Clarithromycin Dosage

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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

Renal Dose Adjustments

CrCl less than 30 mL/min: Dose should be reduced by 50%.

Comments:
-Decreased dose or prolonged dosing intervals may be appropriate.

Concomitant atazanavir or ritonavir:
CrCl 30 to 60 mL/min: Clarithromycin dose should be reduced by 50%.
CrCl less than 30 mL/min: Clarithromycin dose should be reduced by 75%.

Concomitant ranitidine bismuth citrate:
CrCl less than 25 mL/min: Not recommended.

Liver Dose Adjustments

No adjustment recommended.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Comments:
-As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by hemodialysis or peritoneal dialysis.

Other Comments

Administration advice:
-Immediate-release tablets and oral suspension can be taken without regard to food and can be taken with milk.
-Extended-release tablets should be taken with food.
-The oral solution should be shaken well before each use.

Storage requirements:
-250 mg immediate-release tablets: Should be stored at controlled room temperature 15C to 30C (59F to 86F) in a well-closed container; should protect from light
-500 mg immediate-release tablets: Should be stored at controlled room temperature 20C to 25C (68F to 77F) in a well-closed container
-Extended-release tablets: Should be stored at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F)
-Granules for oral suspension (before constitution): Should be stored at controlled room temperature 15C to 30C (59F to 86F) in a well-closed container
-Oral suspension (after constitution): Should be stored at 15C to 30C (59F to 86F), kept tightly closed, and discarded after 14 days; should not be refrigerated

Reconstitution/preparation techniques:
-The manufacturer's product information should be consulted.

General:
-Clarithromycin is for the treatment of mild to moderate infections due to susceptible isolates of the designated bacteria.
-Safety and efficacy of the extended-release formulation in treating other infections for which the immediate-release formulations are approved have not been established.

Patient advice:
-Avoid missing doses and complete the entire course of therapy.

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