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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

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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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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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
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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Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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ARTG ID
Sponsor
Registration Type
Status
Registration Date
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