Overview
Clarithromycin, a semisynthetic macrolide antibiotic derived from erythromycin, inhibits bacterial protein synthesis by binding to the bacterial 50S ribosomal subunit. Binding inhibits peptidyl transferase activity and interferes with amino acid translocation during the translation and protein assembly process. Clarithromycin may be bacteriostatic or bactericidal depending on the organism and drug concentration.
Indication
An alternative medication for the treatment of acute otitis media caused by H. influenzae, M. catarrhalis, or S. pneumoniae in patients with a history of type I penicillin hypersensitivity. Also for the treatment of pharyngitis and tonsillitis caused by susceptible Streptococcus pyogenes, as well as respiratory tract infections including acute maxillary sinusitis, acute bacterial exacerbations of chronic bronchitis, mild to moderate community-acquired pneuomia, Legionnaires' disease, and pertussis. Other indications include treatment of uncomplicated skin or skin structure infections, helicobacter pylori infection, duodenal ulcer disease, bartonella infections, early Lyme disease, and encephalitis caused by Toxoplasma gondii (in HIV infected patients in conjunction with pyrimethamine). Clarithromycin may also decrease the incidence of cryptosporidiosis, prevent the occurence of α-hemolytic (viridans group) streptococcal endocarditis, as well as serve as a primary prevention for Mycobacterium avium complex (MAC) bacteremia or disseminated infections (in adults, adolescents, and children with advanced HIV infection). Clarithromycin is indicated in combination with vonoprazan and amoxicillin as co-packaged triple therapy to treat Helicobacter pylori (H. pylori) infection in adults.
Associated Conditions
- Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
- Acute maxillary sinusitis
- Bacterial Infections
- Bartonellosis
- Community Acquired Pneumonia (CAP)
- Duodenal ulcer caused by helicobacter pylori
- Helicobacter Pylori Infection
- Infective Endocarditis (IE)
- Lyme Disease
- Mycobacterial Infections
- Otitis Media (OM)
- Pertussis
- Streptococcal Pharyngitis
- Tonsillitis streptococcal
- Uncomplicated skin and subcutaneous tissue bacterial infections
Research Report
Clarithromycin (DB01211): A Comprehensive Pharmacological and Clinical Monograph
1.0 Executive Summary & Drug Profile
1.1 Overview of Clarithromycin: A Second-Generation Macrolide
Clarithromycin is a semi-synthetic, second-generation macrolide antibiotic belonging to the polyketide class of natural products.[1] Developed in 1980 and first approved for medical use in 1990, it is derived from erythromycin A through the methylation of the hydroxyl group at the C-6 position of the 14-membered lactone ring.[2] This specific structural modification was engineered to overcome key limitations of its parent compound, erythromycin. The primary advantages conferred by this change are enhanced stability in acidic environments, which significantly reduces the incidence of gastrointestinal side effects, and a more favorable pharmacokinetic profile, including improved oral absorption and a longer half-life.[5]
As a small molecule drug, clarithromycin has become a cornerstone in the treatment of a wide array of common bacterial infections.[1] It is widely prescribed for infections of the upper and lower respiratory tract, skin and soft tissues, and for the eradication of
Helicobacter pylori in peptic ulcer disease.[1] Its clinical utility is further extended to the management of opportunistic infections in immunocompromised individuals, most notably for the treatment and prophylaxis of disseminated
Mycobacterium avium complex (MAC) infection.[2]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/25 | Not Applicable | Completed | Muhammad Aamir Latif | ||
2025/07/16 | Not Applicable | Recruiting | Yongquan Shi | ||
2025/06/27 | Not Applicable | Not yet recruiting | Rehman Medical Institute - RMI | ||
2025/06/27 | Not Applicable | Completed | |||
2025/06/15 | Phase 4 | Not yet recruiting | Rehman Medical Institute - RMI | ||
2025/05/09 | Phase 3 | Not yet recruiting | |||
2025/02/20 | Phase 1 | Completed | |||
2025/02/12 | Phase 1 | Completed | Liaocheng People's Hospital | ||
2025/01/31 | Phase 4 | Recruiting | Dr. Md. Alimur Reza | ||
2024/12/27 | Phase 3 | Recruiting | Daewoong Pharmaceutical Co. LTD. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ranbaxy Pharmaceuticals Inc. | 63304-726 | ORAL | 500 mg in 1 1 | 10/24/2013 | |
| A-S Medication Solutions | 50090-1830 | ORAL | 500 mg in 1 1 | 2/21/2022 | |
