Westcort (Hydrocortisone-17-valerate)

WESTCORT® Preparations

Westwood-Squibb

Hydrocortisone-17-valerate

Topical Corticosteroid

Action And Clinical Pharmacology: Studies conducted in healthy adult volunteers illustrated that 0.2% Hydrocortisone-17-valerate cream and ointment has minimal primary irritant and contact sensitization potential. Adrenal suppression studies with the cream indicated that any observed reduction in pituitary-adrenal function was rapidly reversible.

Indications And Clinical Uses: Topical therapy of acute and chronic corticosteroid responsive dermatoses, where an anti-inflammatory, anti-allergenic and antipruritic activity is required in the topical management of these conditions.

Contra-Indications: Untreated tubercular, bacterial, fungal and most viral lesions of the skin (including herpes simplex, vaccinia and varicella), hypersensitivity to any of the components of the preparation. Not for ophthalmic use.

Manufacturers’ Warnings In Clinical States: Pregnancy and Lactation: The safety of topical corticosteroids during pregnancy and lactation has not been established. The potential benefit should be weighed in these conditions against possible hazard to the fetus or the nursing infant. When indicated, they should not be used extensively, in large amounts or for prolonged periods of time on pregnant patients or nursing mothers.

If used under an occlusive dressing, particularly over extensive areas, sufficient absorption may take place to give rise to adrenal suppression and other systemic effects.

Topical corticosteroids are not for ophthalmic use.

Precautions: Topical corticosteroids should be used with caution on lesions close to the eye.

Although hypersensitivity reactions have been rare with topically applied steroids, the drug should be discontinued, and suitable therapy instituted if there are signs of sensitivity.

In the presence of bacterial infections of the skin, an appropriate antibacterial agent should be used as primary therapy. If it is considered necessary, the topical corticosteroid may be used as an adjunct to control inflammation, erythema, and itching. If a favorable response does not occur within a few days to a week, the steroid should be discontinued until the infection has been adequately controlled.

Significant systemic absorption may occur when steroids are applied over large areas of the body, especially under occlusive dressings. To minimize this possibility, when long-term therapy is anticipated, interrupt treatment periodically or treat one area of the body at a time.

Prolonged use of topical corticosteroid products may produce atrophy of the skin and subcutaneous tissues, particularly on the flexor surfaces and on the face. If this is noted, discontinue the use of topical corticosteroids.

Topical corticosteroids should be used with caution in patients with stasis dermatitis and other skin diseases associated with impaired circulation.

Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.

Occlusive dressings should not be applied if there is an elevation of body temperature.

Adverse Reactions: The following local adverse reactions have been reported with the use of topical corticosteroids: dryness, itching, burning, local irritation, striae, atrophy of s.c. tissues, telangiectasia, hypertrichosis, hypopigmentation and secondary infection. When occlusive dressings are used, pustules, miliaria, folliculitis and pyoderma may occur.

Adrenal suppression has occurred with prolonged use of large doses of topical corticosteroids, particularly under occlusion due to increased percutaneous absorption.

Posterior subcapsular cataracts have been reported following systemic use of corticosteroids.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Percutaneous absorption of corticosteroids can occur when considerable amounts are applied over a large area, particularly when these areas are occluded. Suppression of the adrenal-pituitary axis may result and suitable procedures should be instituted.

Dosage: Gently massage a small amount of cream or ointment into the affected area 2 to 3 times daily as needed.

Availability And Storage: Cream: Each 15, 45 or 60 g tube of cream contains: hydrocortisone-17-valerate 0.2%. Nonmedicinal ingredients: amphoteric-9, carbomer 940, petrolatum, propylene glycol, sodium lauryl sulfate, sodium phosphate, sorbic acid, stearyl alcohol and water.

Ointment: Each 15 or 60 g tube of ointment contains hydrocortisone-17-valerate 0.2%. Nonmedicinal ingredients: carbomer 934, mineral oil, petrolatum, propylene glycol, sodium lauryl sulfate, sodium phosphate, sorbic acid, steareth-2, steareth-100, stearyl alcohol and water.

Store below 26°C.

WESTCORT® Preparations Westwood-Squibb Hydrocortisone-17-valerate Topical Corticosteroid

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