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BIAXIN
Bacterial infections
Hyperacidity, GERD, and ulcers
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Drug Name:

BIAXIN Rx

Generic Name and Formulations:
Clarithromycin 250mg, 500mg; tabs.

Company:
AbbVie

Therapeutic Use:

Indications for BIAXIN:

Mild to moderate susceptible pharyngitis/tonsillitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, acute maxillary sinusitis, acute otitis media, uncomplicated skin and skin structure infections. Disseminated M. intracellulare. Treatment (with other antimycobacterials) and prophylaxis of disseminated Mycobacterium avium complex (MAC).

Adult:

Pharyngitis/tonsillitis: 250mg every 12hrs for 10 days. Bronchitis: 250mg–500mg every 12hrs for 7–14 days. CAP, skin and skin structures: 250mg every 12hrs for 7–14 days. Sinusitis: 500mg every 12hrs for 14 days. MAC: 500mg every 12hrs; continue indefinitely if improvement occurs. Severe renal impairment (CrCl <30mL/min): reduce clarithromycin dose by ½. When moderate or severe renal impairment and concomitant atazanavir or ritonavir: reduce clarithromycin dose by ½ (CrCl 30–60mL/min) or ¾ (CrCl <30mL/min).

Children:

<6 months: not established. Otitis media, pharyngitis/tonsillitis, pneumonia, sinusitis, skin and skin structures: 7.5mg/kg every 12hrs for 10 days. MAC (see full labeling): 7.5mg/kg every 12hrs; max 500mg every 12hrs, continue indefinitely if improvement occurs.

Contraindications:

Concomitant cisapride, pimozide, ergots, HMG-CoA reductase inhibitors extensively metabolized by CYP3A4 (lovastatin or simvastatin). Concomitant colchicine (in renal or hepatic impairment). Cholestatic jaundice/hepatic dysfunction with prior clarithromycin use.

Warnings/Precautions:

Discontinue immediately if hepatitis or severe hypersensitivity reactions occur. Avoid in known QT prolongation, ventricular cardiac arrhythmia (including torsades de pointes), proarrhythmic conditions (eg, hypokalemia, hypomagnesemia, bradycardia). Coronary artery disease. Myasthenia gravis. Severe renal impairment. Elderly. Pregnancy (Cat.C): not recommended (except when no alternative drugs exist). Nursing mothers.

Interactions:

See Contraindications. Class IA (disopyramide, quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmics, or other drugs known to prolong QT interval: not recommended. Sildenafil, tadalafil, vardenafil: not recommended. Antagonized by CYP3A inducers (eg, efavirenz, nevirapine, rifampicin, rifabutin, rifapentine, etravirine); use alternative antibacterial treatment. Doses >1000mg/day should not be coadministered with protease inhibitors. Separate zidovudine dose by at least 2hrs. Potentiated by CYP3A inhibitors (eg, itraconazole, saquinavir, atazanavir, ritonavir). Concomitant atazanavir: see Adults; consider alternative antibacterial therapy for indications other than MAC. May potentiate theophylline, omeprazole, phenytoin, digoxin, midazolam, alprazolam, triazolam, cyclosporine, hexobarbital, tacrolimus, alfentanil, bromocriptine, valproate, carbamazepine, tolterodine, itraconazole, methylprednisolone, cilostazol, vinblastine, quetiapine, maraviroc; monitor these and other drugs metabolized by CYP3A. Myopathy/rhabdomyolysis with statins; max 20mg atorvastatin/day, 40mg pravastatin/day; consider use of statin not dependent on CYP3A metabolism (eg, fluvastatin). Reduce colchicine dose if coadministration is necessary. Hypoglycemia with oral hypoglycemics/insulin; carefully monitor glucose. Oral anticoagulants: frequently monitor INR and prothrombin times. Hypotension with calcium channel blockers metabolized by CYP3A4 (eg, verapamil, amlodipine, diltiazem, nifedipine).

See Also:

BIAXIN XL

BIAXIN ORAL SUSPENSION

Pharmacological Class:

Macrolide.

Adverse Reactions:

Abdominal pain, diarrhea, nausea, vomiting, dysguesia; hepatotoxicity, QT prolongation, C. difficile associated diarrhea, hypersensitivity reactions.

