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Clarithromycin

Class: Other Macrolides
VA Class: AM200
CAS Number: 81103-11-9
Brands: Biaxin, Biaxin XL

Medically reviewed on February 23, 2018

Warning

Special Alerts:

[Posted 02/22/2018]

AUDIENCE: Health Professional, Internal Medicine, Cardiology, Patient

ISSUE: FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. FDAs recommendation is based on a review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue.

The large clinical trial, called the CLARICOR trial, observed an unexpected increase in deaths among patients with coronary heart disease who received a two-week course of clarithromycin that became apparent after patients had been followed for one year or longer. There is no clear explanation for how clarithromycin would lead to more deaths than placebo. Some observational studies also found an increase in deaths or other serious heart-related problems, while others did not. All the studies had limitations in how they were designed. Of the six observational studies published to date in patients with or without coronary artery disease, two found evidence of long-term risks from clarithromycin, and four did not. Overall, results from the prospective, placebo-controlled CLARICOR trial provide the strongest evidence of the increase in risk compared to the observational study results. Based on these studies, FDA is unable to determine why the risk of death is greater for patients with heart disease.

As a result, FDA added a new warning about this increased risk of death in patients with heart disease, and advised prescribers to consider using other antibiotics in such patients. FDA also added the study results to the clarithromycin drug labels. As part of FDA's usual ongoing safety monitoring of drugs, we are continuing to monitor safety reports in patients taking clarithromycin.

BACKGROUND: Clarithromycin is used to treat many types of infections affecting the skin, ears, sinuses, lungs, and other parts of the body, including Mycobacterium avium complex (MAC) infection, a type of lung infection that often affects people with human immunodeficiency virus (HIV). Clarithromycin is not approved to treat heart disease.

RECOMMENDATION: Healthcare professionals should be aware of these significant risks and weigh the benefits and risks of clarithromycin before prescribing it to any patient, particularly in patients with heart disease and even for short periods, and consider using other available antibiotics. Advise patients with heart disease of the signs and symptoms of cardiovascular problems, regardless of the medical condition for which you are treating them with clarithromycin.

Patients should tell your healthcare professionals if you have heart disease, especially when you are being prescribed an antibiotic to treat an infection. Talk to them about the benefits and risks of clarithromycin and any alternative treatments. Do not stop taking your heart disease medicine or antibiotic without first talking to your healthcare professionals. Doing so could be harmful without your health care professionals' direct supervision. Seek medical attention immediately if you experience symptoms of a heart attack or stroke, such as chest pain, shortness of breath or trouble breathing, pain or weakness in one part or side of your body, or slurred speech.

For more information visit the FDA website at: [Web] and [Web].

Introduction

Antibacterial; macrolide antibiotic1

Uses for Clarithromycin

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Acute Otitis Media (AOM)

Treatment of AOM caused by H. influenzae, M. catarrhalis, or S. pneumoniae.1 431

Not a drug of first choice; considered an alternative for patients with a history of type I penicillin hypersensitivity.396 431 May not be effective for AOM that fails to respond to amoxicillin since S. pneumoniae resistant to amoxicillin also may be resistant to clarithromycin.423

Pharyngitis and Tonsillitis

Treatment of pharyngitis or tonsillitis caused by susceptible Streptococcus pyogenes (group A β-hemolytic streptococci).1 2 19 24 25 62 63 143 Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in the prevention of subsequent rheumatic fever has not been established to date.1

CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;107 109 110 396 oral cephalosporins and oral macrolides considered alternatives.107 109 110 396 Amoxicillin sometimes used instead of penicillin V, especially for young children.109 396

Consider that strains of S. pyogenes resistant to macrolides are common in some areas of the world (e.g., Japan, Finland) and clarithromycin-resistant strains have been reported in the US.396 446 461 (See Selection and Use of Anti-infectives under Cautions.)

Respiratory Tract Infections

Treatment of acute maxillary sinusitis caused by Haemophilus influenzae, Moraxella catarrhalis, or S. pneumoniae.1 2 26 144

Treatment of acute bacterial exacerbations of chronic bronchitis caused by H. influenzae, H. parainfluenzae, M. catarrhalis, or S. pneumoniae.1 56

Treatment of mild to moderate community-acquired pneumonia (CAP) caused by H. influenzae, Mycoplasma pneumoniae, Chlamydophila pneumoniae (Chlamydia pneumoniae), S. pneumoniae,1 29 30 46 47 56 96 121 130 131 132 133 H. parainfluenzae, or M. catarrhalis.1

Treatment of Legionnaires’ disease caused by Legionella pneumophila.13 447 448 Drugs of choice are macrolides (usually azithromycin) or fluoroquinolones with or without rifampin.13 447 448 449 450 450

Treatment of pertussis caused by Bordetella pertussis.393 396 452 454 Erythromycin traditionally has been drug of choice for treatment and postexposure prophylaxis of pertussis,396 452 454 but other macrolides (azithromycin, clarithromycin) appear to be as effective and may be associated with better compliance because they are better tolerated.396 452 454

