Nyclobate Cream

Indications

Nyclobate is prescribed for adults, the elderly, and children over 1 year of age for the treatment of the following skin conditions:

• Psoriasis (excluding widespread plaque psoriasis)
• Persistent dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin conditions that have not responded well to milder corticosteroids.

Use this medication only as directed by a registered physician.

Composition

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

Pharmacology

Clobetasol Propionate is a potent topical corticosteroid with strong anti-inflammatory, antipruritic, and vasoconstrictive effects. It works through various mechanisms to suppress allergic reactions, including reducing mast cell density, inhibiting eosinophil activity, and blocking cytokine production. Additionally, it interferes with the metabolism of arachidonic acid, reducing inflammation.

Dosage and Administration

Cream/Ointment: For adults, the elderly, and children over 1 year, apply a thin layer to the affected area twice daily, gently rubbing it in. For stubborn lesions, especially with hyperkeratosis, use of an occlusive dressing overnight may enhance results. Limit treatment to 2 consecutive weeks, with no more than 50 g per week. For children, limit courses to 5 days, with weekly review.

Spray: Apply once or twice daily to the affected scalp area, not exceeding 50 ml per week. If no improvement is seen after one week, discontinue use.

Shampoo: Apply to dry scalp once daily, massaging gently into the lesions and leaving it on for 15 minutes before lathering and rinsing. Limit treatment to 4 weeks, with a maximum of 50 g per week. Not recommended for use under 18 years.

Scalp Solution: Apply once or twice daily, massaging it into the scalp with fingertips. Do not exceed 50 ml per week. Discontinue use after one week if there is no response.

Use as per the advice of a registered physician.

Mode of Application

For cutaneous use only. Creams are best suited for moist or weeping skin, while ointments are ideal for dry, lichenified, or scaly lesions.

Drug Interactions

Drugs that inhibit CYP3A4 (e.g., ritonavir, itraconazole) may interfere with the metabolism of corticosteroids, increasing systemic absorption and exposure.

Contraindications

Nyclobate should not be used in:

• Rosacea, acne vulgaris, and perioral dermatitis
• Primary cutaneous viral infections (e.g., herpes simplex, chickenpox)
• Hypersensitivity to the formulation
• Fungal infections (e.g., candidiasis, tinea) or bacterial skin infections (e.g., impetigo)
• Perianal and genital itching
• Children under 1 year of age, including those with dermatitis or diaper rash.

Side Effects

Prolonged use or excessive application of Clobetasol can lead to systemic absorption, potentially causing hypercorticism. Long-term use of potent corticosteroids may cause skin thinning, striae, and dilation of superficial blood vessels, especially under occlusive dressings. Rarely, psoriasis treatment with corticosteroids can provoke pustular psoriasis or cause pigmentation changes and hypertrichosis. If signs of hypersensitivity appear, discontinue use immediately.

Pregnancy and Lactation

There is limited information on the use of Clobetasol Propionate during pregnancy. Animal studies suggest that corticosteroids may affect fetal development. Use during pregnancy or lactation should be considered only if the potential benefits outweigh the risks. It is unknown whether this drug is excreted in breast milk, so caution is advised.

Warnings and Precautions

Avoid long-term continuous use, particularly in children, as adrenal suppression may occur. If treating the face, use with caution as the face is more susceptible to atrophic changes. Care must be taken to prevent the cream from entering the eyes, as it may cause glaucoma or cataracts. In psoriasis, corticosteroids can cause rebound relapses, tolerance, and local or systemic toxicity. If infections arise, stop corticosteroid use and start appropriate antimicrobial treatment.

Special Populations

Children under 12 years old are more susceptible to the side effects of topical corticosteroids, and long-term use should be avoided.

Overdose

Acute overdose is unlikely. However, in the case of chronic misuse, signs of hypercortisolism may appear, and the treatment should be stopped.

Storage Instructions

Store below 30°C in a cool, dry place, away from light. Do not freeze. Keep out of reach of children.