Clarithromycin (clarithromycin)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Clarithromycin is a semisynthetic macrolide antibiotic with a broader spectrum than that of erythromycins.
Clarithromycin is used orally for the treatment of pharyngitis and tonsillitis, mild to moderate respiratory tract infections (acute bacterial exacerbation of chronic bronchitis, acute maxillary sinusitis, community-acquired pneumonia), uncomplicated skin and skin structure infections, and acute otitis media caused by susceptible organisms. Clarithromycin also is used orally in the treatment of disseminated infections caused by Mycobacterium avium complex (MAC) in patients with advanced human immunodeficiency virus (HIV) infection and for prevention of disseminated MAC infection (both primary and secondary prophylaxis) in HIV-infected individuals.
Generic name: clarithromycin
Pronunciation: (kla-RITH-roe-MYE-sin)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Clarithromycin
Indications
The following indications are listed for Clarithromycin:
- Acute Bacterial Maxillary Sinusitis
- Acute Bacterial Otitis Media
- Acute Exacerbation Of Obstructive Chronic Bronchitis By M. Catarrhalis
- Acute Exacerbation Of Obstructive Chronic Bronchitis By Streptococcus Pneumoniae
- Acute Exacerbation Of Obstructive Chronic Bronchitis Due To H. Flu
- Acute Maxillary Haemophilus Influenzae Sinusitis
- Acute Maxillary Moraxella Catarrhalis Sinusitis
- Acute Maxillary Streptococcus Pneumoniae Sinusitis
- Bacterial Pneumonia
- Chlamydial Pneumonia
- Chronic Bronchitis With Bacterial Exacerbation
- Disseminated Mycobacterium Avium Complex Infection
- H. Pylori Gastrointestinal Tract Infection
- Haemophilus Influenzae Acute Otitis Media
- Haemophilus Influenzae Bronchitis
- Haemophilus Influenzae Pneumonia
- Helicobacter Pylori Gastritis
- Moraxella Catarrhalis Acute Otitis Media
- Moraxella Catarrhalis Bronchitis
- Mycoplasmal Pneumonia
- Pharyngitis Due To Streptococcus Pyogenes
- Pneumococcal Pneumonia
- Prevention Of Mycobacterium Avium Complex Disease
- Skin And Skin Structure Infection
- Skin And Skin Structure Streptococcus Pyogenes Infection
- Staphylococcus Aureus Skin And Skin Structure Infection
- Streptococcus Acute Otitis Media
- Streptococcus Pneumoniae Bronchitis
- Tonsillitis Due To Streptococcus Pyogenes
Also known as: Acute Bacterial Exacerbation Of Chronic Bronchitis, Acute Exacerbation Of Obstructive Chronic Bronchitis By B. Catarrhalis, Acute Exacerbation Of Obstructive Chronic Bronchitis By Branhamella Catarrhalis, Acute Exacerbation Of Obstructive Chronic Bronchitis By Moraxella Catarrhalis, Acute Exacerbation Of Obstructive Chronic Bronchitis By Neisseria Catarrhalis, Acute H. Influenzae Exacerbation Of Obstructive Chronic Bronchitis, Acute Maxillary Sinusitis Due To B. Catarrhalis, Acute Maxillary Sinusitis Due To Branhamella Catarrhalis, Acute Maxillary Sinusitis Due To Diplococcus Pneumoniae, Acute Maxillary Sinusitis Due To Fraenkel's Pneumococcus, Acute Maxillary Sinusitis Due To H. Flu, Acute Maxillary Sinusitis Due To Haemophilus Influenzae, Acute Maxillary Sinusitis Due To Hemophilus Influenzae, Acute Maxillary Sinusitis Due To Influenza Bacillus, Acute Maxillary Sinusitis Due To Moraxella Catarrhalis, Acute Maxillary Sinusitis Due To Neisseria Catarrhalis, Acute Maxillary Sinusitis Due To Pfeiffer's Bacillus, Acute Maxillary Sinusitis Due To Pneumococcus, Acute Maxillary Sinusitis Due To Pneumonococcus, Acute Maxillary Sinusitis From Streptococcus Pneumoniae, Acute Otitis Media Due To H. Flu, Acute Otitis Media Due To Haemophilus Influenzae, Acute Otitis Media Due To Hemophilus Influenzae, Acute Otitis Media Due To Influenza Bacillus, Acute Otitis Media Due To Moraxella Catarrhalis, Acute Otitis Media Due To Pfeiffer's Bacillus, Acute Otitis Media Due To Streptococcus Species, Bacterial Exacerbation Of Chronic Bronchitis, Bacterial Otitis Media, Bronchitis Due To B. Catarrhalis, Bronchitis Due To Branhamella Catarrhalis, Bronchitis Due To Diplococcus Pneumoniae, Bronchitis Due To Fraenkel's Pneumococcus, Bronchitis Due To Fraenkel-Weichselbaum Pneumococcus, Bronchitis Due To H. Flu, Bronchitis Due To H. Influenzae, Bronchitis Due To Haemophilus Influenzae, Bronchitis Due To Hemophilus Influenzae, Bronchitis Due To Influenzae Bacillus, Bronchitis Due To M. Catarrhalis, Bronchitis Due To Moraxella Catarrhalis, Bronchitis Due To Neisseria Catarrhalis, Bronchitis Due To Pfeiffer's Bacillus, Bronchitis Due To Pneumococcus, Bronchitis Due To Pneumonococcus, Bronchitis Due To Streptococcus Pneumoniae, Campylobacter Gastritis, Disseminated Avium Intracellulare Scrofulaceum Group Infection, Disseminated Mac Complex Infection, Disseminated Mac Infection, Disseminated Mais Complex Infection, Disseminated Mycobacterium Avium-Intracellulare Complex Infection, Disseminated Mycobacterium Avium-Intracellulare Infection, Disseminated Mycobacterium, Mais Group Infection, Eaton Agent Pneumonia, Epidemic Sore Throat, H. Flu Pneumonia, H. Influenzae Pneumonia, H. Pylori Gastritis, Hemophilus Influenzae Pneumonia, Infection Of Skin And/Or Subcutaneous