Lice Buyer's Guide: Treatment Product Reviews Go Now

clarithromycin

Pronunciation

Generic Name: clarithromycin (kla RITH roe MYE sin)
Brand Name: Biaxin, Biaxin XL, Biaxin XL-Pak

What is clarithromycin?

Clarithromycin is a macrolide antibiotic. Clarithromycin fights bacteria in your body.

Clarithromycin is used to treat many different types of bacterial infections affecting the skin and respiratory system. Clarithromycin is also used together with other medicines to treat stomach ulcers caused by Helicobacter pylori.

Clarithromycin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about clarithromycin?

You should not use this medicine if you have a life-threatening heart rhythm disorder, a history of Long QT syndrome, if you have ever had jaundice or liver problems caused by taking clarithromycin, or if you have liver or kidney disease and are also taking colchicine.

Many other drugs can interact with clarithromycin. There are certain medicines that can cause life-threatening drug interactions with clarithromycin, and should not be used at the same time. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

What should I discuss with my healthcare provider before taking clarithromycin?

You should not use this medicine if you are allergic to clarithromycin or similar medicines such as azithromycin (Zithromax, Z-Pak, Zmax), erythromycin, or telithromycin, or if you have:

  • a life-threatening heart rhythm disorder;

  • a history of Long QT syndrome;

  • if you have ever had jaundice or liver problems caused by taking clarithromycin; or

  • if you have liver or kidney disease and you are also taking colchicine.

There are certain medicines that can cause life-threatening drug interactions with clarithromycin, and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • cisapride;

  • pimozide;

  • lovastatin or simvastatin; or

  • ergotamine or dihydroergotamine.

To make sure clarithromycin is safe for you, tell your doctor if you have:

  • liver disease;

  • kidney disease;

  • myasthenia gravis;

  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

  • a family history of Long QT syndrome; or

  • if you take certain heart rhythm medicine--amiodarone, disopyramide, dofetilide, flecainide, dronedarone, ibutilide, mexiletine, procainamide, propafenone, quinidine, or sotalol.

FDA pregnancy category C. It is not known whether clarithromycin will harm an unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using this medicine.

In animal studies, clarithromycin caused birth defects. However, very high doses are used in animal studies. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk.

Clarithromycin can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 6 months of age.

How should I take clarithromycin?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take clarithromycin tablets and oral suspension (liquid) with or without food.

Clarithromycin extended-release tablets (Biaxin XL) should be taken with food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Use this medicine for the full prescribed length of time. Clarithromycin is usually given for up to 7 to 14 days. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Clarithromycin will not treat a viral infection such as the flu or a common cold.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Do not keep the oral liquid in a refrigerator. Throw away any liquid that has not been used within 14 days.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe stomach pain, nausea, vomiting, or diarrhea.

What should I avoid while taking clarithromycin?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking clarithromycin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Clarithromycin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • headache with chest pain and severe dizziness, fast or pounding heartbeats, shortness of breath, fainting;

  • diarrhea that is watery or bloody;

  • fever, swollen glands, body aches, flu symptoms, new or worsening cough;

  • skin rash, easy bruising or bleeding, severe tingling, numbness, pain, muscle weakness;

  • problems with your hearing;

  • signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Older adults may be more likely to have heart rhythm side effects, including a life-threatening fast heart rate.

Clarithromycin may also cause severe liver symptoms. Stop taking clarithromycin and call your doctor at once if you have any of these liver symptoms:

  • itching, tired feeling;

  • nausea, upper stomach pain, loss of appetite;

  • dark urine, clay colored stools; or

  • jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • stomach pain, indigestion, gas;

  • vomiting, mild diarrhea;

  • unusual or unpleasant taste in your mouth;

  • headache, sleep problems (insomnia);

  • mild itching or rash; or

  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Clarithromycin dosing information

Usual Adult Dose for Tonsillitis/Pharyngitis:

Immediate-release: 250 mg orally every 12 hours for 10 days

Comments:
-The drug of choice for treatment and prevention of streptococcal infections and prophylaxis of rheumatic fever is IM or oral penicillin.
-In general, clarithromycin effectively eradicates Streptococcus pyogenes from the nasopharynx; efficacy in the subsequent prevention of rheumatic fever has not been established.

