Topicort (Desoximetasone)

TOPICORT® Preparations Hoechst Marion Roussel Desoximetasone Topical Corticosteroid

Action and Clinical

Topicort preparations are primarily effective because of their anti-inflammatory, antipruritic and vasoconstrictive actions.

Indications And Clinical Uses:

For the relief of acute or chronic corticosteroid-responsive dermatoses.

Contra-Indications:

Topical corticosteroids are contraindicated in untreated bacterial, tubercular, fungal and most viral lesions of the skin (including herpes simplex, vaccinia and varicella) and in those patients with a history of hypersensitivity to any of the components of the preparation.:

Topicort preparations are not for ophthalmic use.

Warnings in Clinical States:

Systemic side effects may occur with topical corticosteroid preparations, particularly when these preparations are used over large areas or for an extended period of time or with occlusive dressings. A patient who has been on prolonged therapy, especially occlusive therapy, may develop adrenal suppression due to sufficient absorption of the steroid.

Pregnancy and Lactation: The safety of topical corticosteroid preparations 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 in pregnant patients or nursing mothers.

Precautions:

General: Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see Children).

If local infection exists, suitable concomitant antimicrobial or antifungal therapy should be administered 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 promptly, application of the corticosteroid should be discontinued until the infection is adequately controlled.

If local irritation or sensitization develops, desoximetasone creams, gel and ointment should be discontinued and appropriate therapy instituted.

The use of occlusive dressings increases the percutaneous absorption of corticosteroids; their extensive use increases the possibility of systemic effects and is therefore not advisable. For patients with extensive lesions it may be preferable to use a sequential approach, treating one portion of the body at a time. The patient should be kept under close observation if treated with large amounts of topical corticosteroid or with the occlusive technique over a prolonged period of time.

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

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

Topical corticosteroids should be used with caution on lesions close to the eyes.

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

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

Children: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal [HPA] axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Adverse Reactions:

:Topicort preparations are well tolerated. Side effects have been rare. Similar to other topical corticosteroid preparations, they may cause: burning sensation, dryness, itching, erythema, change in skin pigmentation, folliculitis, pyoderma, striae, telangiectasia and skin atrophy. The following reactions are reported when corticosteroid preparations are used extensively on intertriginous areas or under occlusive dressings: maceration of the skin, secondary infection, striae, miliaria, hypertrichosis and localized skin atrophy.

Adrenal suppression has been shown to occur 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:

OverdoseSymptoms: Toxic effects due to prolonged percutaneous absorption of large amounts of corticosteroids may include: reversible suppression of adrenal function, skin striae, ecchymoses, discoloration or atrophy, acneiform eruptions, hirsutism, infection. Prolonged systemic corticosteroid action may cause hypertension, peptic ulceration, hypokalemia, muscle weakness and wastage and subcapsular cataracts.

Treatment: Treatment should include symptomatic therapy and discontinuation of corticosteroid administration. In chronically affected patients, a gradual discontinuation may prevent the development of steroid withdrawal symptoms.

Dosage And Administration:

Apply a thin film to the affected skin areas twice daily. Rub in gently.

Availability And Storage:

Topicort Cream: Each tube contains: desoximetasone, 0.25%. Nonmedicinal ingredients: isopropyl myristate, methylparaben, propylparaben, wool alcohols and wool alcohols ointment. Tubes of 20 and 60 g.

Topicort Mild Cream: Each tube contains: desoximetasone, 0.05%. Nonmedicinal ingredients: edetate disodium, isopropyl myristate, lactic acid, methylparaben, propylparaben, wool alcohols and wool alcohols ointment. Tubes of 20 and 60 g.

Topicort Gel: Each tube contains: desoximetasone, 0.05%. Nonmedicinal ingredients: alcohol, carbopol 940 (carboxypolymethylene), docusate sodium, edetate disodium, isopropyl myristate, trolamine and water. Extended-tip tubes of 20 and 60 g.

Topicort Ointment: Each tube contains: desoximetasone, 0.25%. Nonmedicinal ingredients: aluminum stearate, beeswax, butylated hydroxyanisole, citric acid, fatty acid pentaerythritol ester, fatty alcohol citrate, propylene glycol, sorbitan sesquioleate and white petrolatum. Tubes of 20 and 60 g.

Store at room temperature, below 25°C.

TOPICORT® Preparations Hoechst Marion Roussel Desoximetasone Topical Corticosteroid

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