Klacid/Klacid MR

Clarithromycin

Upper (eg, sinusitis & pharyngitis) & lower (eg, acute & chronic bronchitis & pneumonia) resp tract infections. Skin & soft tissue infections of mild to moderate severity. Klacid/Klacid Forte Initial therapy in community acquired resp infections. Eradication of H. pylori in patients w/ proven duodenal ulcers. Klacid Paed/Klacid IV Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum or Mycobacterium kansasii. Klacid Paed Acute otitis media.

Klacid/Klacid Forte Resp tract/skin & soft tissue infection 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. Eradication of H. pylori Adult & elderly Triple therapy regimen: Clarithromycin 500 mg bd in conjunction w/ amoxicillin 1,000 mg bd & PPI (standard dose) bd for 7 days. Dual therapy regimen: Clarithromycin 500 mg tds in conjunction w/ omeprazole 40 mg once daily for 14 days followed by omeprazole 40 mg once daily for an additional 14 days. Renal impairment (CrCl <30 mL/min) Reduce dosage by ½ ie, 250 mg once daily or 250 mg bd in more severe infections. Klacid MR Adult & childn >12 yr 500 mg daily. Severe infection Dose may be increased to two 500 mg daily. Usual treatment duration: 7-14 days. Klacid Paed Non-mycobacterial infection Childn 6 mth to 12 yr Recommended daily dosage: 7.5 mg/kg bd up to max of 500 mg bd for 5-10 days. Childn weighing 30-40 kg 125 mg/5 mL: 10 mL bd, 250 mg/5 mL: 5 mL bd; 20-29 kg 125 mg/5 mL: 7.5 mL bd, 250 mg/5 mL: 3.75 mL bd; 12-19 kg 125 mg/5 mL: 5 mL bd, 250 mg/5 mL: 2.5 mL bd; 8-11 kg 125 mg/5 mL: 2.5 mL bd, 250 mg/5 mL: 1.25 mL bd. Mycobacterial infection Recommended dose: 15-30 mg/kg bd. Max dose: 500 mg bd. Renal impairment Childn (CrCl <30 mL/min) Reduce dosage by ½, ie, up to 250 mg once daily or 250 mg bd in more severe infections. Klacid IV Administer as IV infusion over 60 min using soln conc of about 2 mg/mL; should be given as bolus or IM. May be given for 2-5 days & should be changed to oral therapy when appropriate. Adult ≥18 yr & elderly 1 g daily divided into two 500 mg doses. Renal impairment (CrCl <30 mL/min) Reduce to ½ of the normal recommended dose.

FC tab/Forte tab/Paed granules for oral susp: May be taken with or without food. MR tab: Should be taken with food: Swallow whole, do not chew/crush.

Hypersensitivity to macrolides. Concomitant administration w/ astemizole, cisapride, pimozide, terfenadine may result in QT prolongation & cardiac arrhythmias including ventricular tachycardia & fibrillation, Torsades de pointes. Ergot toxicity w/ ergot alkaloids (eg, ergotamine or dihydroergotamine). History of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia including Torsades de pointes. Electrolyte disturbances (hypokalemia or hypomagnesaemia). Increased risk of myopathy including rhabdomyolysis w/ HMG-CoA reductase inhibitors (statins). Concomitant administration w/ oral midazolam; colchicine; ticagrelor & ranolazine; lomitapide. Severe hepatic failure in combination w/ renal impairment. Klacid MR/Klacid Paed Patients w/ CrCl <30 mL/min.

