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Claritrox

Claritrox

clarithromycin

Manufacturer:

SM Pharmaceuticals

Distributor:

SM Pharmaceuticals
Concise Prescribing Info
Contents
Clarithromycin
Indications/Uses
URTI eg, strep pharyngitis/tonsillitis, acute maxillary sinusitis; lower resp tract infections eg, bronchitis, pneumonia; acute otitis media; skin & skin structure infections eg, impetigo, folliculitis, cellulitis, abscesses. Granules for oral susp: Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum or Mycobacterium kansasii.
Dosage/Direction for Use
FC tab Adult 250 mg every 12 hr for 7 days. Severe infections 500 mg every 12 hr for 14 days. Renal impairment ½ adult dose. Ped patient <12 yr Granules for oral susp Non-mycobacterial infections 7.5 mg/kg bd up to max: 500 mg bd for 5-10 days. 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. 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 daily in 2 divided doses. CrCl <30 mL/min/1.73 m2 Reduce to ½ ie, 250 mg once daily. More severe infections 250 mg bd. Duration: Not to exceed 14 days.
Administration
May be taken with or without food: Granules for oral susp: May be taken w/ milk.
Contraindications
Hypersensitivity to clarithromycin, erythromycin or any macrolides. Concomitant use w/ cisapride, pimozide, terfenadine, astemizole & ergot derivatives/alkaloids (eg, ergotamine or dihydroergotamine), domperidone. Granules for oral susp: 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/ oral midazolam, HMG-CoA reductase inhibitors (eg, lovastatin or simvastatin), colchicine, ticagrelor or ranolazine, lomitapide. Severe hepatic failure w/ renal impairment.
Special Precautions
Hypersensitivity to erythromycin & other macrolides. Discontinue use if severe acute hypersensitivity reactions occur. Cross-resistance & -sensitivity. Pseudomembranous colitis; superinfection. Long-term use. Hepatic & moderate to severe renal impairment. Pregnancy & lactation. Granules for oral susp: Discontinue use if signs & symptoms of hepatitis occur. Clostridium difficile-associated diarrhea; CAD, severe cardiac insufficiency, conduction disturbances or clinically relevant bradycardia. Monitor for signs & symptoms of myopathy; glucose levels. Perform sensitivity testing for community-acquired pneumonia, skin & soft tissue infections. Not to be taken by patients w/ fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Concomitant use w/ triazolobenzodiazepines eg, triazolam, midazolam; drugs associated w/ QT prolongation; hydroxychloroquine or chloroquine; 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.
Adverse Reactions
Diarrhoea, nausea, dyspepsia, abdominal pain/discomfort, headache. FC tab: Abnormal taste. Granules for oral susp: Insomnia; dysgeusia, perversion; vomiting; abnormal LFTs; rash, hyperhidrosis.
Drug Interactions
Increased plasma conc of cisapride, pimozide, carbamazepine, terfenadine, astemizole, domperidone, digoxin, phenytoin, theophylline, valproate, omeprazole. Decreased serum conc of rifabutin or rifampicin. Acute ergot toxicity w/ ergotamine or dihydroergotamine. CNS effects w/ triazolam. Decreased zidovudine steady-state conc. FC tab: Elevated serum conc of cyclosporine, tacrolimus, hexobarbital, alfentanil, quinidine/disopyramide, lovastatin, bromocriptine & other CYP450-metabolised drugs. Potentiated warfarin effects. Increased plasma conc w/ Maalox, ranitidine. Granules for oral susp: Increased AUC of midazolam, alprazolam, triazolam; atazanavir. Increased plasma conc of simvastatin; tolterodine; itraconazole; verapamil, amlodipine, diltiazem. Markedly increased transaminases w/ lomitapide. Increased risk of CV events & mortality w/ hydroxychloroquine or chloroquine. Reduced efficacy w/ rifampicin, phenobarb, St. John's wort. Accelerated metabolism w/ efavirenz, nevirapine, rifapentine. Decreased exposure by etravirine. Increased mean Cmin & AUC w/ fluconazole. Increased Cmax, Cmin & AUC w/ ritonavir, saquinavir. Torsade de pointes w/ quinidine or disopyramide. Hypoglycemia w/ nateglinide, repaglinide or insulin. High risk of bleeding w/ direct-acting oral anticoagulants eg, rivaroxaban, apixaban. Increased exposure of sildenafil, tadalafil, vardenafil. Increased exposure to colchicine.
MIMS Class
Macrolides
ATC Classification
J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Claritrox FC tab 250 mg
Packing/Price
3 × 10's
Form
Claritrox FC tab 500 mg
Packing/Price
10 × 10's
Form
Claritrox granules for oral susp 125 mg/5 mL
Packing/Price
60 mL x 1's
Form
Claritrox granules for oral susp 250 mg/5 mL
Packing/Price
60 mL x 1's
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