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Biaxin XL






Treatment of the following mild to moderate infections caused by susceptible isolates of bacteria: (Tab/Sus) Pharyngitis/tonsillitis, acute maxillary sinusitis, community-acquired pneumonia (CAP), uncomplicated skin and skin structure infections (SSSIs), and disseminated mycobacterial infections. Mycobacterium avium complex (MAC) prophylaxis in advanced HIV infection. Acute bacterial exacerbation of chronic bronchitis (ABECB) in adults. Acute otitis media in pediatric patients. (Tab) Combination therapy for Helicobacter pylori infection w/ duodenal ulcer disease (active or 5-yr history of duodenal ulcer) in adults. (XL) Acute maxillary sinusitis, CAP, and ABECB in adults.


Mycobacterial Infections

Prophylaxis of Disseminated Mycobacterium avium Complex (MAC) in Patients w/ Advanced HIV Infection:
Usual: 500mg bid

Treatment of Disseminated Infection Due to MAC or M. intracellulare:
500mg bid; continue therapy if clinical response is observed
D/C when the patient is considered at low risk of disseminated infection


Due to Streptococcus pyogenes:
250mg q12h for 10 days

Acute Maxillary Sinusitis

Due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae:
500mg q12h for 14 days

XL Tab:
1000mg q24h for 14 days

Community-Acquired Pneumonia

Haemophilus influenzae:
250mg q12h for 7 days
Streptococcus pneumoniae, Chlamydophila pneumoniae, or Mycoplasma pneumoniae: 250mg q12h for 7-14 days

XL Tab:
H. influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, S. pneumoniae, C. pneumoniae, or M. pneumoniae:
1000mg q24h for 7 days

Skin and Skin Structure Infections

Uncomplicated Infections Due to Staphylococcus aureus or Streptococcus pyogenes:
250mg q12h for 7-14 days

Helicobacter pylori Eradication

Triple Therapy:
500mg + 1g amoxicillin + 20mg omeprazole, all q12h for 10 days; give additional 20mg omeprazole qd for 18 days for ulcer healing/symptom relief if an ulcer was present at the time of initiation
500mg + 1g amoxicillin + 30mg lansoprazole, all q12h for 10 or 14 days

Dual Therapy:
500mg q8h + 40mg omeprazole qam for 14 days; give additional 20mg omeprazole qd for 14 days for ulcer healing/symptom relief
500mg q8h or q12h + 400mg ranitidine bismuth citrate q12h for 14 days; give additional 400mg ranitidine bismuth citrate bid for 14 days for ulcer healing/symptom relief

Acute Bacterial Exacerbation of Chronic Bronchitis

Moraxella catarrhalis or Streptococcus pneumoniae:
250mg q12h for 7-14 days
Haemophilus influenzae:
500mg q12h for 7-14 days
Haemophilus parainfluenzae:
500mg q12h for 7 days

XL Tab:
H. influenzae, H. parainfluenzae, M. catarrhalis, or S. pneumoniae:
1000mg q24h for 7 days


General Dosing

Pharyngitis/tonsillitis due to Streptococcus pyogenes; community-acquired pneumonia due to Mycoplasma pneumoniae, S. pneumoniae, or Chlamydophila pneumoniae; acute maxillary sinusitis or acute otitis media due to Haemophilus influenzae, Moraxella catarrhalis, or S. pneumoniae; or uncomplicated skin and skin structure infections due to Staphylococcus aureus or S. pyogenes

≥6 Months of Age:
15mg/kg/day divided q12h for 10 days

Mycobacterial Infections

≥20 Months of Age:
Prophylaxis of Disseminated Mycobacterium avium Complex (MAC) in Patients w/ Advanced HIV Infection:
7.5mg/kg bid, up to 500mg bid

Treatment of Disseminated Infection Due to MAC or M. intracellulare:
Usual: 7.5mg/kg bid, up to 500mg bid; continue therapy if clinical response is observed
D/C when the patient is considered at low risk of disseminated infection


Concomitant Medications
Ranitidine Bismuth Citrate: Not recommended if CrCl <25mL/min or w/ history of acute porphyria

Renal Impairment

Severe (CrCl <30mL/min): Reduce dose by 50%

Concomitant Atazanavir or Ritonavir:
CrCl 30-60mL/min: Reduce dose by 50%
CrCl <30mL/min: Reduce dose by 75%


Oral route

Take w/ or w/o food; may be taken w/ milk

Shake well before each use
Reconstitute 50mL bottle sizes w/ 27mL of water and 100mL bottle sizes w/ 55mL of water
Add water in 2 portions and shake after each aliquot
Use w/in 14 days

XL Tab
Take w/ food
Swallow whole; do not chew, crush, or break


Sus: 125mg/5mL, 250mg/5mL [50mL, 100mL]; Tab: 250mg, 500mg; Tab, Extended-Release (XL): 500mg


History of cholestatic jaundice/hepatic dysfunction associated w/ prior use of clarithromycin. History of QT prolongation or ventricular cardiac arrhythmia, including torsades de pointes. Concomitant use w/ cisapride, pimozide, astemizole, terfenadine, ergotamine, or dihydroergotamine, and w/ HMG-CoA reductase inhibitors that are extensively metabolized by CYP3A4 (lovastatin or simvastatin). Concomitant use w/ colchicine in patients w/ renal/hepatic impairment.


