Dermazol (Cream) Instructions for Use

Marketing Authorization Holder

Kusum Healthcare, Pvt. Ltd. (India)

ATC Code

D01AC08 (Ketoconazole)

Active Substance

Ketoconazole (Rec.INN registered by WHO)

Dosage Form

Dermazol

Cream for external use 2%: tube 15 g or 30 g

Dosage Form, Packaging, and Composition

15 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal agent. It has fungicidal and fungistatic effects.

The mechanism of action consists in inhibiting the synthesis of ergosterol and altering the lipid composition of the membrane.

It is active against the causative agent of pityriasis versicolor Malassezia furfur, the causative agents of some dermatomycoses (Trichophyton, Epidermophyton floccosum, Microsporum), the causative agents of candidiasis (Candida), as well as the causative agents of systemic mycoses (Cryptococcus).

It is also active against gram-positive cocci: Staphylococcus spp., Streptococcus spp.

Indications

• Apply for the treatment and prevention of fungal infections of the scalp skin.
• Use for dermatomycosis of smooth skin, tinea cruris, and tinea of hands and feet.
• Indicated for the management of skin candidiasis.

ICD codes

Dosage Regimen

Apply a thin layer of cream to the affected and surrounding skin areas once or twice daily.

The frequency and duration of application depend on the specific indication and clinical response. Continue treatment for several days after clinical symptoms have resolved to prevent recurrence.

For pityriasis versicolor, the typical treatment duration is 11 to 22 days. For seborrheic dermatitis, use for 2 to 4 weeks.

Adverse Reactions

Local skin reactions at the application site may occur, including redness, itching, burning, stinging, or irritation.

In rare cases, allergic contact dermatitis may develop. Discontinue use immediately if signs of a severe skin reaction or systemic allergic reaction appear.

Drug Interactions

Concomitant use with drugs that are CYP3A4 substrates (e.g., certain HMG-CoA reductase inhibitors, immunosuppressants) may increase their systemic exposure if significant absorption occurs, potentially elevating the risk of adverse effects.

Avoid concurrent use with other topical preparations on the same area to prevent physical or chemical incompatibilities and potential local skin irritation.

Contraindications

• Do not use in patients with a known hypersensitivity to ketoconazole, any other azole antifungal agents, or any of the excipients in the cream formulation.
• Contraindicated in individuals with acute or chronic liver disease.
• Use is prohibited during pregnancy and lactation (breastfeeding).
• Do not administer to children under 12 years of age.

Overdose

Topical application is unlikely to result in systemic overdose due to minimal absorption through intact skin.

In case of accidental ingestion, perform gastric lavage and administer activated charcoal if a large quantity is consumed. Provide symptomatic and supportive care as there is no specific antidote.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during the lactation (breastfeeding) period.

Use in Hepatic Impairment

Contraindicated in severe liver function disorders.

Use in Renal Impairment

Contraindicated in severe renal function disorders.

Special Precautions

If corticosteroids were used for the treatment of skin diseases, then Ketoconazole is prescribed no earlier than 2 weeks after their discontinuation.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.