg in 1 1 | 12/8/2021 | |
| Asclemed USA, Inc. | 76420-213 | ORAL | 250 mg in 1 1 | 3/7/2022 | |
| ACI Healthcare USA, Inc. | 71093-175 | ORAL | 500 mg in 1 1 | 12/4/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Azithromycin for Injection | 国药准字H20074176 | 化学药品 | 注射剂 | 7/16/2022 | |
| Azithromycin for Injection | 国药准字H19990389 | 化学药品 | 注射剂 | 4/2/2020 | |
| Azithromycin for Injection | 国药准字H20237135 | 化学药品 | 注射剂 | 10/27/2023 | |
| Azithromycin for Injection | 国药准字H20243582 | 化学药品 | 注射剂 | 4/24/2024 | |
| Azithromycin for Injection | 国药准字H20020269 | 化学药品 | 注射剂 | 9/8/2020 | |
| Azithromycin for Injection | 国药准字H20063284 | 化学药品 | 注射剂 | 9/9/2020 | |
| Azithromycin for Injection | 国药准字H20000197 | 化学药品 | 注射剂(冻干) | 7/13/2020 | |
| Azithromycin for Injection | 国药准字H20254211 | 化学药品 | 注射剂 | 5/20/2025 | |
| Azithromycin for Injection | 国药准字H20066777 | 化学药品 | 注射剂(冻干粉针剂) | 7/15/2020 | |
| Azithromycin for Injection | 国药准字H20066778 | 化学药品 | 注射剂(冻干粉针剂) | 7/15/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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