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Pronunciation
(kla RITH roe mye sin)
Generic Available (U.S.)
Yes
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Children:
Acute otitis media (H. influenzae, M. catarrhalis, or S. pneumoniae)
Community-acquired pneumonia due to susceptible Mycoplasma pneumoniae, S. pneumoniae, or Chlamydia pneumoniae (TWAR)
Pharyngitis/tonsillitis due to susceptible S. pyogenes, acute maxillary sinusitis due to susceptible H. influenzae, S. pneumoniae, or Moraxella catarrhalis, uncomplicated skin/skin structure infections due to susceptible S. aureus, S. pyogenes, and mycobacterial infections
Prevention of disseminated mycobacterial infections due to MAC disease in patients with advanced HIV infection
Adults:
Pharyngitis/tonsillitis due to susceptible S. pyogenes
Acute maxillary sinusitis due to susceptible H. influenzae, M. catarrhalis, or S. pneumoniae
Acute exacerbation of chronic bronchitis due to susceptible H. influenzae, H. parainfluenzae, M. catarrhalis, or S. pneumoniae
Community-acquired pneumonia due to susceptible H. influenzae, H. parainfluenzae, Mycoplasma pneumoniae, S. pneumoniae, or Chlamydia pneumoniae (TWAR), Moraxella catarrhalis
Uncomplicated skin/skin structure infections due to susceptible S. aureus, S. pyogenes
Disseminated mycobacterial infections due to M. avium or M. intracellulare
Prevention of disseminated mycobacterial infections due to M. avium complex (MAC) disease (eg, patients with advanced HIV infection)
Duodenal ulcer disease due to H. pylori in regimens with other drugs including amoxicillin and lansoprazole or omeprazole, ranitidine bismuth citrate, bismuth subsalicylate, tetracycline, and/or an H2 antagonist
Use: Dental
Alternate oral antibiotic for prevention of infective endocarditis in individuals allergic to penicillins or ampicillin, when amoxicillin cannot be used; alternate antibiotic in the treatment of common orofacial infections caused by aerobic gram-positive cocci and susceptible anaerobes
Use: Unlabeled
Pertussis (CDC guidelines); alternate antibiotic for prophylaxis of infective endocarditis in patients who are allergic to penicillin and undergoing surgical or dental procedures (ACC/AHA guidelines)
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse fetal effects have been documented in some animal studies; therefore, clarithromycin is classified as pregnancy category C. Clarithromycin crosses the placenta. The manufacturer recommends that clarithromycin not be used in a pregnant woman unless there are no alternative therapies. An increased risk of teratogenic events has not been observed following maternal use of clarithromycin.
Lactation
Excretion in breast milk unknown/use caution
Breast-Feeding Considerations
It is not known if clarithromycin is excreted in human breast milk. The manufacturer recommends that caution be exercised when administering clarithromycin to breast-feeding women.
Other macrolides are considered compatible with breast-feeding and clarithromycin is used therapeutically in infants. Nondose-related effects could include modification of bowel flora.
Contraindications
Hypersensitivity to clarithromycin, erythromycin, or any macrolide antibiotic; use with ergot derivatives, pimozide, cisapride, astemizole, terfenadine, colchicine (if patient has concomitant renal or hepatic impairment); history of cholestatic jaundice or hepatic dysfunction with prior clarithromycin use
Warnings/Precautions
Concerns related to adverse effects:
• Altered cardiac conduction: Macrolides have been associated with rare QTc prolongation and ventricular arrhythmias, including torsade de pointes; use with caution in patients at risk of prolonged cardiac repolarization.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Coronary artery disease (CAD): Use with caution in patients with CAD; postmarketing safety trial suggests increased risk of cardiovascular mortality with short-term clarithromycin use (vs placebo) in patients with stable CAD. However, more smokers were randomized to the clarithromycin arm.
• Hepatic effects: Elevated liver function tests and hepatitis (hepatocellular, cholestatic) have been reported; usually reversible after discontinuation of clarithromycin. May lead to hepatic failure or death (rarely), especially in the presence of pre-existing hepatic disease or concomitant use of hepatotoxic medications.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms and new onset of symptoms has occurred.
• Renal impairment: Dosage adjustment required with severe renal impairment; decreased dosage or prolonged dosing interval may be appropriate.
Concurrent drug therapy issues:
• Colchicine: Colchicine toxicity (including fatalities) has been reported with concomitant use; reduction of colchicine dose is recommended if coadministration is necessary. Use caution in the elderly; concomitant use is contraindicated in patients with renal or hepatic impairment.
Dosage form specific issues:
• Extended release formulation: The extended release formulation consists of drug within a nondeformable matrix; following drug release/absorption, the matrix/shell is expelled in the stool. The use of nondeformable products in patients with known stricture/narrowing of the GI tract has been associated with symptoms of obstruction.
