Each 100 g contains: Ketoconazole 2g (2% w/w).
Pharmacology: Fungistatic; may be fungicidal and sporocidal, depending on concentration. Ketoconazole inhibits biosynthesis of ergosterol or other sterols, damaging the fungal cell membrane and altering its permeability; as a result, loss of essential intracellular elements may occur. It also inhibits biosynthesis of triglycerides and phospholipids by fungi. In addition, it inhibits oxidative and peroxidative enzyme activity, resulting in intracellular buildup of toxic concentrations of hydrogen peroxide, which may contribute to deterioration of subcellular organelles and cellular necrosis. In the treatment of Candida albicans, inhibits transformation of blastospores into invasive mycelial form.
Pharmacokinetics: Absorption: After a single topical application of ketoconazole cream to the chest, back and arms of normal volunteers, systemic absorption of ketoconazole was detected during the following 72-hr period, using a minimum detection level of 5 ng/mL in blood.
Treatment of tinea corporis, tinea cruris, tinea pedis, tinea versicolor, cutaneous candidiasis, seborrheic dermatitis.
Adult and adolescent: Tinea corporis or Tinea cruris or Tinea pedis or Pityriasis versicolor: To the affected skin and surrounding areas, once a day.
Candidiasis, cutaneous: To the affected skin and surrounding areas, once a day. More resistant cases may require twice a day treatment.
Seborrheic dermatitis: To the affected skin and surrounding areas, two times a day.
Pediatric: Safety and efficacy have not been established.
Proper use of this medication: Avoiding contact with eyes. Applying sufficient medication to cover affected and surrounding areas, and rubbing in gently. Compliance with full course of therapy; fungal infections may require prolonged therapy.
Missed dose: Applying as soon as possible; not applying if almost time for next dose.
Note: To reduce the possibility of recurrence of infection, Tinea corporis and Tinea cruris should be treated for at least 2 to 4 weeks. Candida and Pityriasis versicolor should be treated for at least 2 to 3 weeks. Seborrheic dermatitis should be treated for at least 4 weeks or until clinical clearing occurs. Tinea pedis should be treated for approximately 4 to 6 weeks.
Administration: Topical.
Treatment: There has been no experience of overdosage with ketoconazole cream.
To Avoid Aspiration: Gastric lavage or induced emesis should not be performed. It has been reported that ketoconazole cannot be removed by hemodialysis.
Specific Treatment: Use general supportive measures and appropriate routine overdose management.
Supportive Care: Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.
Hypersensitivity to topical ketoconazole and to sulfites present in ketoconazole cream.
Cross Sensitivity and/or Related Problems: Persons sensitive to miconazole or other imidazoles may also be sensitive to ketoconazole.
Carcinogenicity: A long-term feeding study in Swiss albino mice and Wistar rats has shown no evidence of carcinogenicity.
Mutagenicity: The dominant lethal mutation test in male and female mice, given single oral doses of ketoconazole as high as 80 mg/kg of body weight (mg/kg), has shown no mutations at any stage of germ cell development. The Ames salmonella microsomal activator assay has also shown negative results.
Use in children: No information is available on the relationship of age to the effects of Diazon Cream in pediatric patients. Safety and efficacy have not been established.
Use in the elderly: No information is available on the relationship of age to the effects of Diazon Cream in geriatric patients.
Use in pregnancy: Ketoconazole crosses the placenta. Adequate and well-controlled studies in humans have not been done. Studies in rats, given oral doses of 80 mg/kg/day [10 times the maximum recommended human dose (MRHD)], have shown ketoconazole to be teratogenic, causing syndactyly and oligodactyly. However, these effects may be related to maternal toxicity, which was seen at this dose level.
Use in lactation: It is not known whether ketoconazole cream, applied topically on a regular basis, is absorbed systemically in sufficient amounts to be distributed into breast milk in detectable quantities. However, no systemic absorption was detected following a single application of ketoconazole cream to the chest, back and arms of healthy volunteers. Therefore, topical ketoconazole is unlikely to be distributed into breast milk in significant amounts or to cause adverse effects in the nursing infant.
Less Frequent Incidence: Itching, stinging or irritation not present before therapy.
Rare Incidence: Contact dermatitis (skin rash).
Store at temperature not more than 30°C.
D01AC08 - ketoconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Cream 2 g (2% w/w) x 15 g x 1's.
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