Klacid/Klacid MR

Klacid/Klacid MR





Zuellig Pharma
Concise Prescribing Info
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.
Dosage/Direction for Use
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 & proton pump inhibitor (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 <30 mL/min Reduce to ½ ie, 250 mg once daily or 250 mg bd in more severe infections. Klacid MR Adult & childn >12 yr 500 mg once daily. Severe infection Dose may be increased to two 500 mg daily. Usual duration of treatment: 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 not exceeding a max dose of 500 mg bd. Renal impairment Childn (CrCl <30 mL/min) Dose should be reduced by ½, ie, up to 250 mg once daily or 250 mg bd in more severe infections. Klacid IV Adult ≥18 yr 1 g daily divided to two 500 mg doses. IV therapy may be given for 2-5 days & administer as an IV infusion over 60 min using 2 mg/mL soln conc. Should be given as a bolus or IM inj. Renal impairment (CrCl <30 mL/min) Should be reduced 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, ventricular 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. Hypokalemia. Increased risk of myopathy including rhabdomyolysis w/ HMG-CoA reductase inhibitors (statins). Concomitant administration w/ oral midazolam; colchicine; ticagrelor & ranolazine. Severe hepatic failure in combination w/ renal impairment. Klacid MR/Klacid Paed Patients w/ CrCl <30 mL/min.
Special Precautions
Superinfection may occur w/ prolonged use. Discontinue use if signs & symptoms of hepatitis (eg, anorexia, jaundice, dark urine, pruritus or tender abdomen) & severe acute hypersensitivity reactions [eg, anaphylaxis, severe cutaneous adverse reactions (SCAR) (eg, acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS & Henoch-Schonlein purpura] occur. Monitor for occurrence of Clostridium difficile-associated diarrhea. Impaired hepatic function & moderate to severe renal impairment. Concomitant use w/ colchicine may cause toxicity in elderly & patients w/ renal insufficiency. Concurrent use w/ triazolobenzodiazepines (eg, triazolam & IV or oromucosal midazolam). Patients w/ CAD, severe cardiac insufficiency, bradycardia, hypomagnesaemia & concomitantly used w/ drugs associated w/ QT prolongation or history of ventricular arrhythmia. Perform sensitivity testing if to be used in community-acquired pneumonia & to monitor mild to moderately severe skin & soft tissue infections. Cross-resistance w/ other macrolides, lincomycin & clindamycin. Monitor for signs & symptoms of myopathy if concomitant use w/ statins cannot be avoided. Monitor glucose carefully in concomitant use w/ hypoglycemics, & INR & prothrombin time in concomitant use w/ oral anticoagulants. May affect ability to drive or operate machinery. Pregnancy & lactation. Elderly. Klacid Paed Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Klacid MR Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Childn <12 yr.
Adverse Reactions
Inj site phlebitis. Insomnia; dysguesia, headache; vasodilation; diarrhea, vomiting, dyspepsia, nausea, abdominal pain; abnormal liver function test; rash, hyperhidrosis; inj site pain & inflammation. Klacid MR Taste perversion.
Drug Interactions
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. Induced metabolism leading to reduced efficacy w/ CYP3A4 inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort). Decreased serum levels w/ rifabutin. Lower plasma levels w/ strong CYP450 inducers (eg, efavirenz, nevirapine, rifampicin, rifabutin & rifapentine). Decreased exposure by etravirine. Increase in mean Cmin & AUC w/ fluconazole. Increased Cmax, Cmin & AUC w/ ritonavir. QTc prolongation w/ antiarrhythmics. Hypoglycemia may occur w/ disopyramide & hypoglycemics or insulin. May increase or prolong therapeutic & adverse effects of drugs primarily metabolized by CYP3A. 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. May increase exposure of colchicine. Elevated serum conc of digoxin. Decreased steady-state conc of zidovudine in HIV-infected adult patients. Increased serum levels of phenytoin & valproate. 2-fold increased exposure in co-administration w/ atazanavir. Plasma conc may be increased mutually in concomitant use w/ Ca channel blockers or itraconazole. Mutual increase in AUC & Cmax in concomitant use w/ saquinavir; consider potential effects of ritonavir on clarithromycin during co-administration w/ saquinavir/ritonavir therapy.
MIMS Class
ATC Classification
J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Klacid IV powd for inj 500 mg
Klacid Paed granules for oral susp 125 mg/5 mL
60 mL x 1's
Klacid Forte tab 500 mg
Klacid MR tab 500 mg
Klacid FC tab 250 mg
Klacid Paed granules for oral susp 250 mg/5 mL
60 mL x 1's
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