Clarithromycin

Pronunciation

(kla RITH roe mye sin)

U.S. Brand Names

Biaxin®; Biaxin® XL

Synonyms

Cla

Generic Available

Canadian Brand Names

Biaxin®; Biaxin® XL; ratio-Clarithromycin

Use

Children:

Pharyngitis/tonsillitis, acute maxillary sinusitis, uncomplicated skin/skin structure infections, and mycobacterial infections due to the above organisms

Acute otitis media ( H. influenzae , M. catarrhalis , or S. pneumoniae )

Prevention of disseminated mycobacterial infections due to MAC disease in patients with advanced HIV infection

Adults:

Pharyngitis/tonsillitis due to susceptible S. pyogenes

Acute maxillary sinusitis and acute exacerbation of chronic bronchitis due to susceptible H. influenzae , M. catarrhalis , or S. pneumoniae

Pneumonia due to susceptible H. influenzae , Mycoplasma pneumoniae , S. pneumoniae , or Chlamydia pneumoniae (TWAR);

Uncomplicated skin/skin structure infections due to susceptible S. aureus , S. pyogenes

Disseminated mycobacterial infections due to M. avium or M. intracellulare

Prevention of disseminated mycobacterial infections due to M. avium complex (MAC) disease (eg, patients with advanced HIV infection)

Duodenal ulcer disease due to H. pylori in regimens with other drugs including amoxicillin and lansoprazole or omeprazole, ranitidine bismuth citrate, bismuth subsalicylate, tetracycline, and/or an H2 antagonist

Alternate antibiotic for prophylaxis of bacterial endocarditis in patients who are allergic to penicillin and undergoing surgical or dental procedures

Use - Dental

Alternate antibiotic in the treatment of common orofacial infections caused by aerobic gram-positive cocci and susceptible anaerobes alternate antibiotic for the prevention of bacterial endocarditis in patients undergoing dental procedures

Pregnancy Risk Factor

Pregnancy Implications

There are no adequate and well-controlled studies in pregnant women. Due to adverse fetal effects reported in animal studies, the manufacturer recommends that clarithromycin not be used in a pregnant woman unless there are no alternatives to therapy.

Lactation

Excretion in breast milk unknown/use caution

Contraindications

Hypersensitivity to clarithromycin, erythromycin, or any macrolide antibiotic; use with ergot derivatives, pimozide, cisapride; combination with ranitidine bismuth citrate should not be used in patients with history of acute porphyria or Clcr<25 mL/minute

Warnings/Precautions

Dosage adjustment required with severe renal impairment, decreased dosage or prolonged dosing interval may be appropriate; antibiotic-associated colitis has been reported with use of clarithromycin. Macrolides (including clarithromycin) have been associated with rare QT prolongation and ventricular arrhythmias, including torsade de pointes. The extended release formulation consists of drug within a nondeformable matrix; following drug release/absorption, the matrix/shell is expelled in the stool. The use of nondeformable products in patients with known stricture/narrowing of the GI tract has been associated with symptoms of obstruction. Safety and efficacy in children <6 months of age have not been established.

Adverse Reactions

1% to 10%:

Central nervous system: Headache (adults and children 2%)

Dermatologic: Rash (children 3%)

Gastrointestinal: Diarrhea (adults 6%, children 6%); vomiting (children 6%); nausea (adults 3%); abnormal taste (adults 7%); heartburn (adults 2%); abdominal pain (adults 2%, children 3%)

Hepatic: Prothrombin time increased (1%)

Renal: BUN increased (4%)

<1%, postmarketing, and/or case reports (limited to important or life-threatening); Clostridium difficile colitis, alkaline phosphatase increased, anaphylaxis, anorexia, anxiety, AST increased, bilirubin increased, dizziness, dyspnea, glossitis, hallucinations, hearing loss (reversible), hepatic failure, hepatitis, hypoglycemia, jaundice, leukopenia, manic behavior, neuromuscular blockade (case reports), neutropenia, pancreatitis, psychosis, QT prolongation, seizure, serum creatinine increased, Stevens-Johnson syndrome, thrombocytopenia, tongue discoloration, tooth discoloration, torsade de pointes, toxic epidermal necrolysis, tremor, ventricular tachycardia, vertigo, vomiting

Overdosage/Toxicology

Symptoms of overdose include nausea, vomiting, diarrhea, prostration, reversible pancreatitis, hearing loss with or without tinnitus, or vertigo. Treatment includes symptomatic and supportive care.

