Klacid/Klacid MR

Clarithromycin

Lower & upper resp tract, soft tissue, skin & soft tissue infections. Prevention & treatment of Mycobacterium avium complex (MAC) infection. Eradication of H. pylori infection. Acute otitis media. Odontogenic infection. Ped oral susp only: Skin & skin structure infections (eg, impetigo, folliculitis, cellulitis, abscesses). 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 250 mg bid. Severe infections 500 mg bid. Duration: 5-14 days excluding treatment of community-acquired pneumonia & sinusitis which require 6-14 days of therapy. MAC infection 500 mg bid. Odontogenic infection 250 mg bid for 5 days. Peptic ulcer due to H. pylori 500 mg bid in combination w/ other appropriate anti-microbial treatments & a proton-pump inhibitor for 7-14 days. Renal impairment CrCl <30 mL/min Reduce to ½ ie, 250 mg once daily or 250 mg bid in more severe infections. Klacid ped susp Ped patient <12 yr 7.5 mg/kg bid up to a max of 500 mg bid. Usual duration: 5-10 days depending on pathogen involved & severity of condition. Childn (dosage in standard 5 mL tsp given bid) weighing 30-40 kg 10 mL, 20-29 kg 7.5 mL, 12-19 kg 5 mL, 8-11 kg 2.5 mL. Childn w/ renal impairment CrCl <30 mL/min/1.73 m² Reduce by ½ ie, up to 250 mg once daily or 250 mg bid in more severe infections. Do not continue beyond 14 days. Childn w/ mycobacterial infections 7.5 mg to 15 mg/kg bid. Max: 500 mg bid. Klacid MR 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, excluding treatment of community-acquired pneumonia & sinusitis which require 6-14 days. 

FC tab/Ped susp: May be taken with or without food. May take susp w/ milk. MR tab: Should be taken with food: Swallow whole, do not chew/crush.

Hypersensitivity to macrolides. Concomitant use w/ astemizole, terfenadine, pimozide or cisapride, ergot alkaloids, oral midazolam, HMG-CoA reductase inhibitors (lovastatin or simvastatin), colchicine, ticagrelor or ranolazine. Patients w/ history of QT prolongation or ventricular cardiac arrhythmia, including Torsades de pointes. Hypokalemia. Severe hepatic failure in combination w/ renal impairment.

Immediately discontinued if severe acute hypersensitivity reactions eg, anaphylaxis, severe cutaneous adverse reactions (SCAR) (eg, acute generalized exanthematous pustulosis (AGEP), SJS, TEN & DRESS) occurs. Impaired hepatic function & moderate to severe renal impairment. Superinfection may occur w/ prolonged use. Discontinue if hepatitis occurs. Clostridium difficile-associated diarrhea must be considered in all patients who present w/ diarrhea following antibiotic use. Concomitant use w/ colchicine, astemizole, cisapride, pimozide & terfenadine, lovastatin or simvastatin is contraindicated. Concomitant use w/ triazolobenzodiazepines eg, triazolam & IV or oromucosal midazolam; drugs associated w/ QT prolongation; oral hypoglycemics; statins; CYP3A4 enzyme inducers. Monitor vestibular & auditory function during & after treatment (FC & MR tab only). Patients w/ CAD, severe cardiac insufficiency, conduction disturbances or clinically relevant bradycardia; electrolyte disturbances eg, hypomagnesaemia. Do not give to patients w/ hypokalemia. Do not use in patients w/ congenital or acquired QT prolongation or history of ventricular arrhythmia. Perform sensitivity testing if to be used in community-acquired pneumonia & skin & soft tissue infections of mild to moderate severity. Should be in combination w/ additional appropriate antibiotics if to be used for hospital-acquired pneumonia. Monitor for signs & symptoms of myopathy if concomitant use w/ statins cannot be avoided. Monitor INR & prothrombin time in concomitant use w/ oral anticoagulants. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (MR tab only). Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency; sucrose content for diabetics (oral susp only). Pregnancy & lactation.

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

Elevate levels of cisapride & pimozide. May alter metabolism of terfenadine & astemizole. Acute ergot toxicity may occur w/ ergotamine or dihydroergotamine. Increased AUC of midazolam. Increase plasma conc of lovastatin or simvastatin. Induced metabolism w/ rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort. Decreased serum levels w/ rifabutin. Lower plasma levels w/ efavirenz, nevirapine, rifampicin, rifabutin & rifapentine. Decreased exposure by etravirine. Increase in mean C_min & AUC w/ fluconazole. Increased C_max, C_min & AUC w/ ritonavir. QTc prolongation w/ antiarrhythmics. Hypoglycemia may occur w/ disopyramide & certain hypoglycemics eg, nateglanide & repaglinide, or insulin. May increase or prolong therapeutic & adverse effects of CYP3A inhibitors & drugs primarily metabolized by CYP3A. Increase steady-state plasma conc of omeprazole. Increase phosphodiesterase inhibitor exposure w/ sildenafil, tadalafil or vardenafil. Increase levels of theophylline or carbamazepine. May cause higher serum conc of tolterodine. Increase AUC of midazolam, alprazolam & triazolam. CNS effects w/ triazolam. Increase exposure of colchicine. Elevated serum conc of digoxin. Decrease steady-state conc of zidovudine. Increased serum levels of phenytoin & valproate. Atazanavir. Risk of hypotension w/ Ca channel blockers metabolized by CYP3A4 (eg, verapamil, amlodipine, diltiazem). May increase plasma levels of itraconazole. May increase AUC & C_max of saquinavir.

Macrolides

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

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