ACME LABORATORIES LTD.
CLOBETASOL PROPIONATE [TOPICAL PREPARATION]
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.s
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.
There are limited data from the use of Clobetasol Propionate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, the administration of Clobetasol Propionate Cream during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs the possible risks of treatment. It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur and in this situation topical steroid should be discontinued.
In case of using occlusive dressings, the skin should be cleansed before a fresh dressing is applied. Topical corticosteroids should be used with caution in psoriasis as rebound relapses, and development of local or systemic toxicity due to impaired barrier function of the skin may occur. If used on the face, treatment should be limited to 5 days. When Clobetasol Propionate used on eyelids, care should be taken to avoid the eyes as cataract and glaucoma might result from repeated exposure.
Keep below 308C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.d