Adverse Reactions
1% to 10%:
Central nervous system: Headache (adults and children 2%)
Dermatologic: Rash (children 3%)
Gastrointestinal: Abnormal taste (adults 3% to 7%), diarrhea (adults 3% to 6%; children 6%), vomiting (children 6%), nausea (adults 3%), abdominal pain (adults 2%; children 3%), dyspepsia (adults 2%)
Hepatic: Prothrombin time increased (adults 1%)
Renal: BUN increased (4%)
<1%, postmarketing, and/or case reports (limited to important or life-threatening): Alkaline phosphatase increased, ALT increased, anaphylaxis, anorexia, anxiety, AST increased, behavioral changes, bilirubin increased, cholestatic hepatitis, Clostridium difficile colitis, confusion, depersonalization, depression, disorientation, dizziness, GGT increased, glossitis, hallucinations, hearing loss (reversible), hepatic dysfunction, hepatic failure, hepatitis, hypoglycemia, insomnia, interstitial nephritis, jaundice, leukopenia, LDH increased, manic behavior, neutropenia, nightmares, oral moniliasis, pancreatitis, psychosis, QT prolongation, seizure, serum creatinine increased, smell loss, Stevens-Johnson syndrome, stomatitis, thrombocytopenia, tinnitus, tongue discoloration, tooth discoloration (reversible), torsade de pointes, toxic epidermal necrolysis, tremor, urticaria, ventricular tachycardia, ventricular arrhythmia, vertigo, white blood cell count decreased
Metabolism/Transport Effects
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP1A2 (weak), CYP3A4 (strong), P-glycoprotein
Drug Interactions
Alfentanil: Macrolide Antibiotics may decrease the metabolism of Alfentanil. Risk D: Consider therapy modification
Alfuzosin: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Alfuzosin. Risk X: Avoid combination
Alfuzosin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Almotriptan: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Almotriptan. Management: Limit initial almotriptan adult dose to 6.25 mg and maximum adult dose to 12.5 mg/24-hrs when used with a strong CYP3A4 inhibitor. Avoid concurrent use in patients with impaired hepatic or renal function. Risk D: Consider therapy modification
Alosetron: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Alosetron. Risk C: Monitor therapy
Antifungal Agents (Azole Derivatives, Systemic): Macrolide Antibiotics may decrease the metabolism of Antifungal Agents (Azole Derivatives, Systemic). Antifungal Agents (Azole Derivatives, Systemic) may decrease the metabolism of Macrolide Antibiotics. Risk D: Consider therapy modification
Antineoplastic Agents (Vinca Alkaloids): Macrolide Antibiotics may increase the serum concentration of Antineoplastic Agents (Vinca Alkaloids). Macrolides may also increase the distribution of Vinca Alkaloids into certain cells and/or tissues. Management: Consider an alternative to using a macrolide antibiotic when possible in order to avoid the potential for increased vinca alkaloid toxicity. Risk D: Consider therapy modification
ARIPiprazole: CYP3A4 Inhibitors (Strong) may increase the serum concentration of ARIPiprazole. Management: Decrease aripiprazole dose to 50% of the usual dose with concomitant use of strong CYP3A4 inhibitors or to 25% of usual dose with concomitant use of strong CYP3A4 and 2D6 inhibitors or with use of a strong 3A4 inhibitor in a poor 2D6 metabolizer Risk D: Consider therapy modification
Artemether: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Axitinib: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Axitinib. Management: Avoid concurrent use of axitinib with any strong CYP3A inhibitor whenever possible. If a strong CYP3A inhibitor must be used with axitinib, a 50% axitinib dose reduction is recommended. Risk X: Avoid combination
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Benzodiazepines (metabolized by oxidation): Macrolide Antibiotics may decrease the metabolism of Benzodiazepines (metabolized by oxidation). Risk D: Consider therapy modification
Bortezomib: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Bortezomib. Risk C: Monitor therapy
Brentuximab Vedotin: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Brentuximab Vedotin. Specifically, concentrations of the active monomethyl auristatin E (MMAE) component may be increased. Risk C: Monitor therapy
Brinzolamide: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Brinzolamide. Risk C: Monitor therapy
Budesonide (Nasal): CYP3A4 Inhibitors (Strong) may increase the serum concentration of Budesonide (Nasal). Risk C: Monitor therapy
Budesonide (Systemic, Oral Inhalation): CYP3A4 Inhibitors (Strong) may increase the serum concentration of Budesonide (Systemic, Oral Inhalation). Management: Consider reducing the oral budesonide dose when used together with a CYP3A4 inhibitor. This interaction is likely less severe with orally inhaled budesonide. Monitor patients closely for signs/symptoms of corticosteroid excess. Risk D: Consider therapy modification
BusPIRone: Macrolide Antibiotics may decrease the metabolism of BusPIRone. Risk D: Consider therapy modification
Calcium Channel Blockers: Macrolide Antibiotics may decrease the metabolism of Calcium Channel Blockers. Management: Consider using a noninteracting macrolide. Monitor for increased therapeutic effects of calcium channel blockers if an interacting macrolide antibiotic is initiated, or decreased effects if a macrolide is discontinued. Exceptions: Clevidipine. Risk D: Consider therapy modification
CarBAMazepine: Macrolide Antibiotics may decrease the metabolism of CarBAMazepine. Risk D: Consider therapy modification
Cardiac Glycosides: Macrolide Antibiotics may increase the serum concentration of Cardiac Glycosides. Risk D: Consider therapy modification
Chloroquine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Ciclesonide: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Ciclesonide. Specifically, concentrations of the active des-ciclesonide metabolite may be increased. Risk C: Monitor therapy
Cilostazol: Macrolide Antibiotics may decrease the metabolism of Cilostazol. Risk D: Consider therapy modification
Ciprofloxacin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Ciprofloxacin (Systemic): May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Cisapride: Macrolide Antibiotics may decrease the metabolism of Cisapride. Risk X: Avoid combination
Clopidogrel: Macrolide Antibiotics may diminish the therapeutic effect of Clopidogrel. Risk C: Monitor therapy
CloZAPine: Macrolide Antibiotics may decrease the metabolism of CloZAPine. Risk D: Consider therapy modification
Colchicine: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Colchicine. Management: Colchicine is contraindicated in patients with impaired renal or hepatic function who are also receiving a strong CYP3A4 inhibitor. In those with normal renal and hepatic function, reduce colchicine dose as directed. Risk D: Consider therapy modification
Colchicine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Colchicine. Colchicine distribution into certain tissues (e.g., brain) may also be increased. Management: Colchicine is contraindicated in patients with impaired renal or hepatic function who are also receiving a p-glycoprotein inhibitor. In those with normal renal and hepatic function, reduce colchicine dose as directed. Risk D: Consider therapy modification
