Trade Names:Biaxin- Tablets 250 mg- Tablets 500 mg- Granules for oral suspension 125 mg per 5 mL after reconstitution- Granules for oral suspension 250 mg per 5 mL after reconstitution
Trade Names:Biaxin XL- Tablets, ER 500 mgApo-Clarithromycin (Canada)Biaxin BID (Canada)
Binds to the 50S ribosomal subunit of susceptible microorganisms, resulting in inhibition of protein synthesis.
Rapidly absorbed. Bioavailability is about 50%. T max is 2 to 3 h. Steady state achieved within 3 days.
Widely distributed into body tissues and fluids.
Metabolized to 14-OH clarithromycin (active).
The half-life is about 3 to 4 h (250 mg) and 5 to 7 h (500 mg). 20% to 40% is excreted in urine as unchanged drug; 10% to 15% is excreted as 14-OH clarithromycin.
Treatment of pharyngitis/tonsillitis; acute maxillary sinusitis; acute bacterial exacerbation of chronic bronchitis; community-acquired pneumonia; uncomplicated skin and skin structure infections; disseminated mycobacterial infections; Helicobacter pylori and duodenal ulcer disease when used in combination with amoxicillin and lansoprazole or omeprazole; H. pylori and active duodenal ulcer when used in combination with omeprazole or ranitidine bismuth citrate; prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection; treatment of disseminated mycobacterial infections caused by M. avium or Mycobacterium intracellulare .ER tablets
Treatment of acute maxillary sinusitis; acute bacterial exacerbation of chronic bronchitis; community-acquired pneumonia.Children Immediate-release tablets and oral suspension
Pharyngitis/tonsillitis; community-acquired pneumonia; acute maxillary sinusitis; acute otitis media; uncomplicated skin and skin structure infections; prevention of disseminated MAC disease in children with advanced HIV infection; treatment of M. avium or M. intercellulare .
Patients receiving astemizole, cisapride, dihydroergotamine, ergotamine, pimozide, or terfenadine; hypersensitivity to clarithromycin, erythromycin, or any macrolide antibiotic.
PO Clarithromycin 500 mg, lansoprazole 30 mg, and amoxicillin 1 g every 12 h for 10 or 14 days; or clarithromycin 500 mg, omeprazole 20 mg, and amoxicillin 1 g every 12 h for 10 days then, for patients with ulcer present at time of initiation of therapy, omeprazole 20 mg once daily for additional 18 days; or clarithromycin 500 mg every 8 h and omeprazole 40 mg every day for 14 days then omeprazole 20 mg once daily for additional 14 days; or clarithromycin 500 mg every 12 or every 8 h and ranitidine bismuth citrate 400 mg every 12 h for 14 days, then ranitidine bismuth citrate 400 mg every 12 h for additional 14 days.Acute Exacerbation of Chronic Bronchitis Caused By Haemophilus influenza , H. parainfluenza , Moraxella catarrhalis , or Streptococcus pneumoniaeAdults Immediate-release tablets/oral suspension H. influenza
PO 500 mg every 12 h for 7 to 14 days.H. parainfluenza
PO 500 mg every 12 h for 7 days.M. catarrhalis or S. pneumoniae
PO 250 mg every 12 h for 7 to 14 days.Adults
PO Two 500 mg ER tablets every 24 h for 7 days.Acute Maxillary Sinusitis Caused By H. influenzaAdults Immediate-release tablet/oral suspension
PO 500 mg every 12 h or two 500 mg ER tablets every 24 h for 14 days.Children 6 mo of age and older
PO 7.5 mg/kg (max, 500 mg) every 12 h for 10 days.Acute Otitis MediaChildren 6 mo of age and older Immediate-release tablets/oral suspension
PO 7.5 mg/kg (max, 500 mg) every 12 h for 10 days.Community-Acquired Pneumonia Caused By H. influenza , S. pneumoniae , C. pneumoniae , or M. pneumoniaeAdults Immediate-release tablets/oral suspension H. influenza
PO 250 mg every 12 h for 7 days.S. pneumoniae , C. pneumoniae , or M. pneumoniae
PO 250 mg every 12 h for 7 to 14 days.Children 6 mo of age and older Immediate-release tablets/oral suspension
PO 7.5 mg/kg (max, 500 mg) every 12 h for 10 days.Community-Acquired Pneumonia Caused By C. pneumoniae , H. influenzae , H. parainfluenzae , M. catarrhalis , M. pneumoniae , or S. pneumoniaeAdults
PO Two ER 500 mg tablets every 24 h for 7 days.Mycobacterial InfectionsAdults Immediate-release tablets/oral suspension
PO 500 mg every 12 h for prevention and treatment.Children 20 mo of age and older Immediate-release tablets/oral suspension
PO 7.5 mg/kg (max, 500 mg) every 12 h for prevention and treatment.Pharyngitis/Tonsillitis Caused By S. pyogenesAdults Immediate-release tablet/oral suspension
PO 250 mg every 12 h for 10 days.Children 6 months of age and older
PO 7.5 mg/kg (max, 500 mg) every 12 h for 10 days.Uncomplicated Skin and Skin Structure InfectionsAdults Immediate-release tablets/oral suspension
PO 250 mg every 12 h for 7 to 14 days.Children 6 mo of age and older
PO 7.5 mg/kg (max, 500 mg) every 12 h for 10 days.Renal Function ImpairmentAdults
PO Halve the dose or double the dosing interval in patients with severe renal function impairment (CrCl less than 30 mL/min).