Drug Interactions

Substrate of CYP3A4 (major); Inhibits CYP1A2 (weak), 3A4 (strong)

Alfentanil (and possibly other narcotic analgesics): Serum levels may be increased by clarithromycin; monitor for increased effect.

Antipsychotic agents (particularly mesoridazine and thioridazine): Risk of QTc prolongation and malignant arrhythmias may be increased.

Benzodiazepines (those metabolized by CYP3A4, including alprazolam, midazolam, triazolam): Serum levels may be increased by clarithromycin; somnolence and confusion have been reported.

Bromocriptine: Serum levels may be increased by clarithromycin; monitor for increased effect.

Buspirone: Serum levels may be increased by clarithromycin; monitor.

Calcium channel blockers (felodipine, verapamil, and potentially others metabolized by CYP3A4): Serum levels may be increased by clarithromycin; monitor.

Carbamazepine: Serum levels may be increased by clarithromycin; monitor.

Cilostazol: Serum levels may be increased by clarithromycin; monitor.

Cisapride: Serum levels may be increased by clarithromycin; serious arrhythmias have occurred; concurrent use contraindicated.

Clindamycin (and lincomycin): Use with clarithromycin may result in pharmacologic antagonism; manufacturer recommends avoiding this combination.

Clozapine: Serum levels may be increased by clarithromycin; monitor.

Colchicine: serum levels/toxicity may be increased by clarithromycin; monitor.

Cyclosporine: Serum levels may be increased by clarithromycin; monitor serum levels.

CYP3A4 inducers: CYP3A4 inducers may decrease the levels/effects of clarithromycin. Example inducers include aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins.

CYP3A4 inhibitors: May increase the levels/effects of clarithromycin. Example inhibitors include azole antifungals, ciprofloxacin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, and verapamil.

CYP3A4 substrates: Clarithromycin may increase the levels/effects of CYP3A4 substrates. Example substrates include benzodiazepines, calcium channel blockers, mirtazapine, nateglinide, nefazodone, tacrolimus, and venlafaxine. Selected benzodiazepines (midazolam and triazolam), cisapride, ergot alkaloids, selected HMG-CoA reductase inhibitors (lovastatin and simvastatin), and pimozide are generally contraindicated with strong CYP3A4 inhibitors.

Delavirdine: Serum levels may be increased by clarithromycin; monitor.

Digoxin: Serum levels may be increased by clarithromycin; digoxin toxicity and potentially fatal arrhythmias have been reported; monitor digoxin levels.

Disopyramide: Serum levels may be increased by clarithromycin; in addition, QTc prolongation and risk of malignant arrhythmia may be increased; avoid combination.

Ergot alkaloids: Concurrent use may lead to acute ergot toxicity (severe peripheral vasospasm and dysesthesia).

Fluconazole: Increases clarithromycin levels and AUC by ~25%

HMG-CoA reductase inhibitors (atorvastatin, lovastatin, and simvastatin); Clarithromycin may increase serum levels of "statins" metabolized by CYP3A4, increasing the risk of myopathy/rhabdomyolysis (does not include fluvastatin and pravastatin). Switch to pravastatin/fluvastatin or suspend treatment during course of clarithromycin therapy.

Loratadine: Serum levels may be increased by clarithromycin; monitor.

Methylprednisolone: Serum levels may be increased by clarithromycin; monitor.

Neuromuscular-blocking agents: May be potentiated by clarithromycin (case reports).

Phenytoin: Serum levels may be increased by clarithromycin; other evidence suggested phenytoin levels may be decreased in some patients; monitor.

Pimozide: Serum levels may be increased, leading to malignant arrhythmias; concomitant use is contraindicated.

Protease inhibitors (amprenavir, nelfinavir, and ritonavir): May increase serum levels of clarithromycin.

QTc-prolonging agents: Concomitant use may increase the risk of malignant arrhythmias.

Quinidine: Serum levels may be increased by clarithromycin; in addition, the risk of QTc prolongation and malignant arrhythmias may be increased during concurrent use.

Quinolone antibiotics (sparfloxacin, gatifloxacin, or moxifloxacin): Concurrent use may increase the risk of malignant arrhythmias.

Rifabutin: Serum levels may be increased by clarithromycin; monitor.

