Dosing & Uses
Dosage Forms & Strengths
Note: Only available in U.S. as generic
oral suspension
- 125mg/5mL
- 250mg/5mL
tablet
- 250mg
- 500mg
tablet, extended release
- 500mg
Acute Exacerbation of Chronic Bronchitis
Indicated for treatment of mild-to-moderate infections caused by susceptible isolates caused by Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
250-500 mg PO q12hr for 7-14 days
Extended release: 1000 mg PO once daily for 7 days
Acute Maxillary Sinusitis
Indicated for the treatment of mild-to-moderate infections caused by susceptible isolates caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
500 mg PO q12hr for 14 days
Extended release: 1000 mg PO once daily for 14 days
Mycobacterial Infection
Indicated treatment and prophylaxis of mycobacterial infections
500 mg PO q12hr for 7-14 days
For treatment of disseminated infection caused by mycobacterium avium complex (MAC); use in combination with other antimycobacterial drugs (eg, ethambutol)
Peptic Ulcer Disease
Indicated for H pylori eradication when treating patients with active or history of peptic ulcer disease
500 mg PO q8-12hr for 10-14 days
Administer as part of 2- or 3-drug combination regimen with bismuth subsalicylate, amoxicillin, H2 receptor antagonist, or proton pump inhibitor
Pharyngitis, Tonsillitis
250 mg PO q12hr for 10 days
Community-Acquired Pneumonia
Indicated for the treatment of mild-to-moderate infections caused by susceptible isolates caused by Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydophila pneumoniae
250 mg PO q12hr for 7-14 days
Extended release: 1000 mg PO once daily for 7 days
Skin/Skin Structure Infection
250 mg PO q12hr for 7-14 days
Pertussis (Off-label)
Used off-label for treatment of pertussis or for postexposure prophylaxis
500 mg PO twice daily for 7 days
Endocarditis (Off-label)
Used off-label for bacterial endocarditis prophylaxis
500 mg PO 30-60 minutes before procedure
Dosage Modifications
Coadministration with atazanavir: Decrease clarithromycin dose by 50%
Renal impairment
- Moderate
- CrCl 30-60 mL/min: No dosage adjustment necessary
- CrCl 30-60 mL/min and concomitant atazanavir or ritonavir-containing regimens: Decrease clarithromycin dose by 50%
- Severe
- CrCl <30 mL/min: Decrease clarithromycin dose by 50%
- CrCl <30 mL/min and concomitant atazanavir or ritonavir-containing regimens: Decrease clarithromycin dose by 75%
Dosing Considerations
Limitations of use
- Extended-release tablet is indicated only for acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia in adults
- Resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus; when clinically indicated, perform susceptibility tests
Susceptible organisms
- Actinobacillus actinomycetemcomitans, Actinomyces israelii, Actinomyces naeslundii, Actinomyces odontolyticus, Afipia felis, Arachnia propionica, Bartonella henselae, Bartonella quintana, Chlamydia pneumoniae (TWAR agent), Bordetella pertussis, Borrelia recurrentis, Calymmatobacterium granulomatis, Campylobacter jejuni, Chlamydia spp, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Legionella pneumophila, Mycobacterium avium complex (MAC), Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium genavense, Mycobacterium gordonae, Mycobacterium kansasii, Mycobacterium leprae, Mycobacterium marinum, Mycobacterium scrofulaceum, Mycobacterium simiae, Mycobacterium szulgai, Mycobacterium ulcerans, Mycobacterium xenopi, Mycoplasma pneumoniae, Moraxella (Branhamella) catarrhalis, Staphylococcus aureus, Streptococcus (group C, G), Streptococcus agalactiae (group B), Streptococcus bovis (group D), Streptococcus intermedius group (Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus), Streptococcus pneumoniae (penicillin sensitive; minimal inhibitory concentration [MIC] <0.1 mcg/mL), Streptococcus pyogenes (group A), viridans streptococci, Ureaplasma urealyticum
- H pylori (with lansoprazole and amoxicillin)
- First-line: A felis, B henselae, B quintana, B pertussis, C jejuni, C pneumoniae, H ducreyi, H pylori, Legionella spp, MAC, M chelonae, M fortuitum, M genavense, M gordonae, M marinum, M scrofulaceum, M simiae, M xenopi; no unanimity on others (eg, H influenzae)
