Nyclobate Cream

Indications

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

• Psoriasis (excluding widespread plaque psoriasis)
• Recalcitrant dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin conditions that have not responded adequately to milder steroid treatments.

Use under the guidance of a registered physician.

Composition

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

Pharmacology

Clobetasol Propionate is a highly potent topical corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive effects. It works by inhibiting late-stage allergic reactions through multiple mechanisms, including reducing mast cells, limiting eosinophil activity, lowering cytokine production, and blocking arachidonic acid metabolism.

Dosage and Administration

• Cream/Ointment: For adults, the elderly, and children over 1 year, apply a thin layer to the affected areas twice daily, rubbing it in gently. Short-term courses are recommended to manage flare-ups. In cases with hyperkeratosis, occlusion with polythene film may enhance effectiveness, but should only be done overnight. Limit treatment to 2 consecutive weeks and do not exceed 50g per week. For children, treatment should not extend beyond five days and should be reviewed weekly.
• Spray: Apply once or twice daily to the affected scalp areas, not exceeding 50 ml per week. If no improvement is noted after one week, treatment should be discontinued. Brief periods of use are recommended.
• Shampoo: Use on dry scalp, applying only to affected areas. Massage in, leave for 15 minutes, then rinse. Limit treatment to four consecutive weeks, and do not exceed 50g per week. Not recommended for individuals under 18.
• Scalp Solution: Apply once or twice daily to the affected scalp areas, not exceeding 50 ml per week. Massage in with fingertips. Discontinue use if no improvement occurs after one week.

Use under the guidance of a registered physician.

Route of Administration

Topical use only. Creams are ideal for moist or weeping skin, while ointments are suitable for dry, scaly, or thickened lesions.

Drug Interactions

CYP3A4 inhibitors (e.g., ritonavir, itraconazole) may impede the metabolism of corticosteroids, increasing systemic exposure.

Contraindications

• Rosacea, acne vulgaris, or perioral dermatitis
• Viral skin infections (e.g., herpes simplex, chickenpox)
• Hypersensitivity to Clobetasol Propionate
• Infections primarily caused by fungi or bacteria (e.g., candidiasis, tinea, impetigo)
• Perianal and genital pruritus
• Dermatoses in children under one year, including diaper rashes

Side Effects

Prolonged use of Clobetasol Propionate, especially over large areas or under occlusive dressings, can lead to systemic absorption and signs of hypercorticism. Intensive use may also cause skin thinning, striae, and dilated blood vessels. In rare cases, it can trigger pustular psoriasis or cause pigmentation changes and hypertrichosis. Discontinue use if hypersensitivity develops.

Pregnancy & Lactation

There is limited data on the use of Clobetasol Propionate during pregnancy. Animal studies have shown that topical corticosteroids can cause fetal abnormalities. Therefore, the use of Clobetasol Propionate in pregnant and breastfeeding women should only be considered if the benefits outweigh the risks. It is unknown if the drug is excreted in human milk, so caution is advised.

Precautions & Warnings

Avoid long-term continuous use, particularly in children and infants, as this may lead to adrenal suppression. Care should be taken when using the product on the face, especially around the eyes, due to the risk of glaucoma or cataracts. In cases of psoriasis, close supervision is recommended due to risks such as rebound effects, tolerance, or systemic toxicity.

If infection occurs, appropriate antimicrobial therapy should be started, and corticosteroid use should be discontinued.

Special Populations

In children under 12, avoid prolonged continuous use to prevent adrenal suppression and skin atrophy.

Overdose Effects

Overdose is unlikely; however, chronic overuse may lead to signs of hypercorticism. In such cases, discontinue use.

Therapeutic Class

Topical corticosteroids for skin conditions.

Storage

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