Skin and Skin Structure Infections

Treatment of uncomplicated skin or skin structure infections caused by Staphylococcus aureus or S. pyogenes.1 56 57 136 137 138 139 140

Helicobacter pylori Infection and Duodenal Ulcer Disease

Treatment of Helicobacter pylori infection and duodenal ulcer disease (active or 1-year history of duodenal ulcer);1 335 353 377 378 eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.1 335 353 377 378

Used in a multidrug regimen that includes amoxicillin, clarithromycin, and either lansoprazole or omeprazole (triple therapy).1 335 353 377 378 393 Also used with omeprazole (dual therapy) or ranitidine bismuth citrate (dual therapy).1 324

Bartonella Infections

Treatment of infections caused by B. henselae (e.g., cat scratch disease, bacillary angiomatosis, peliosis hepatitis).444 465

Cat scratch disease generally self-limited in immunocompetent individuals and may resolve spontaneously in 2–4 months; some clinicians suggest that anti-infectives be considered for acutely or severely ill patients with systemic symptoms, particularly those with hepatosplenomegaly or painful lymphadenopathy, and such therapy probably is indicated in immunocompromised patients.396 465

Anti-infectives also indicated in patients with B. henselae infections who develop bacillary angiomatosis, neuroretinitis, or Parinaud’s oculoglandular syndrome.396

Optimum regimens have not been identified; some clinicians recommend azithromycin, clarithromycin, ciprofloxacin, erythromycin, doxycycline, rifampin, co-trimoxazole, gentamicin, or third generation cephalosporins.393 396 444

Cryptosporidiosis

May decrease incidence of cryptosporidiosis in HIV-infected adults.105 111 204 Anti-infectives may suppress the infection, but none has been found to reliably eradicate Cryptosporidium.105 106 444 445 CDC, NIH, IDSA, and others state that the most appropriate treatment for cryptosporidiosis in HIV-infected individuals is the use of potent antiretroviral agents (to restore immune function) and symptomatic treatment of diarrhea.105 106 444 445

Lyme Disease

Alternate for treatment of early Lyme disease.290 388 389 387 390 391 392 394 395 396 397 398 427 428 IDSA, AAP, and others recommend doxycycline, amoxicillin, or cefuroxime;345 393 396 427 428 429 macrolides may be less effective than these first-line agents.290 345 388 389 390 391 392 393 394 395 396 397 398 427 428

Mycobacterial Infections

Primary prevention (primary prophylaxis) of Mycobacterium avium complex (MAC) bacteremia or disseminated infections in adults, adolescents, and children with advanced HIV infection.1 201 203 204 210 293 350 Recommended by USPHS/IDSA as a drug of choice for primary prevention of MAC in HIV-infected patients.204

Treatment of disseminated MAC infection in HIV-infected adults, adolescents, and children.1 7 172 173 175 176 177 178 185 187 211 293 350 444 445 ATS, CDC, NIH, IDSA, and others recommend a regimen of clarithromycin (or azithromycin) and ethambutol and state that consideration may be given to adding a third drug (preferably rifabutin).201 215 221 350 369 393 444 445 Clarithromycin usually the preferred macrolide for initial treatment; azithromycin can be substituted if clarithromycin cannot be used because of drug interactions or intolerance and is preferred in pregnant women.444 445

Prevention of recurrence (secondary prophylaxis) of disseminated MAC infection in HIV-infected adults, adolescents, and children.1 175 177 185 204 350 444 445 USPHS/IDSA, CDC, NIH, IDSA, and others recommend a macrolide (clarithromycin or azithromycin) given with ethambutol (with or without rifabutin).204 444 445 Azithromycin usually the preferred macrolide for use in conjunction with ethambutol for secondary prophylaxis in pregnant women.204 444

Treatment of pulmonary MAC infections in HIV-negative patients.350 451 A multiple-drug regimen of clarithromycin (or azithromycin), ethambutol, and either rifabutin or rifampin usually recommended.350

Treatment of M. kansasii infections; an alternative agent.350 393

Treatment of cutaneous infections caused by M. abscessus or Mycobacterium chelonae.188 350 393 462

Treatment of cutaneous M. marinum infection.189 350 393

Toxoplasmosis

Has been used in conjunction with pyrimethamine for treatment of encephalitis caused by Toxoplasma gondii in HIV-infected patients;2 48 444 not a preferred or alternative agent.444 445 464 CDC, NIH, IDSA, and others usually recommend pyrimethamine in conjunction with sulfadiazine and leucovorin for treatment of toxoplasmosis in adults and children, especially immunocompromised patients (e.g., HIV-infected individuals).444 445 464

Prevention of Bacterial Endocarditis

Alternative for prevention of α-hemolytic (viridans group) streptococcal endocarditis in penicillin-allergic patients undergoing certain dental, oral, respiratory tract, or esophageal procedures who have cardiac conditions that put them at high or moderate risk.345

