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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/01/26 | Phase 3 | Completed | |||
2021/01/06 | Phase 4 | Completed | Xijing Hospital of Digestive Diseases | ||
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 |
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 |
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