Conivaptan: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Conivaptan. Risk X: Avoid combination
Corticosteroids (Orally Inhaled): CYP3A4 Inhibitors (Strong) may increase the serum concentration of Corticosteroids (Orally Inhaled). Management: Monitor for signs and symptoms of adrenal suppression if inhaled budesonide or mometasone are coadministered with a strong CYP3A4 inhibitor. Avoid combining inhaled fluticasone with any strong CYP3A4 inhibitor. Exceptions: Beclomethasone; Beclomethasone (Oral Inhalation); Triamcinolone; Triamcinolone (Systemic). Risk C: Monitor therapy
Corticosteroids (Systemic): Macrolide Antibiotics may decrease the metabolism of Corticosteroids (Systemic). Risk D: Consider therapy modification
Crizotinib: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Crizotinib. Risk X: Avoid combination
CycloSPORINE: Macrolide Antibiotics may decrease the metabolism of CycloSPORINE. Risk C: Monitor therapy
CycloSPORINE (Systemic): Macrolide Antibiotics may decrease the metabolism of CycloSPORINE (Systemic). Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May increase serum concentrations of the active metabolite(s) of Clarithromycin. Clarithromycin may increase the serum concentration of CYP3A4 Inducers (Strong). CYP3A4 Inducers (Strong) may decrease the serum concentration of Clarithromycin. Risk D: Consider therapy modification
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Risk D: Consider therapy modification
CYP3A4 Substrates: CYP3A4 Inhibitors (Strong) may decrease the metabolism of CYP3A4 Substrates. Risk D: Consider therapy modification
Dabigatran Etexilate: P-glycoprotein/ABCB1 Inhibitors may increase serum concentrations of the active metabolite(s) of Dabigatran Etexilate. Management: Dabigatran dose reductions may be needed. Specific recommendations vary considerably according to US vs Canadian labeling, specific P-gp inhibitor, renal function, and indication for dabigatran treatment. Refer to full monograph or dabigatran labeling. Risk D: Consider therapy modification
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Dienogest: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Dienogest. Risk C: Monitor therapy
Dihydroergotamine: Clarithromycin may increase the serum concentration of Dihydroergotamine. Risk X: Avoid combination
Disopyramide: Macrolide Antibiotics may enhance the QTc-prolonging effect of Disopyramide. Macrolide Antibiotics may decrease the metabolism of Disopyramide. Risk X: Avoid combination
Dronedarone: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Dronedarone. Risk X: Avoid combination
Dronedarone: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Dronedarone. Risk X: Avoid combination
Dutasteride: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Dutasteride. Risk C: Monitor therapy
Eletriptan: Macrolide Antibiotics may decrease the metabolism of Eletriptan. Risk D: Consider therapy modification
Eplerenone: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Eplerenone. Risk X: Avoid combination
Eplerenone: Macrolide Antibiotics may decrease the metabolism of Eplerenone. Risk C: Monitor therapy
Ergot Derivatives: Macrolide Antibiotics may enhance the adverse/toxic effect of Ergot Derivatives. Specifically leading the development of ergotism. Exceptions: Cabergoline. Risk D: Consider therapy modification
Ergotamine: Clarithromycin may increase the serum concentration of Ergotamine. Risk X: Avoid combination
Etravirine: May decrease the serum concentration of Macrolide Antibiotics. Clarithromycin AUC is reduced and levels of the active metabolite (14-hydroxy-clarithromycin) are modestly increased. Management: For the treatment of Mycobacterium avium complex, consider changing to alternative agent, such as azithromycin. Risk D: Consider therapy modification
Everolimus: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Everolimus. Risk X: Avoid combination
Everolimus: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Everolimus. Management: Everolimus dose reductions are required for patients being treated for subependymal giant cell astrocytoma or renal cell carcinoma. See prescribing information for specific dose adjustment and monitoring recommendations. Risk D: Consider therapy modification
FentaNYL: CYP3A4 Inhibitors (Strong) may increase the serum concentration of FentaNYL. Management: Monitor patients extra closely for several days following initiation of the combination, and fentanyl dosage reductions should be made as appropriate. Risk D: Consider therapy modification
Fesoterodine: CYP3A4 Inhibitors (Strong) may increase serum concentrations of the active metabolite(s) of Fesoterodine. Management: Avoid fesoterodine doses greater than 4 mg daily in adult patients who are also receiving strong CYP3A4 inhibitors. Risk D: Consider therapy modification
Fluticasone (Nasal): CYP3A4 Inhibitors (Strong) may increase the serum concentration of Fluticasone (Nasal). Risk C: Monitor therapy
Fluticasone (Oral Inhalation): CYP3A4 Inhibitors (Strong) may increase the serum concentration of Fluticasone (Oral Inhalation). Risk X: Avoid combination
Gadobutrol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk D: Consider therapy modification
GlipiZIDE: Clarithromycin may increase the serum concentration of GlipiZIDE. Risk C: Monitor therapy
GlyBURIDE: Clarithromycin may increase the serum concentration of GlyBURIDE. Risk C: Monitor therapy
GuanFACINE: CYP3A4 Inhibitors (Strong) may increase the serum concentration of GuanFACINE. Risk C: Monitor therapy
Halofantrine: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Halofantrine. Risk X: Avoid combination
Herbs (CYP3A4 Inducers): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
HMG-CoA Reductase Inhibitors: Macrolide Antibiotics may decrease the metabolism of HMG-CoA Reductase Inhibitors. Management: Avoid lovastatin or simvastatin with erythro-, clarithro-, or telithromycin. Limit pitavastatin to a 1 mg/day maximum adult dose with erythromycin. Atorvastatin dose adjustments may be required. Increase monitoring for toxicity with any such combination. Exceptions: Fluvastatin; Pravastatin; Rosuvastatin. Risk D: Consider therapy modification
Iloperidone: CYP3A4 Inhibitors (Strong) may increase serum concentrations of the active metabolite(s) of Iloperidone. Specifically, concentrations of the metabolites P88 and P95 may be increased. CYP3A4 Inhibitors (Strong) may increase the serum concentration of Iloperidone. Management: Reduce iloperidone dose by half when administered with a strong CYP3A4 inhibitor. Risk D: Consider therapy modification
Indacaterol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Ivacaftor: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Ivacaftor. Management: Decrease ivacaftor dose to 150 mg twice a week in patients also receiving strong CYP3A4 inhibitors. Risk D: Consider therapy modification
Ixabepilone: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Ixabepilone. Risk D: Consider therapy modification
