Klacid

Clarithromycin

Treatment of lower resp tract infections (eg, bronchitis, pneumonia); URTIs (eg, pharyngitis, sinusitis); skin & soft tissue infections (eg, folliculitis, cellulitis, erysipelas). FC tab: Initial therapy in community-acquired resp infections. In combination w/ omeprazole or lansoprazole for the eradication of H. pylori in patients w/ duodenal ulcers. Granules for oral susp: Treatment of acute otitis media.

FC tab Adult, childn ≥12 yr, & elderly Resp tract, skin & soft tissue infection 250 mg bd, may be increased to 500 mg bd in severe infections. Duration of therapy: 6-14 days. Adult & elderly Eradication of H. pylori in duodenal ulcer Duration of therapy: 6-14 days. Triple therapy: Clarithromycin 500 mg bd combined w/ lansoprazole 30 mg bd & amoxicillin 1,000 mg bd or metronidazole 400 mg bd; or w/ omeprazole 40 mg daily & amoxicillin 1,000 mg bd or metronidazole 400 mg bd; or w/ omeprazole 20 mg daily & amoxicillin 1,000 mg bd. Patient w/ renal impairment (CrCl <30 mL/min) Reduce dose by ½. Do not continue treatment beyond 14 days. MR tab Adult, childn ≥12 yr, & elderly 500 mg once daily, may be increased to 1,000 mg once daily in more severe infections. Duration of therapy: 5-14 days (6-14 days for sinusitis & community-acquired pneumonia). Patient w/ renal impairment (CrCl <30 mL/min) 250 mg once daily (500 mg once daily in more severe infections). Do not continue treatment beyond 14 days. Patient concomitantly treated w/ ritonavir & w/ normal renal function Max daily dose: 1,000 mg, Limited renal function (CrCl 30-60 mL/min) Max daily dose: 500 mg. Granules for oral susp Duration of therapy: 5-10 days. Max dose: 500 mg bd. Childn <12 yr weighing 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 Dose on a per kg basis (approx 7.5 mg/kg bd). Childn w/ CrCl <30 mL/min/1.73 m² Reduce dose by ½ to 7.5 mg/kg/day. Do not continue treatment beyond 14 days.

FC tab: May be taken with or without food. MR tab: Should be taken with food: Do not divide/crush/chew. Take w/ sufficient fluid intake. Granules for oral susp: May be taken with or without food: Can be taken w/ milk.

Hypersensitivity to macrolides. Concomitant administration w/ ergot alkaloids (eg, ergotamine or dihydroergotamine); oral midazolam; lomitapide; astemizole, cisapride, domperidone, pimozide & terfenadine; ticagrelor or ranolazine; HMG-CoA reductase inhibitors that are extensively metabolized by CYP3A4 (lovastatin or simvastatin); colchicine. Patients w/ history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia including torsades de pointes; electrolyte disturbances (hypokalaemia or hypomagnesaemia); severe hepatic failure in combination w/ renal impairment.

Immediately discontinue treatment in case of severe acute hypersensitivity reactions eg, anaphylaxis, severe cutaneous adverse reactions (eg, acute generalised exanthematous pustulosis, SJS, TEN & DRESS). Possibility of cross resistance w/ other macrolides, as well as lincomycin & clindamycin. Long-term use may result in colonisation w/ increased numbers of non-susceptible bacteria & fungi. Perform sensitivity testing when prescribing for community-acquired pneumonia, & mild to moderate skin & soft tissue infections. Use in combination w/ additional appropriate antibiotics for hospital-acquired pneumonia. Reports of hepatic dysfunction, including increased liver enzymes, & hepatocellular &/or cholestatic hepatitis, w/ or w/o jaundice; pseudomembranous colitis; Clostridioides difficile-associated diarrhoea. Risk of QT prolongation. Consider potential for dizziness, vertigo, confusion & disorientation before driving or using machines. Caution in patients w/ CAD, severe cardiac insufficiency, conduction disturbances or clinically relevant bradycardia; hypomagnesaemia; hepatic impairment; moderate to severe renal impairment. Should not be prescribed to pregnant women w/o carefully weighing benefits against risks, particularly during the 1st 3 mth of pregnancy. Safety for use during breast-feeding has not been established. FC tab: Not recommended for childn <12 yr. MR tab: Should not be taken by patients w/ rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption. Not recommended for childn <12 yr. Granules for oral susp: Should not be taken by patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Consider sucrose content when prescribing to diabetic patients.

Insomnia; dysgeusia, headache; diarrhoea, vomiting, dyspepsia, nausea, abdominal pain; abnormal LFT; rash, hyperhidrosis.

Elevated levels of cisapride, pimozide & terfenadine. Increased plasma conc of lovastatin & simvastatin. Reduced efficacy w/ CYP3A inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort). Increased serum levels of rifabutin. Strong CYP450 inducers (eg, efavirenz, nevirapine, rifampicin, rifabutin, rifapentine) may lower clarithromycin plasma levels, while increasing those of 14-OH-clarithromycin (microbiologically active metabolite). Etravirine decreased clarithromycin exposure, but increased conc of 14-OH-clarithromycin. Increased C_min & AUC w/ fluconazole. Marked inhibition of clarithromycin metabolism w/ ritonavir. Complete inhibition of 14-OH-clarithromycin formation w/ ritonavir. Increased steady-state plasma conc of omeprazole. Increased exposure of sildenafil, tadalafil & vardenafil. Increased circulating levels of theophylline or carbamazepine. Increased serum conc of tolterodine. Increased AUC of triazolam, alprazolam & oral/oromucosal/IV midazolam. Increased exposure of colchicine & digoxin. Decreased steady-state conc of oral zidovudine. Increased serum levels of phenytoin & valproate. Bi-directional drug interaction w/ atazanavir, verapamil, amlodipine, diltiazem, itraconazole, saquinavir. Potential interaction w/ cilostazol, ciclosporin, ibrutinib, methadone, methylprednisolone, quetiapine, sildenafil, sirolimus, tacrolimus, vinblastine. Risk of QT prolongation & cardiac arrhythmias (including ventricular tachycardia, ventricular fibrillation, & torsades de pointes) w/ co-administration of clarithromycin & astemizole, cisapride, domperidone, pimozide or terfenadine. Risk of acute ergot toxicity w/ co-administration of clarithromycin & ergotamine or dihydroergotamine. Increased risk of myopathy (including rhabdomyolysis) w/ co-administration of clarithromycin & lovastatin or simvastatin. Increased risk of uveitis w/ co-administration of clarithromycin & rifabutin. Potential for markedly increased transaminases w/ co-administration of clarithromycin & lomitapide. Risk of torsades de pointes w/ co-administration of clarithromycin & quinidine or disopyramide. Risk of hypoglycemia w/ co-administration of clarithromycin & disopyramide, oral hypoglycaemic agents or insulin. Risk of serious haemorrhage & significant elevations in INR & prothrombin time w/ co-administration of clarithromycin & oral anticoagulants (eg, warfarin, dabigatran, rivaroxaban, apixaban). Risk of CNS effects (eg, somnolence & confusion) w/ co-administration of clarithromycin & triazolam. Potential risk of CV events & mortality w/ co-administration of clarithromycin & hydroxychloroquine or chloroquine. Risk of hypotension, bradyarrhythmia & lactic acidosis w/ co-administration of clarithromycin & verapamil. Possibility of contraceptive failure if diarrhoea, vomiting or breakthrough bleeding occur in patients taking OCs.

Macrolides

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

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