Immediately discontinue & initiate appropriate treatment in the event of severe acute hypersensitivity reactions eg, anaphylaxis, severe cutaneous AR (eg, acute generalized exanthematous pustulosis, SJS, TEN, DRESS & Henoch-Schonlein purpura]. Superinfection may occur w/ long-term use. Immediately discontinue use if signs & symptoms of hepatitis (eg, anorexia, jaundice, dark urine, pruritus or tender abdomen) occur. Monitor for occurrence of Clostridioides difficile-associated diarrhea. Possible colchicine toxicity when used concomitantly in elderly & patients w/ renal insufficiency. Concomitant use w/ triazolobenzodiazepines (eg, triazolam & IV or oromucosal midazolam). Patients w/ CAD, severe cardiac insufficiency, conduction disturbances or clinically relevant bradycardia; hypokalaemia or hypomanesaemia; concomitantly taking other drugs associated w/ QT prolongation; history of ventricular arrhythmia. Potentially increased risk of CV events & mortality in patients taking hydroxychloroquine or chloroquine. Consider rare short-term risk of arrhythmia, MI & macrolide-associated CV mortality when prescribing. Perform sensitivity testing if to be used in community-acquired pneumonia & skin & soft tissue infections of mild to moderate severity. Use in combination w/ additional appropriate antibiotics in hospital-acquired pneumonia. Concurrent administration w/ CYP3A4 inducers. Cross-resistance w/ other macrolides, lincomycin & clindamycin. Possible rhabdomyolysis w/ statins; monitor for signs & symptoms of myopathy. Monitor glucose carefully in concomitant use w/ oral hypoglycemics (eg, sulphonylureas) &/or insulin; INR & prothrombin time in concomitant use w/ oral anticoagulants. Co-administration w/ dabigatran, rivaroxaban or apixaban particularly to patients at high risk of bleeding. May affect ability to drive or operate machinery. Hepatic impairment. Moderate to severe renal impairment. Carefully weigh benefits against risk particularly during 1st 3 mth of pregnancy. Lactation. Childn <12 yr (Klacid/Klacid Forte/Klacid MR); <18 yr (Klacid IV). Elderly. Klacid Paed Not to be taken by patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Klacid MR Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Patients on controlled Na diet; contains Na 15.3 mg/tab.

Inj site phlebitis. Insomnia; dysgeusia, headache; vasodilation; diarrhea, vomiting, dyspepsia, nausea, abdominal pain; abnormal LFT; rash, hyperhidrosis; inj site pain & inflammation. Klacid MR Taste perversion.

Elevated levels of cisapride & pimozide. May alter metabolism of terfenadine & astemizole. Acute ergot toxicity w/ ergotamine or dihydroergotamine. Increased plasma conc of lovastatin or simvastatin. Potential for markedly increased transaminases w/ lomitapide. Hydroxychloroquine or chloroquine. May induce metabolism leading to reduced efficacy w/ CYP3A4 inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort). Decreased serum levels & increased risk of uveitis w/ rifabutin. Lower plasma levels w/ strong CYP450 inducers (eg, efavirenz, nevirapine, rifampicin, rifabutin & rifapentine). Decreased exposure by etravirine. Increased mean C_min & AUC w/ fluconazole. Increased C_max, C_min & AUC w/ ritonavir. QTc prolongation w/ antiarrhythmics. Hypoglycemia may occur w/ disopyramide; oral hypoglycemics (eg, pioglitazone, rosiglitazone, nateglinide & repaglinide) or insulin. May increase or prolong therapeutic & adverse effects of drugs primarily metabolized by CYP3A. Risk of bleeding w/ direct acting oral anticoagulants. Increased steady-state plasma conc of omeprazole. Increased phosphodiesterase inhibitor exposure w/ sildenafil, tadalafil or vardenafil. Increase levels of theophylline or carbamazepine. May cause higher serum conc of tolterodine. Increased AUC of midazolam, alprazolam & triazolam. Concomitant use w/ triazolam may cause CNS effects (eg, somnolence & confusion). May increase exposure to colchicine. Elevated serum conc of digoxin. Decreased steady-state conc of zidovudine in HIV-infected adult patients. Increased serum levels of phenytoin & valproate. Co-administration w/ atazanavir. Plasma conc may be increased mutually in concomitant use w/ Ca channel blockers or itraconazole. Mutual increase in AUC & C_max in concomitant use w/ saquinavir; consider potential effects of ritonavir on clarithromycin during co-administration w/ saquinavir/ritonavir therapy.

Macrolides

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

POM