Consult most recent AHA recommendations for specific information on which cardiac conditions are associated with high or moderate risk of endocarditis and which procedures require prophylaxis.345

Clarithromycin Dosage and Administration

Administration

Oral Administration

Conventional tablets and oral suspension: Administer orally without regard to meals.1 2 3 Oral suspension may be administered with milk.1 2 3

Extended-release tablets: Administer orally with food.1 2 3 Should be swallowed whole and not chewed, broken, or crushed.1

Reconstitution

Reconstitute granules for oral suspension at the time of dispensing by adding the amount of water specified on the bottle in two portions; agitate well after each addition.1 Agitate well just prior to use.1

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Extended-release tablets may be used only for treatment of acute maxillary sinusitis, acute bacterial exacerbations of chronic bronchitis, and CAP in adults; safety and efficacy not established for treatment of other infections in adults or for use in pediatric patients.1

Pediatric Patients

Acute Otitis Media (AOM)
Oral

7.5 mg/kg every 12 hours for 10 days.1 431

Pharyngitis and Tonsillitis
Oral

7.5 mg/kg every 12 hours for 10 days.1

Respiratory Tract Infections
Acute Bacterial Sinusitis
Oral

7.5 mg/kg every 12 hours for 10 days.1

Community-acquired Pneumonia (CAP)
Oral

7.5 mg/kg every 12 hours for 10 days.1

Pertussis
Oral

15–20 mg/kg daily in 2 divided doses (up to 1 g daily) for 7 days.396 7.5 mg/kg twice daily for 7 days has been used in children 1 month to 16 years of age.454

Skin and Skin Structure Infections
Oral

7.5 mg/kg every 12 hours for 10 days.1

Bartonella Infections
Cat Scratch Disease Caused by Bartonella henselae
Oral

500 mg daily for 4 weeks.465

Bartonella Infections in HIV-infected Individuals
Oral

Adolescents: 500 mg twice daily for ≥3 months recommended by CDC, NIH, and IDSA.444 If relapse occurs, consider lifelong secondary prophylaxis (chronic maintenance therapy) with erythromycin or doxycycline.444

Lyme Disease
Oral

7.5 mg/kg (up to 500 mg) twice daily for 14–21 days for treatment of early localized or early disseminated disease.428

Mycobacterium avium Complex (MAC) Infections
Primary Prevention of MAC in Children with Advanced HIV Infection
Oral

7.5 mg/kg (up to 500 mg) every 12 hours.1 204

USPHS/IDSA recommends initiation of primary prophylaxis if CD4+ T-cell count is <750/mm3 in those <1 year, <500/mm3 in those 1–2 years, <75/mm3 in those 2–6 years, or <50/mm3 in those ≥6 years of age.204

Primary Prevention of MAC in Adolescents with Advanced HIV Infection
Oral

500 mg every 12 hours.1 204

USPHS/IDSA recommends initiation of primary prophylaxis if CD4+ T-cell count is <50/mm3.204 May be discontinued if there is immune recovery in response to antiretroviral therapy and an increase in CD4+ T-cell count to >100/mm3 sustained for ≥3 months.204 Reinitiate prophylaxis if CD4+ T-cell count decreases to <50–100/mm3.204

Treatment of Disseminated MAC in HIV-infected Children
Oral

Manufacturer recommends 7.5 mg/kg (up to 500 mg) every 12 hours.1

CDC, NIH, and IDSA recommend 7.5–15 mg/kg (maximum 500 mg) twice daily in conjunction with ethambutol (15–25 mg/kg once daily [up to 1 g daily]) with or without rifabutin (10–20 mg/kg once daily [up to 300 mg daily]).445

Treatment of Disseminated MAC in HIV-infected Adolescents
Oral

500 mg every 12 hours444 in conjunction with ethambutol (15 mg/kg daily) with or without a third drug (e.g., rifabutin 300 mg once daily) recommended by CDC, NIH, and IDSA.444 Higher dosage not recommended since such dosage has been associated with reduced survival in clinical studies.171 201 204 211 214 223 224 351

Prevention of MAC Recurrence in HIV-infected Children
Oral

7.5 mg/kg (maximum 500 mg) twice daily1 204 in conjunction with ethambutol (15 mg/kg [maximum 900 mg] once daily) with or without rifabutin (5 mg/kg [maximum 300 mg] once daily).204

Secondary prophylaxis to prevent MAC recurrence in HIV-infected children usually continued for life.204 445 The safety of discontinuing secondary MAC prophylaxis in children whose CD4+ T-cell count increases in response to antiretroviral therapy has not been studied.204 445

Prevention of MAC Recurrence in HIV-infected Adolescents
Oral

500 mg every 12 hours1 204 444 in conjunction with ethambutol (15 mg/kg once daily) with or without rifabutin (300 mg once daily).204 444