Sildenafil, tadalafil, vardenafil: Serum levels may be increased by clarithromycin. Do not exceed single sildenafil doses of 25 mg in 48 hours, a single tadalafil dose of 10 mg in 72 hours, or a single vardenafil dose of 2.5 mg in 24 hours.

Tacrolimus: Serum levels may be increased by clarithromycin; monitor serum concentration.

Theophylline: Serum levels may be increased by clarithromycin; monitor.

Valproic acid (and derivatives): Serum levels may be increased by clarithromycin; monitor.

Vinblastine (and vincristine): Serum levels may be increased by clarithromycin.

Warfarin: Effects may be potentiated; monitor INR closely and adjust warfarin dose as needed or choose another antibiotic

Zafirlukast: Serum levels may be decreased by clarithromycin; monitor.

Zidovudine: Peak levels (but not AUC) of zidovudine may be increased; other studies suggest levels may be decreased.

Zopiclone: Serum levels may be increased by clarithromycin; monitor.

Ethanol/Nutrition/Herb Interactions

Food: Delays absorption; total absorption remains unchanged.

Herb/Nutraceutical: St John's wort may decrease clarithromycin levels.

Stability

Store tablets and granules for oral suspension at controlled room temperature. Reconstituted oral suspension should not be refrigerated because it might gel; microencapsulated particles of clarithromycin in suspension is stable for 14 days when stored at room temperature

Mechanism of Action

Exerts its antibacterial action by binding to 50S ribosomal subunit resulting in inhibition of protein synthesis. The 14-OH metabolite of clarithromycin is twice as active as the parent compound against certain organisms.

Pharmacodynamics/Kinetics

Absorption: Highly stable in presence of gastric acid (unlike erythromycin); food delays but does not affect extent of absorption

Distribution: Widely into most body tissues except CNS

Metabolism: Partially hepatic; converted to 14-OH clarithromycin (active metabolite)

Bioavailability: 50%

Half-life elimination: 5-7 hours

Time to peak: 2-4 hours

Excretion: Primarily urine

Clearance: Approximates normal GFR

Dosage

Oral:

Children 6 months: 15 mg/kg/day divided every 12 hours for 10 days

Mycobacterial infection (prevention and treatment): 7.5 mg/kg twice daily, up to 500 mg twice daily

Prophylaxis of bacterial endocarditis: 15 mg/kg 1 hour before procedure (maximum dose: 500 mg)

Adults:

Usual dose: 250-500 mg every 12 hours or 1000 mg (two 500 mg extended release tablets) once daily for for 7-14 days

Upper respiratory tract: 250-500 mg every 12 hours for 10-14 days

Pharyngitis/tonsillitis: 250 mg every 12 hours for 10 days

Acute maxillary sinusitis: 500 mg every 12 hours or 1000 mg (two 500 mg extended release tablets) once daily for 14 days

Lower respiratory tract: 250-500 mg every 12 hours for 7-14 days

Acute exacerbation of chronic bronchitis due to:

M. catarrhalis and S. pneumoniae : 250 mg every 12 hours or 1000 mg (two 500 mg extended release tablets) once daily for 7-14 days

H. influenzae : 500 mg every 12 hours for 7-14 days

Pneumonia due to:

C. pneumoniae , M. pneumoniae , and S. pneumoniae : 250 mg every 12 hours for 7-14 days or 1000 mg (two 500 mg extended release tablets) once daily for 7 days

H. influenzae: 250 mg every 12 hours for 7 days or 1000 mg (two 500 mg extended release tablets) once daily for 7 days

Mycobacterial infection (prevention and treatment): 500 mg twice daily (use with other antimycobacterial drugs, eg, ethambutol, clofazimine, or rifampin)

Prophylaxis of bacterial endocarditis: 500 mg 1 hour prior to procedure

Uncomplicated skin and skin structure: 250 mg every 12 hours for 7-14 days

Helicobacter pylori : Combination regimen with bismuth subsalicylate, tetracycline, clarithromycin, and an H2-receptor antagonist; or combination of omeprazole and clarithromycin; 250 mg twice daily to 500 mg 3 times/day

Dosing adjustment in renal impairment:

Clcr<30 mL/minute: Half the normal dose or double the dosing interval

In combination with ritonavir:

Clcr 30-60 mL/minute: Decrease clarithromycin dose by 50%

Clcr<30 mL/minute: Decrease clarithromycin dose by 75%

Dosing adjustment in hepatic impairment: No dosing adjustment is needed as long as renal function is normal

Elderly: Pharmacokinetics are similar to those in younger adults; may have age-related reductions in renal function; monitor and adjust dose if necessary

Administration

Clarithromycin may be given with or without meals. Give every 12 hours rather than twice daily to avoid peak and trough variation.

