Itrazole Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Itraconazole

Indications/Uses

Vulvovag & oropharyngeal candidiosis, pityriasis versicolor, dermatophytoses caused by susceptible organisms (eg, tinea pedis, tinea cruris, tinea corporis, tinea manuum), onychomycosis caused by dermatophytes &/or yeasts, histoplasmosis. Systemic fungal conditions when 1st-line systemic antifungal therapy is inappropriate or proven ineffective. Aspergillosis & candidiasis. Cryptococcosis (including cryptococcal meningitis) in immunocompromised patients w/ cryptococcosis & in all patients w/ cryptococcosis of the CNS. Maintenance therapy in AIDS patient to prevent relapse of underlying fungal infection. Prevention of fungal infection during prolonged neutropenia when standard therapy is considered inappropriate.

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Dosage/Direction for Use

Vulvovag candidiosis 200 mg bid for 1 day. Pityriasis versicolor 200 mg once daily for 7 days. Tinea corporis, tinea cruris 100 mg once daily for 15 days or 200 mg once daily for 7 days. Tinea pedis, tinea manuum 100 mg once daily for 30 days. Oropharyngeal candidiosis 100 mg once daily for 15 days. Patient w/ AIDS or neutropenia Increase to 200 mg once daily for 15 days. Onychomycosis (toenails w/ or w/o fingernail involvement) 200 mg once daily for 3 mth. Aspergillosis 200 mg once daily, increase dose to 200 mg bid in case of invasive or disseminated disease. Candidiosis 100-200 mg once daily, increase dose to 200 mg bid in case of invasive or disseminated disease. Histoplasmosis 200 mg once daily or bid. Maintenance in AIDS 200 mg once daily. Neutropenia prophylaxis 200 mg once daily.

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Overdosage

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Administration

Should be taken with food.

Contraindications

Hypersensitivity. Co-administration w/ CYP3A4 substrates. Patients w/ ventricular dysfunction eg, CHF or a history of CHF except for the treatment of life-threatening or other serious infections. Concurrent quinidine administration may cause hearing loss. Not to be used during pregnancy except for life-threatening cases.

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Special Precautions

Hypersensitivity to other azoles. Discontinue use if signs or symptoms of CHF; neuropathy occur. Patients w/ elevated or abnormal liver enzymes or active liver disease, or who have experienced liver toxicity w/ other drugs. Reduced gastric acidity. Transient or permanent hearing loss. Immunocompromised patients (eg, neutropenic, AIDS or organ transplant patients). Not recommended in patients w/ immediately life-threatening systemic fungal infections. Monitor liver function in patients w/ pre-existing hepatic function abnormalities or those who have experience liver toxicity w/ other medication. Renal impairment. Women of childbearing potential should use contraception. Pregnancy & lactation. Not recommended in ped patients. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache; abdominal pain, nausea.

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Drug Interactions

Decreased plasma conc w/ acid neutralizing medicines eg, Al hydroxide, or acid secretion suppressors eg, H₂-receptor antagonists & PPIs. Not recommended w/ INH, rifabutin, rifampicin; carbamazepine, phenobarb, phenytoin; efavirenz, nevirapine. Increased plasma conc w/ ciprofloxacin, clarithromycin, erythromycin; ritonavir-boosted darunavir, ritonavir-boosted fosamprenavir, indinavir.

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Storage

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Description

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Action

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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

Presentation/Packing

Form

Itrazole cap 100 mg

Packing/Price

40's (P2,720/box)

Itrazole

itraconazole

Manufacturer:

Torrent

Distributor:

Torrent