Close
New

Medscape is available in 5 Language Editions – Choose your Edition here.

 

clarithromycin (Rx)Brand and Other Names:Biaxin, Biaxin XL

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral suspension

  • 125mg/5mL
  • 250mg/5mL

tablet

  • 250mg
  • 500mg

tablet, extended release

  • 500mg
more...

Acute Exacerbation of Chronic Bronchitis

250-500 mg PO q12hr for 7-14 days

Extended release: 1000 mg PO once daily for 7 days

Acute Maxillary Sinusitis

500 mg PO q12hr for 14 days

Extended release: 1000 mg PO once daily for 14 days

Mycobacterial Infection

Prophylaxis and treatment

500 mg PO q12hr for 7-14 days

Use with antimycobacterial drugs such as rifampin and ethambutol

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

250 mg PO q12hr for 7-14 days

Extended release: 1000 mg PO once daily for 7 days

Pertusis (Off-label)

500 mg PO twice daily for 7 days

Skin/Skin Structure Infection

250 mg PO q12hr for 7-14 days

Endocarditis

Prophylaxis

500 mg PO 30-60 minutes before surgical procedure

Crohn Disease (Orphan)

Treatment of pediatric Crohn disease in combination with rifabutin and clofazimine

Orphan indication sponsor

  • RedHill Biopharma Ltd; 42 Givati St; Israel

Dosing Modifications

Renal impairment (CrCl <30 mL/min): Reduce normal dose by 50%

In combination with atazanavir: CrCl 30-60 mL/min decrese, dose by 50%; CrCl <30 mL/min, decrease dose by 75%

Dosing Considerations

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

oral suspension

  • 125mg/5mL
  • 250mg/5mL

tablet

  • 250mg
  • 500mg
more...

Extended-release tablets: Safety and efficacy not established in children

Community-Acquired Pneumonia, Sinusitis, Bronchitis, Skin Infections

15 mg/kg/day PO divided q12hr for 10 days  

Mycobacterial Infection

Prophylaxis and treatment

7.5 mg/kg PO q12hr; individual dose not to exceed 500 mg

<20 months: Safety of clarithromycin for MAC not studied

Endocarditis

Prophylaxis

15 mg/kg PO 30-60 minutes before surgical procedure; individual dose not to exceed 500 mg 

Streptococcal Pharyngitis

7 mg/kg q12hr for 10 days; individual dose not to exceed 500 mg

Pertussis

<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

Next

Interactions

Interaction Checker

clarithromycin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
             activity indicator 
            Previous
            Next

            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, 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

            Previous
            Next

            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

            Severe renal impairment

            Oral solution must not be refrigerated

            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

            Use for endocarditis prophylaxis is appropriate only for high-risk patients, per American Heart Association (AHA) guidelines

            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; do not coadminister with class IA (eg, quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmics

            Elderly patients may be more susceptible to drug-associated QT prolongation

            Use caution in patients with coronary artery disease; postmarketing trials suggest increased risk of cardiovascular mortality

            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)

            Clostridium difficile associated diarrhea reported with use of nearly all antibacterial agents, including clarithromycin

            May cause kidney injury when administered concomitantly with calcium channel blockers metabolized by CYP3A4

            Do not coadminister with ranitidine/bismuth citrate with history of acute porphyria or if CrCl <25 mL/min

            Coadministration with quetiapine may result in quetiapine related toxicities including neuroleptic malignant syndrome, QT prolongation, somnolence, orthostatic hypotension, altered state of consciousness

            Exacerbation of myasthenia gravis or new onset of symptoms reported

            Hepatic dysfunction

            • Increased liver enzyme activity and hepatocellular or cholestatic hepatitis, with or without jaundice, have been reported; this may be severe and is usually reversible
            • In some instances, hepatic failure with fatal outcome has been reported, generally in association with serious underlying diseases or concomitant medications
            • Discontinue clarithromycin immediately if signs and symptoms of hepatitis occur (eg, anorexia, jaundice, dark urine, pruritus, or tender abdomen)
            Previous
            Next

            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...
            Previous
            Next

            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%)

            Previous
            Next

            Images

            Previous
            Next

            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Add or Remove Plans
            Plans for
            Select State:
            Non-Medicare PlansMedicare Plans

            Select a box to add or remove a plan.

            Select a class to view formulary status for similar drugs

            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
             
             
             
            All material on this website is protected by copyright, Copyright © 1994-2016 by WebMD LLC. This website also contains material copyrighted by 3rd parties.