Dermex 20g Ointment

Clobetasol Propionate is indicated for adults, elderly and children over 1 year in following dermatoses.

• Psoriasis (excluding widespread plaque psoriasis)
• Recalcitrant dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin conditions which do not respond satisfactorily to less potent steroids

Other Topical corticosteroids

Clobetasol Propionate is a very potent topical corticosteroid. It has anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.

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.

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.

Topical Spray:

• Clobetasol 0.05% topical spray is for topical use only, and not for ophthalmic, oral or intravaginal use. Spray should be sprayed directly onto the affected skin areas twice daily and rubbed in  gently and completely. The total dosage should not exceed 50 g (59 ml or 2 fluid ounces) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Do not use more than 26 sprays per application or 52 sprays per day.
• Clobetasol 0.05% spray contains a topical corticosteroid; therefore treatment should be limited to 4 weeks. Therapy should be discontinued when control has been achieved. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with Clobetasol Spray. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression.
• Use in pediatric patients younger than 18 years is not recommended because of the potential for HPA axis suppression

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 can inhibit CYP3A4 (eg ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.

It is contraindicated in patient with hypersensitivity to any component of the preparation. It should not be used in rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation, untreated cutaneous infections.

The most reported side effects are burning and stinging sensation. Less frequent adverse reactions are itching, skin atrophy, cracking and fissuring of the skin. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol Propionate formulations.