Nyclobate Scalp Solution

Indications

Nyclobate is suitable for use in adults, the elderly, and children over one year old for the treatment of various dermatoses, including:

• Psoriasis (excluding extensive plaque psoriasis)
• Persistent dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin conditions that do not respond effectively to milder steroid treatments.

Always follow the advice of a registered healthcare professional when using this medication.

Composition

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

Pharmacology

Clobetasol Propionate is a potent topical corticosteroid known for its anti-inflammatory, antipruritic, and vasoconstrictive effects. It alleviates inflammation through various mechanisms, including the inhibition of late-phase allergic reactions. This medication decreases mast cell density, chemotaxis, and eosinophil activation, reduces cytokine production, and inhibits arachidonic acid metabolism.

Dosage

• Cream and Ointment: For adults, elderly patients, and children over one year, apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected areas twice daily. Gently rub in until fully absorbed. For stubborn lesions, especially those with hyperkeratosis, occlusive dressings may enhance effectiveness. Short treatment courses are advisable, not exceeding two consecutive weeks, with a maximum dose of 50 g per week. In pediatric cases, treatment should ideally be limited to five days and assessed weekly.
• Spray: Apply the required amount once or twice daily to the affected scalp areas and gently massage in. Total weekly dosage should not exceed 50 ml. Discontinue if no improvement is observed after one week or once lesions heal.
• Shampoo: Apply to dry scalp once daily to the affected areas. Massage gently into lesions and leave for 15 minutes before rinsing. Limit treatment to four consecutive weeks, ensuring the total dosage does not exceed 50 g per week. Not recommended for individuals under 18.
• Scalp Solution: Apply the necessary quantity of Clobetasol Scalp Solution once or twice daily, massaging gently into the scalp. The total weekly dose should not exceed 50 ml. Therapy should cease if no improvement is noted after one week or upon healing.

Always follow the advice of a registered healthcare professional when using this medication.

Administration

• Route: Topical application. Creams are ideal for moist or weeping surfaces, while ointments are better suited for dry, lichenified, or scaly lesions. Always follow the advice of a registered healthcare professional when using this medication.

Interactions

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

Contraindications

Nyclobate is contraindicated in:

• Rosacea, acne vulgaris, and perioral dermatitis.
• Primary cutaneous viral infections (e.g., herpes simplex, chickenpox).
• Hypersensitivity to Clobetasol Propionate.
• Primarily infected skin lesions from fungal (e.g., candidiasis, tinea) or bacterial (e.g., impetigo) infections.
• Dermatoses in children under one year, including dermatitis and diaper rashes.

Side Effects

Prolonged use or treatment over large areas may result in systemic absorption, leading to hypercorticism symptoms. Long-term treatment with highly potent corticosteroids can cause local atrophic changes like skin thinning, striae, and dilation of superficial blood vessels, particularly under occlusive dressings or in skin folds. In rare cases, corticosteroid treatment for psoriasis may trigger the pustular variant of the disease. While Nyclobate is generally well-tolerated, discontinue use immediately if hypersensitivity reactions occur, as symptom exacerbation may follow.

Pregnancy & Lactation

Limited data is available regarding the use of Clobetasol Propionate cream in pregnant women. Topical corticosteroids may cause developmental abnormalities in pregnant animals; however, the relevance to humans is unclear. The use of Clobetasol Propionate Cream during pregnancy and lactation should be considered only if the potential benefits to the mother outweigh any risks.

It is uncertain whether Clobetasol Propionate is excreted in human milk. Exercise caution when administering this medication to nursing women.

Precautions & Warnings

Long-term continuous topical therapy should be avoided, especially in infants and children, due to the risk of adrenal suppression. In cases involving children or facial applications, treatment should be limited to five days without occlusion.

The face is particularly susceptible to atrophic changes after prolonged treatment with potent corticosteroids, so caution is advised when treating conditions like psoriasis, discoid lupus erythematosus, and severe eczema.

Avoid applying to eyelids to prevent entry into the eyes, which could lead to glaucoma or cataracts.

Topical corticosteroids can be problematic in psoriasis due to risks such as rebound relapses, tolerance development, generalized pustular psoriasis, and systemic toxicity due to impaired skin barrier function. Careful patient supervision is essential when using these treatments for psoriasis.

Appropriate antimicrobial therapy should accompany treatments for inflammatory lesions that become infected. Any spread of infection necessitates discontinuation of topical corticosteroid therapy and the initiation of systemic antimicrobial agents. Bacterial infections may arise from the warm, moist environment fostered by occlusive dressings, so clean the skin before applying new dressings.

Use in Special Populations

In infants and children under 12, long-term continuous use of topical corticosteroids should be avoided to minimize the risk of adrenal suppression. Children may also be more prone to atrophic changes from these medications.

Overdose Effects

Acute overdose is unlikely, but chronic overdosage or misuse may lead to symptoms of hypercortisolism, requiring cessation 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.