Klerimed

Klerimed

clarithromycin

Manufacturer:

Medochemie

Distributor:

Medochemie
Concise Prescribing Info
Contents
Clarithromycin
Indications/Uses
Lower resp infections eg, acute & chronic bronchitis & pneumonia; upper resp infections eg, sinusitis & pharyngitis; initial therapy in community acquired resp infections; skin & soft tissue infections of mild to moderate severity; eradication of H. pylori infections in patients w/ duodenal ulcer.
Dosage/Direction for Use
Resp tract/skin & soft tissue infections Adult & childn ≥12 yr 250 mg bd for 7 days, may be increased to 500 mg bd for up to 14 days in severe infections. Childn >12 yr As for adults; <12 yr Susp should be used. Eradication of H. pylori Adult Triple therapy regimen: Clarithromycin 500 mg bd w/ amoxicillin 1,000 mg bd & standard dose of proton pump inhibitor bd for 7 days. Dual therapy regimen: Clarithromycin 500 mg tds w/ omeprazole 40 mg once daily for 14 days, followed by omeprazole 40 mg once daily for additional 14 days.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to macrolide antibiotics. Concomitant w/ astemizole, cisapride, pimozide, terfenadine & oral midazolam may result in QT prolongation & cardiac arrhythmias; ergot alkaloids (eg, ergotamine or dihydroergotamine); HMG-CoA reductase inhibitors. History of QT prolongation or ventricular cardiac arrhythmia including Torsades de pointes. Patients w/ hypokalemia, severe hepatic failure w/ renal impairment. Concomitant w/ colchicine in patients w/ renal or hepatic impairment.
Special Precautions
Long-term use may result in colonization w/ increased numbers of nonsusceptible bacteria & fungi. Discontinue treatment if signs & symptoms of hepatitis occur. Pseudomembranous colitis, Clostridium difficile-associated diarrhea; exacerbation of myasthenia gravis symptoms. Hepatic impairment. Moderate to severe renal impairment. Monitor clinical symptoms of colchicine toxicity (especially in elderly). Concomitant w/ triazolobenzodiazepines eg, triazolam & IV midazolam. Coronary artery disease, severe cardiac insufficiency, hypomagnesemia, bradycardia (<50 bpm). Perform sensitivity testing for community-acquired pneumonia. Discontinue treatment immediately & appropriate treatment should be urgently initiated if severe acute hypersensitivity reactions eg, anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash w/ eosinophilia & systemic symptoms & Henoch-Schonlein purpura. May result significant hypoglycemia in concomitant w/ oral hypoglycemic agents &/or insulin; risk of serious hemorrhage & significant elevations in INR & prothrombin time w/ warfarin; statins. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn <12 yr.
Adverse Reactions
Inj site phlebitis. Insomnia, dysgeusia, headache, taste perversion; vasodilation; diarrhea, vomiting, dyspepsia, nausea, abdominal pain; abnormal liver function test; rash, hyperhidrosis; inj site pain & inflammation.
Drug Interactions
Elevated levels of cisapride, pimozide, astemizole & terfenadine. Acute ergot toxicity w/ ergotamine or dihydroergotamine. Induce metabolism w/ CYP3A inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort). May accelerate metabolism w/ strong CYP450 inducers (eg, efavirenz, nevirapine, rifabutin & rifapentine). Decreased exposure w/ etravirine. Increased in mean steady-state min conc & AUC w/ fluconazole. Increased Cmax, Cmin & AUC w/ ritonavir. Increased steady-state plasma conc of omeprazole. Increased phosphodiesterase inhibitor exposure w/ sildenafil, tadalafil or vardenafil. Increased levels of theophylline or carbamazepine. Increased serum conc of tolterodine. Increased AUC of midazolam. Increased exposure to colchicine. Increased serum conc of digoxin. Decreased steady-state zidovudine conc. Increase exposure w/ atazanavir. Risk of hypotension w/ Ca channel blockers (eg, verapamil, amlodipine, diltiazem). May increase plasma levels of itraconazole. Quinidine or disopyramide; alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporine, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, oral anticoagulants (eg, warfarin), pimozide, simvastatin, tacrolimus, triazolam & vinblastin, tolterodine; valproate; saquinavir.
MIMS Class
Macrolides
ATC Classification
J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Klerimed FC tab 250 mg
Packing/Price
1 × 10's;100 × 10's
Form
Klerimed FC tab 500 mg
Packing/Price
100 × 7's
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