DERMASOL 0.05%

Description

Indications

Dermasol is indicated for use in adults, the elderly, and children over one year old for managing the following conditions:

• Psoriasis (excluding widespread plaque psoriasis)

• Recalcitrant dermatoses

• Lichen planus

• Discoid lupus erythematosus

• Other skin conditions unresponsive to less potent corticosteroids.

Always use under the guidance of a registered physician.

Composition

Dermasol is available in multiple formulations, each containing Clobetasol Propionate BP 0.5 mg (0.05% w/w) as the active ingredient:

• Cream: 1 g of cream

• Ointment: 1 g of ointment

• Scalp Application: 1 g of lotion

• Shampoo: 1 g of shampoo

• Lotion: 1 g of lotion

• Spray: 1 g of spray

Pharmacology

Clobetasol Propionate is a potent topical corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It alleviates inflammation by inhibiting allergic responses, reducing mast cell density, and suppressing eosinophil activation and cytokine production. It also reduces arachidonic acid metabolism, contributing to its therapeutic effects.

Dosage and Administration

Cream and Ointment:

• Apply a thin layer to the affected area twice daily.

• For resistant lesions, use occlusion (e.g., polythene film) overnight if necessary.

• Limit treatment to two consecutive weeks, not exceeding 50 g per week.

• In children, treatment should not exceed five days and should be reviewed weekly.

Spray:

• Apply once or twice daily to affected scalp areas.

• Do not exceed 50 ml per week.

Shampoo:

• Apply to the dry scalp (not wet) once daily and leave for 15 minutes before rinsing.

• Treatment should not exceed four weeks or 50 g per week. Not recommended for children under 18 years.

Scalp Solution:

• Apply once or twice daily and massage gently.

• Do not exceed 50 ml per week.

Note: Creams are ideal for moist lesions, while ointments suit dry or scaly lesions.

Interactions

Drugs that inhibit CYP3A4 (e.g., ritonavir, itraconazole) may increase systemic exposure to corticosteroids.

Contraindications

• Rosacea, acne vulgaris, and perioral dermatitis

• Primary cutaneous viral infections (e.g., herpes simplex, chickenpox)

• Fungal or bacterial infections (e.g., candidiasis, tinea, impetigo)

• Children under one year (including dermatitis or napkin eruptions)

• Hypersensitivity to any component of the preparation

Side Effects

• Local effects: Skin thinning, striae, dilated blood vessels, pigmentation changes, hypertrichosis

• Systemic effects: Hypercorticism with prolonged use or extensive application

• Psoriasis: Risk of rebound relapses or pustular psoriasis

• Hypersensitivity reactions

If hypersensitivity occurs, discontinue use immediately.

Pregnancy and Lactation

• Limited data is available on its use in pregnancy. Use only if the benefit outweighs potential risks.

• It is unknown if the drug is excreted in human milk. Exercise caution during breastfeeding.

Precautions and Warnings

• Avoid long-term or continuous use, particularly in children, due to the risk of adrenal suppression.

• Use on the face should be limited to short durations due to potential atrophic changes.

• Avoid contact with eyes to prevent glaucoma or cataract development.

• Monitor closely when used for psoriasis to prevent systemic toxicity.

• Avoid occlusive dressings unless necessary to minimize the risk of infection.

Use in Special Populations

• Prolonged use in children under 12 years should be avoided due to increased susceptibility to corticosteroid side effects.

Overdose Effects

Acute overdose is unlikely. Chronic misuse may result in hypercorticism, requiring cessation of treatment.

Therapeutic Class

Other topical corticosteroids

Storage Conditions

• Store below 30°C, protected from light and moisture.

• Do not freeze.

• Keep out of reach of children.