Approved indications: Pharyngitis/tonsillitis due to Streptococcus pyogenes

Usual Adult Dose for Sinusitis:

Immediate-release: 500 mg orally every 12 hours for 14 days
Extended-release: 1000 mg orally every 24 hours for 14 days

Approved indications: Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or S pneumoniae

Usual Adult Dose for Bronchitis:

Immediate-release:
-Due to H influenzae: 500 mg orally every 12 hours for 7 to 14 days
-Due to H parainfluenzae: 500 mg orally every 12 hours for 7 days
-Due to M catarrhalis or S pneumoniae: 250 mg orally every 12 hours for 7 to 14 days

Extended-release: 1000 mg orally every 24 hours for 7 days

Approved indications: Acute bacterial exacerbation of chronic bronchitis due to H influenzae, H parainfluenzae, M catarrhalis, or S pneumoniae

Usual Adult Dose for Pneumonia:

Immediate-release:
-Due to H influenzae: 250 mg orally every 12 hours for 7 days
-Due to S pneumoniae or Chlamydophila pneumoniae: 250 mg orally every 12 hours for 7 to 14 days

Approved indications: Community-acquired pneumonia due to H influenzae, S pneumoniae, or C pneumoniae (TWAR)

Extended-release: 1000 mg orally every 24 hours for 7 days

Approved indications: Community-acquired pneumonia due to H influenzae, H parainfluenzae, M catarrhalis, S pneumoniae, C pneumoniae (TWAR)

Usual Adult Dose for Mycoplasma Pneumonia:

Immediate-release: 250 mg orally every 12 hours for 7 to 14 days
Extended-release: 1000 mg orally every 24 hours for 7 days

Approved indications: Community-acquired pneumonia due to Mycoplasma pneumoniae

Usual Adult Dose for Skin and Structure Infection:

Immediate-release: 250 mg orally every 12 hours for 7 to 14 days

Comments:
-Abscesses usually require surgical drainage.

Approved indications: Uncomplicated skin and skin structure infections due to Staphylococcus aureus or S pyogenes

Usual Adult Dose for Helicobacter pylori Infection:

Immediate-release:
Triple therapy:
-Clarithromycin plus lansoprazole and amoxicillin: Clarithromycin 500 mg orally every 12 hours for 10 to 14 days
-Clarithromycin plus omeprazole and amoxicillin: Clarithromycin 500 mg orally every 12 hours for 10 days

Dual therapy:
-Clarithromycin plus omeprazole: Clarithromycin 500 mg orally every 8 hours for 14 days
-Clarithromycin plus ranitidine bismuth citrate: Clarithromycin 500 mg orally every 8 to 12 hours for 14 days

Comments:
-Helicobacter pylori eradication shown to reduce the risk of duodenal ulcer recurrence
-Regimens with clarithromycin as the only antimicrobial agent are more likely to be associated with clarithromycin resistance in patients who fail therapy.
-Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin-resistant isolates; efficacy of therapy is reduced.
-Susceptibility testing is recommended in patients who fail therapy; if clarithromycin resistance is established, a non-clarithromycin-containing regimen is recommended.
-The manufacturer's product information of the other drugs indicated in combination with clarithromycin should be consulted.

Approved indications:
-Triple therapy: In combination with amoxicillin and (lansoprazole or omeprazole), for the treatment of patients with H pylori infection and duodenal ulcer disease (active or 5-year history of duodenal ulcer) to eradicate H pylori
-Dual therapy: In combination with omeprazole or ranitidine bismuth citrate, for the treatment of patients with active duodenal ulcer associated with H pylori infection

Usual Adult Dose for Mycobacterium avium-intracellulare -- Prophylaxis:

Immediate-release: 500 mg orally twice a day

Approved indication: Prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection

CDC, National Institutes of Health (NIH), and Infectious Diseases Society of America (IDSA) Recommendations for HIV-infected Patients:
Primary prevention of disseminated MAC disease: 500 mg orally twice a day

Comments:
-Primary prophylaxis against disseminated MAC disease recommended for patients with CD4 count less than 50 cells/mm3 (after active disseminated MAC disease has been ruled out based on clinical assessment).
-Clarithromycin is a preferred prophylactic agent (except during pregnancy).
-The combination of clarithromycin and rifabutin should not be used; not more effective than clarithromycin alone.
-Primary MAC prophylaxis should be discontinued in patients responding to antiretroviral therapy (ART) with increase in CD4 count to greater than 100 cells/mm3 for at least 3 months; should restart if CD4 count decreases to less than 50 cells/mm3.

