Nyclobate 0.05%

Indications

Nyclobate is approved for use in adults, the elderly, and children aged over one year for the following skin conditions:

• Psoriasis (excluding widespread plaque psoriasis)
• Recalcitrant dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin disorders that fail to respond adequately to less potent steroid treatments.

Note: Use as directed by a registered healthcare professional.

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 highly potent topical corticosteroid known for its anti-inflammatory, antipruritic, and vasoconstrictive effects. It works by inhibiting late-phase allergic reactions through various mechanisms, such as reducing mast cell density, suppressing eosinophil activation and chemotaxis, decreasing cytokine production, and inhibiting arachidonic acid metabolism.

Dosage

• Cream and Ointment: For adults, the elderly, and children over one year, apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin twice daily. Gently rub it in until fully absorbed. For more resistant lesions, especially with hyperkeratosis, occluding the treatment area with polythene film overnight may enhance effectiveness. Limit treatment duration to a maximum of 2 consecutive weeks, and do not exceed 50 g per week. For children, limit treatment courses to five days and assess weekly.
• Spray: Apply the necessary amount of spray once or twice daily to the affected scalp areas, gently massaging it in. The total weekly dosage should not exceed 50 ml. Discontinue therapy if no improvement is observed after one week or once the lesions have healed.
• Shampoo: Apply to a dry scalp once daily on affected areas, massaging gently into the lesions. Leave in for 15 minutes before lathering and rinsing. Treatment should not exceed 4 consecutive weeks, with a total weekly dosage not exceeding 50 g. Not recommended for individuals under 18 years.
• Scalp Solution: Similar to the spray, apply once or twice daily to the affected scalp areas and gently rub in. Total application should not exceed 50 ml weekly. Discontinue if no improvement occurs after one week or when lesions heal.

Note: Use as directed by a registered healthcare professional.

Administration

• Route of Administration: Topical application. Creams are ideal for moist or weeping surfaces, while ointments are suited for dry, lichenified, or scaly lesions.

Note: Use as directed by a registered healthcare professional.

Interaction

Concurrent use of drugs that inhibit CYP3A4 (e.g., ritonavir, itraconazole) may impede corticosteroid metabolism, leading to increased systemic absorption.

Contraindications

• Not suitable for individuals with rosacea, acne vulgaris, or perioral dermatitis.
• Not to be used on primary cutaneous viral infections (e.g., herpes simplex, chickenpox).
• Hypersensitivity to any component of the formulation.
• Not indicated for primarily infected skin lesions caused by fungi (e.g., candidiasis, tinea) or bacteria (e.g., impetigo), or for perianal and genital pruritus.
• Not recommended for children under one year of age, including those with dermatitis and diaper rashes.

Side Effects

Prolonged use or application to extensive areas can lead to systemic absorption, resulting in hypercorticism symptoms. Long-term use of highly active corticosteroids may cause localized atrophic skin changes, such as thinning, striae, and visible blood vessels, particularly with occlusive dressings. Rare cases have reported the development of pustular psoriasis due to corticosteroid treatment or withdrawal. Users may experience pigmentation changes and hypertrichosis. While Nyclobate is generally well tolerated, hypersensitivity reactions warrant immediate discontinuation. Symptoms may worsen upon treatment initiation.

Pregnancy & Lactation

Data on the use of Clobetasol Propionate cream during pregnancy is limited. Topical corticosteroids have been linked to fetal development abnormalities in animal studies, but their relevance to humans remains unclear. Therefore, the use of Clobetasol Propionate Cream during pregnancy and lactation should only be considered when the potential benefits to the mother justify the risks involved. It is unknown if Clobetasol Propionate is excreted in human milk; caution is advised when administering it to nursing mothers.

Precautions & Warnings

Avoid prolonged continuous topical therapy whenever possible, particularly in infants and children, to reduce the risk of adrenal suppression. Limit treatment duration to five days for pediatric patients and avoid occlusion. The face is more susceptible to atrophic changes from prolonged use of potent corticosteroids. Caution is essential when applying to the eyelids to prevent potential eye complications, such as glaucoma or cataracts.

Topical corticosteroids may pose risks in psoriasis due to possible rebound relapses, tolerance development, and local or systemic toxicity. Careful patient supervision is necessary. If treating infected inflammatory lesions, appropriate antimicrobial therapy should accompany treatment. Any signs of infection should lead to the immediate cessation of topical corticosteroids and the initiation of systemic antibiotics.

Use in Special Populations

In infants and children under 12 years, long-term continuous therapy should be minimized to prevent adrenal suppression. Children are at a greater risk of atrophic changes due to topical corticosteroids.

Overdose Effects

Acute overdosage is unlikely; however, chronic misuse may result in hypercortisolism symptoms, necessitating the discontinuation of topical steroid use.

Therapeutic Class

Other topical corticosteroids

Storage Conditions

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