Phytoral 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

Ketoconazole

Indications/Uses

Tab: Candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis & paracoccidioidomycosis. Oint: Topical treatment of tinea corporis & tinea cruris caused by Trichophyton rubrum, T. mentagrophytes & Epidermophyton floccosum; tinea versicolor caused by Malassezia furfur; cutaneous candidiasis caused by Candida sp & seborrheic dermatitis.

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Dosage/Direction for Use

Tab Adult Recommended starting dose: 200 mg daily. Very severe infection Dosage can be doubled. Childn >2 yr 3.3-6.6 mg/kg daily as a single dose. Oint Apply once daily to cover the affected area, for 2 wk. Seborrheic dermatitis Apply bd for 4 wk.

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Overdosage

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Administration

Should be taken with food.

Contraindications

Hypersensitivity. Tab: Concomitant use w/ terfenadine & astemizole.

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Special Precautions

Tab: Hepatotoxicity, primarily of the hepatocellular type. Patients w/ preexisting liver disease. Perform liver function tests before starting therapy. Report promptly any signs & symptoms of liver dysfunction eg, anorexia, nausea/vomiting, fatigue, jaundice, dark urine or pale stools. Oint: Not for ophth use. Discontinue use if reaction suggesting sensitivity or chemical irritation occur. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Tab: Hypersensitivity, nausea &/or vomiting, abdominal pain, pruritus. Oint: Irritation, pruritus & stinging.

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Drug Interactions

Reduced absorption w/ anticholinergic agents, antacids & H₂-receptor antagonists. Increased plasma conc of cyclosporin.

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Storage

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Description

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

Action

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MIMS Class

Antifungals / Topical Antifungals & Antiparasites

ATC Classification

J02AB02 - ketoconazole ; Belongs to the class of imidazole derivatives. Used in the systemic treatment of mycotic infections.
D01AC08 - ketoconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.

Regulatory Classification

POM

Presentation/Packing

Form

Phytoral oint 2%

Packing/Price

15 g x 1's

Form

Phytoral tab 200 mg

Packing/Price

10 × 10's;3 × 10's

Phytoral

ketoconazole

Manufacturer:

Micro Labs

Distributor:

Zizawa Healthcare