Klaricid/Klaricid OD

Lower resp tract infections (eg, bronchitis, pneumonia); URTI (eg, pharyngitis, sinusitis); skin & soft tissue infections (eg, folliculitis, cellulitis, erysipelas). Klaricid tab/Klaricid OD Odontogenic infections. Klaricid tab/granules for oral susp Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum or Mycobacterium kansasii. Klaricid tab Prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV-infected patients w/ CD4 lymphocyte counts ≤100 cells/mm³. Eradication of H. pylori in the presence of acid suppression. Klaricid granules for oral susp Acute otitis media.

Klaricid tab Adult & childn ≥12 yr 250 mg bid. Can be increased to 500 mg bid in more severe infections. Duration of therapy: 5-14 days; community acquired pneumonia & sinusitis: 6-14 days. Mycobacterial infections 500 mg bid. MAC prophylaxis 500 mg bid. Odontogenic infections 250 mg bid for 5 days. Peptic ulcer due to H. pylori infection 500 mg bid in combination w/ other appropriate antimicrobial treatments & PPI for 7-14 days. Patient w/ renal impairment w/ CrCl <30 mL/min Reduce dose by ½ ie, 250 mg once daily, or 250 mg bid in more severe infections. Klaricid granules for oral susp Childn <12 yr 7.5 mg/kg bid up to max of 500 mg bid for non-mycobacterial infections for 5-10 days. Mycobacterial infections 7.5-15 mg/kg bid. Max: 500 mg bid. Klaricid OD MR tab Adult & childn ≥12 yr 500 mg once daily. May be increased to 1,000 mg once daily in more severe infections. Duration: 5-14 days; community acquired pneumonia & sinusitis: 6-14 days. Odontogenic infections 500 mg once daily for 5 days. Patient w/ severe renal impairment (CrCl <30 mL/min) 250 mg once daily, or 500 mg once daily in more severe infections.

Klaricid tab May be taken with or without food. Klaricid granules for oral susp May be taken with or without food. May be taken w/ milk. Klaricid OD MR tab Should be taken with food. Swallow whole, do not chew/crush.

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

Immediately discontinue use in the event of severe acute hypersensitivity reactions eg, anaphylaxis, severe cutaneous adverse reactions; & if signs & symptoms of hepatitis occur. Long-term use may result in colonization w/ increased numbers of non-susceptible bacteria & fungi. Reports of hepatic dysfunction, including increased liver enzymes, & hepatocellular &/or cholestatic hepatitis, w/ or w/o jaundice; pseudomembranous colitis & Clostridioides difficile-associated diarrhea; prolonged cardiac repolarisation & QT interval. Perform sensitivity testing in patients w/ community-acquired pneumonia & skin & soft tissue infections. Possibility of cross resistance between clarithromycin & other macrolide drugs, as well as lincomycin & clindamycin. Concomitant use w/ triazolobenzodiazepines eg, triazolam, & IV or oromucosal midazolam; CYP3A4 inducers; statins; oral hypoglycemic agents (eg, sulphonylureas) &/or insulin; warfarin; direct acting oral anticoagulants eg, dabigatran, rivaroxaban, apixaban & edoxaban. Patients w/ hepatic impairment or moderate to severe renal impairment. Potential for dizziness, vertigo, confusion & disorientation may affect ability to drive & use machines. Not advised during pregnancy w/o carefully weighing the benefits against risks. Safety of use during breast-feeding has not been established. Klaricid tab Use has not been studied in childn <12 yr. Klaricid granules for oral susp Patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Take sucrose content into account in diabetic patients.

Abdominal pain, diarrhea, nausea, vomiting & taste perversion.

May result in QT prolongation & cardiac arrhythmias w/ cisapride, pimozide, terfenadine, astemizole & other macrolides. Acute ergot toxicity w/ ergotamine/dihydroergotamine. Increased AUC of oral midazolam. Increased plasma conc of lovastatin or simvastatin; ticagrelor, ivabradine, ranolazine; omeprazole. Increased transaminases w/ lomitapide. Accelerated metabolism & lower plasma levels w/ strong CYP450 inducers eg, efavirenz, nevirapine, rifampicin, rifabutin & rifapentine. Decreased exposure w/ etravirine. Marked inhibition of metabolism w/ ritonavir. Post-marketing reports of torsades de pointes w/ quinidine or disopyramide. Post-marketing reports of hypoglycemia w/ disopyramide. Risk of hypoglycemia w/ certain hypoglycemic drugs eg, nateglinide & repaglinide. Elevated drug conc of CYP3A substrates. Potential for increased systemic exposure to corticosteroids that are primarily metabolized by CYP3A; sildenafil, tadalafil & vardenafil; colchicine; digoxin. Increased INR & prothrombin time w/ warfarin. High risk of bleeding w/ dabigatran, edoxaban, rivaroxaban & apixaban. Increased circulating levels of theophylline or carbamazepine. Higher serum conc of tolterodine in CYP2D6 poor metabolizer population. Increased AUC of IV or oromucosal midazolam; other benzodiazepines that are metabolized by CYP3A, including triazolam & alprazolam. Post-marketing reports of CNS effects w/ triazolam. Decreased steady state conc of zidovudine. Increased risk of CV events & mortality w/ hydroxychloroquine or chloroquine. Co-administration w/ atazanavir resulted in increase in exposure to clarithromycin, decrease in exposure to 14-OH-clarithromycin, w/ increase in AUC of atazanavir. Risk of hypotension w/ Ca channel blockers metabolized by CYP3A4 (eg, verapamil, amlodipine, diltiazem). Increased plasma levels of itraconazole & clarithromycin when co-administered. Increased AUC & C_max of saquinavir & clarithromycin when co-administered. Reports of interaction w/ drugs not thought to be metabolized by CYP3A (eg, phenytoin & valproate).

Macrolides

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

Rx