Dermex Ointment 0.05%

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.

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

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

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

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

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

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

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.

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

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.

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.

Rosacea, acne vulgaris and perioral dermatitis. Primary cutaneous viral infections (e.g. herpes simplex, chickenpox).

Hypersensitivity to the preparation.

The use of Clobetasol Propionate skin preparations is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi (e.g. candidiasis, tinea), or bacteria (e.g.impetigo): perianal and genital pruritus.

Dermatoses in children under one year of age, including dermatitis and napkin eruptions.

As with other topical corticosteroids prolonged use of large amounts, or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercorticism.

Prolonged and intensive treatment with a highly active corticosteroid preparation may cause local atrophic changes in the skin such as thinning, striae and dilatation of the superficial blood vessels, particularly when occlusive dressings are used or when skin folds are involved.

In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease.

There are reports of pigmentation changes and hypertrichosis with topical steroids. Clobetasol Propionate is usually well tolerated, but if signs of hypersensitivity appear, application should be stopped immediately. Exacerbation of symptoms may occur.

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.

Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur readily even without occlusion. If used in childhood or on the face, courses should be limited if possible to five days and occlusion should not be used.

The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema.

If applied to the eye lids, care is needed to ensure that the preparation does not enter the eye, as glaucoma or cataract might result.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.

Appropriate anti-microbial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of anti-microbial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.

In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to the use of topical corticosteroids which develops atrophic changes.

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.

Other Topical corticosteroids

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