Secondary prophylaxis to prevent MAC recurrence usually continued for life in HIV-infected adolescents.204 USPHS/IDSA states that consideration can be given to discontinuing such prophylaxis after ≥12 months in those who remain asymptomatic with respect to MAC and have an increase in CD4+ T-cell count to >100/mm3 sustained for ≥6 months.204 444

Treatment of Cutaneous Mycobacterium abscessus Infections
Oral

15 mg/kg daily (with or without incision and drainage of lesions) has been used in children 1–15 years of age.462

Prevention of Bacterial Endocarditis
Patients Undergoing Certain Dental, Oral, Respiratory Tract, or Esophageal Procedures
Oral

15 mg/kg as a single dose given 1 hour prior to the procedure.345

Adults

Pharyngitis and Tonsillitis
Oral

250 mg every 12 hours for 10 days.1

Respiratory Tract Infections
Acute Bacterial Sinusitis
Oral

Conventional tablets or oral suspension: 500 mg every 12 hours for 14 days.1

Extended-release tablets: 1 g (two 500-mg extended release tablets) once daily for 14 days.1

Acute Exacerbations of Chronic Bronchitis
Oral

Conventional tablets or oral suspension: 500 mg every 12 hours for 7–14 days for H. influenzae,1 500 mg every 12 hours for 7 days for H. parainfluenzae,1 or 250 mg every 12 hours for 7–14 days for M. catarrhalis or S. pneumoniae.1

Extended-release tablets: 1 g (two 500-mg extended-release tablets) once daily for 7 days.1

Community-acquired Pneumonia (CAP)
Oral

Conventional tablets or oral suspension: 250 mg every 12 hours for 7 days for H. influenzae or for 7–14 days for S. pneumoniae, C. pneumoniae, or M. pneumoniae.1

Extended-release tablets: 1 g (two 500-mg extended-release tablets) once daily for 7 days.1

Legionnaires’ Disease
Oral

Conventional tablets or oral suspension: 500 mg twice daily.447 448 Usual duration is 10 days for mild to moderate infections in immunocompetent patients;447 longer duration of treatment (3 weeks) may be necessary to prevent relapse, especially in those with more severe infections or with underlying comorbidity or immunodeficiency.447 448

Skin and Skin Structure Infections
Oral

Conventional tablets or oral suspension: 250 mg every 12 hours for 7–14 days.1

Helicobacter pylori Infection and Duodenal Ulcer Disease
Oral

Conventional tablets or oral suspension: 500 mg twice daily for 10 or 14 days given in conjunction with amoxicillin and lansoprazole (triple therapy);1 353 378 500 mg twice daily for 10 days given in conjunction with amoxicillin and omeprazole (triple therapy);377 500 mg 3 times daily for 14 days given in conjunction with omeprazole or ranitidine bismuth citrate (dual therapy).1 377

Bartonella Infections
Cat Scratch Disease Caused by Bartonella henselae
Oral

Conventional tablets or oral suspension: 500 mg daily for 4 weeks.465

Bartonella Infections in HIV-infected Individuals
Oral

Conventional tablets or oral suspension: 500 mg twice daily for ≥3 months recommended by CDC, NIH, and IDSA.444 If relapse occurs, consider lifelong secondary prophylaxis (chronic maintenance therapy) with erythromycin or doxycycline.444

Lyme Disease
Oral

Conventional tablets or oral suspension: 500 mg twice daily for 14–21 days for treatment of early localized or early disseminated disease.428

Mycobacterial Infections
Primary Prevention of MAC in Adults with Advanced HIV Infection
Oral

Conventional tablets or oral suspension: 500 mg every 12 hours.1 204

USPHS/IDSA recommends initiation of primary prophylaxis if CD4+ T-cell count is <50/mm3.204 May be discontinued if there is immune recovery in response to antiretroviral therapy and an increase in CD4+ T-cell count to >100/mm3 sustained for ≥3 months.204 Reinitiate prophylaxis if CD4+ T-cell count decreases to <50–100/mm3.204

Treatment of Disseminated MAC in HIV-infected Adults
Oral

Conventional tablets or oral suspension: 500 mg every 12 hours1 444 in conjunction with ethambutol (15 mg/kg daily) with or without a third drug (e.g., rifabutin 300 mg once daily).444 Higher dosage not recommended since such dosage has been associated with reduced survival in clinical studies.171 201 204 211 214 223 224 351

Prevention of MAC Recurrence in HIV-infected Adults
Oral

Conventional tablets or oral suspension: 500 mg every 12 hours1 204 444 in conjunction with ethambutol (15 mg/kg once daily) with or without rifabutin (300 mg once daily).204 444

Secondary prophylaxis to prevent MAC recurrence usually continued for life in HIV-infected adults.204 USPHS/IDSA states that consideration can be given to discontinuing such prophylaxis after ≥12 months in those who remain asymptomatic with respect to MAC and have an increase in CD4+ T-cell count to >100/mm3 sustained for ≥6 months.204 444