Dosage Forms & Strengths
Note: Only available in U.S. as generic
oral suspension
- 125mg/5mL
- 250mg/5mL
tablet
- 250mg
- 500mg
Otitis Media
Indicated for treatment of acute otitis media caused by H influenzae, M catarrhalis, or S pneumoniae
Because of increased resistance to S Pneumoniae and H Influenzae, not routinely recommended as treatment option
<6 months: Safety and efficacy not established
≥6 months: 15 mg/kg/day PO divided q12hr for 10 days; not to exceed 500 mg/dose
Community-Acquired Pneumonia
Indicated for community-acquired pneumonia caused by Mycoplasma pneumoniae, S pneumoniae, or Chlamydophila pneumoniae
<3 months: Safety and efficacy not established
≥3 months: 15 mg/kg/day PO divided q12hr for 10 days; not to exceed 500 mg/dose
Sinusitis
Indicated for the treatment of mild-to-moderate infections caused by susceptible isolates caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
<6 months: Safety and efficacy not established
≥6 months: 15 mg/kg/day PO divided q12hr for 10 days; not to exceed 500 mg/dose
Bronchitis
Indicated for treatment of mild-to-moderate infections caused by susceptible isolates caused by Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
<6 months: Safety and efficacy not established
≥6 months: 15 mg/kg/day PO divided q12hr for 10 days; not to exceed 500 mg/dose
Skin Infections
Indicated for uncomplicated skin and skin structure infection caused by S aureus or S pyogenes
<6 months: Safety and efficacy not established
≥6 months: 15 mg/kg/day PO divided q12hr for 10 days; not to exceed 250 mg/dose
Mycobacterial Infection
Indicated treatment and prophylaxis of mycobacterial infections
When used for treatment of disseminated infection caused by mycobacterium avium complex (MAC), administer in combination with other antimycobacterial drugs (eg, ethambutol)
<20 months: Safety and efficacy not established
≥20 months: 7.5 mg/kg PO q12hr; individual dose not to exceed 500 mg
Streptococcal Pharyngitis
Indicated for pharyngitis/tonsillitis caused by susceptible S pyogenes
<6 months: Safety and efficacy not established
≥6 months: 7.5 mg/kg q12hr for 10 days; individual dose not to exceed 250 mg
Endocarditis (Off-label)
Used off-label for bacterial endocarditis prophylaxis
15 mg/kg PO 30-60 minutes before procedure; individual dose not to exceed 500 mg
Pertussis (Off-label)
Used off-label for treatment of pertussis or for postexposure prophylaxis
<1 month: Safety and efficacy not established
1-6 months: 7.5 mg/kg/dose PO q12hr for 7 days
>6 months: 7.5 mg/kg/dose PO q12hr for 7 days
Dosing Considerations
Administer only oral suspension or immediate-release tablets to children; do not use extended-release
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
Gastrointestinal (GI) effects, general (13%)
1-10%
Abnormal taste (adults, 3-7%)
Diarrhea (3-6%)
Nausea (adults, 3-6%)
Vomiting (adults, 1%; children, 6%)
Elevated blood urea nitrogen (BUN; 4%)
Abdominal pain (adults, 2%; children, 3%)
Rash (children, 3%)
Dyspepsia (2%)
Heartburn (adults, 2%)
Headache (2%)
Elevated prothrombin time (PT; 1%)
<1%
Anaphylaxis
Anorexia
Anxiety
Clostridium difficile colitis
Dizziness
Dyspnea
Elevated liver function tests
Glossitis
Hallucinations
Hepatic dysfunction
Hepatitis
Hypoglycemia
Increased alkaline phosphatase
Increased aspartate aminotransferase
Increased bilirubin
Increased serum creatinine
Jaundice
Leukopenia
Manic behavior
Neuromuscular blockade
Neutropenia
Pancreatitis
Psychosis
QT prolongation
Seizures
Stevens-Johnson syndrome
Thrombocytopenia
Postmarketing Reports
Blood and lymphatic system disorders: Thrombocytopenia, agranulocytosis
Cardiac disorders: Torsades de pointes, ventricular tachycardia, ventricular arrhythmia
Ear and labyrinth disorders: Deafness was reported chiefly in elderly women and was usually reversible
Gastrointestinal disorders: Pancreatitis acute, tongue discoloration, tooth discoloration
Hepatobiliary disorders: Hepatic failure, jaundice hepatocellular
Immune system disorders: Anaphylactic reaction, angioedema
Infections and infestations: Pseudomembranous colitis
Investigations: Prothrombin time prolonged, white blood cell count decreased, international normalized ratio increased; abnormal urine color has been reported, associated with hepatic failure