| Rising Pharma Holdings, Inc. | 57237-045 | ORAL | 500 mg in 1 1 | 1/10/2024 | |
| A-S Medication Solutions | 50090-3193 | ORAL | 500 mg in 1 1 | 10/12/2016 | |
| Allied Pharma Inc | 76267-061 | ORAL | 500 mg in 1 1 | 5/5/2014 | |
| Alembic Pharmaceuticals Limited | 46708-345 | ORAL | 500 mg in 1 1 | 5/29/2023 | |
| Aidarex Pharmaceuticals LLC | 33261-618 | ORAL | 500 mg in 1 1 | 12/18/2013 | |
| Lannett Company, Inc. | 0527-1932 | ORAL | 500 mg in 1 1 | 11/13/2023 | |
| Preferred Pharmaceuticals Inc. | 68788-8480 | ORAL | 500 mg in 1 1 | 3/28/2024 | |
| Chartwell RX, LLC. | 62135-616 | ORAL | 250 mg in 1 1 | 12/23/2022 |
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 |
|---|---|---|---|---|---|
| CLARIPEN GRANULES FOR ORAL SUSPENSION 125 mg/5 ml | SIN12429P | GRANULE, FOR SUSPENSION | 125 mg/5 ml | 9/23/2003 | |
| KLERIMED 250 TABLET 250 mg | SIN11969P | TABLET, FILM COATED | 250 mg | 5/30/2002 | |
| KLAR 500 Tablets 500 mg | SIN14357P | TABLET, FILM COATED | 500.000 mg | 6/5/2013 | |
| Clarie OD Tablets 500mg | SIN14089P | TABLET, FILM COATED, EXTENDED RELEASE | 500mg | 2/3/2012 | |
| CLARYTAS 250 TABLET 250 mg | SIN11742P | TABLET, FILM COATED | 250 mg | 12/6/2001 | |
| CRIXAN TABLET 250 mg | SIN11958P | TABLET, FILM COATED | 250 mg | 5/25/2002 | |
| KLACID TABLET 250 mg | SIN07085P | TABLET, FILM COATED | 250 mg | 6/22/1992 | |
| CLARIMYCIN FILM COATED TABLET 500MG | SIN15535P | TABLET, FILM COATED | 500MG | 9/5/2018 | |
| KLERIMED 500 TABLET 500 mg | SIN11968P | TABLET, FILM COATED | 500 mg | 5/30/2002 | |
| CLARIPEN GRANULES FOR ORAL SUSPENSION 250 mg/5 ml | SIN12033P | GRANULE, FOR SUSPENSION | 250 mg/5 ml | 7/26/2002 |
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 |
|---|---|---|---|---|---|
| SYNCLAR-250 TAB 250MG | N/A | N/A | N/A | 7/30/2002 | |
| ROLACIN 500 TAB 500MG | N/A | N/A | N/A | 5/31/2007 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| AVA-CLARITHROMYCIN | avanstra inc | 02366398 | Tablet - Oral | 500 MG | 9/19/2011 |
| CLARITHROMYCIN | sivem pharmaceuticals ulc | 02442485 | Tablet - Oral | 500 MG | 7/22/2015 |
| M-CLARITHROMYCIN | mantra pharma inc | 02471388 | Tablet - Oral | 250 MG | 3/7/2018 |
| TARO-CLARITHROMYCIN | sun pharma canada inc | 02361434 | Tablet - Oral | 500 MG | 2/1/2011 |
| CLARITHROMYCIN | sivem pharmaceuticals ulc | 02442469 | Tablet - Oral | 250 MG | 7/22/2015 |
| BIAXIN | BGP Pharma ULC | 02244641 | Granules For Suspension - Oral | 250 MG / 5 ML | 5/28/2002 |
| AVA-CLARITHROMYCIN | avanstra inc | 02366371 | Tablet - Oral | 250 MG | 9/19/2011 |
| BIAXIN | BGP Pharma ULC | 02146908 | Granules For Suspension - Oral | 125 MG / 5 ML | 12/31/1995 |
| AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN | aa pharma inc | 02470780 | Capsule
,
Kit
,
Tablet
,
Capsule (Delayed Release) - Oral | 500 MG / TAB | 8/3/2018 |
| PMS-CLARITHROMYCIN | 02247574 | Tablet - Oral | 500 MG | 8/10/2007 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| CLARITROMICINA BROWN & BURK 500 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Brown & Burk Ir Limited | 90080 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| CLARITROMICINA FARMALIDER 500 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Farmalider S.A. | 64671 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| CLARITROMICINA ALTER 250 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Alter S.A. | 64607 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| CLARITROMICINA ALMUS 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Almus Farmaceutica S.A.U. | 72873 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| CLARITROMICINA ARAFARMA GROUP 250 mg COMPRIMIDOS RECUBIERTOS EFG | Arafarma Group S.A. | 67897 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| CLARITROMICINA SANDOZ 250 mg COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Sandoz Farmaceutica S.A. | 75638 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| CLARITROMICINA CINFA 250 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Cinfa S.A. | 67638 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| CLARITROMICINA NORMON 250 mg COMPRIMIDOS RECUBIERTOS EFG | Laboratorios Normon S.A. | 64824 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| KLACID 500 mg comprimidos recubiertos con pelicula | 60515 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| CLARITROMICINA TECNIGEN 250 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tecnimede España Industria Farmaceutica S.A. | 72876 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | 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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