Clarithromycin Stella

Clarithromycin

Treatment of lower resp tract infections & URTIs; mild to moderate skin & soft tissue infections. Initial therapy in community-acquired resp infections. Eradication of H. pylori in patients w/ duodenal ulcers.

Adult, childn ≥12 yr & elderly Treatment of resp tract/skin & soft tissue infections 250 mg bd for 6-14 days, may be increased to 500 mg bd in severe infections. Adult & elderly Eradication of H. pylori in patients w/ duodenal ulcers Usual treatment duration: 6-14 days. Triple therapy: Clarithromycin 500 mg bd + lansoprazole 30 mg bd + amoxicillin 1,000 mg bd; or clarithromycin 500 mg bd + lansoprazole 30 mg bd + metronidazole 400 mg bd; or clarithromycin 500 mg bd + omeprazole 40 mg daily + amoxicillin 1,000 mg bd or metronidazole 400 mg bd; or clarithromycin 500 mg bd + amoxicillin 1,000 mg bd + omeprazole 20 mg daily. Patient w/ severe renal impairment (CrCl <30 mL/min) Total daily dose: Reduce by ½, should not be continued beyond 14 days.

May be taken with or without food.

Hypersensitivity to clarithromycin or other macrolide antibiotics. Patients w/ history of QT prolongation (congenital or documented acquired) or ventricular cardiac arrhythmia, including torsades de pointes. Patients w/ hypokalaemia. Concomitant use w/ ergot alkaloids (eg, ergotamine or dihydroergotamine); oral midazolam; astemizole, cisapride, pimozide & terfenadine; ticagrelor or ranolazine; HMG-CoA reductase inhibitors that are extensively metabolized by CYP3A4 (lovastatin or simvastatin); colchicine. Patients w/ severe hepatic failure in combination w/ renal impairment.

Immediately discontinue in case of severe acute hypersensitivity reactions eg, anaphylaxis, severe cutaneous adverse reactions (eg, acute generalised exanthematous pustulosis, SJS, TEN, DRESS). Use of any antimicrobial therapy to treat H. pylori infection may select for drug-resistant organisms. Perform sensitivity testing when prescribing for community-acquired pneumonia & skin & soft tissue infections due to possible/emerging resistance (Strep pneumoniae, Staph aureus, Strep pyogenes). Should be used w/ additional appropriate antibiotics in hospital-acquired pneumonia. Long-term use may result in colonisation w/ increased numbers of non-susceptible bacteria & fungi. Possibility of cross-resistance w/ other macrolide drugs, as well as lincomycin & clindamycin. Reports of hepatic dysfunction, including increased liver enzymes, & hepatocellular &/or cholestatic hepatitis, w/ or w/o jaundice. Reports of pseudomembranous colitis; Clostridium difficile-associated diarrhoea. Risk of arrhythmia, MI & CV mortality. Reports of rhabdomyolysis w/ statins. Monitor for signs & symptoms of myopathy. Use of a statin that is not dependent on CYP3A metabolism (eg, fluvastatin) can be considered, if concomitant use w/ statins cannot be avoided. Risk of significant hypoglycaemia w/ oral hypoglycaemic agents (eg, sulphonylureas) &/or insulin. Careful glucose monitoring is recommended. Risk of serious haemorrhage & significant elevations in INR & prothrombin time w/ warfarin. Frequently monitor INR & prothrombin times. Concomitant use of CYP3A4 inducers; triazolobenzodiazepines eg, triazolam & IV/oromucosal midazolam. Patients w/ CAD, severe cardiac insufficiency, conduction disturbances or clinically relevant bradycardia; electrolyte disturbances, eg, hypomagnesaemia. Patients concomitantly taking other medicinal products associated w/ QT prolongation. Patients w/ hepatic impairment, pre-existing hepatic disease, or taking other hepatotoxic medicinal products. Patients w/ moderate to severe renal impairment. Pregnancy & lactation. Not recommended for childn <12 yr.

Insomnia; dysgeusia, headache, taste perversion; diarrhoea, vomiting, dyspepsia, nausea, abdominal pain; abnormal liver function test; rash, hyperhidrosis.

QT prolongation & cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation & torsades de pointes w/ cisapride, pimozide, astemizole, terfenadine. Acute ergot toxicity w/ ergotamine or dihydroergotamine. Increased AUC of oral midazolam. Increased risk of myopathy, including rhabdomyolysis, w/ lovastatin or simvastatin. Induced metabolism w/ CYP3A inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort). Increased risk of uveitis w/ rifabutin. Decreased clarithromycin & increased metabolite (14-OH-clarithromycin) plasma levels w/ strong CYP450 inducers (eg, efavirenz, nevirapine, rifampicin, rifabutin, rifapentine); etravirine. Inhibited metabolism w/ ritonavir. Elevated drug conc of CYP3A substrates (eg, alprazolam, astemizole, carbamazepine, cilostazol, cisapride, ciclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (eg, warfarin), atypical antipsychotics (eg, quetiapine), pimozide, quinidine, rifabutin, sildenafil, simvastatin, sirolimus, tacrolimus, terfenadine, triazolam, vinblastine); other CYP450 substrates (eg, phenytoin, theophylline, valproate). Risk of torsades de pointes w/ quinidine or disopyramide. Risk of hypoglycemia w/ disopyramide; nateglinide, repaglinide. Increased plasma conc of omeprazole. Increased exposure of sildenafil, tadalafil or vardenafil. Increased serum conc of tolterodine. Increased AUC of triazolobenzodiazepines (eg, midazolam, alprazolam, triazolam). P-gp &/or CYP3A inhibition by clarithromycin may lead to increased exposure to colchicine. Elevated digoxin serum conc leading to signs of digoxin toxicity. Decreased steady-state oral zidovudine conc in HIV-infected adult patients. Bi-directional drug interaction w/ atazanavir; itraconazole; saquinavir. Risk of hypotension w/ Ca channel blockers metabolized by CYP3A4 (eg, verapamil, amlodipine, diltiazem). Possibility of contraceptive failure if diarrhoea, vomiting or breakthrough bleeding occur in patients taking OCs.

Macrolides

J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.

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