Calmurid (Hydrocortisone – Urea)

CALMURID® HC

Galderma

Hydrocortisone – Urea

Topical Corticosteroid – Emollient

Action And Clinical Pharmacology: Topical corticosteroids are synthetic derivatives of cortisone which are effective when applied locally to control many types of inflammatory, allergic and pruritic dermatoses.

They are thought to act by controlling the rate of synthesis of proteins. The primary action of the corticosteroid is to interfere with the synthesis of arachidonic acid by inhibiting the phospholipase A2 synthesis. The overall effect of corticosteroids is a catabolic one.

Corticosteroid responsive dermatoses may be divided into those which are very responsive and those which require higher concentrations of corticosteroids, occlusion of the drug under a plastic film or intralesional administration. Attention must be paid to the concentration of topical corticosteroid used. Although effectiveness is enhanced by the application of the corticosteroid preparation under a transparent plastic wrapping, systemic absorption is also enhanced, occasionally sufficiently to suppress the pituitary-adrenal axis.

Indications And Clinical Uses: For topical therapy of corticosteroid responsive acute and chronic skin disorders where an anti-inflammatory, antiallergic and antipruritic activity in the topical management is required.

Contra-Indications: Untreated tubercular, bacterial, and fungal infections involving the skin and in certain viral diseases such as herpes simplex, chickenpox and vaccinia; hypersensitivity to any of the components of the preparation.

In concurrent mycotic infections, combine with antimycotic treatment.

Manufacturers’ Warnings In Clinical States: Pregnancy and Lactation: The safety of topical corticosteroids during pregnancy or lactation has not been established. The potential benefit of topical corticosteroids, if used during pregnancy or lactation, should be weighed against possible hazard to the fetus or the nursing infant.

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.

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 steroid products, this drug should be discontinued and appropriate therapy initiated if there are signs of reaction.

Prolonged use of topical corticosteroid products may produce atrophy of the skin and of subcutaneous tissues, particularly on flexor surfaces and on the face. However, this side effect is rarely seen when using hydrocortisone. If this is noted, discontinue the use of the drug.

In cases of bacterial infections of the skin, appropriate antibacterial agents should be used in primary therapy. If it is considered necessary, a topical corticosteroid may be used as an adjunct to control inflammation, erythema and itching.

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

If a symptomatic response is not noted within a few days to a week, the local applications of corticosteroid should be discontinued and the patient re-evaluated. During the use of topical corticosteroids secondary infections may occur.

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

Advise patients to inform subsequent physicians of the prior use of corticosteroids.

Adverse Reactions: The following local adverse reactions have been reported with the use of topical corticosteroids: dryness, itching, burning, local irritation, striae, skin atrophy, atrophy of subcutaneous tissues, telangiectasia, hypertrichosis, change in pigmentation and secondary infection.

These side effects are very rarely observed, even under occlusive conditions, with low potency topical glucocorticosteroid preparations such as hydrocortisone creams.

Adrenal suppression has also been reported following topical corticosteroid therapy.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: No cases of overdosage with this drug are known.

However, percutaneous absorption of topically applied corticosteroids can occur especially under occlusive conditions. When large amounts of corticosteroids are absorbed, toxic effects may be indicated by ecchymoses of the skin, peptic ulceration, hypertension, aggravation of the infection, hirsutism, acne, edema and muscle weakness due to protein depletion. No specific antidote is available. Toxic effects are nearly always manifestations of overdosage and should be treated symptomatically and dosage reduced or the drug withdrawn.

Dosage: Apply a thin layer of cream to the affected skin area(s), 3 to 4 times daily, until the skin has healed, or as prescribed by the physician.

Availability And Storage: Each g of cream contains: hydrocortisone 1% and urea 10%. Nonmedicinal ingredients: betaine monohydrate, cholesterol, diethanolamine cetylphosphate complex, glyceryl monostearate, hard fat, lactic acid, purified water and sodium chloride. Noncollapsible propylene tubes of 30 and 100 g. Store in a cool place (8 to 15°C).

CALMURID® HC Galderma Hydrocortisone – Urea Topical Corticosteroid – Emollient

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