Lapatinib: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Lapatinib. Management: If an overlap in therapy cannot be avoided, consider reducing lapatinib dose to 500 mg/day during, and within 1 week of completing, treatment with the strong CYP3A4 inhibitor. Risk X: Avoid combination
Lovastatin: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Lovastatin. Risk X: Avoid combination
Lumefantrine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Lumefantrine: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Lumefantrine. Risk C: Monitor therapy
Lurasidone: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Lurasidone. Risk X: Avoid combination
Maraviroc: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Maraviroc. Management: Reduce the adult dose of maraviroc to 150 mg twice daily when used with a strong CYP3A4 inhibitor. Do not use maraviroc with strong CYP3A4 inhibitors in patients with Clcr less than 30 mL/min. Risk D: Consider therapy modification
MethylPREDNISolone: CYP3A4 Inhibitors (Strong) may increase the serum concentration of MethylPREDNISolone. Management: Consider methylprednisolone dose titration and/or adjustments in patients receiving strong CYP3A4 inhibitors (eg, azole antifungals, protease inhibitors) and monitor for increased steroid related adverse effects. Risk D: Consider therapy modification
Nilotinib: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Nilotinib: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Nilotinib. Risk X: Avoid combination
Nisoldipine: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Nisoldipine. Risk X: Avoid combination
Paricalcitol: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Paricalcitol. Risk C: Monitor therapy
Pazopanib: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Pazopanib. Management: Avoid concurrent use of pazopanib with strong inhibitors of CYP3A4 whenever possible. If it is not possible to avoid such a combination, reduce pazopanib adult dose to 400 mg. Further dose reductions may also be required. Risk D: Consider therapy modification
P-glycoprotein/ABCB1 Substrates: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy
Pimecrolimus: CYP3A4 Inhibitors (Strong) may decrease the metabolism of Pimecrolimus. Risk C: Monitor therapy
Pimozide: Macrolide Antibiotics may enhance the QTc-prolonging effect of Pimozide. Macrolide Antibiotics may decrease the metabolism of Pimozide. This mechanism may not apply to azithromycin. Risk X: Avoid combination
Pimozide: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Pimozide. Risk X: Avoid combination
Pimozide: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Pimozide. Risk X: Avoid combination
Prasugrel: CYP3A4 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of Prasugrel. Risk C: Monitor therapy
Propafenone: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Propafenone. Risk C: Monitor therapy
Protease Inhibitors: May diminish the therapeutic effect of Clarithromycin. Specifically, certain protease inhibitors may decrease formation of the active 14-hydroxy-clarithromycin metabolite, which may negatively impact clarithromycin effectiveness vs. H. influenzae and other non-MAC infections. Clarithromycin may increase the serum concentration of Protease Inhibitors. Protease Inhibitors may increase the serum concentration of Clarithromycin. Clarithromycin dose adjustment in renally impaired patients may be needed. Management: Avoid clarithromycin doses greater than 1000 mg/day when used with a protease inhibitor. Further dose reductions may be needed in patients with impaired renal function. Consider alternative antimicrobial for any non-MAC infection. Risk D: Consider therapy modification
Prucalopride: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Prucalopride. Risk C: Monitor therapy
QTc-Prolonging Agents: May enhance the adverse/toxic effect of other QTc-Prolonging Agents. Their effects can be additive, causing life-threatening ventricular arrhythmias. Risk D: Consider therapy modification
QUEtiapine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
QuiNIDine: Macrolide Antibiotics may decrease the metabolism of QuiNIDine. Risk D: Consider therapy modification
QuiNINE: Macrolide Antibiotics may increase the serum concentration of QuiNINE. Risk X: Avoid combination
QuiNINE: QTc-Prolonging Agents may enhance the QTc-prolonging effect of QuiNINE. QuiNINE may enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Ranolazine: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Ranolazine. Risk X: Avoid combination
Repaglinide: Macrolide Antibiotics may increase the serum concentration of Repaglinide. Risk C: Monitor therapy
Rifamycin Derivatives: Macrolide Antibiotics may decrease the metabolism of Rifamycin Derivatives. Exceptions: Rifapentine. Risk D: Consider therapy modification
Rivaroxaban: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Rivaroxaban. Risk X: Avoid combination
Rivaroxaban: Clarithromycin may increase the serum concentration of Rivaroxaban. Risk C: Monitor therapy
Rivaroxaban: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Rivaroxaban. Risk C: Monitor therapy
RomiDEPsin: CYP3A4 Inhibitors (Strong) may increase the serum concentration of RomiDEPsin. Risk X: Avoid combination
Ruxolitinib: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Ruxolitinib. Management: Reduce ruxolitinib initial adult dose to 10 mg twice daily in patients receiving strong CYP3A4 inhibitors whose platelet count is 100*10^9/L or greater. Avoid in patients with lower platelet count. Risk D: Consider therapy modification
Salmeterol: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Salmeterol. Risk X: Avoid combination
Saxagliptin: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Saxagliptin. Management: Limit saxagliptin adult dose to 2.5 mg/day and monitor for increased saxagliptin levels/effects (e.g., hypoglycemia) when used with a strong CYP3A4 inhibitor. Monitor for decreased saxagliptin levels/effects if discontinuing CYP3A4 inhibitor. Risk D: Consider therapy modification
Selective Serotonin Reuptake Inhibitors: Macrolide Antibiotics may decrease the metabolism of Selective Serotonin Reuptake Inhibitors. Exceptions: FluvoxaMINE; PARoxetine. Risk C: Monitor therapy
Sildenafil: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Sildenafil. Management: When used for treatment of pulmonary arterial hypertension, use of sildenafil with strong CYP3A4 inhibitors should be avoided. When used for erectile dysfunction, starting dose should be reduced to 25 mg. Max dose with ritonavir is 25 mg per 48 hours. Risk D: Consider therapy modification
Silodosin: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Silodosin. Risk X: Avoid combination
Silodosin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Silodosin. Risk X: Avoid combination
Simvastatin: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Simvastatin. Risk X: Avoid combination
Sirolimus: Macrolide Antibiotics may decrease the metabolism of Sirolimus. Risk D: Consider therapy modification
SORAfenib: CYP3A4 Inhibitors (Strong) may increase the serum concentration of SORAfenib. Risk C: Monitor therapy
Tacrolimus: Macrolide Antibiotics may increase the serum concentration of Tacrolimus. Risk C: Monitor therapy
Tacrolimus (Systemic): Macrolide Antibiotics may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy
Tacrolimus (Topical): Macrolide Antibiotics may increase the serum concentration of Tacrolimus (Topical). Risk C: Monitor therapy
Tadalafil: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Tadalafil. Management: Recommendations regarding use of tadalafil in patients also receiving strong CYP3A4 inhibitors may vary based on indication and/or international labeling. Consult appropriate product labeling. Risk D: Consider therapy modification
Tamsulosin: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Tamsulosin. Risk X: Avoid combination
Telaprevir: Clarithromycin may increase the serum concentration of Telaprevir. Telaprevir may increase the serum concentration of Clarithromycin. Risk C: Monitor therapy
Temsirolimus: Macrolide Antibiotics may enhance the adverse/toxic effect of Temsirolimus. Levels of sirolimus, the active metabolite, may be increased, likely due to inhibition of CYP-mediated metabolism. Risk D: Consider therapy modification
Terfenadine: Macrolide Antibiotics may enhance the QTc-prolonging effect of Terfenadine. Macrolide Antibiotics may increase the serum concentration of Terfenadine. Risk X: Avoid combination
Tetrabenazine: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Tetrabenazine. Risk X: Avoid combination
Theophylline Derivatives: Macrolide Antibiotics may decrease the metabolism of Theophylline Derivatives. Exceptions: Dyphylline. Risk D: Consider therapy modification
Thioridazine: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Thioridazine. Risk X: Avoid combination
Ticagrelor: CYP3A4 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of Ticagrelor. CYP3A4 Inhibitors (Strong) may increase the serum concentration of Ticagrelor. Risk X: Avoid combination
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Tolterodine: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Tolterodine. Management: The maximum recommended dose of long-acting tolterodine is 2 mg/day when used together with a strong CYP3A4 inhibitor. Risk D: Consider therapy modification
Tolvaptan: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Tolvaptan. Risk X: Avoid combination
Topotecan: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Topotecan. Risk X: Avoid combination
Toremifene: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Toremifene. The risk for potentially dangerous arrhythmias may be increased. Risk X: Avoid combination
Toremifene: CYP3A4 Inhibitors (Strong) may enhance the adverse/toxic effect of Toremifene. CYP3A4 Inhibitors (Strong) may increase the serum concentration of Toremifene. Risk X: Avoid combination
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification
Vandetanib: QTc-Prolonging Agents may enhance the arrhythmogenic effect of Vandetanib. Risk X: Avoid combination
Vardenafil: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Vardenafil. Management: Recommendations regarding concomitant use of vardenafil with strong CYP3A4 inhibitors may vary depending on brand name (e.g., Levitra, Staxyn) or by international labeling. Consult appropriate product labeling for specific recommendations. Risk D: Consider therapy modification
Vardenafil: Clarithromycin may increase the serum concentration of Vardenafil. Management: Recommendations regarding the concomitant use of vardenafil with clarithromycin vary between international labelings and between commercially available vardenafil brand name products (Levitra, Staxyn). Consult appropriate product labelings. Risk D: Consider therapy modification
Vemurafenib: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Vemurafenib. Risk X: Avoid combination
Vemurafenib: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Vemurafenib. Risk C: Monitor therapy
Vilazodone: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Vilazodone. Management: Limit maximum adult vilazodone dose to 20 mg/day in patients receiving strong CYP3A4 inhibitors. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Macrolide Antibiotics may increase the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy
Zidovudine: Clarithromycin may enhance the myelosuppressive effect of Zidovudine. Clarithromycin may decrease the serum concentration of Zidovudine. Management: Monitor response to zidovudine closely when used with clarithromycin, and consider staggering zidovudine and clarithromycin doses when possible in order to minimize the potential for interaction. Risk D: Consider therapy modification
Ziprasidone: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Ziprasidone. The risk of a severe arrhythmia may be increased. Risk X: Avoid combination
Zopiclone: Macrolide Antibiotics may increase the serum concentration of Zopiclone. Risk D: Consider therapy modification
Zuclopenthixol: CYP3A4 Inhibitors (Strong) may increase the serum concentration of Zuclopenthixol. Management: Consider zuclopenthixol dosage reduction with concomitant use of a strong CYP3A4 inhibitor (eg, ketoconazole) in poor CYP2D6 metabolizers or with strong CYP2D6 inhibitors (eg, paroxetine). Monitor for increased zuclopenthixol levels/toxicity. Risk D: Consider therapy modification
Ethanol/Nutrition/Herb Interactions
Food: Immediate release: Food delays rate, but not extent of absorption; Extended release: Food increases clarithromycin AUC by ~30% relative to fasting conditions.
Herb/Nutraceutical: St John's wort may decrease clarithromycin levels.
Storage
Immediate release 250 mg tablets and granules for oral suspension: Store at controlled room temperature of 15°C to 30°C (59°F to 86°F). Reconstituted oral suspension should not be refrigerated because it might gel; microencapsulated particles of clarithromycin in suspension are stable for 14 days when stored at room temperature. Protect tablets from light.
Immediate release 500 mg tablets and Biaxin® XL: Store at controlled room temperature of 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Mechanism of Action
Exerts its antibacterial action by binding to 50S ribosomal subunit resulting in inhibition of protein synthesis. The 14-OH metabolite of clarithromycin is twice as active as the parent compound against certain organisms.
Pharmacodynamics/Kinetics
Absorption: Immediate release: Rapid; food delays rate, but not extent of absorption
Distribution: Widely into most body tissues except CNS
Protein binding: 42% to 50%
Metabolism: Partially hepatic via CYP3A4; converted to 14-OH clarithromycin (active metabolite)
Bioavailability: ~50%
Half-life elimination: Immediate release: Clarithromycin: 3-7 hours; 14-OH-clarithromycin: 5-9 hours
Time to peak: Immediate release: 2-3 hours
Excretion: Primarily urine (20% to 40% as unchanged drug; additional 10% to 15% as metabolite)
Clearance: Approximates normal GFR
Dosage
Usual dosage range:
Children ≥6 months: Oral: 7.5 mg/kg every 12 hours (maximum: 500 mg/dose) for 10 days
Adults: Oral: 250-500 mg every 12 hours or 1000 mg (two 500 mg extended release tablets) once daily for 7-14 days
Indication-specific dosing:
Children: Oral:
Community-acquired pneumonia (CAP) (IDSA/PIDS, 2011): Infants >3 months and Children: Note: A beta-lactam antibiotic should be added if typical bacterial pneumonia cannot be ruled out.