Biaxin® XL: Should be given with food. Do not crush or chew extended release tablet.

Dietary Considerations

May be taken with or without meals; may be taken with milk. Biaxin® XL should be taken with food.

Patient Education

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Take full course of therapy; do not discontinue without consulting prescriber. Tablets or suspension may be taken with or without food or milk. Extended release tablets should be taken with food. Do not crush or chew extended release tablets. Do not refrigerate oral suspension (more palatable at room temperature). Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. May cause nausea, heartburn, or abnormal taste (small, frequent meals, frequent mouth care, chewing gum or sucking lozenges may help); diarrhea (buttermilk, boiled milk, or yogurt may help); or headache or abdominal cramps (consult prescriber for analgesic). Report rapid heartbeat or palpitations, persistent fever or chills, easy bruising or bleeding, joint pain, severe persistent diarrhea, skin rash, sores in mouth, foul-smelling urine, or respiratory difficulty. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Cardiovascular Considerations

Because of potential drug interactions, serious arrhythmias may occur when clarithromycin and other macrolides are used in combination with cisapride. Clarithromycin may also increase theophylline, some HMG-CoA reductase inhibitors, digoxin, warfarin, and cyclosporine levels (among others). Clarithromycin may be used in penicillin-allergic patients for prevention of bacterial endocarditis.

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Abnormal taste.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

Macrolides have been reported to cause nightmares, confusion, anxiety, and mood lability

Mental Health: Effects on Psychiatric Treatment

Contraindicated with pimozide; increases carbamazepine and triazolam levels; monitor for signs of toxicity

Dosage Forms

Granules for oral suspension (Biaxin®): 125 mg/5 mL (50 mL, 100 mL); 250 mg/5 mL (50 mL, 100 mL) [fruit punch flavor]

Tablet [film coated] (Biaxin®): 250 mg, 500 mg

Tablet, extended release [film coated] (Biaxin® XL): 500 mg

References

"1997 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected With Human Immunodeficiency Virus. USPHS/IDSA Prevention of Opportunistic Working Group," MMWR Recomm Rep , 1997, 46(RR-12):1-46.

American Thoracic Society, "Guidelines for the Initial Management of Adults With Community-Acquired Pneumonia: Diagnosis, Assessment of Severity, and Initial Antimicrobial Therapy," Am Rev Respir Dis , 1993, 148(5):1418-26.

Amsden GW, "Erythromycin, Clarithromycin, and Azithromycin: Are the Differences Real?" Clin Ther , 1996, 18(1):56-72.

Aspin MM, Hoberman A, McCarty J, et al, "Comparative Study of the Safety and Efficacy of Clarithromycin and Amoxicillin-Clavulanate in the Treatment of Acute Otitis Media in Children," J Pediatr , 1994, 125(1):136-41.

Barradell LB, Plosker GL, and McTavish D, "Clarithromycin. A Review of Its Pharmacological Properties and Therapeutic Use in Mycobacterium avium-intracellulare Complex Infection in Patients With Acquired Immune Deficiency Syndrome," Drugs , 1993, 46(2):289-312.

Chu SY, Wilson DS, Guay DR, et al, "Clarithromycin Pharmacokinetics in Healthy Young and Elderly Volunteers," J Clin Pharmacol , 1992, 32(11):1045-9.

Dajani AS, Taubert KA, Wilson W, et al, "Prevention of Bacterial Endocarditis Recommendations by the American Heart Association," JAMA 1997, 277(22):1794-801.

Goldman MP and Longworth DL, "The Role of Azithromycin and Clarithromycin in Clinical Practice," Cleve Clin J Med , 1993, 60(5):359-64.

Guay DR, "Pharmacokinetics of New Macrolides," Infect Med , 1992, 9(Suppl A):9-13.

Guay DR and Craft JC, "Overview of the Pharmacology of Clarithromycin Suspension in Children and a Comparison With That in Adults," Pediatr Infect Dis J , 1993, 12(12 Suppl 3):S106-11.