Tissue, Infection Of The Lungs Due To Chlamydia, Influenza Bacillus Pneumonia, Mac Complex Prophylaxis, Mac Infection Prophylaxis, Maic Prophylaxis, Mais Complex Prophylaxis, Mycobacterium Avium Complex Prophylaxis, Mycobacterium Avium-Intracellulare Complex Prophylaxis, Mycobacterium Avium-Intracellulare Prophylaxis, Mycobacterium, Mais Group Prophylaxis, Pfeiffer's Bacillus Pneumonia, Pharyngitis Due To Group A Beta-Hemolytic Streptococci, Pharyngitis Due To Streptococcus Epidemicus, Pneumonia Due To Haemophilus Influenzae, Pneumonia Due To Streptococcus Pneumoniae, Primary Atypical Pneumonia, Septic Sore Throat, Skin & Skin Soft Tissue Streptococcus Pyogenes Infection, Skin And Skin Soft Tissue Staphylococcus Aureus Infection, Skin And Soft Tissue Skin Infection, Streptococcal Pharyngitis, Streptococcus Pyogenes Tonsillitis.
Dosing
Safety and efficacy of clarithromycin extended-release tablets have been established for the treatment of acute bacterial exacerbations of chronic bronchitis, acute maxillary sinusitis, and community-acquired pneumonia (CAP) in adults; safety and efficacy of the extended-release formulation of the drug have not been established for the treatment of other infections that are treated with clarithromycin conventional tablets or oral suspension.
Clarithromycin generally may be used without dosage adjustment in patients with hepatic impairment and normal renal function. However, in patients with creatinine clearances less than 30 mL/minute with or without hepatic impairment, the dosage should be halved or the dosing interval for clarithromycin doubled. An initial clarithromycin dose of 500 mg (conventional tablets or oral suspension) followed by 250 mg twice daily has been suggested for adults with creatinine clearances less than 30 mL/minute when a usual dosage of 500 mg twice daily would have been used in adults with normal renal function; a dosage of 250 mg (conventional tablets or oral suspension) daily has been suggested for such patients when a usual dosage of 250 mg twice daily would have been used in individuals with normal renal function.
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Drug interactions
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There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
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There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
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There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Although there are no adequate and controlled studies to date in humans, clarithromycin has been associated with adverse effects on pregnancy outcome and/or embryofetal development in animals at dosages that produced plasma drug concentrations 2-17 times those achieved with the maximum recommended human dosage. While the potential risk to the fetus has not been clearly elucidated to date, the manufacturer states that clarithromycin should be used during pregnancy only when safer drugs cannot be used or are ineffective. If clarithromycin is administered during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be informed of the potential hazard to the fetus.
Teratogenicity studies in rats with oral or IV clarithromycin dosages up to 160 mg/kg daily administered during the period of major organogenesis and in rabbits at oral dosages up to 125 mg/kg daily (approximately twice the maximum recommended human dosage on a mg/m2 basis) or IV dosages of 30 mg/ kg daily administered during days 6-18 of gestation did not demonstrate evidence of teratogenicity. However, other studies in a different rat strain demonstrated a low incidence of cardiovascular anomalies at a clarithromycin dosage of 150 mg/kg daily (resulting in plasma concentrations 2 times those in humans) administered during gestation days 6-15. Studies in mice revealed a variable incidence of cleft palate with oral dosages of 1000 mg/kg daily (resulting in plasma concentrations 17 times those in humans) during gestation days 6-15; cleft palate also was observed at a dosage of 500 mg/kg daily. In monkeys, an oral dosage of 70 mg/kg daily (approximately equivalent to the maximum recommended human dosage on a mg/m2 basis) produced fetal growth retardation at plasma concentrations twice those attained in humans.
Clarithromycin should be used with caution in nursing women. The drug is distributed into milk. In 12 women who received oral clarithromycin in a dosage of 250 mg twice daily for 6 days, mean peak concentrations of clarithromycin and 14-hydroxyclarithromycin in milk were 25 and 75%, respectively, of corresponding serum concentrations. Pre-weaned rats, exposed indirectly via consumption of milk from dams treated with 150 mg/kg daily of clarithromycin for 3 weeks, did not demonstrate adverse effects despite evidence indicating higher drug concentrations in milk than in plasma.
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ICD codes
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Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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