Nyclobate Spray

Indications

Nyclobate is recommended for the treatment of various dermatological conditions in adults, the elderly, and children over 1 year old, including:

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

Note: Always use as directed by a registered healthcare provider.

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 with anti-inflammatory, antipruritic, and vasoconstrictive properties. It works by reducing late-phase allergic reactions and decreasing the density of mast cells. It also inhibits eosinophil activation, reduces cytokine production, and blocks arachidonic acid metabolism, providing effective relief from inflammatory skin conditions.

Dosage

• Cream and Ointment: Apply a thin layer to the affected area twice daily. Gently rub it in. For resistant cases, occlusion with a polythene film overnight may enhance the effect. Limit treatment to two consecutive weeks, with a maximum weekly dose of 50 grams. For children, treatment duration should be as brief as possible, typically limited to five days.
• Spray: Apply to the affected scalp area once or twice daily. The total weekly dose should not exceed 50 ml. Discontinue if there is no response after one week or as soon as the lesions heal.
• Shampoo: Apply to a dry scalp, massaging into affected areas. Leave for 15 minutes before rinsing. Limit use to four weeks, with a maximum dose of 50 grams per week. Not recommended for children under 18.
• Scalp Solution: Apply once or twice daily to affected areas, gently massaging in. The total dose should not exceed 50 ml weekly. Therapy should be limited to short durations.

Note: Always follow the guidance of a registered healthcare provider.

Administration

Route of administration: Topical (cutaneously). Creams are ideal for moist or weeping surfaces, while ointments are better for dry, scaly, or lichenified lesions.

Note: Always consult a healthcare professional before use.

Drug Interactions

Concomitant use of drugs that inhibit CYP3A4 (e.g., ritonavir, itraconazole) may increase systemic exposure to corticosteroids, potentially leading to adverse effects.

Contraindications

Clobetasol Propionate should not be used in:

• Rosacea, acne vulgaris, perioral dermatitis, and viral skin infections (e.g., herpes simplex, chickenpox).
• Hypersensitivity to the active ingredients.
• Primary infected skin lesions (e.g., fungal infections like candidiasis or tinea, bacterial infections like impetigo).
• Dermatoses in infants under 1 year, including napkin eruptions.

Side Effects

While Nyclobate is generally well tolerated, prolonged or excessive use of topical corticosteroids can lead to systemic absorption, causing hypercorticism.

• Long-term use may result in skin thinning, striae, and visible blood vessels, especially with occlusive dressings.
• In rare cases, corticosteroid use can trigger pustular psoriasis.
• Other side effects may include pigmentation changes and excessive hair growth. If any hypersensitivity reactions occur, discontinue use immediately.

Pregnancy and Lactation

Although limited data exists on the use of Clobetasol Propionate during pregnancy, topical corticosteroid use in animals has shown developmental risks. Therefore, the medication should only be used during pregnancy if the benefit outweighs the potential risks.
It is unknown whether Clobetasol Propionate passes into human breast milk, so caution is advised when used by nursing mothers.

Precautions and Warnings

• Avoid long-term continuous use, particularly in infants and children, as it can lead to adrenal suppression.
• Prolonged use on the face may cause atrophic skin changes.
• Be cautious when applying near the eyes as corticosteroids can cause glaucoma or cataracts.
• If using on psoriasis, careful monitoring is essential to avoid rebound or systemic side effects.
• Infected lesions require antimicrobial therapy alongside corticosteroid treatment.

Use in Special Populations

Topical corticosteroid therapy should be limited in children under 12 years of age due to the increased risk of side effects, including adrenal suppression and atrophic skin changes.

Overdose Effects

Chronic misuse or overuse of Nyclobate may lead to symptoms of hypercortisolism. If this occurs, discontinue use of the steroid.

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.