Chronic maintenance therapy (secondary prophylaxis) for disseminated MAC disease: Same as treatment regimen (500 mg orally twice a day plus ethambutol)

Comments:
-Patients with disseminated MAC disease should continue chronic maintenance therapy (secondary prophylaxis) unless immune reconstitution occurs due to ART.
-Chronic maintenance therapy may be stopped in patients at low risk of MAC recurrence; such patients have completed at least 12 months of MAC therapy, have no signs/symptoms of MAC disease, and have an increase in CD4 count to greater than 100 cells/mm3 for more than 6 months in response to ART; should restart if CD4 count decreases to less than 100 cells/mm3.

Usual Adult Dose for Mycobacterium avium-intracellulare -- Treatment:

Immediate-release: 500 mg orally twice a day

Comments:
-Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to MAC.
-Clarithromycin should be used in combination with other antimycobacterial agents that have shown in vitro activity against MAC or clinical benefit in MAC treatment.
-Clarithromycin therapy should continue if clinical response is observed; can discontinue clarithromycin when patient considered at low risk of disseminated infection.

Approved indications: Disseminated mycobacterial infections due to M avium or M intracellulare

CDC, NIH, and IDSA Recommendations for HIV-infected Patients:
Treatment of disseminated MAC disease: 500 mg orally twice a day plus ethambutol

Comments:
-Combination therapy with at least 2 antimycobacterial drugs is recommended for initial treatment of MAC disease to prevent/delay resistance development.
-Clarithromycin is the preferred first agent (except during pregnancy); ethambutol is the recommended second agent.
-Addition of a third or fourth agent should be considered for patients with CD4 count less than 50 cells/mm3, high mycobacterial loads, or when effective ART is absent; some experts recommend rifabutin as a third agent.
-MAC isolates should be tested for susceptibility to clarithromycin in all patients.
-Patients with disseminated MAC disease should continue chronic maintenance therapy (secondary prophylaxis) unless immune reconstitution occurs due to ART.

Usual Adult Dose for Bacterial Endocarditis Prophylaxis:

(Not approved by FDA)

American Heart Association (AHA) recommendations for patients allergic to penicillins:
Immediate-release: 500 mg orally as a single dose 30 to 60 minutes before procedure

Usual Adult Dose for Legionella Pneumonia:

(Not approved by FDA)

For Legionnaires' disease, some experts recommend:
Immediate-release: 500 mg orally every 12 hours

Duration of therapy:
-For mild to moderate infections in immunocompetent patients: 10 days
-To prevent relapse, especially in patients with more severe infections or with underlying comorbidity or immunodeficiency: 3 weeks may be necessary

Usual Adult Dose for Pertussis Prophylaxis:

(Not approved by FDA)

CDC recommendations for treatment and postexposure prophylaxis:
Immediate-release: 500 mg orally every 12 hours for 7 days

Comments:
-Macrolides are preferred agents for the treatment of pertussis.

Usual Adult Dose for Pertussis:

(Not approved by FDA)

CDC recommendations for treatment and postexposure prophylaxis:
Immediate-release: 500 mg orally every 12 hours for 7 days

Comments:
-Macrolides are preferred agents for the treatment of pertussis.

