Clarithromycin

Generic Name
Clarithromycin
Brand Names
Biaxin, Biaxin Bid, Omeclamox, Prevpac, Voquezna 14 Day Triplepak 20;500;500
Drug Type
Small Molecule
Chemical Formula
C38H69NO13
CAS Number
81103-11-9
Unique Ingredient Identifier
H1250JIK0A
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
Associated Therapies
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Study of the Ability of Clarithromycin to Induce Oxidative Stress

Phase 1
Completed
Conditions
Interventions
First Posted Date
2008-06-30
Last Posted Date
2008-08-11
Lead Sponsor
Rigshospitalet, Denmark
Target Recruit Count
26
Registration Number
NCT00707330
Locations
🇩🇰

Department of Clinical Pharmacology Q, Rigshospitalet, Blegdamsvej 9, Kopenhagen O, Denmark

Comparative Bioavailability Study of Clarithromycin 250 mg Tablets

Phase 1
Completed
Conditions
Interventions
First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
32
Registration Number
NCT00648830
Locations
🇨🇦

Algorithme Pharma, Montreal, Quebec, Canada

Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State

Phase 1
Completed
Conditions
Interventions
First Posted Date
2008-04-01
Last Posted Date
2008-04-01
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
64
Registration Number
NCT00648960
Locations
🇨🇦

Algorithme Pharma, Laval, Quebec, Canada

Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed State

Phase 1
Completed
Conditions
Interventions
First Posted Date
2008-04-01
Last Posted Date
2008-04-01
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
44
Registration Number
NCT00648128
Locations
🇨🇦

Algorithme Pharma, Laval, Quebec, Canada

Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia

First Posted Date
2008-02-22
Last Posted Date
2017-03-14
Lead Sponsor
Forest Laboratories
Target Recruit Count
606
Registration Number
NCT00621504
Locations
🇸🇰

Slovakia, Nitra-Zobor, Slovakia

🇧🇷

Investigational site, Porto Alegre, Brazil

🇧🇷

Investigational Site 1, Belo Horizonte MG, Brazil

and more 4 locations

Bioequivalency Study of Clarithromycin Tablets Under Fed Conditions

Not Applicable
Completed
Conditions
First Posted Date
2008-01-28
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
28
Registration Number
NCT00602498
Locations
🇺🇸

MDS Pharma Services, Phoenix, Arizona, United States

Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions

Not Applicable
Completed
Conditions
First Posted Date
2008-01-28
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
40
Registration Number
NCT00601315
Locations
🇺🇸

MDS Pharma Services, Phoenix, Arizona, United States

Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)

First Posted Date
2008-01-25
Last Posted Date
2017-05-23
Lead Sponsor
The University of Texas Health Science Center at Tyler
Target Recruit Count
210
Registration Number
NCT00600769
Locations
🇺🇸

The University of Texas Health Science Center at Tyler, Tyler, Texas, United States

Phase II Study of Thalidomide, Clarithromycin, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma

First Posted Date
2007-10-03
Last Posted Date
2021-05-24
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
26
Registration Number
NCT00538733
Locations
🇺🇸

Weill Medical College of Cornell University, New York, New York, United States

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