Treatment of MAC in HIV-negative Adults
Oral

Conventional tablets or oral suspension: 500 mg every 12 hours in conjunction with ethambutol and rifabutin or rifampin.350

Mycobacterium abscessus or M. chelonae Infections
Oral

Conventional tablets or oral suspension: 0.5–1 g twice daily for 6 months.188 462

M. marinum Infections
Oral

Conventional tablets or oral suspension: 500 mg twice daily for at least 3 months.350

Prevention of Bacterial Endocarditis
Patients Undergoing Certain Dental, Oral, Respiratory Tract, or Esophageal Procedures
Oral

Conventional tablets or oral suspension: 500 mg as a single dose given 1 hour prior to the procedure.345

Special Populations

Hepatic Impairment

No dosage adjustment required.1 56 97 98

Renal Impairment

If Clcr <30 mL/minute, reduce dose by 50% or double dosing interval.1 2 126 Alternatively (for conventional tablets or oral suspension), 500 mg initially followed by 250 mg twice daily (if the usual dosage in adults with normal renal function is 500 mg twice daily) or 250 mg daily (if the usual dosage in adults with normal renal function is 250 mg twice daily).97 121

Geriatric Patients

No dosage adjustments except those related to renal impairment.1 97 121 126 128 (See Renal Impairment under Dosage and Administration.)

Cautions for Clarithromycin

Contraindications

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Known hypersensitivity to clarithromycin, erythromycin, any macrolide, or any ingredient in the formulation.1 353

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity

Animal studies indicate adverse effects on pregnancy outcome and/or embryofetal development.1 Use during pregnancy only when safer drugs cannot be used or are ineffective.1

Superinfection/Clostridium difficile-associated Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi with prolonged therapy.1 Institute appropriate therapy if superinfection occurs.1

Treatment with anti-infectives may permit overgrowth of clostridia.1 Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.1 400 401 402 403 404

Sensitivity Reactions

Hypersensitivity and Dermatologic Reactions

Possible allergic reactions (e.g., mild urticaria and skin eruptions).1 2 29 47 370 371 Severe reactions (e.g., anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported rarely.1 370 371

General Precautions

Hepatic Effects

Severe, reversible hepatic dysfunction (including cholestasis, with or without jaundice)1 and hepatomegaly2 29 47 reported.1

Fatal hepatic failure occurred in association with serious underlying disease and/or concomitant drugs.1

Resistance in Helicobacter pylori

Increased risk of developing clarithromycin resistance if used as the sole anti-infective agent in regimens for treatment of H. pylori infection.1 If therapy fails, perform in vitro susceptibility testing.1 197 377 378 Do not use clarithromycin if H. pylori is resistant.1 197 377 378

Cardiac Effects

Ventricular tachycardia and torsades de pointes reported rarely in patients with prolonged QT intervals.1

History of Acute Porphyria

Concomitant therapy with ranitidine bismuth citrate not recommended.1

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of clarithromycin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1

Consider that S. pyogenes (group A β-hemolytic streptococci) resistant to clarithromycin have been reported.396 446 461

Specific Populations

Pregnancy

Category C.1 (See Fetal/Neonatal Morbidity under Cautions.)

Lactation

Distributed into milk following oral administration.460 Use with caution.1

Pediatric Use

Safety and efficacy not established in children <6 months of age.1

Manufacturer states safety not established in children <20 months of age with MAC infection,1 but USPHS/IDSA recommends use of the drug for HIV-infected infants and children.204

Geriatric Use

Adverse effect profile similar to that in younger adults.1 121 126

Dosage adjustment based solely on age not required.1 97 121 126 128

Clearance may be reduced due to age-related decreases in renal function.97 98 Consider need for dosage adjustment in those with severe renal impairment. (See Renal Impairment under Dosage and Administration.)

Renal Impairment

Increased half-life.1 2 56 97 98 Dosage adjustment may be necessary.1 2 126 (See Renal Impairment under Dosage and Administration.)

Concomitant therapy with ranitidine bismuth citrate not recommended if Clcr <25 mL/minute.1

Common Adverse Effects

GI adverse effects (diarrhea, nausea, abnormal taste, dyspepsia, abdominal pain) and headache.1

Interactions for Clarithromycin

Clarithromycin is metabolized by and inhibits CYP3A4.1

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions with substrates, inhibitors, or inducers of CYP3A4 are likely.1

Specific Drugs

Drug

Interaction

Comments

Amprenavir

Increased amprenavir concentrations and AUC;437 438 439 possible decreased clarithromycin concentrations and decreased 14-hydroxyclarithromycin concentrations and AUC439

No dosage adjustments recommended437 438 439

Anticoagulants, oral

Increased anticoagulant effect1

Monitor PT carefully1

Antihistamines (astemizole, terfenadine)