Metabolism and nutrition disorders: Hypoglycemia has been reported in patients taking oral hypoglycemic agents or insulin
Musculoskeletal and connective tissue disorders: Myopathy, rhabdomyolysis was reported and in some of the reports, clarithromycin was administered concomitantly with statins, fibrates, colchicine or allopurinol
Nervous system disorders: Convulsion, ageusia, parosmia, anosmia, paraesthesia Psychiatric disorders:
Psychotic disorder, confusional state, depersonalization, depression, disorientation, manic behavior, hallucination, abnormal behavior, abnormal dreams
Renal and urinary disorders: Nephritis interstitial, renal failure
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, acne
Vascular disorders: Hemorrhage
Other: Reports of colchicine toxicity, some resulting in death, with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency
Use may result in fungal or bacterial superinfection
Decreased survival observed in HIV patients with mycobacterium avium complex treated with clarithromycin doses above maximum recommended dose; maximum recommended dosing should not be exceeded in this population; development of resistance to clarithromycin observed when used as prophylaxis and treatment of MAC infection
Warnings
Contraindications
Documented hypersensitivity
Coadministration with pimozide, cisapride, ergotamine, and dihydroergotamine
History of cholestatic jaundice or hepatic dysfunction associated with previous use of clarithromycin
Coadministration with colchicine in patients with renal or hepatic impairment
Coadministration with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin, simvastatin), due to the increased risk of myopathy, including rhabdomyolysis
Cautions
Acute hypersensitivity reactions; discontinue immediately if severe hypersensitivity reactions occur (eg, anaphylaxis, Stevens-Johnson syndrome, TEN, drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome, Henoch-Schonlein purpura)
Associated with QT interval prolongation and infrequent cases of arrhythmias, including torsade de pointes; avoid using with ongoing proarrhythmic conditions (eg, uncorrected hypokalemia or hypomagnesemia), clinically significant bradycardia; patients aged ≥65 yr may be more susceptible to drug-associated QT prolongation (also see Drug Interaction Overview)
Hepatic dysfunction, including increased liver enzyme activity and hepatocellular or cholestatic hepatitis, with or without jaundice, have been reported; this may be severe and is usually reversible
Discontinue clarithromycin immediately if signs and symptoms of hepatitis occur (eg, anorexia, jaundice, dark urine, pruritus, tender abdomen)
May increase morbidity among patients with coronary heart disease who received a 2-week course of clarithromycin; in an observational study, this risk became apparent after patients had been followed for ≥1 year; based on this study, the FDA added a warning to the prescribing information (CLARICOR trial; BMJ 2006;332:22-7)
Clostridium difficile associated diarrhea reported with use of nearly all antibacterial agents, including clarithromycin
Not for use in pregnancy, except when there is no alternative therapy; apprise patient about potential hazard to fetus if pregnancy occurs while in therapy
Exacerbation of myasthenia gravis or new onset of symptoms reported
Drug interaction overview
- Clarithromycin is a strong CYP3A4 inhibitor and also inhibits P-pg transport (ABCB1)
- CYP3A4
- Clarithromycin is a strong CYP3A4 inhibitor; drugs primarily metabolized by CYP3A4 may result in higher exposure to these medications (also see Contraindications)
- Reduce colchicine dose if coadministered with clarithromycin in patients with normal hepatic and renal function (contraindicated with hepatic and renal impairment)
- Decrease dose of atorvastatin or pravastatin if coadministered with clarithromycin
- Coadministration of clarithromycin with oral hypoglycemic agents and/or insulin can result in significant hypoglycemia; examples of or hypoglycemic agents that are CYP3A substrates include nateglinide, pioglitazone, repaglinide and rosiglitazone
