Phytoral

Phytoral

ketoconazole

Manufacturer:

Micro Labs

Distributor:

Zizawa Healthcare
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.
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.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Tab: Concomitant use w/ terfenadine & astemizole.
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.
Adverse Reactions
Tab: Hypersensitivity, nausea &/or vomiting, abdominal pain, pruritus. Oint: Irritation, pruritus & stinging.
Drug Interactions
Reduced absorption w/ anticholinergic agents, antacids & H2-receptor antagonists. Increased plasma conc of cyclosporin.
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.
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
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