Presumed atypical (M. pneumoniae, C. pneumoniae, C. trachomatis) infection, mild-to-severe atypical infection or step-down therapy (alternative to azithromycin): 7.5 mg/kg/dose (maximum: 1 g) every 12 hours
Mycobacterial infection (prevention and treatment):
Manufacturer's recommendation: 7.5 mg/kg/dose (maximum: 500 mg/dose) twice daily. Note: Safety of clarithromycin for MAC not studied in children <20 months.
HIV-exposed/-positive (unlabeled use; CDC, 2009):
Primary prophylaxis: 7.5 mg/kg/dose (maximum: 500 mg/dose) twice daily
Secondary prophylaxis: 7.5 mg/kg/dose (maximum: 500 mg/dose) twice daily, plus ethambutol, with or without rifabutin
Treatment: 7.5-15 mg/kg/dose (maximum: 500 mg/dose) twice daily plus ethambutol, plus rifabutin (for severe disease)
Pertussis (unlabeled use; CDC, 2005):
Children 1-5 months: 7.5 mg/kg/dose every 12 hours for 7 days
Children ≥6 months: 7.5 mg/kg/dose every 12 hours for 7 days (maximum: 1 g/day)
Prophylaxis against infective endocarditis (unlabeled use): 15 mg/kg 30-60 minutes before procedure. Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.
Sinusitis, bronchitis, skin infections: 7.5 mg/kg/dose every 12 hours for 10 days
Adults: Oral:
Acute exacerbation of chronic bronchitis:
M. catarrhalis and S. pneumoniae: 250 mg every 12 hours for 7-14 days or 1000 mg (two 500 mg extended release tablets) once daily for 7 days
H. influenzae: 500 mg every 12 hours for 7-14 days or 1000 mg (two 500 mg extended release tablets) once daily for 7 days
H. parainfluenzae: 500 mg every 12 hours for 7 days or 1000 mg (two 500 mg extended release tablets) once daily for 7 days
Acute maxillary sinusitis: 500 mg every 12 hours or 1000 mg (two 500 mg extended release tablets) once daily for 14 days
Mycobacterial infection (prevention and treatment): 500 mg twice daily (use with other antimycobacterial drugs, eg, ethambutol or rifampin)
Peptic ulcer disease: Eradication of Helicobacter pylori: Dual or triple combination regimens with bismuth subsalicylate, amoxicillin, an H2-receptor antagonist, or proton-pump inhibitor: 500 mg every 8-12 hours for 10-14 days
Pertussis (unlabeled use; CDC, 2005): 500 mg twice daily for 7 days
Pharyngitis, tonsillitis: 250 mg every 12 hours for 10 days
Pneumonia:
C. pneumoniae, M. pneumoniae, and S. pneumoniae: 250 mg every 12 hours for 7-14 days or 1000 mg (two 500 mg extended release tablets) once daily for 7 days
H. influenzae: 250 mg every 12 hours for 7 days or 1000 mg (two 500 mg extended release tablets) once daily for 7 days
H. parainfluenzae and M. catarrhalis: 1000 mg (two 500 mg extended release tablets) once daily for 7 days
Prophylaxis against infective endocarditis (unlabeled use): 500 mg 30-60 minutes prior to procedure. Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.
Skin and skin structure infection, uncomplicated: 250 mg every 12 hours for 7-14 days
Elderly: Pharmacokinetics are similar to those in younger adults; may have age-related reductions in renal function; monitor and adjust dose if necessary
Dosing adjustment in renal impairment:
Clcr <30 mL/minute: Decrease clarithromycin dose by 50%
Hemodialysis: Administer after HD session is completed (Aronoff, 2007).
In combination with atazanavir or ritonavir:
Clcr 30-60 mL/minute: Decrease clarithromycin dose by 50%
Clcr <30 mL/minute: Decrease clarithromycin dose by 75%
Dosing adjustment in hepatic impairment: No dosing adjustment is needed as long as renal function is normal
Dental Usual Dosing
Prophylaxis against infective endocarditis (unlabeled use): Oral:
Children: 15 mg/kg 30-60 minutes before procedure
Adults: 500 mg 30-60 minutes prior to procedure
Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.
Administration: Oral
Clarithromycin immediate release tablets and oral suspension may be administered with or without meals. Give every 12 hours rather than twice daily to avoid peak and trough variation. Shake suspension well before each use.
Extended release tablets: Should be given with food. Do not crush or chew extended release tablet.
Monitoring Parameters
CBC with differential, BUN, creatinine; perform culture and sensitivity studies prior to initiating drug therapy
Dietary Considerations
Clarithromycin immediate release tablets and oral suspension may be given with or without meals, and may be taken with milk. Extended release tablets should be taken with food.
Patient Education
Tables and suspension may be taken with or without meals or milk. Extended release formulation (XL) should be taken with meals; do not break or chew extended release tablets. Maintain adequate hydration, unless instructed to restrict fluid intake. May cause nausea, heartburn, abnormal taste, diarrhea, headaches, or abdominal pain. Report rapid heartbeat or palpitations, persistent fever or chills, easy bruising or bleeding, joint pain, severe persistent diarrhea, skin rash, sores in mouth, or foul-smelling urine.
Geriatric Considerations
Considered one of the drugs of choice in the outpatient treatment of community-acquired pneumonia in elderly. After doses of 500 mg every 12 hours for 5 days, 12 healthy elderly subjects had significantly increased Cmax and Cmin, elimination half-lives of clarithromycin and 14-OH clarithromycin compared to 12 healthy young subjects. These changes were attributed to a significant decrease in renal clearance; at a dose of 1000 mg twice daily, 100% of 13 elderly subjects experienced an adverse event compared to only 10% taking 500 mg twice daily.
Cardiovascular Considerations
Because of potential drug interactions, serious arrhythmias may occur when clarithromycin and other macrolides are used in combination with cisapride. Clarithromycin may also increase theophylline, some HMG-CoA reductase inhibitors, digoxin, warfarin, and cyclosporine levels (among others). Clarithromycin may be used in penicillin-allergic patients for prevention of bacterial endocarditis.