Increased plasma concentrations of astemizole or terfenadine; prolonged QT interval and serious cardiac arrhythmias 1 150 154 155 157 158 159 161 162 163 164 166 167 352

Contraindicated1 150 156 157 191 160 161 162 163 164

Antimycobacterials (rifabutin)

Potential inhibition of rifabutin metabolism373 and induction of clarithromycin metabolism;227 373 possible increased incidence of uveitis with concomitant rifabutin and clarithromycin 373 374 375 376

Atazanavir

Increased atazanavir plasma concentrations;430 increased clarithromycin plasma concentrations and decreased 14-hydroxyclarithromycin plasma concentrations;430 437 increased clarithromycin concentrations may cause QTc prolongation430 437

Consider reducing clarithromycin dosage by 50%;430 437 consider alternative to clarithromycin430 437 for indications other than Mycobacterium avium complex (MAC)430

Benzodiazepines (alprazolam, midazolam, triazolam)

Potential decreased clearance of midazolam or triazolam and increased pharmacologic effects of the benzodiazepines1

Somnolence and confusion reported with clarithromycin and triazolam1

Carbamazepine

Increased carbamazepine plasma concentrations and carbamazepine toxicity (i.e., drowsiness, dizziness, ataxia)2 51 338

Use with caution; consider reducing carbamazepine dosage and/or monitoring plasma carbamazepine concentrations1 338

Cisapride

Increased cisapride plasma concentrations;339 prolonged QT interval and serious cardiac arrhythmias; some fatalities1

Contraindicated1

Colchicine

Possible increased risk of colchicine toxicity when used concomitantly with clarithromycin, especially in elderly patients and/or patients with renal impairment1 463

Some clinicians state colchicine and clarithromycin should not be used concomitantly463

Darifenacin

Possible pharmacokinetic interaction455

Manufacturer of darifenacin states darifenacin dosage should not exceed 7.5 mg daily in patients receiving a potent CYP3A4 inhibitor (e.g., clarithromycin)455

Delavirdine

Increased clarithromycin concentrations and AUC;112 437 increased delavirdine concentrations437

Dosage adjustment not needed in those with normal renal function;112 437 reduce clarithromycin dosage by 50% if Clcr is 30–60 mL/minute; reduce clarithromycin dosage by 75% if Clcr is <30 mL/minute112

Didanosine

No clinically important pharmacokinetic interactions 1

Digoxin

Increased serum digoxin concentrations and digoxin toxicity (including potentially fatal arrhythmias)1

Monitor serum digoxin concentrations carefully1

Disopyramide

Potential increased half-life of disopyramide340 and risk of prolonged QT interval and serious cardiac arrhythmias1 340

Monitor ECGs and serum disopyramide concentrations1

Efavirenz

Decreased clarithromycin AUC and peak plasma concentrations;435 437 increased 14-hydroxyclarithromycin AUC and peak plasma concentrations;435 no effect on AUC of efavirenz;435 rash reported with concomitant administration435

Dosage adjustment of efavirenz not recommended; monitor for efficacy of the macrolide437 or consider use of an alternative anti-infective435 437

Ergot alkaloids (ergotamine, dihydroergotamine)

Acute ergot toxicity (vasospasm and ischemia of extremities and other tissues, including CNS)1 225

Concomitant use contraindicated1

Erlotinib

Possible pharmacokinetic interaction456

Manufacturer of erlotinib recommends caution in patients receiving a potent CYP3A4 inhibitor (e.g., clarithromycin);456 consider reducing erlotinib dosage if severe adverse effects occur456

Eszopiclone

Possible pharmacokinetic interaction457

Manufacturer of eszopiclone recommends eszopiclone dosage be reduced in patients receiving a potent CYP3A4 inhibitor (e.g., clarithromycin);457 initial eszopiclone dosage should be <1 mg, but may be increased to 2 mg if clinically indicated457

Fluconazole

Increased clarithromycin plasma concentrations1

Fosamprenavir

Studies using amprenavir indicate possible increased amprenavir concentrations and AUC437 440

Not considered clinically important;441 dosage adjustments not recommended437

Hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors

Increased HMG-CoA reductase inhibitor plasma concentrations and potential for rhabdomyolysis1

Indinavir

Increased indinavir and clarithromycin concentrations437 443

Indinavir manufacturer states appropriate dosages for concomitant use with respect to safety and efficacy not established;443 some experts state dosage adjustments not needed437

Lopinavir

Increased clarithromycin AUC433 437

Reduce clarithromycin dosage by 50% if Clcr is 30–60 mL/minute; reduce clarithromycin dosage by 75% if Clcr is <30 mL/minute433

Nevirapine

Decreased clarithromycin AUC and peak plasma concentration;436 437 increased 14-hydroxyclarithromycin AUC and peak plasma concentration;436 increased nevirapine concentrations437

Monitor for efficacy of the macrolide or use an alternative anti-infective436 437

