Klacid/Klacid MR

Clarithromycin

Upper (eg, tonsillitis, sinusitis, pharyngitis) & lower (eg, bronchitis, pneumonia) resp tract infections. Skin & soft tissue infections eg, impetigo, erysipelas, folliculitis, furunculosis, septic wounds, cellulitis, abscesses. Klacid tab H pylori eradication in patients w/ duodenal ulcers in presence of acid suppression effected by omeprazole. Klacid granules for oral susp Acute otitis media. Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum or Mycobacterium kansasii.

Klacid tab Adult & childn ≥12 yr 250 mg bd. More severe infections 500 mg bd. Duration: 5-14 days. Community-acquired pneumonia, sinusitis 6-14 days. H pylori eradication in duodenal ulcers Adult & elderly 500 mg tds for 14 days. Dual therapy: 500 mg tds + omeprazole 40 mg once daily for 14-28 days. Triple therapy: 500 mg bd + amoxicillin 1,000 mg bd + omeprazole 20 mg daily for 10 days. Ped patient <12 yr Klacid granules for oral susp Non-mycobacterial infections 7.5 mg/kg bd up to max: 500 mg bd for 5-10 days. Klacid granules for oral susp 125 mg/5 mL Childn 30-40 kg 10 mL bd, 20-29 kg 7.5 mL bd, 12-19 kg 5 mL bd, 8-11 kg 2.5 mL bd, <8 kg approx 7.5 mg/kg bd. Mycobacterial infections 7.5-15 mg/kg bd up to max: 500 mg bd. Klacid granules for oral susp 250 mg/5 mL Childn 30-40 kg 5 mL bd, 20-29 kg 3.75 mL bd, 12-19 kg 2.5 mL bd, 8-11 kg 1.25 mL bd, <8 kg approx 7.5 mg/kg bd. Mycobacterial infections 15-30 mg/kg in 2 divided doses. Renal impairment CrCl <30 mL/min Reduce to ½ ie, 250 mg once daily. More severe infections 250 mg bd. Klacid MR tab Adult & childn ≥12 yr 500 mg once daily. Severe infections 1,000 mg once daily. Duration: 5-14 days. Community-acquired pneumonia, sinusitis 6-14 days. Renal impairment CrCl <30 mL/min Reduce to ½ ie, 250 mg once daily. More severe infections 500 mg once daily.

May be taken with or without food: MR tab: Take w/ meals. Swallow whole, do not chew/crush.

Hypersensitivity to macrolides. History of congenital or documented acquired QT prolongation or ventricular cardiac arrhythmia including Torsade de pointes; electrolyte disturbances eg, hypokalemia or hypomagnesaemia. Concomitant use w/ astemizole, cisapride, domperidone, pimozide, terfenadine, ergot alkaloids, oral midazolam, HMG-CoA reductase inhibitors (eg, lovastatin or simvastatin), colchicine, lomitapide, ticagrelor or ranolazine. Severe hepatic failure w/ renal impairment.

Discontinue use if severe acute hypersensitivity reactions; signs & symptoms of hepatitis occurs. Not to be used in patients w/ congenital or documented acquired QT prolongation, history of ventricular arrhythmia; hypokalaemia or hypomagnesaemia. Pseudomembranous colitis, Clostridium difficile-associated diarrhea; CAD, severe cardiac insufficiency, conduction disturbances or clinically relevant bradycardia. Superinfection due to long-term use. Perform sensitivity testing if to be used in community-acquired pneumonia, mild to moderate skin & soft tissue infections. Cross-resistance w/ other macrolides eg, lincomycin, clindamycin. Not to be used concomitantly w/ colchicine, astemizole, cisapride, domperidone, pimozide, terfenadine, lovastatin or simvastatin. Concomitant use w/ triazolobenzodiazepines eg, triazolam, midazolam; drugs associated w/ QT prolongation; CYP3A4 inducers; other statins; oral hypoglycemic agents (eg, sulphonylureas), insulin; warfarin, direct-acting oral anticoagulants eg, dabigatran, rivaroxaban, apixaban. May affect ability to drive & use machines. Hepatic & moderate to severe renal impairment. Not to be used during 1st trimester of pregnancy. Lactation. Klacid FC tab/Klacid MR tab Childn <12 yr. Klacid granules for oral susp Diabetic patients. Not to be taken by patients w/ fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Klacid MR tab Patients on controlled Na diet. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Insomnia; dysgeusia, headache; diarrhea, vomiting, dyspepsia, nausea, abdominal pain; abnormal LFT; rash, hyperhidrosis. Klacid granules for oral susp Perversion.

Elevated levels of cisapride, pimozide. Altered metabolism of terfenadine, astemizole. Acute ergot toxicity w/ ergotamine or dihydroergotamine. Increased AUC of midazolam, alprazolam, triazolam; atazanavir. Increased plasma conc of lovastatin or simvastatin; omeprazole; theophylline or carbamazepine; phenytoin, valproate; itraconazole. Markedly increased transaminases w/ lomitapide. Induced metabolism w/ rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort. Decreased serum levels w/ rifabutin. Accelerated metabolism w/ efavirenz, nevirapine, rifampicin, rifabutin, rifapentine. Decreased exposure by etravirine. Increased mean C_min & AUC w/ fluconazole. Increased C_max, C_min & AUC w/ ritonavir. Torsade de pointes w/ antiarrhythmics eg, quinidine or disopyramide. Hypoglycemia w/ disopyramide & certain hypoglycemics eg, nateglanide, repaglinide or insulin. Monitor serum conc of CYP3A substrate w/ narrow safety margin eg, carbamazepine; CYP3A-metabolized drugs. High risk of bleeding w/ direct-acting oral anticoagulants eg, rivaroxaban, apixaban. Increased phosphodiesterase inhibitor exposure w/ sildenafil, tadalafil or vardenafil. Elevated serum conc of tolterodine; digoxin. CNS effects w/ triazolam. Increased exposure to colchicine. Decreased steady-state conc of zidovudine. Risk of hypotension w/ CYP3A4-metabolized Ca-channel blockers eg, verapamil, amlodipine, diltiazem. Increased AUC & C_max of saquinavir.

Macrolides

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

B