The FDA issued an alert for clarithromycin (Biaxin®, Abbott Laboratories) on December 8, 2005. These actions were based upon results of a Danish trial (CLARICOR) that was recently published online in the British Medical Journal (Jesperson, 2006). This was a multicenter, double-blind, randomized, placebo-controlled trial evaluating the effects of clarithromycin (500 mg daily for 14 days) on mortality in patients with stable coronary artery disease. Over 13,000 patients having a discharge diagnosis (from 1993-99) of myocardial infarction or angina pectoris were recruited for the trial. The primary outcome was a composite of all cause mortality, MI, or unstable angina during the three-year follow up. The secondary outcome measure consisted of cardiovascular mortality, MI, or unstable angina. Two thousand one hundred and seventy two patients were randomized to clarithromycin and 2200 to placebo. The groups were well matched except there were more smokers in the clarithromycin group. Compliance was over 90% in both groups. There was no difference between the two groups with regard to the composite outcomes (primary or secondary). All cause mortality was significantly higher in the clarithromycin group (HR 1.27; CI 1.03-1.54; p = 0.03) as a result of a higher cardiovascular mortality (HR 1.45; CI 1.09-1.92; p = 0.01). When a multivariant analysis was done, all cause mortality was insignificantly increased (HR 1.21; CI 0.99-1.48; p = 0.07), but cardiovascular mortality continued to be significantly increased in the clarithromycin group (HR 1.38; CI 1.03-1.85; p = 0.03). One hundred and eighty four patients died in the clarithromycin group (89 from cardiovascular events) and 159 patients died in the placebo group (70 from cardiovascular events). The authors conclude that short-term clarithromycin therapy in patients with stable coronary artery disease may cause significantly higher cardiovascular mortality. This result came as a surprise to the authors who were not evaluating the safety of clarithromycin in patients with CAD. Further study is needed to evaluate the clinical validity of this unexpected finding.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Abnormal taste.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
Clarithromycin is one of the drugs confirmed to prolong the QT interval and is accepted as having a risk of causing torsade de pointes. In terms of epinephrine, it is not known what effect vasoconstrictors in the local anesthetic regimen will have in patients with a known history of congenital prolonged QT interval or in patients taking any medication that prolongs the QT interval. Until more information is obtained, it is suggested that the clinician consult with the physician prior to the use of a vasoconstrictor in suspected patients, and that the vasoconstrictor (epinephrine, mepivacaine and levonordefrin [Carbocaine® 2% with Neo-Cobefrin®]) be used with caution. See Dental Health Professional Considerations.
Dental Comment
The FDA issued a special alert in December 2005 stating that short-term therapy with clarithromycin in patients with stable coronary artery disease may cause significantly higher cardiovascular mortality. The use of 500 mg clarithromycin daily for 14 days in patients with the above condition resulted in significantly higher all-cause mortality compared to patients taking placebo. This information is provided to the dental practitioner on the possible association between short-term use of clarithromycin for infections and increases in mortality in patients with a history of stable coronary artery disease.
Clarithromycin is known to prolong the QT interval. The QT interval is measured as the time and distance between the Q point of the QRS complex and the end of the T wave in the ECG tracing. After adjustment for heart rate, the QT interval is defined as prolonged if it is more than 450 msec in men and 460 msec in women. A long QT syndrome was first described in the 1950s and 60s as a congenital syndrome involving QT interval prolongation and syncope and sudden death. Some of the congenital long QT syndromes were characterized by a peculiar electrocardiographic appearance of the QRS complex involving a premature atria beat followed by a pause, then a subsequent sinus beat showing marked QT prolongation and deformity. This type of cardiac arrhythmia was originally termed “torsade de pointes” (translated from the French as “twisting of the points”). Clarithromycin is considered as having a risk of causing torsade de pointes. Since it is not known what effect vasoconstrictors in the local anesthetic regimen will have in patients with a known history of congenital prolonged QT interval or in patients taking any medication that prolongs the QT interval, a medical consult is suggested.
Mental Health: Effects on Mental Status
Macrolides have been reported to cause nightmares, confusion, anxiety, and mood lability
Mental Health: Effects on Psychiatric Treatment
Contraindicated with pimozide; increases carbamazepine and triazolam levels; monitor for signs of toxicity
Nursing: Physical Assessment/Monitoring
Assess results of culture and sensitivity tests and patient's allergy history prior to therapy. Use with caution in presence of severe renal impairment, myasthenia gravis, or coronary artery disease. Evaluate results of laboratory monitoring with long-term use.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Granules for suspension, oral: 125 mg/5 mL (50 mL, 100 mL); 250 mg/5 mL (50 mL, 100 mL)
Biaxin®: 125 mg/5 mL (50 mL, 100 mL); 250 mg/5 mL (50 mL, 100 mL) [fruit-punch flavor]
Tablet, oral: 250 mg, 500 mg
Biaxin®: 250 mg, 500 mg
Tablet, extended release, oral: 500 mg
Biaxin® XL: 500 mg
Pricing: U.S. (www.drugstore.com)
Suspension (reconstituted) (Clarithromycin)
125 mg/5 mL (50): $27.99
125 mg/5 mL (100): $39.99
250 mg/5 mL (50): $42.99
250 mg/5 mL (100): $79.99
Tablet, 24-hour (Biaxin XL)
500 mg (20): $135.00
Tablet, 24-hour (Biaxin XL Pac)
500 mg (14): $95.99
Tablet, 24-hour (Clarithromycin)
500 mg (60): $295.99
Tablets (Biaxin)
250 mg (60): $361.00
500 mg (20): $129.98
Tablets (Clarithromycin)
250 mg (30): $148.99
500 mg (30): $125.99
References
American Thoracic Society, “Guidelines for the Initial Management of Adults With Community-Acquired Pneumonia: Diagnosis, Assessment of Severity, and Initial Antimicrobial Therapy,” Am Rev Respir Dis, 1993, 148(5):1418-26.
Aronoff GR, Bennett WM, Berns JS, et al, Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children, 5th ed. Philadelphia, PA: American College of Physicians; 2007.
