Dermotil 0.05% (Cream)

Indications

• Psoriasis (excluding widespread plaque psoriasis)
• Recalcitrant dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin conditions which do not respond satisfactorily to less potent steroids

Composition

• Clobetasol Propionate Cream: Each gram cream contains Clobetasol Propionate BP 0.5 mg (0.05% w/w)
• Clobetasol Propionate Ointment: Each gram ointment contains Clobetasol Propionate BP 0.5 mg (0.05% w/w)
• Clobetasol Propionate Scalp Application: Each gram lotion contains Clobetasol Propionate BP 0.5 mg (0.05% w/w)
• Clobetasol Propionate Shampoo: Each gram shampoo contains Clobetasol Propionate BP 0.5 mg (0.05% w/w)
• Clobetasol Propionate Lotion: Each gram lotion contains Clobetasol Propionate BP 0.5 mg (0.05% w/w)
• Clobetasol Propionate Spray: Each gram spray contains Clobetasol Propionate BP 0.5 mg (0.05% w/w)

Pharmacology

Clobetasol Propionate is a very potent topical corticosteroid with anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions, decrease mast cell density, chemotaxis and activation of eosinophils, reduce cytokine production and inhibit the metabolism of arachidonic acid.

Dosage

• Cream, Ointment:
  • Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely
  • Treatment should be limited to 2 consecutive weeks with a maximum weekly dose not exceeding 50 gm/week for adults, elderly, and children over 1 year
• Spray: Apply required quantity of spray once or twice daily to the affected areas of the scalp and gently rub in, not exceeding 50 ml weekly
• Shampoo: Apply to the dry (not wet) scalp once a day to the affected areas only, with treatment limited to 4 consecutive weeks and total dosage not exceeding 50 g per week, not recommended under 18 years
• Scalp Solution: Apply required quantity of spray once or twice daily to the affected areas of the scalp and gently rub in, not exceeding 50 ml weekly

Administration

Route of administration is cutaneous, with creams appropriate for moist or weeping surfaces, and ointments appropriate for dry, lichenified or scaly lesions.

Interaction

Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids, leading to increased systemic exposure.

Contraindications

• Rosacea, acne vulgaris, and perioral dermatitis
• Hypersensitivity to the preparation
• Not indicated for the treatment of primarily infected skin lesions caused by infection with fungi or bacteria, perianal and genital pruritus
• Dermatoses in children under one year of age

Side Effects

• Prolonged use of large amounts can result in sufficient systemic absorption to produce the features of hypercorticism
• Prolonged and intensive treatment may cause local atrophic changes in the skin such as thinning, striae, and dilatation of the superficial blood vessels
• In rare instances, treatment of psoriasis is thought to have provoked the pustular form of the disease
• Reports of pigmentation changes and hypertrichosis with topical steroids
• Exacerbation of symptoms may occur

Pregnancy & Lactation

Limited data from the use of Clobetasol Propionate cream in pregnant women, caution should be exercised when administered to a nursing woman.

Precautions & Warnings

Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur readily. If used in childhood or on the face, courses should be limited if possible to five days and occlusion should not be used.

Use in Special Populations

In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.

Overdose Effects

Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur.

Therapeutic Class

Other Topical corticosteroids

Storage Conditions

Keep below 30°C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.

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