Avoid in pregnancy, except in clinical circumstances where no alternative therapy is appropriate. Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, w/ or w/o jaundice, reported; d/c immediately if signs/symptoms of hepatitis occur. QT interval prolongation, arrhythmia (infrequent), and torsades de pointes reported; avoid w/ ongoing proarrhythmic conditions (eg, uncorrected hypokalemia, hypomagnesemia) and clinically significant bradycardia. Clostridium difficile-associated diarrhea (CDAD) reported; may need to d/c if CDAD is suspected or confirmed. D/C therapy immediately and initiate prompt treatment if severe acute hypersensitivity reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash w/ eosinophilia and systemic symptoms, Henoch-Schonlein purpura) occur. May result in bacterial resistance w/ prolonged use in the absence of a proven/suspected bacterial infection or a prophylactic indication. Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome reported. Caution in elderly.


Diarrhea, N/V, dysgeusia, abdominal pain.


See Contraindications and Dose Modification. Avoid Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. May increase serum theophylline, carbamazepine, omeprazole, and digoxin, drugs metabolized by CYP3A, colchicine, saquinavir, tolterodine, and itraconazole levels. Bradyarrhythmias and lactic acidosis observed w/ verapamil. Hypotension and acute kidney injury may occur w/ calcium channel blockers metabolized by CYP3A4 (eg, verapamil, amlodipine, diltiazem). Increased levels w/ fluconazole, itraconazole, and saquinavir. Avoid doses of >1000mg/day w/ protease inhibitors. May potentiate oral anticoagulant effects. Risk of serious hemorrhage and significant elevations in PT/INR w/ warfarin; monitor PT/INR frequently. Caution w/ other drugs known to be CYP3A enzyme substrates, especially if substrate has a narrow safety margin (eg, carbamazepine) and/or substrate is extensively metabolized by this enzyme. Decreased levels w/ CYP3A inducers (eg, efavirenz, rifampicin, rifapentine); consider alternative antibacterial treatment. May increase levels of rifabutin and increase risk of uveitis w/ rifabutin. Etravirine may decrease exposure; consider alternative for treatment of MAC. Concomitant use w/ phosphodiesterase inhibitors (sildenafil, tadalafil, vardenafil) is not recommended. Consider reduction of sildenafil dose. CNS effects, increased sedation, and prolongation of sedation reported w/ concomitant triazolobenzodiazepines (eg, triazolam, midazolam); monitor for additive CNS effects and consider appropriate dose adjustments. May increase AUC of midazolam; possible prolongation and intensity of effect should be anticipated. Occurrence of torsades de pointes w/ quinidine or disopyramide reported; monitor serum levels and for QT prolongation. Interactions may occur w/ cyclosporine, tacrolimus, alfentanil, rifabutin, methylprednisolone, cilostazol, bromocriptine, vinblastine, phenobarbital, St. John's wort, hexobarbital, phenytoin, and valproate. Significant hypoglycemia may occur w/ oral hypoglycemic agents (eg, nateglinide, pioglitazone, repaglinide) and/or insulin. Caution when prescribing w/ statins; if concomitant use w/ atorvastatin or pravastatin cannot be avoided, do not exceed 20mg/day of atorvastatin and 40mg/day of pravastatin. Consider use of a statin that is not dependent on CYP3A metabolism (eg, fluvastatin); prescribe the lowest registered dose if concomitant use cannot be avoided. (Tab) May decrease levels of zidovudine; separate zidovudine administration by at least 2 hrs.


Category C, caution in nursing.


Semisynthetic macrolide antibiotic; exerts antibacterial action by binding to the 50S ribosomal subunit of susceptible microorganisms, resulting in inhibition of protein synthesis.


Absorption: Rapid; (250mg tab) absolute bioavailability (50%). Administration of variable doses resulted in different parameters. Distribution: Found in breast milk. Metabolism: 14-OH clarithromycin (primary metabolite). Elimination: Urine: 20% (250mg tab), 30% (500mg tab), 40% (250mg sus), 10-15% (14-OH clarithromycin). T1/2=3-4 hrs (250mg tab), 5-7 hrs (500mg). 14-OH clarithromycin: T1/2=5-6 hrs (250mg), 7-9 hrs (500mg).


Assess for history of cholestatic jaundice/hepatic dysfunction associated w/ prior use of clarithromycin, hepatic/renal impairment, history of QT prolongation, ongoing proarrhythmic conditions, clinically significant bradycardia, ventricular cardiac arrhythmia, torsades de pointes, myasthenia gravis, history of acute porphyria, pregnancy/nursing status, possible drug interactions, and hypersensitivity to the drug, any of its ingredients, erythromycin, or any of the macrolide antibiotics.


Monitor for development of drug-resistant bacteria, CDAD, hepatitis, QT prolongation, severe acute hypersensitivity reactions, exacerbation of myasthenia gravis, new onset of symptoms of myasthenic syndrome, and other adverse reactions. Monitor LFTs and renal function. Frequently monitor INR/PT w/ oral anticoagulants.


Inform about potential benefits/risks of therapy. Counsel that therapy should only be used to treat bacterial, not viral, infections. Instruct to take exactly ud; inform that skipping doses or not completing full course may decrease effectiveness and increase antibiotic resistance. Instruct to notify physician if watery/bloody diarrhea (w/ or w/o stomach cramps and fever) develops, even as late as ≥2 months after treatment. Instruct to notify physician if pregnant/nursing and of all medications currently being taken.


(250mg tab) 15-30°C (59-86°F). Protect from light. (500mg tab) 20-25°C (68-77°F). (Sus) <25°C (77°F). Do not refrigerate. (XL tab) 20-25°C (68-77°F); excursions permitted 15-30°C (59-86°F).


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