Clarithromycin Ext-rel

  • Bacterial infections

Clarithromycin Ext-rel Generic Name & Formulations

General Description

Clarithromycin 500mg.

Pharmacological Class


How Supplied

Contact supplier

Clarithromycin Ext-rel Indications


Mild to moderate susceptible acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia.

Clarithromycin Ext-rel Dosage and Administration


Swallow whole. Take with food. 1g once daily. Sinusitis: for 14 days. Bronchitis, pneumonia: for 7 days. 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).


Not established.

Clarithromycin Ext-rel Contraindications


Concomitant cisapride, pimozide, ergots, lomitapide, 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.

Clarithromycin Ext-rel Boxed Warnings

Not Applicable

Clarithromycin Ext-rel 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. Embryo-fetal toxicity. Pregnancy: not recommended (except when no alternatives are appropriate). Nursing mothers.

Clarithromycin Ext-rel Pharmacokinetics

See Literature

Clarithromycin Ext-rel 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).

Clarithromycin Ext-rel Adverse Reactions

Adverse Reactions

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

Clarithromycin Ext-rel Clinical Trials

See Literature

Clarithromycin Ext-rel Note


Formerly known under the brand name Biaxin, Biaxin Oral Suspension, Biaxin XL.

Clarithromycin Ext-rel Patient Counseling

See Literature