- QT prolongation
- Contraindicated with pimozide with cisapride (each are known to prolong QT interval and are also CYP3A4 substrates)
- Avoid coadministration with drugs with known risk of QT prolongation
- Coadministration with quetiapine may result in quetiapine related toxicities including neuroleptic malignant syndrome, QT prolongation, somnolence, orthostatic hypotension, altered state of consciousness
- Cautiously monitor if coadministered with drugs that may prolong QT interval
- Other interactions
- Macrolides may increase the serum concentration of vitamin K antagonists (eg, warfarin); monitor INR
- Increased and prolonged sedation may occur when coadministered with benzodiazepines (eg, triazolam, midazolam)
- May increase digoxin levels via P-gp inhibition
Pregnancy & Lactation
Pregnancy
Based on findings from animal studies, drug is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate; if pregnancy occurs while taking drug, patient should be apprised of potential hazard to fetus
Limited data from a small number of published human studies with therapy use during pregnancy are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
- In animal reproduction studies, administration of oral clarithromycin to pregnant mice, rats, rabbits, and monkeys during the period of organogenesis produced malformations in rats (cardiovascular anomalies) and mice (cleft palate) at clinically relevant doses based on body surface area comparison; fetal effects in mice, rats, and monkeys (e.g., reduced fetal survival, body weight, body weight gain) and implantation losses in rabbits were generally considered to be secondary to maternal toxicity
Lactation
Based on limited human data, clarithromycin and its active metabolite 14-OH clarithromycin are present in human milk at less than 2% of the maternal weight-adjusted dose; in a separate observational study, reported adverse effects on breast-fed children (rash, diarrhea, loss of appetite, somnolence) were comparable to amoxicillin; no data are available to assess effects of clarithromycin or 14-OH clarithromycin on milk production
Development and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breast-fed child from therapy or from underlying maternal condition
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Semisynthetic macrolide antibiotic that reversibly binds to P site of 50S ribosomal subunit of susceptible organisms and may inhibit RNA-dependent protein synthesis by stimulating dissociation of peptidyl t-RNA from ribosomes, thereby inhibiting bacterial growth
Absorption
Highly stable in presence of gastric acid (unlike erythromycin); food delays but does not affect extent of absorption
Bioavailability: 50%
Peak plasma time: 2-3 hr (immediate release); 5-8 hr (extended release)
Distribution
Distributed widely into most body tissues except central nervous system (CNS)
Protein bound: 42-50%
Metabolism
Partially metabolized by CYP3A4
Metabolites: 14-OH clarithromycin (active)
Elimination
Half-life: Immediate release, 3-7 hr; active metabolite, 5-9 hr
Renal clearance: Approximates normal glomerular filtration rate (GFR)
Excretion: Urine (30-55%)
Administration
Preparation of Oral Suspension
Add half the volume of water to the bottle containing granules and shake vigorously, THEN
Add the remainder of water to the bottle and shake
Shake well before each use
Volume of water to add
- 125 mg/5 mL (50-mL bottle): 27 mL
- 125 mg/5 mL (100-mL bottle): 55 mL
- 250 mg/5 mL (50-mL bottle): 27 mL
- 250 mg/5 mL (100-mL bottle): 55 mL
Oral Administration
Tablet or granules may be administered with or without food
Extended-release tablet
- Administer with food
- Swallow whole; do not chew, break, or crush
Storage
Tablets: Store at controlled room temperature of 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
Granules for oral suspension
- Granules: Store below 25°C (77°F) in a well-closed container
- Reconstituted
- Do not refrigerate after reconstituting granules
- After mixing, store at 15-30°C (59-86°F) and use within 14 days
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Formulary
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