BIAXIN ORAL SUSPENSION Rx

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BIAXIN ORAL SUSPENSION

Bacterial infections
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Generic Name and Formulations:

Clarithromycin 125mg/5mL, 250mg/5mL; granules for oral susp; fruit-punch flavor.

Company:

AbbVie

Select therapeutic use:

Indications for BIAXIN ORAL SUSPENSION:

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 12 hours for 10 days. Bronchitis: 250mg–500mg every 12 hours for 7–14 days. CAP, skin and skin structures: 250mg every 12 hours for 7–14 days. Sinusitis: 500mg every 12 hours for 14 days. MAC: 500mg every 12 hours 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 12 hours for 10 days. MAC (see full labeling): 7.5mg/kg every 12 hours; max 500mg twice daily, continue indefinitely if improvement occurs.

Contraindications:

Concomitant cisapride, pimozide, ergots, HMG-CoA reductase inhibitors extensively metabolized by CYP3A4 (lovastatin or simvastatin). History of QT prolongation or ventricular cardiac arrhythmia (including torsades de pointes). 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 occurs. Severe renal impairment. Proarrhythmic conditions (eg, hypokalemia, hypomagnesemia, bradycardia); avoid. Myasthenia gravis. History of porphyria; avoid concomitant ranitidine bismuth citrate. Elderly. Pregnancy (Cat.C): usually not recommended. Nursing mothers.

Interactions:

See Contraindications. Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmics: 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, disopyramide, bromocriptine, valproate, carbamazepine, tolterodine, itraconazole, methylprednisolone, cilostazol, vinblastine, quetiapine; 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).

See Also:

BIAXIN

BIAXIN XL

Pharmacological Class:

Macrolide.

Adverse Reactions:

Diarrhea, vomiting, dyspepsia, nausea, abdominal pain, abnormal taste, headache, insomnia, rash, increased BUN; 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