Usual Pediatric Dose for Tonsillitis/Pharyngitis:

Immediate-release:
6 months or older: 7.5 mg/kg orally every 12 hours for 10 days

Approved indications: Pharyngitis/tonsillitis due to S pyogenes

Usual Pediatric Dose for Sinusitis:

Immediate-release:
6 months or older: 7.5 mg/kg orally every 12 hours for 10 days

Approved indications: Acute maxillary sinusitis due to H influenzae, M catarrhalis, or S pneumoniae

Usual Pediatric Dose for Mycoplasma Pneumonia:

Immediate-release:
6 months or older: 7.5 mg/kg orally every 12 hours for 10 days

Approved indications: Community-acquired pneumonia due to M pneumoniae, S pneumoniae, or C pneumoniae (TWAR)

Usual Pediatric Dose for Pneumonia:

Immediate-release:
6 months or older: 7.5 mg/kg orally every 12 hours for 10 days

Approved indications: Community-acquired pneumonia due to M pneumoniae, S pneumoniae, or C pneumoniae (TWAR)

Usual Pediatric Dose for Otitis Media:

Immediate-release:
6 months or older: 7.5 mg/kg orally every 12 hours for 10 days

Approved indications: Acute otitis media due to H influenzae, M catarrhalis, or S pneumoniae

Usual Pediatric Dose for Skin and Structure Infection:

Immediate-release:
6 months or older: 7.5 mg/kg orally every 12 hours for 10 days

Comments:
-Abscesses usually require surgical drainage.

Approved indications: Uncomplicated skin and skin structure infections due to S aureus or S pyogenes

Usual Pediatric Dose for Mycobacterium avium-intracellulare -- Prophylaxis:

Immediate-release:
20 months or older: 7.5 mg/kg orally twice a day
Maximum dose: 500 mg/dose

Approved indication: Prevention of disseminated MAC disease in patients with advanced HIV infection

CDC, NIH, IDSA, and American Academy of Pediatrics (AAP) Recommendations for HIV-exposed and HIV-infected Infants and Children:
Primary prevention of MAC infections: 7.5 mg/kg orally twice a day
Maximum dose: 500 mg/dose

Comments:
-Primary prophylaxis recommended for patients aged 6 years or older with CD4 count less than 50 cells/mm3, aged 2 to 5 years with CD4 count less than 75 cells/mm3, aged 1 to 2 years with CD4 count less than 500 cells/mm3, and aged less than 1 year with CD4 count less than 750 cells/mm3.
-Before prophylaxis is started, active disseminated MAC disease should be ruled out based on clinical assessment.
-Primary prophylaxis can be discontinued in patients older than 2 years if they have received stable highly active ART (HAART) for at least 6 months and have sustained an increase in CD4 count well above the age-specific target for starting prophylaxis (e.g., greater than 100 cells/mm3 for patients aged 6 years or older; greater than 200 cells/mm3 for patients aged 2 to 5 years) for longer than 3 months; specific recommendations for discontinuing MAC prophylaxis in patients younger than 2 years have not been established.

Chronic suppressive therapy for MAC infections: 7.5 mg/kg (maximum: 500 mg/dose) orally twice a day plus ethambutol, with or without rifabutin

Comments:
-To prevent recurrence, lifelong prophylaxis is recommended for children with history of disseminated MAC.
-Some experts recommend stopping chronic suppressive therapy in patients older than 2 years who have completed at least 12 months of MAC therapy, who have no signs/symptoms of MAC disease, and who receive stable HAART and have sustained an increase in CD4 count well above the age-specific target for starting primary prophylaxis (e.g., greater than 100 cells/mm3 for patients older than 6 years; greater than 200 cells/mm3 for patients aged 2 to 6 years) for at least 6 months; should restart if CD4 count falls below age-specific targets.

CDC, NIH, and IDSA Recommendations for HIV-infected Adolescents:
Primary prevention of disseminated MAC disease: 500 mg orally twice a day

Comments:
-Primary prophylaxis against disseminated MAC disease recommended for patients with CD4 count less than 50 cells/mm3 (after active disseminated MAC disease has been ruled out based on clinical assessment).
-Clarithromycin is a preferred prophylactic agent (except during pregnancy).
-The combination of clarithromycin and rifabutin should not be used; not more effective than clarithromycin alone.
-Primary MAC prophylaxis should be discontinued in patients responding to antiretroviral therapy (ART) with increase in CD4 count to greater than 100 cells/mm3 for at least 3 months; should restart if CD4 count decreases to less than 50 cells/mm3.

