Xenovate Ointment 30gm

Product Information

XENOVATE

Xenovate®(Clobetasol Propionate)

Presentation

Xenovate ointment: Homogenous ointment; each gram ointment contains Clobetasol Propionate BP 0.5mg.

Xenovate cream: White, smooth, water washable cream; each gram cream contains Clobetasol Propionate BP 0.5mg.

Indications

Xenovate (Clobetasol Propionate) ointment and cream are indicated for the topical therapy of recalcitrant corticosteroid

responsive dermatoses, including severe cases of psoriasis (excluding widespread plaque psoriasis) and eczematous dermatitis.

Xenovate (Clobetasol Propionate) ointment is generally chosen for dry, lichenified or scaly lesions or where a more occlusive

effect is required.

Xenovate (Clobetasol Propionate) cream is suitable for moist or weeping lesions.

Dosage & administration

Xenovate (Clobetasol Propionate) ointment and cream are applied sparingly to cover the affected area, and gently rubbed into the

skin. Frequency of application is two to three times daily according to the severity of the condition. The total dose of

Clobetasol Propionate cream and ointment applied should not exceed 50grams weekly. Therapy should be discontinued if no response

is noted after a week or as soon as the lesion heals. It is advisable to use Clobetasol Propionate (Xenovate) cream and ointment

for brief periods only.

Contra-indications, warnings, etc.

Contra-indications: Clobetasol Propionate ointment and cream are contraindicated in patients with hypersensitivity to Clobetasol

Propionate. This preparation is contraindicated also in the treatment of primary infected bacterial or fungal skin lesions if no

anti-infective agent is used simultaneously, in primary cutaneous viral infections (i.e.,herpes simplex, vaccinia and

varicella) and in tuberculous skin lesions. Clobetasol Propionate is also contraindicated in dermatoses in children under one year

of age, including dermatitis and diaper eruptions.

Warnings & precautions: Clobetasol Propionate should be used with caution on lesions close to the eye. When Clobetasol Propionate

is used over extensive areas for prolonged periods, it is possible that sufficient absorption may take place to give rise to

adrenal suppression. This is particularly true for pediatric patients who may be more susceptible to systemic toxicity

from equivalent doses due to their larger skin surface to body mass ratio. Topical corticosteroids may be hazardous in psoriasis

for a number of reasons including rebound relapases, development of tolearance, 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 antimicrobial 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

antimicrobial 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.

Drug interaction: There has been no report of interaction with Clobetasol Propionate ointment and cream.

Use in pregnancy & lactation: Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal

development. The relevance of this finding to human beings has not been established. The safe use of Clobetasol Propionate during

lactation has not been established. However, the administration of Clobetasol Propionate during pregnancy and lactation should

only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. Drugs of this class

should not be used extensively in pregnant patients in large amounts or for prolonged periods of time.

Side effects: As with other topical corticosteroids, prolonged use of large amounts of Clobetasol Propionate or treatment of

extensive areas can result in sufficient systemic absorption to produce the features of hypercortisolism. This effect is more

likely to occur in infants and children, and if occlusive dressings are used. Local atrophy may occur after prolonged

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

pustular form of the diseases Clobetasol Propionate is usually well tolerated, but if signs of hypersensitivity appear,

application should be stopped immediately.

Overdosage: Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of

hypercortisolism may appear and in this situation topical steroids should be discontinued gradually. However, because of the risk

of acute adrenal suppression this should be done under medical supervision.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Xenovate 10gm ointment : Cartons containing 10gm ointment in tube.

Xenovate 30gm ointment : Cartons containing 30gm ointment in tube.

Xenovate 10gm cream: Cartons containing 10gm cream in tube.