clarithromycin (Rx)

Brand and Other Names:
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Note: Only available in U.S. as generic

oral suspension

  • 125mg/5mL
  • 250mg/5mL

tablet

  • 250mg
  • 500mg

tablet, extended release

  • 500mg
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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
more...

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

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Interactions

Interaction Checker

and clarithromycin

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

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            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
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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Drug is excreted in breast milk; use with caution

            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.

            more...
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            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%)

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            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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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.