Omeprazole

Increased concentrations of clarithromycin, 14-hydroxyclarithromycin, and omeprazole194 196

Pimozide

Potential increased pimozide plasma concentrations and risk of prolonged QT interval and serious cardiac arrhythmias1 271 272

Contraindicated1 272

Quinidine

Risk of prolonged QT interval and serious cardiac arrhythmias1

Monitor ECGs and serum quinidine concentrations1

Ranitidine

Increased plasma ranitidine concentrations and increased 14-hydroxyclarithromycin concentrations;1 not considered clinically important1

Ritonavir

Increased AUC and peak plasma concentration of ritonavir and of clarithromycin;1 434 decreased AUC and peak plasma concentration of 14-hydroxyclarithromycin1 434

Dosage adjustment not needed in patients with normal renal function; reduce clarithromycin dosage by 50% if Clcr is 30–60 mL/minute; reduce clarithromycin dosage by 75% if Clcr is <30 mL/minute1 434

Saquinavir

Increased clarithromycin AUC and plasma concentrations; decreased 14-hydroxyclarithromycin AUC; increased AUC and plasma concentrations of saquinavir432 437 442

Dosage adjustments may not be needed437 if used concomitantly for a limited time432 442

For those receiving ritonavir-boosted saquinavir, manufacturer of saquinavir states modification of dosage not necessary in those with normal renal function but clarithromycin dosage should be reduced 50% in those with Clcr 30–60 mL/minute and reduced 75% in those with Clcr <30 mL/minute432 442

Sildenafil

Potential increased exposure to sildenafil1

Consider reducing sildenafil dosage1

Theophylline

Potential increased serum theophylline concentrations1 2 50

Monitor serum theophylline concentrations in those receiving high theophylline dosage or with baseline in the upper therapeutic range;1 adjust theophylline dosage as needed when clarithromycin is initiated or discontinued121 126

Zidovudine

Decreased zidovudine plasma concentrations1 2 52

Clarithromycin Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed from GI tract.1 2 56 97 98 With conventional tablets or oral suspension, peak serum concentrations within 1–4 hours.2 56 With extended-release tablets, peak serum concentrations within 5–8 hours.1

Absolute bioavailability of conventional tablets is about 50–55%;1 2 53 56 98 absolute bioavailability may be an underestimate of systemic activity because of rapid first-pass metabolism and an active metabolite (14-hydroxyclarithromycin).98

Food

With conventional tablets, food causes a slight delay in onset of clarithromycin absorption but extent of absorption is unaffected.1 56 With extended-release tablets, food increases the extent of absorption by 30%.1

Distribution

Extent

Clarithromycin and 14-hydroxyclarithromycin distributed into most body tissues and fluids1 2 54 55 56 68 in concentrations greater than serum concentrations.1 56 68

Distributed into CSF following oral administration.458

Not known whether clarithromycin is distributed into milk.1

Plasma Protein Binding

42–72%.2 98 126

Elimination

Metabolism

Extensively metabolized in the liver, principally by oxidative N-demethylation and hydroxylation.98 At least 7 metabolites identified; 14-hydroxyclarithromycin is the principal metabolite in serum and the only one with substantial antibacterial activity.1 2 3 4 56 97

Elimination Route

Eliminated by both renal and nonrenal mechanisms;1 2 3 56 97 98 approximately 38% of a dose excreted in urine and 40% in feces.1 2 4 126

Half-life

4–11 hours.1 2 4

Special Populations

Renal impairment decreases clearance of clarithromycin and 14-hydroxyclarithromycin.1 2 56 70 97 98

Hepatic impairment reduces formation of the active metabolite; however, an increase in renal clearance of the parent drug obviates the need for a dosage reduction unless renal impairment also is present.1 56 97 98

Stability

Storage

Oral

For Suspension

Granules for oral suspension: Tight container at 15–30°C.1 Following reconstitution, do not refrigerate.1

Tablets

Conventional 250-mg tablets: Tight, light-resistant container at 15–30°C and protect from light.1

Conventional 500-mg tablets: Tight container at 20–25°C.1

Extended-release tablets: 20–25°C (may be exposed to 15–30°C).1

Clarithromycin Combinations

Kit containing clarithromycin, amoxicillin, and lansoprazole: 20–25°C.353

Actions and Spectrum

  • Usually bacteriostatic,2 12 83 84 85 but may be bactericidal against highly susceptible organisms or when present in high concentrations.2 12 84 92 94

  • Like other macrolides, inhibits protein synthesis in susceptible organisms by binding to 50S ribosomal subunits.1 2 56

  • Spectrum of activity includes many gram-positive1 2 80 83 84 85 86 92 94 95 and -negative1 2 12 16 18 56 80 83 84 85 86 92 96 aerobic bacteria, many anaerobic bacteria,1 83 121 some mycobacteria,2 32 34 35 36 77 86 87 88 and some other organisms including Mycoplasma,2 37 47 76 93 Ureaplasma,2 37 76 93 Chlamydia,1 2 17 38 39 56 61 91 96 Toxoplasma,2 41 42 43 and Borrelia.97 104