Metabolism:

Hepatic.

Elimination:

Renal.

Generic Availability:

XL, tabs (YES); susp (NO)

How Supplied:

XL tabs, tabs—60; Biaxin XL-Pac (14 x 500mg XL tabs)—4; Susp—50mL, 100mL

Indications for BIAXIN:

Triple therapy (w. amoxicillin + lansoprazole or omeprazole) for treating patients with H. pylori infection and duodenal ulcer disease. Dual therapy (w. omeprazole) for treating active duodenal ulcer associated with H. pylori infection.

Adult:

Triple therapy: clarithromycin 500mg + lansoprazole 30mg + amoxicillin 1g, all every 12hrs for 10 or 14 days. Or, clarithromycin 500mg + omeprazole 20mg + amoxicillin 1g, all every 12hrs for 10 days; may continue omeprazole for days 11–28 if ulcer was present at start. Dual therapy: clarithromycin 500mg every 8hrs + omeprazole 40mg once daily in the AM on days 1–14, then omeprazole 20mg once daily in the AM on days 15–28. Severe renal impairment (CrCl <30mL/min): reduce clarithromycin dose by ½. When moderate or severe renal impairment and concomitant atazanavir or ritonavir: reduce clarithromycin dose by ½ (CrCl 30–60mL/min) or ¾ (CrCl <30mL/min).

Children:

Not established.

Contraindications:

Concomitant cisapride, pimozide, ergots, HMG-CoA reductase inhibitors extensively metabolized by CYP3A4 (lovastatin or simvastatin). Concomitant colchicine (in renal or hepatic impairment). Cholestatic jaundice/hepatic dysfunction with prior clarithromycin use.

Warnings/Precautions:

Discontinue immediately if hepatitis or severe hypersensitivity reactions occur. Avoid in known QT prolongation, ventricular cardiac arrhythmia (including torsades de pointes), proarrhythmic conditions (eg, hypokalemia, hypomagnesemia, bradycardia). Coronary artery disease. Myasthenia gravis. Severe renal impairment. Elderly. Pregnancy (Cat.C): not recommended (except when no alternative drugs exist). Nursing mothers.

Interactions:

See Contraindications. Class IA (disopyramide, quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmics, or other drugs known to prolong QT interval: not recommended. Sildenafil, tadalafil, vardenafil: not recommended. Antagonized by CYP3A inducers (eg, efavirenz, nevirapine, rifampicin, rifabutin, rifapentine, etravirine); use alternative antibacterial treatment. Doses >1000mg/day should not be coadministered with protease inhibitors. Separate zidovudine dose by at least 2hrs. Potentiated by CYP3A inhibitors (eg, itraconazole, saquinavir, atazanavir, ritonavir). Concomitant atazanavir: see Adults; consider alternative antibacterial therapy for indications other than MAC. May potentiate theophylline, omeprazole, phenytoin, digoxin, midazolam, alprazolam, triazolam, cyclosporine, hexobarbital, tacrolimus, alfentanil, bromocriptine, valproate, carbamazepine, tolterodine, itraconazole, methylprednisolone, cilostazol, vinblastine, quetiapine, maraviroc; monitor these and other drugs metabolized by CYP3A. Myopathy/rhabdomyolysis with statins; max 20mg atorvastatin/day, 40mg pravastatin/day; consider use of statin not dependent on CYP3A metabolism (eg, fluvastatin). Reduce colchicine dose if coadministration is necessary. Hypoglycemia with oral hypoglycemics/insulin; carefully monitor glucose. Oral anticoagulants: frequently monitor INR and prothrombin times. Hypotension with calcium channel blockers metabolized by CYP3A4 (eg, verapamil, amlodipine, diltiazem, nifedipine).

Pharmacological Class:

Macrolide.

Adverse Reactions:

Abdominal pain, diarrhea, nausea, vomiting, dysguesia; hepatotoxicity, QT prolongation, C. difficile associated diarrhea, hypersensitivity reactions.

Note:

See Prilosec entry for more information on omeprazole. See Prevacid entry for more information on lansoprazole. See Amoxil entry for more information on amoxicillin.

Metabolism:

Hepatic.

Elimination:

Renal.

Generic Availability:

XL, tabs (YES); susp (NO)

How Supplied:

Tabs—60

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