Xenosal Ointment 30gm

Product Information

XENOSAL

Presentation

Xenosal ointment: Each gram ointment contains Clobetasol Propionate BP 0.5mg and Salicylic Acid BP 30mg.

Indications

Xenosal Ointment is indicated for the relief of the inflammatory manifestations of hyperkeratotic and dry corticosteroid

responsive dermatoses such as, psoriasis, chronic atopic dermatitis, neurodermatitis (licehen Simplex, Chronicus), lichen planus,

eczema (including nummular eczema, hand eczema, eczematous dermatitis), seborrheic dermatitis of the scalp, ichthyosis vulgaris

and other ichthyotic conditions.

Dosage & administration

Apply a thin layer of this ointment to the affected skin areas twice daily and rub in gently & completely. For some patients,

adequate maintenance therapy may be achieved with less frequent application. As with other higher active corticosteroids, therapy

should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be

necessary. It should not be used with occlusive dressing. Treatment beyond 2 consecutive weeks is not exceeding 50gm/week because

of the potential for the drug to suppress the hypothalamic pituitary adrenal axis.

Children: Use in pediatric patients under 12 years of age is not recommended.

Contra-indications, warnings, etc.

For external use only.

Contra-indications: ClobetasolPropionatev is 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. Salicylic Acid is contraindicated in patients displaying salicylate hyersensitivity, or

sensitivity to any other ingredient in the preparation.

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 generalisedpustular 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. Avoid contact with broken or inflammed skin. Salicylate toxicity may occur if applied to large

areas of skin or to the skin of neonates.

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

interactions of Salicylic Acid when used as indicated. However, topical salicylic acid may increase the absorption of other

topically applied medicines. Concomitant use of Salicylic Acid Ointment and other topical medicines on the same area of skin

should therefore be avoided.

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. Whilst there are no known

contra-indications to the use of Salicylic Acid ointment during pregnancy and lactation, the safety has not been established.

Salicylic Acid ointment shold therefore be used with caution.

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. Possible sensitivity reactions, drying and irritation when using Salicylic Acid.

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. Symptoms osslystemic salicylate poisoning (tinnitus,

dizziness and deafness) have been reported after the application of Salicylic Acid to large areas of skin and for prolonged

periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is ullikely to occur if

Salicylic Acid ointment is used as indicated. Salicylate poisoining is usually associated with plasma concentrations >350mg/L.

Most adult deaths occur in patients whose concentrations exceed 700ml/L. Single doses less than 100mg/kg are unlikely to cause

serious poisoning.

Pharmaceutical precautions

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

Packaging quantity

Xenosalointment : Carton containing 30gm ointment in alu tube.

Manufactured by

UniMed&UniHealth Manufacturers Ltd.

Gazipur, Bangladesh

® Registered Trademark