Aspin MM, Hoberman A, McCarty J, et al, “Comparative Study of the Safety and Efficacy of Clarithromycin and Amoxicillin-Clavulanate in the Treatment of Acute Otitis Media in Children,” J Pediatr, 1994, 125(1):136-41.
Barradell LB, Plosker GL, and McTavish D, “Clarithromycin. A Review of Its Pharmacological Properties and Therapeutic Use in Mycobacterium avium-intracellulare Complex Infection in Patients With Acquired Immune Deficiency Syndrome,” Drugs, 1993, 46(2):289-312.
Bonow RO, Carabello B, de Leon Jr, AC, et al, “ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients with Valvular Heart Disease),” J Am Coll Cardiol, 1998, 32(5):1486-1588.
Bradley JS, Byington CL, Shah SS, et al. “The Management of Community-Acquired Pneumonia in Infants and Children Older Than 3 Months of Age: Clinical Practice Guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America”, Clin Infect Dis, 2011, 53(7):e25-76.
Centers for Disease Control and Prevention, “Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV-Exposed and HIV-Infected Children: Recommendations from CDC, the National Institutes of Health, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics,” MMWR Recomm Rep, 2009, 58(RR-11):1-166. Available at http://aidsinfo.nih.gov/contentfiles/Pediatric_OI.pdf
Chey WD and Wong B, “American College of Gastroenterology Guideline on the Management of Helicobacter pylori Infection,” Am J Gastroenterol, 2007 102(8):1808-25.
Chu SY, Wilson DS, Guay DR, et al, “Clarithromycin Pharmacokinetics in Healthy Young and Elderly Volunteers,” J Clin Pharmacol, 1992, 32(11):1045-9.
Dajani AS, Taubert KA, Wilson W, et al, “Prevention of Bacterial Endocarditis Recommendations by the American Heart Association,” JAMA 1997, 277(22):1794-801.
Goldman MP and Longworth DL, “The Role of Azithromycin and Clarithromycin in Clinical Practice,” Cleve Clin J Med, 1993, 60(5):359-64.
Guay DR, “Pharmacokinetics of New Macrolides,” Infect Med, 1992, 9(Suppl A):9-13.
Guay DR and Craft JC, “Overview of the Pharmacology of Clarithromycin Suspension in Children and a Comparison With That in Adults,” Pediatr Infect Dis J, 1993, 12(12 Suppl 3):106-11.
Husson RN, Ross LA, Sandelli S, et al, “Orally Administered Clarithromycin for the Treatment of Systemic Mycobacterium avium Complex Infection in Children With Acquired Immunodeficiency Syndrome,” J Pediatr, 1994, 124(5 Pt 1):807-14.
Jespersen CM, Als-Nielsen B, Damgaard M, et al, “Randomised Placebo Controlled Multicentre Trial to Assess Short Term Clarithromycin for Patients with Stable Coronary Heart Disease: CLARICOR Trial,” BMJ, 2006, 332(7532):22-7.
Langtry HD and Brogden RN, “Clarithromycin. A Review of Its Efficacy in the Treatment of Respiratory Tract Infections in Immunocompetent Patients,” Drugs, 1997, 53(6):973-1004.
McConnell SA and Amsden GW, “Review and Comparison of Advanced-Generation Macrolides Clarithromycin and Dirithromycin,” Pharmacotherapy, 1999, 19(4):404-15.
Nightingale SD, Koster FT, Mertz GJ, et al, “Clarithromycin-Induced Mania in Two Patients With AIDS,” Clin Infect Dis, 1995, 20(6):1563-4.
Oteo JA, Gomez-Cadinanos RA, Rosel L, et al, “Clarithromycin-Induced Thrombocytopenic Purpura,” Clin Infect Dis, 1994, 19(6):1170-1.
Peters DH and Clissold SP, “Clarithromycin: A Review of its Antimicrobial Activity, Pharmacokinetic Properties, and Therapeutic Potential,” Drugs, 1992, 44(1):117-64.
“Pimozide (Orap) Contraindicated With Clarithromycin (Biaxin) and Other Macrolide Antibiotics,” FDA Medical Bulletin, October 1996, 3.
Pollak PT, Sketris IS, MacKenzie SL, et al, “Delirium Probably Induced by Clarithromycin in a Patient Receiving Fluoxetine,” Ann Pharmacother, 1995, 29(5):486-8.
Public Health Service Task Force on Prophylaxis and Therapy for Mycobacterium avium Complex, “Recommendations on Prophylaxis and Therapy for Disseminated Mycobacterium avium Complex Disease in Patients Infected With the Human Immunodeficiency Virus,” N Engl J Med, 1993, 329(12):898-904.
Stafstrom CE, Nohria V, Loganbill H, et al, “Erythromycin-induced Carbamazepine Toxicity: A Continuing Problem,” Arch Pediatr Adolesc Med, 1995, 149(1):99-101.
Talley NJ and Vakil N, “Practice Parameters Committee of the American College of Gastroenterology. Guidelines for the Management of Dyspepsia,” Am J Gastroenterol, 2005, 100(10):2324-37.
Tartaglione TA, “Therapeutic Options for the Management and Prevention of Mycobacterium avium Complex Infection in Patients With the Acquired Immunodeficiency Syndrome,” Pharmacotherapy, 1996, 16(2):171-82.
Teare JP, Booth JC, Brown JL, et al, “Pseudomembranous Colitis Following Clarithromycin Therapy,” Eur J Gastroenterol Hepatol, 1995, 7(3):275-7.
Tiwari T, Murphy TV, and Moran J, “Recommended Antimicrobial Agents for the Treatment and Postexposure Prophylaxis of Pertussis: 2005 CDC Guidelines,” MMWR Recomm Rep, 2005, 54(RR-14):1-16.
Wallace RJ Jr, Brown BA, and Griffith DE, “Drug Intolerance to High-Dose Clarithromycin Among Elderly Patients,” Diagn Microbiol Infect Dis, 1993, 16(3):215-21.
Wilson W, Taubert KA, Gewitz M, et al, “Prevention of Infective Endocarditis. Guidelines From the American Heart Association. A Guideline From the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group,” Circulation, 2007, 115.
International Brand Names
Lexi-Comp.com
Last full review/revision March 2012
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