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.
Background
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
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/01/06 | Not Applicable | Completed | |||
2020/12/08 | Not Applicable | UNKNOWN | |||
2020/12/03 | Phase 3 | UNKNOWN | |||
2020/11/16 | Phase 2 | Active, not recruiting | |||
2020/11/10 | Not Applicable | Completed | |||
2020/11/09 | Not Applicable | Completed | University of Split, School of Medicine | ||
2020/11/05 | Phase 4 | Completed | |||
2020/09/22 | Phase 4 | UNKNOWN | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2020/09/16 | Phase 1 | Completed | |||
2020/08/25 | Early Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
NuCare Pharmaceuticals,Inc. | 68071-2869 | ORAL | 500 mg in 1 1 | 11/7/2022 | |
Blenheim Pharmacal, Inc. | 10544-522 | ORAL | 500 mg in 1 1 | 1/12/2016 | |
Chartwell RX, LLC. | 62135-615 | ORAL | 500 mg in 1 1 | 12/23/2022 | |
Dispensing Solutions, Inc. | 66336-429 | ORAL | 500 mg in 1 1 | 2/2/2012 | |
A-S Medication Solutions | 50090-2515 | ORAL | 500 mg in 1 1 | 12/10/2019 | |
Strides Pharma Science Limited | 64380-905 | ORAL | 250 mg in 1 1 | 6/13/2023 | |
NuCare Pharmaceuticals,Inc. | 68071-5045 | ORAL | 500 mg in 1 1 | 12/6/2023 | |
Wockhardt Limited | 55648-949 | ORAL | 500 mg in 1 1 | 6/20/2013 | |
Rebel Distributors Corp. | 21695-558 | ORAL | 500 mg in 1 1 | 7/25/2008 | |
AvPAK | 50268-178 | ORAL | 250 mg in 1 1 | 1/9/2024 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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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 |
---|---|---|---|---|---|
Clarithromycin Capsules | 国药准字H20083584 | 化学药品 | 胶囊剂 | 1/12/2023 | |
Clarithromycin Capsules | 国药准字H20040808 | 化学药品 | 胶囊剂 | 12/31/2019 | |
Clarithromycin Capsules | 国药准字H20000203 | 化学药品 | 胶囊剂 | 8/25/2020 | |
Clarithromycin Capsules | 国药准字H20000563 | 化学药品 | 胶囊剂 | 7/29/2020 | |
Clarithromycin Capsules | 国药准字H20000129 | 化学药品 | 胶囊剂 | 9/15/2020 | |
Clarithromycin Capsules | 国药准字H19991054 | 化学药品 | 胶囊剂 | 6/1/2020 | |
Clarithromycin Capsules | 国药准字H44024314 | 化学药品 | 胶囊剂 | 8/25/2021 | |
Clarithromycin Capsules | 国药准字H20000106 | 化学药品 | 胶囊剂 | 4/7/2020 | |
Clarithromycin Capsules | 国药准字H19990276 | 化学药品 | 胶囊剂 | 12/23/2019 | |
Clarithromycin Capsules | 国药准字H19991049 | 化学药品 | 胶囊剂 | 3/9/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |