Canditral Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Warnings Special Precautions Adverse Reactions Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Itraconazole

Indications/Uses

Fungal infections in immunocompromised & non-immunocompromised patients: Blastomycosis, pulmonary & extrapulmonary; histoplasmosis, including chronic cavitary pulmonary disease & disseminated, nonmeningeal histoplasmosis; aspergillosis, pulmonary & extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy; tinea versicolor; tinea corporis, tinea cruris; dermatomycosis of palms & soles (tinea manuum, tinea pedis). Fungal infections in non-immunocompromised patients: Onychomycosis of the toenail, w/ or w/o fingernail involvement, due to dermatophytes (tinea unguium); onychomycosis of the fingernail due to dermatophytes.

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Dosage/Direction for Use

Blastomycosis & histoplasmosis 200 mg once daily (2 cap). Increase in 100-mg increments to max 400 mg daily if there is no obvious improvement, or there is evidence of progressive fungal disease. Doses >200 mg/day should be given in 2 divided doses. Aspergillosis 200-400 mg daily. Life-threatening situations Loading dose: 200 mg tid (600 mg/day) for the 1st 3 days of treatment. Onychomycosis of the toenails w/ or w/o fingernail involvement 200 mg once daily for 12 consecutive wk. Onychomycosis of the fingernails only 2 treatment pulses, each consisting of 200 mg bid (400 mg/day) for 1 wk. Pulses are separated by a 3-wk period w/o itraconazole. Tinea versicolor 2 cap once daily for 7 days. Tinea corporis, tinea cruris 1 cap once daily for 2 wk. Dermatomycosis of palms & soles (tinea manus, tinea pedis) 1 cap once daily for 4 wk.

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Administration

Should be taken with food: Take w/ a full meal to ensure max absorption. Swallow whole.

Contraindications

Hypersensitivity to itraconazole or other azole antifungals. For treatment of onychomycosis in patients w/ evidence of ventricular dysfunction (eg, CHF or history of CHF). Co-administration w/ CYP3A4 substrates eg, methadone, disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids [eg, dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)], irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin &, in subjects w/ renal or hepatic impairment, colchicine. For treatment of onychomycosis to pregnant patients or women contemplating pregnancy.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Canditral detailed prescribing information

Special Precautions

Do not use interchangeably w/ itraconazole oral soln. Associated w/ rare cases of serious hepatotoxicity. Monitor liver function in all patients. Discontinue treatment & perform LFT if clinical signs or symptoms consistent w/ liver disease develop. Reports of CHF, peripheral edema, pulmonary edema. Discontinue administration if signs or symptoms of CHF appear. Discontinue treatment if neuropathy occurs that may be attributable to itraconazole cap. Reports of transient or permanent hearing loss. Advise patients to not drive or use machines in case of dizziness or blurred/double vision. Concomitant use w/ Ca channel blockers; antacids or gastric acid secretion suppressors. Patients w/ renal or hepatic impairment.

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Adverse Reactions

Nausea, vomiting, diarrhea, abdominal pain, anorexia, edema, fatigue, fever, malaise, rash, pruritus, headache, dizziness, somnolence, decreased libido, HTN, hypokalemia, albuminuria, abnormal hepatic function, impotence.

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Drug Interactions

Concomitant use w/ quinidine, dofetilide, pimozide, cisapride; HMG-CoA reductase inhibitors eg, lovastatin & simvastatin; oral midazolam & triazolam; Ca channel blockers eg, dihydropyridines (nifedipine, felodipine) & verapamil; antacids; warfarin; antimycobacterial drugs eg, rifampicin, rifabutin & INH; nevirapine; oral hypoglycemic drugs; PIs.

Description

View Canditral description for details of the chemical structure and excipients (inactive components).

Action

View Canditral mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Antifungals

ATC Classification

J02AC02 - itraconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.

Regulatory Classification

Patient Counseling Information

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Presentation/Packing

Form

Canditral cap 100 mg

Packing/Price

28's (P2,571/box)

Canditral

itraconazole

Manufacturer:

Glenmark

Distributor:

Glenmark