Husson RN, Ross LA, Sandelli S, et al, "Orally Administered Clarithromycin for the Treatment of Systemic Mycobacterium avium Complex Infection in Children With Acquired Immunodeficiency Syndrome," J Pediatr , 1994, 124(5 Pt 1):807-14.

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International Brand Names

Abbotic® (ID); Adel® (MX); Aeroxina® (AR); Bacterfin® (EC); Bactirel® (DO, GT, HN, PA, SV); Biaxin® (CA, DE); Biaxin® XL (CA); Biclar® (BE, LU); Biclar IV® (BE); Bicrolid® (ID); Binoklar® (ID); Bremon® (ES); Bremon Unidia® (ES); Cempax® (CL); Centromicina® (AR); Clacine® (ID); Clambiotic® (ID); Clamicin® (BR); Clanil® (EC); Clapharma® (ID); Claribac® (CO, DO, GT, HN, SV); Claribid® (IN); Claricide® (TR); Claricin® (BD); Claridar® (HK, JO, KW, LB, MT, MY, RO); Clarimac® (IN); Claripen® (SG); Clari® (SG); Clarith® (JP, TH); Clarithromycin Sandoz® (FI); Claritrol® (CO); Claritromicina Alter® (ES); Claritromicina Aphar® (ES); Claritromicina Bexal® (ES); Claritromicina® (BR, EC); Claritromicina Busto® (ES); Claritromicina Combino Pharm® (ES); Claritromicina Cuve® (ES); Claritromicina Edigen® (ES); Claritromicina Fabra® (AR); Claritromicina Fada® (AR); Claritromicina Fyse® (ES); Claritromicina Geminis® (ES); Claritromicina Kern® (ES); Claritromicina Merck® (ES); Claritromicina MK® (CO, CR, EC, GT, HN, PA, SV); Claritromicina Montvel® (ES); Claritromicina Normon® (ES); Claritromicina Northia® (AR); Claritromicina Pharmagen® (ES); Claritromicina Ratiopharm® (ES); Claritromicina Richet® (AR); Claritromicina Richet® [inj.] (AR); Claritromicina Vegal® (ES); Claron® (TH); Clatromicin® (AR); Clormicin® (CO); Comtro® (ID); Corixa® (AR); Crixan® (RU, SG, TH); Cyllind® (DE); Deklarit® (TR); Euromicina® (CL); Extrem® (CL); Finasept® (AR); Fromilid® (CZ, HR, HU, PL, RO, RU, SI); Hecobac® (ID); Helas® (AR); Heliclar® (BE, LU); HeliClear® (GB); Helimox® (EC); Infex® (CL); Iset® (AR); Italclar® (EC); Karin® (IL); Klabax® (PL); Klabion® (PL); Klacid® (AT, AU, CH, CZ, DE, DK, EG, ES, FI, HK, HR, HU, IE, IL, IT, JO, KW, LB, NL, NO, NZ, PL, PT, RO, RU, SE, SG, SI, SY, TH, TR, YU, ZA); Klacid® [inj.] (AT, CH, NZ, RO, SI); Klacid-Lactobionat® (AT); Klacid One® (CH); Klacid Unidia® (ES); Klacid UNO® (HU, PL); Klacina® (CO); Klaciped® (CH); Klaribac® (BG, JO, KW, LB, MA, MY, SY); Klaricid® (AR, BD, BR, CL, CO, CR, DO, GB, GT, HN, JP, MX, PA, SV); Klaricid Orifarm® (DK); Klaricid UD® (BR, CL, CR, DO, GT, HN, PA, SV); Klaricid XL® (GB); Klarid® (ID); Klarimax® (JO, LB); Klarit® (GT); Klari UNO® (HU); Klarolid® (TR); Klaromin® (TR); Klax® (TR); Klerimed® (SG); Kofron® (ES); Lagur® (BR); Lagur UD® (BR); Laricid® (TR); Lekoklar® (CZ, HR, PL, SI); Mabicrol® (CR, GT, HN, MX, PA, SV); Macladin® (IT); Maclar® (AT, BE, LU); Macrol® (TR); Macromicina® (AR); Makcin® (HR); Mavid® (DE); Monaxin® (BE); Monocid® (AT); Mus® (CL); Mus TC® (CL); Naxy® (FR); Pre-Clar® (CL); ratio-Clarithromycin (CA); Ritromi® (DO); Rolicytin® (GT); Taclar® (PL); Uniklar® (TR); Veclam® (IT); Xilin® (EC); Zeclar® (FI, FR)

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