Store 250 mg immediate-release tablets and ER tablets at controlled room temperature (59° to 86°F). Protect from light. Store 500 mg immediate-release tablets at controlled room temperature (68° to 77°F). Store granules for oral suspension at 59° to 86°F. Do not refrigerate.Reconstituted suspension
Store at controlled room temperature (59° to 86°F). Keep tightly closed. Do not refrigerate suspension. Discard any unused suspension after 14 days.
Risk of life-threatening cardiac arrhythmias, including torsades de pointes, may be increased.Astemizole, cisapride, dihydroergotamine, ergotamine, pimozide, terfenadine
Coadministration with clarithromycin is contraindicated. Coadministration of clarithromycin with astemizole, cisapride, pimozide, or terfenadine may increase the risk of life-threatening cardiac arrhythmias, including torsades de pointes. Coadministration of clarithromycin with dihydroergotamine or ergotamine may increase the risk of acute ergotism.Benzodiazepines (eg, midazolam, triazolam)
Increased and prolonged CNS effects.Cabergoline
Cabergoline plasma concentrations may be elevated, increasing the risk of toxicity.Carbamazepine
May increase plasma concentrations of carbamazepine; monitor carbamazepine levels closely.Colchicine
Risk of colchicine toxicity may be increased, especially in elderly patients.Conivaptan
Because of the increased risk of adverse reactions, clarithromycin is contraindicated in patients receiving conivaptan.Darunavir, fluconazole, grapefruit juice, ritonavir
Clarithromycin plasma levels may be elevated, increasing the risk of side effects.Digoxin
Elevated serum digoxin levels may occur.Drugs primarily metabolized by CYP3A4 (eg, alfentanil, benzodiazepines [eg, midazolam], bromocriptine, buspirone, carbamazepine, cilostazol, conivaptan, cyclosporine, dihydroergotamine, disopyramide, eplerenone, ergotamine, HMG-CoA reductase inhibitors [eg, lovastatin, simvastatin], lapatinib, methylprednisolone, proton pump inhibitors [eg, esomeprazole, lansoprazole, omeprazole] quinidine, repaglinide, sildenafil, tacrolimus, temsirolimus, terfenadine, triazolobenziodidiazepines [eg, alprazolam, triazolam])
Plasma concentrations of these agents may be elevated, increasing the pharmacologic effects and risk of adverse reactions or toxicity.Eplerenone
Plasma concentrations of eplerenone may be elevated, increasing the risk of hyperkalemia and associated serious arrhythmias. Eplerenone is contraindicated in patients receiving clarithromycin.HMG-CoA reductase inhibitors (eg, lovastatin)
Increased risk of myopathy and rhabdomyolysis.Ranitidine bismuth citrate
Clarithromycin may increase plasma concentrations of ranitidine bismuth citrate.Rifamycins (eg, rifabutin)
Antimicrobial effects of clarithromycin may be decreased, while adverse effect of rifamycins may be increased.Serotonin reuptake inhibitors (eg, fluoxetine, sertraline)
Risk of serotonin syndrome may be increased.Theophylline
May increase theophylline plasma concentration; monitor theophylline levels.Verapamil
Risk of cardiotoxicity may be increased.Warfarin
The anticoagulant effect may be increased, increasing the risk of hemorrhage.Zidovudine
Serum levels may be increased or decreased by clarithromycin.
None well documented.
QT prolongation, ventricular arrhythmias including ventricular tachycardia and torsades de pointes (postmarketing).
Headache (2%); anxiety, behavioral changes, confusional states, convulsions, depersonalization, disorientation, dizziness, hallucinations, insomnia, manic behavior, nightmares, psychosis, tinnitus, tremor, vertigo (postmarketing).
Rash (3%); Stevens-Johnson syndrome, toxic epidermal necrolysis (postmarketing).
Alterations in sense of smell, hearing loss (postmarketing).
Abnormal taste (7%); diarrhea, vomiting (6%); abdominal pain/discomfort, nausea (3%); dyspepsia, flatulence (2%); anorexia, glossitis, oral moniliasis, pancreatitis, stomatitis, taste perversion or loss, tongue discoloration, tooth discoloration (postmarketing).
Interstitial nephritis (postmarketing).
Leukopenia, neutropenia, thrombocytopenia (postmarketing).
Hepatic dysfunction including increased liver enzymes, hepatocellular and/or cholestatic hepatitis with or without jaundice (postmarketing).
Elevated alkaline phosphatase, ALT, AST, BUN, gamma-glutamyltransferase, LDH, serum creatinine, and total bilirubin; elevated PT and lactate dehydrogenase; decreased WBC (postmarketing).
Allergic reactions ranging from urticaria and mild skin eruptions to anaphylaxis (postmarketing).
Monitor patient's response to therapy. Monitor patient for GI, DERM, and general body side effects, and signs of superinfection. Advise patient to immediately report severe diarrhea, diarrhea containing blood or pus, or severe abdominal cramping.
Category C . Do not use in pregnant women unless there is no appropriate alternative.
Safety and efficacy in children younger than 6 mo of age not established. Safety in treatment of MAC in children younger than 20 mo of age not established.
Consider dosage adjustments in elderly patients with severe renal function impairment.
Use with caution and consider reduced dose or prolonged dosing intervals in patients with severe renal function impairment. Clarithromycin in combination with ranitidine bismuth citrate therapy is not recommended in patients with CrCl less than 25 mL/min.
Dosage adjustments are not needed in patients with hepatic function impairment.
Consider possibility in patients in whom diarrhea develops.
Abdominal pain, diarrhea, nausea, vomiting.
Copyright © 2009 Wolters Kluwer Health.