Exovate Ointment 0.05%

Indications:

Exovate is prescribed for the treatment of various skin conditions in adults, the elderly, and children over 1 year of age. It is effective in managing:

• Psoriasis (excluding extensive plaque psoriasis)
• Persistent dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin disorders resistant to less potent steroids

Composition:

• Exovate Clobetasol Propionate Cream: Each gram contains 0.5 mg (0.05% w/w) of Clobetasol Propionate BP.
• Exovate Clobetasol Propionate Ointment: Each gram contains 0.5 mg (0.05% w/w) of Clobetasol Propionate BP.
• Exovate Clobetasol Propionate Scalp Application: Each gram contains 0.5 mg (0.05% w/w) of Clobetasol Propionate BP.
• Exovate Clobetasol Propionate Shampoo: Each gram contains 0.5 mg (0.05% w/w) of Clobetasol Propionate BP.
• Exovate Clobetasol Propionate Lotion: Each gram contains 0.5 mg (0.05% w/w) of Clobetasol Propionate BP.
• Exovate Clobetasol Propionate Spray: Each gram contains 0.5 mg (0.05% w/w) of Clobetasol Propionate BP.

Pharmacology:

Clobetasol Propionate is a highly potent topical corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It acts by inhibiting late-phase allergic reactions, decreasing mast cell density, and reducing eosinophil activity. It also lowers cytokine production and inhibits arachidonic acid metabolism.

Dosage:

• Cream and Ointment: For adults, elderly, and children over 1 year, apply a thin layer twice daily to affected areas. Gently rub in and may use occlusive dressings for resistant lesions. Limit use to 2 consecutive weeks and do not exceed 50 grams per week. For children, limit treatment to five days and review weekly.
• Spray: Apply once or twice daily to the scalp, not exceeding 50 ml per week. Massage into the scalp if needed. Discontinue if no improvement is seen within one week or as soon as lesions heal.
• Shampoo: Apply to dry scalp once daily, massage into lesions, leave for 15 minutes, then rinse. Limit to 4 consecutive weeks and do not exceed 50 grams per week. Not recommended for those under 18.
• Scalp Solution: Apply once or twice daily to the scalp, not exceeding 50 ml per week. Massage into scalp as needed. Discontinue if no improvement within one week or as soon as lesions heal.

Administration:

• Route: Cutaneous.
• Creams: Best for moist or weeping surfaces.
• Ointments: Suitable for dry, lichenified, or scaly lesions.

Interactions:

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

Contraindications:

• Rosacea, acne vulgaris, perioral dermatitis, primary cutaneous viral infections (e.g., herpes simplex, chickenpox).
• Hypersensitivity to Clobetasol Propionate.
• Not indicated for fungal (e.g., candidiasis, tinea) or bacterial infections (e.g., impetigo) and perianal or genital pruritus.
• Not suitable for dermatoses in children under one year.

Side Effects:

• Long-term or excessive use may lead to systemic absorption and signs of hypercorticism.
• Prolonged use can cause local skin thinning, striae, and dilatation of superficial blood vessels, especially with occlusive dressings.
• May provoke pustular psoriasis in rare cases.
• Possible pigmentation changes and hypertrichosis.

Pregnancy & Lactation:

Limited data is available on the use of Clobetasol Propionate in pregnant women. Potential risks to fetal development have been noted in animal studies. Use during pregnancy and lactation should be considered only if the benefits outweigh the risks. It is unknown if this drug is excreted in human milk.

Precautions & Warnings:

Avoid long-term continuous use, especially in infants and children, due to the risk of adrenal suppression. Limit use on the face and avoid occlusion. Avoid application to eyelids to prevent glaucoma or cataracts. Monitor for rebound relapses, tolerance, or generalised pustular psoriasis in psoriasis patients.

Use in Special Populations:

Avoid long-term use in children under 12 years due to the risk of adrenal suppression and atrophic changes.

Overdose Effects:

Acute overdosage is unlikely. Chronic misuse may lead to hypercortisolism. Discontinue use if symptoms of hypercortisolism occur.

Therapeutic Class:

Topical Corticosteroids

Storage Conditions:

Store below 30°C, away from light and moisture. Do not freeze. Keep out of reach of children.