Chronic maintenance therapy (secondary prophylaxis) for disseminated MAC disease: Same as treatment regimen (500 mg orally twice a day plus ethambutol)

Comments:
-Patients with disseminated MAC disease should continue chronic maintenance therapy (secondary prophylaxis) unless immune reconstitution occurs due to ART.
-Chronic maintenance therapy may be stopped in patients at low risk of MAC recurrence; such patients have completed at least 12 months of MAC therapy, have no signs/symptoms of MAC disease, and have an increase in CD4 count to greater than 100 cells/mm3 for more than 6 months in response to ART; should restart if CD4 count decreases to less than 100 cells/mm3.

Usual Pediatric Dose for Mycobacterium avium-intracellulare -- Treatment:

Immediate-release:
20 months or older: 7.5 mg/kg orally twice a day
Maximum dose: 500 mg/dose

Comments:
-Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to MAC.
-Clarithromycin should be used in combination with other antimycobacterial agents that have shown in vitro activity against MAC or clinical benefit in MAC treatment.
-Clarithromycin therapy should continue if clinical response is observed; can discontinue clarithromycin when patient considered at low risk of disseminated infection.

Approved indications: Disseminated mycobacterial infections due to M avium or M intracellulare

CDC, NIH, IDSA, and AAP Recommendations for HIV-exposed and HIV-infected Infants and Children:
Treatment of MAC infections: 7.5 to 15 mg/kg (maximum dose: 500 mg/dose) orally twice a day plus ethambutol, with or without rifabutin

Comments:
-Combination therapy with at least 2 antimycobacterial drugs is recommended to prevent/delay resistance development.
-Some experts use clarithromycin as the preferred first agent; ethambutol is the recommended second agent; some experts recommend rifabutin as a third agent for severe disease.
-MAC isolates should be tested for susceptibility to clarithromycin.
-Chronic suppressive therapy (secondary prophylaxis) is recommended after initial therapy.

CDC, NIH, and IDSA Recommendations for HIV-infected Adolescents:
Treatment of disseminated MAC disease: 500 mg orally twice a day plus ethambutol

Comments:
-Combination therapy with at least 2 antimycobacterial drugs is recommended for initial treatment of MAC disease to prevent/delay resistance development.
-Clarithromycin is the preferred first agent (except during pregnancy); ethambutol is the recommended second agent.
-Addition of a third or fourth agent should be considered for patients with CD4 count less than 50 cells/mm3, high mycobacterial loads, or when effective ART is absent; some experts recommend rifabutin as a third agent.
-MAC isolates should be tested for susceptibility to clarithromycin in all patients.
-Patients with disseminated MAC disease should continue chronic maintenance therapy (secondary prophylaxis) unless immune reconstitution occurs due to ART.

Usual Pediatric Dose for Pertussis Prophylaxis:

(Not approved by FDA)

CDC recommendations for treatment and postexposure prophylaxis:
Immediate-release:
1 month or older: 7.5 mg/kg orally every 12 hours for 7 days
Maximum dose: 500 mg/dose

Comments:
-Macrolides are preferred agents for the treatment of pertussis.

Usual Pediatric Dose for Pertussis:

(Not approved by FDA)

CDC recommendations for treatment and postexposure prophylaxis:
Immediate-release:
1 month or older: 7.5 mg/kg orally every 12 hours for 7 days
Maximum dose: 500 mg/dose

Comments:
-Macrolides are preferred agents for the treatment of pertussis.

Usual Pediatric Dose for Bacterial Endocarditis Prophylaxis:

(Not approved by FDA)

AHA recommendations for children allergic to penicillins:
Immediate-release: 15 mg/kg orally as a single dose 30 to 60 minutes before procedure
Maximum dose: 500 mg/dose

What other drugs will affect clarithromycin?

Many drugs can interact with clarithromycin. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with clarithromycin, especially:

  • saquinavir;

  • carbamazepine;

  • theophylline;

  • a blood thinner (warfarin, Coumadin, Jantoven);

  • sildenafil (Viagra) and other erectile dysfunction medicines;

  • ergot medicine--ergonovine, methylergonovine; or

  • heart rhythm medication such as amiodarone, disopyramide, dofetilide, procainamide, quinidine, or sotalol.

This list is not complete and many other drugs can interact with clarithromycin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about clarithromycin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 16.01. Revision Date: 2014-03-13, 2:25:32 PM.

Hide
(web2)