  • In vitro activity similar to75 84 86 92 or greater than that of erythromycin against erythromycin-susceptible organisms.2 56 83 94

  • The principal metabolite (14-hydroxyclarithromycin) has clinically important antimicrobial activity.1

  • Gram-positive aerobes: Active in vitro and in clinical infections against Staphylococcus aureus,1 S. pneumoniae,1 and S. pyogenes (group A β-hemolytic streptococci),1 Enterococci (e.g., Enterococcus faecalis) and oxacillin-resistant (methicillin-resistant) staphylococci are resistant.1

  • Gram-negative aerobes: Active in vitro and in clinical infections against Haemophilus influenzae,1 H. parainfluenzae,1 and Moraxella catarrhalis.1

  • Other organisms: Active in vitro and in clinical infections against C. pneumoniae and 1 M. pneumoniae.1 Also active against MAC.1

  • Organisms resistant to erythromycin generally resistant to clarithromycin.2 45

  • Complete cross-resistance occurs between azithromycin and clarithromycin in MAC.350

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Advise patients that antibacterials (including clarithromycin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).1

  • Importance of completing full course of therapy, even if feeling better after a few days.1

  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with clarithromycin or other antibacterials in the future.1

  • Importance of taking clarithromycin extended-release tablets with food;1 clarithromycin immediate-release tablets and oral suspension can be taken without regard to meals.1

  • Importance of reporting persistent or worsening symptoms of infection.1

  • Importance of not refrigerating oral suspension.1

  • Importance of discontinuing therapy and informing clinician if an allergic reaction occurs.1

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Clarithromycin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For suspension

125 mg/5 mL*

Biaxin Granules (with povidone)

Abbott

Clarithromycin for Suspension

Dava, Ranbaxy

250 mg/5 mL*

Biaxin Granules (with povidone)

Abbott

Clarithromycin for Suspension

Dava, Ranbaxy

Tablets, film-coated

250 mg*

Biaxin Filmtab (with povidone and propylene glycol)

Abbott

Clarithromycin Tablets

Dava, Ranbaxy, Roxane

500 mg*

Biaxin Filmtab (with povidone and propylene glycol)

Abbott

Clarithromycin Tablets

Dava, Ranbaxy, Roxane

Tablets, extended-release, film-coated

500 mg

Biaxin XL Filmtab (with propylene glycol)

Abbott

Biaxin XL Abbo-Pac (with propylene glycol; available as a 7-day mnemonic pack of 14 tablets)

Abbott

1 g*

Clarithromycin Tablets ER

Ranbaxy

Clarithromycin Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Kit

4 Capsules, Amoxicillin (trihydrate) 500 mg (of amoxicillin) (Trimox)

2 Capsules, delayed-release (containing enteric-coated granules), Lansoprazole, 30 mg (Prevacid)

2 Tablets, film-coated, Clarithromycin, 500 mg (Biaxin Filmtab (with povidone and propylene glycol)

Prevpac

TAP Pharmaceuticals

AHFS DI Essentials. © Copyright 2018, Selected Revisions February 23, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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66. Moellering RC Jr. Principles of anti-infective therapy. In: Mandell GL, Douglas RG Jr, Bennett JE, eds. Principles and practice of infectious diseases. 3rd ed. New York: Churchill Livingstone Inc; 1991:206-18.

67. Fraschini F, Scaglione F, Pintucci JP et al. Clarithromycin and its 14-OH-metabolite. Pharmacokinetics and tissues distribution in humans. Proceedings of ICAAC Chicago 1991. Abstract No. 512.

68. Kohno Y, Yoshida H, Suwa T et al. Comparative pharmacokinetics of clarithromycin (TE-031), a new macrolide antibiotic, and erythromycin in rats. Antimicrob Agents Chemother. 1989; 33:751-6. http://www.ncbi.nlm.nih.gov/pubmed/2526615?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=172527&blobtype=pdf

69. Chu SY, Cavanaugh J, Guay D. Pharmacokinetics of clarithromycin and 14-OH-clarithromycin following oral administration of clarithromycin 500 mg tablet. Proceedings of ICAAC Chicago 1991. Abstract No. 513.

70. Chu SY, Sunnello LT, Bunnell ST. Pharmacokinetics of clarithromycin in subjects with varying renal function. Proceedings of ICAAC Chicago 1991. Abstract No. 514.

71. Gan VN, Chu SY, Kusmiesz HT et al. Single & multi-dose pharmacokinetics in children of clarithromycin granules for suspension. Proceedings of ICAAC Chicago 1991. Abstract No. 517.

72. Zundörf H, Wishchmann L, Fassender M et al. Pharmacokinetics of clarithromycin and possible with H2 blocker and antacids. Proceedings of ICAAC Chicago 1991. Abstract No. 515.

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