Philazole 2% Cream
Ketoconazole
20mg/g
PHILADELPHIA PHARMACEUTICALS
| Pack size | 15g Collapsible Tube |
|---|---|
| Dispensing mode | POM |
| Source | JORDAN |
| Agent | FUJAIRAH DRUG STORE |
| Retail Price | 6.00 AED |
Indications
Philazole 2% Cream is used for:
Candidiasis, Fungal infections, Pityriasis versicolor, Seborrhoeic dermatitis
Adult Dose
Oral
Fungal infections
Adult: 200 mg once daily; may increase to 400 mg once daily if clinical response is insufficient. Continue treatment until symptoms have cleared and cultures have become negative.
Chronic vag candidiasis
400 mg once daily for 5 days.
Elderly: No dosage adjustment needed.
Hepatic impairment: Contraindicated.
Child Dose
Oral
Fungal infections
Child: >2 yr 3.3-6.6 mg/kg/day once daily.
Treatment duration: 1-2 wk for candidiasis; at least 4 wk in recalcitrant dermatophyte infections and up to 6 mth for other systemic mycoses.
Renal Dose
Renal impairment: No dosage adjustment needed.
Administration
Should be taken with food.
Contra Indications
Hypersensitivity; preexisting liver disease, porphyria. Concurrent use with cisapride, terfenadine or astemizole.
Precautions
Hepatic impairment; monitor liver function regularly. Pregnancy, lactation. Predisposition to adrenocortical insufficiency. Discontinue treatment if there is persistent or worsening of liver enzyme elevation.
Pregnancy-Lactation
Pregnancy category: C
Lactation: Drug enters breast milk
Interactions
Reduced absorption w/ antimuscarinics, antacids, H2-blockers, PPIs, sucralfate. Reduced plasma concentrations w/ rifampicin, isoniazid, efavirenz, nevirapine, phenytoin. May also reduce concentrations of isoniazid and rifampicin. May reduce efficacy of oral contraceptives. May increase serum levels of CYP3A4 substrates e.g. digoxin, oral anticoagulants, sildenafil, tacrolimus.
Potentially Fatal: May potentiate and prolong sedative and hypnotic effects of midazolam and triazolam. Increased plasma levels and prolonged QT intervals of astemizole, cisapride, dofetilide, pimozide, quinidine and terfenadine which may lead to torsade de pointes. Increased risk of myopathy w/ HMG-CoA reductase inhibitors (e.g. lovastatin, simvastatin). Markedly increased plasma levels of nisoldipine. Increased risk of hyperkalaemia and hypotension w/ eplerenone. Increased risk of vasospasm potentially leading to cerebral ischaemia w/ ergot alkaloids (e.g. ergotamine, dihydroergotamine).
Adverse Effects
Side effects of Ketoconazole :
1-10%
Nausea and vomiting (3-10%), Pruritus (2%), Abdominal pain (1%)
<1%
Alopecia, Headache, Dizziness, Hyperlipidemia, Somnolence, Fever, Chills, Bulging fontanelles, Depression, Gynecomastia, Diarrhea, Impotence, Thrombocytopenia, Leukopenia, Hemolytic anemia, Erythema multiforme, Orthostatic hypotension, Jaundice, Dyspepsia, Dysgeusia, Hepatotoxicity, Decreased platelet count, Xeroderma, Photophobia
Potentially Fatal: Hepatotoxicity.
Mechanism of Action
Ketoconazole interferes w/ biosynthesis of triglycerides and phopholipids by blocking fungal CYP450, thus altering cell membrane permeability in susceptible fungi. It also inhibits other fungal enzymes resulting in the accumulation of toxic concentrations of hydrogen peroxide.
Note
Philazole 2% 20mg/g Cream manufactured by PHILADELPHIA PHARMACEUTICALS. Its generic name is Ketoconazole. Philazole 2% is availble in United Arab Emirates.
Farmaco UAE drug index information on Philazole 2% Cream is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.