Xenovate 0.05%

Description

Indications:
Xenovate is indicated for adults, the elderly, and children over 1 year for the treatment of the following dermatoses:

• Psoriasis (excluding widespread plaque psoriasis)
• Recalcitrant dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin conditions unresponsive to less potent steroids.

Use as per registered physician’s advice.

Composition:

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

Pharmacology:
Clobetasol Propionate is a potent topical corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It inhibits late-phase allergic reactions, reduces mast cell density, suppresses cytokine production, and inhibits arachidonic acid metabolism.

Dosage & Administration:

• Cream, Ointment: Apply a thin layer to the affected skin twice daily. Do not exceed 50g per week. In children, treatment should be limited to five days and reviewed weekly.
• Spray: Apply once or twice daily to the scalp. Do not exceed 50 ml per week. If no response is observed after one week, discontinue use.
• Shampoo: Apply to a dry scalp once daily, massage gently, leave for 15 minutes, then rinse. Use for up to four weeks. Not recommended for patients under 18.
• Scalp Solution: Apply once or twice daily, rubbing gently into the scalp. Do not exceed 50 ml per week. Use for brief periods only.

Use as per registered physician’s advice.

Interaction:
Co-administration with CYP3A4 inhibitors (e.g., ritonavir, itraconazole) may increase systemic exposure to corticosteroids.

Contraindications:

• Rosacea, acne vulgaris, perioral dermatitis.
• Primary viral skin infections (e.g., herpes simplex, chickenpox).
• Hypersensitivity to Clobetasol Propionate.
• Fungal or bacterial skin infections.
• Perianal and genital pruritus.
• Children under one year, including dermatitis and napkin eruptions.

Side Effects:

• Prolonged use may cause skin thinning, striae, dilated blood vessels, hypertrichosis, and pigmentation changes.
• Systemic absorption may lead to hypercorticism.
• Rare cases of pustular psoriasis after corticosteroid treatment.
• Hypersensitivity reactions; discontinue if symptoms worsen.

Pregnancy & Lactation:

• Limited human data; use only if benefits outweigh risks.
• Avoid prolonged or excessive application during pregnancy.
• It is unknown if excreted in breast milk; caution is advised.

Precautions & Warnings:

• Avoid long-term continuous therapy, especially in infants and children, due to adrenal suppression risk.
• Use with caution on the face to prevent atrophic skin changes.
• Avoid eye contact to prevent glaucoma or cataracts.
• Monitor closely when used for psoriasis due to risks of rebound relapse and systemic toxicity.
• If infection occurs, discontinue and switch to antimicrobial therapy.
• The skin should be cleaned before applying fresh occlusive dressings.

Use in Special Populations:

• Avoid prolonged use in children under 12 due to increased risk of systemic absorption.

Overdose Effects:

• Acute overdose is unlikely. Chronic overuse may lead to hypercortisolism. Discontinue treatment gradually.

Therapeutic Class:

• Other topical corticosteroids.

Storage Conditions:

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

Use as per the registered physician’s advice.