Clobetasol Propionate is indicated in adults, elderly patients, and children above 1 year of age for the treatment of the following dermatoses:

• Psoriasis (excluding widespread plaque psoriasis)
• Resistant or difficult-to-treat dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin conditions that do not respond adequately to less potent corticosteroids

Clobetasol Propionate Cream: Each gram of cream contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).

Clobetasol Propionate Ointment: Each gram of ointment contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).

Clobetasol Propionate Scalp Application: Each gram of lotion contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).

Clobetasol Propionate Shampoo: Each gram of shampoo contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).

Clobetasol Propionate Lotion: Each gram of lotion contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).

Clobetasol Propionate Spray: Each gram of spray contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).

Clobetasol Propionate is a highly potent topical corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It exerts its anti-inflammatory effects through multiple mechanisms, including suppression of late-phase allergic reactions. It reduces mast cell density, inhibits chemotaxis and activation of eosinophils, decreases cytokine production, and blocks the metabolism of arachidonic acid.

Like other topical corticosteroids, clobetasol propionate demonstrates anti-inflammatory, antipruritic, and vasoconstrictive actions. Although the exact mechanism is not fully defined, it is believed to act by inducing phospholipase A2 inhibitory proteins (lipocortins). These proteins regulate the synthesis of inflammatory mediators such as prostaglandins and leukotrienes by preventing the release of their precursor, arachidonic acid, from membrane phospholipids.

Cream, Ointment: Adults, elderly and children over 1 year: Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely. Repeated short courses of Clobetasol Propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response.

Clobetasol Propionate is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks. The maximum weekly dose should not be exceeded 50 gm/week. In case of children, courses should be limited if possible to five days and reviewed weekly.

Spray: Apply required quantity of spray of once or twice daily to the affected areas of the scalp and gently rub in. The total dose applied should not exceed 50 ml weekly. If necessary, Clobetasol Propionate scalp solution may be massaged into the scalp using the tips of the fingers. Therapy should be discontinued if no response is noted after one week or as soon as the lesion heals. It is advisable to use Clobetasol Propionate scalp solution for brief periods only.

Shampoo: It should be applied to the dry (not wet) scalp once a day to the affected areas only. It should be massaged gently into the lesions and left in place for 15 minutes before lathering and rinsing. Treatment should be limited to 4 consecutive weeks. Total dosage of shampoo should not exceed 50 g per week. Under 18 years this preparation is not recommended.

Scalp Solution: Apply required quantity of spray of Clobetasol Scalp Solution once or twice daily to the affected areas of the scalp and gently rub in. The total dose applied should not exceed 50 ml weekly. If necessary, Clobetasol Scalp Solution may be massaged into the scalp using the tips of the fingers. Therapy should be discontinued if no response is noted after one week or as soon as the lesion heals. It is advisable to use Clobetasol Scalp Solution for brief periods only.

Administration

Route of administration: Cutaneous. Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.

Co-administered drugs that inhibit CYP3A4 (such as ritonavir, itraconazole) may reduce the metabolism of corticosteroids, resulting in increased systemic exposure.

• Rosacea, acne vulgaris, and perioral dermatitis. Primary viral skin infections (e.g., herpes simplex, chickenpox).
• Hypersensitivity to any component of the preparation.
• Not indicated for primarily infected skin lesions caused by fungi (e.g., candidiasis, tinea) or bacteria (e.g., impetigo), including perianal and genital itching.
• Dermatoses in children under one year of age, including dermatitis and napkin rash.

• Prolonged use of large amounts or application over extensive areas may lead to systemic absorption causing features of hypercorticism.
• Long-term and intensive treatment with potent corticosteroids may cause local skin atrophy, including thinning, striae, and dilation of superficial blood vessels, especially under occlusion or in skin folds.
• In rare cases, treatment (or withdrawal) of psoriasis with corticosteroids may trigger pustular psoriasis.
• Changes in skin pigmentation and excessive hair growth (hypertrichosis) have been reported. Although generally well tolerated, treatment should be discontinued if hypersensitivity occurs. Worsening of symptoms may also happen.

There is limited information on the use of Clobetasol Propionate in pregnant women. Animal studies have shown possible fetal developmental abnormalities with corticosteroids. Therefore, it should be used during pregnancy and lactation only if the expected benefit outweighs the potential risk.

It is not known whether this drug is excreted in human breast milk. Caution should be exercised when administered to breastfeeding women.

Long-term continuous use of topical corticosteroids should be avoided, especially in infants and children, due to the risk of adrenal suppression. In children or when applied to the face, treatment duration should be limited (preferably up to five days), and occlusive dressings should be avoided.

The face is more prone to atrophic changes with prolonged use of potent corticosteroids. This should be considered when treating conditions such as psoriasis, discoid lupus erythematosus, and severe eczema.

Care should be taken to avoid contact with the eyes, as it may lead to glaucoma or cataract.

In psoriasis, topical corticosteroids should be used cautiously due to risks such as rebound relapse, tolerance, generalized pustular psoriasis, and systemic toxicity from impaired skin barrier function.

When treating infected inflammatory lesions, appropriate antimicrobial therapy should be used. If infection spreads, discontinue corticosteroid therapy and initiate systemic antimicrobial treatment. Occlusive dressings may increase the risk of infection, so the skin should be cleaned before applying a new dressing.

In infants and children under 12 years of age, long-term use of topical corticosteroids should be avoided due to the risk of adrenal suppression. Children are more susceptible to developing atrophic skin changes.

Acute overdose is unlikely. However, chronic overuse or misuse may lead to hypercorticism; in such cases, treatment should be discontinued.

Other Topical corticosteroids

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