Lotriderm (Clotrimazole – Betamethasone)

LOTRIDERM®

Schering

Clotrimazole – Betamethasone

Dipropionate

Topical Antifungal – Corticosteroid

Action And Clinical Pharmacology: Betamethasone dipropionate with clotrimazole combines the anti-inflammatory, antipruritic and vasoconstrictive activity of betamethasone dipropionate with the antifungal activity of clotrimazole. The primary action of clotrimazole is against dividing and growing organisms, possibly through reaction with the cell membrane.

Indications And Clinical Uses: For the topical treatment of the following fungal dermal infections complicated by inflammatory pruritus: tinea pedis, tinea cruris and tinea corporis due to T. rubrum, T. mentagrophytes, E. floccosum, and M. canis.

Contra-Indications: Patients who are sensitive to betamethasone dipropionate, clotrimazole, other corticosteroids or imidazoles, or to any one of the components in this preparation.

Topical steroids are contraindicated in untreated bacterial and tubercular infections involving the skin and in certain viral diseases such as herpes simplex, chickenpox and vaccinia.

Manufacturers’ Warnings In Clinical States: Lotriderm should not be used in or near the eyes since this preparation is not formulated for ophthalmic use.

Pregnancy: There are no adequate and well-controlled studies in pregnant women on teratogenic effects of a topically applied combination of clotrimazole and betamethasone dipropionate. Therefore, this cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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

Lactation: Since it is not known whether the components of Lotriderm Cream are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Children: Any of the side effects that have been reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.

Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and 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. Use of topical corticosteroids in children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with growth and development of children.

Precautions: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia and glucosuria in some patients.

Significant systemic absorption may occur when steroids 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 (see Dosage). Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

If irritation or hypersensitivity develops with the use of the cream, treatment should be discontinued and appropriate therapy instituted.

Suitable precautions should be taken in using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation.

Prolonged use of corticosteroid preparations may produce striae or atrophy of the skin or s.c. tissue. If this occurs, treatment should be discontinued.

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

Children: Safety and effectiveness in children below the age of 12 have not been established with Lotriderm Cream.

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 dermatologics containing a corticosteroid 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.

Laboratory tests: If there is a lack of response to the cream, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy.

The following tests may be helpful in evaluating HPA axis suppression due to the corticosteroid component: urinary free cortisol test and ACTH stimulation test.

Adverse Reactions: The following adverse reactions have been reported in connection with the use of Lotriderm cream: paresthesia in 5 of 270 patients (1.85%), maculopapular rash, edema, and secondary infection, each in 1 of 270 (0.37%) patients.

Adverse reactions reported with the use of clotrimazole are as follows: erythema, stinging, blistering, peeling, edema, pruritus, urticaria and general irritation of the skin.

The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: No specific antidote is available and treatment should be symptomatic.

Betamethasone Dipropionate: Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism, including Cushing’s disease.

Clotrimazole: Overdosage by topical clotrimazole administration is highly improbable, since application of C4labeled clotrimazole to intact or diseased skin under occlusive dressing for 6 hours did not yield measurable quantities (lower detection limit 0.001 g/mL) of radioactive material in the sera of human subjects.

Treatment: Appropriate symptomatic treatment of corticosteroid overdosage is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In cases of chronic toxicity, slow withdrawal of corticosteroids is advised.

Dosage And Administration: A thin film of cream should be applied to cover completely the affected and surrounding skin areas twice daily, in the morning and at night, for 2 weeks in tinea cruris and tinea corporis and for 4 weeks in tinea pedis. The use of the cream for longer than 4 weeks is not recommended.

Clinical improvement, with relief of erythema and pruritus, usually occurs within 3 to 5 days of treatment. If a patient with tinea cruris and tinea corporis shows no clinical improvement after 1 week of treatment, the diagnosis should be reviewed. In tinea pedis, the treatment should be applied for 2 weeks prior to making that decision. Treatment with Lotriderm should be discontinued if the condition persists after 2 weeks in tinea cruris and tinea corporis and after 4 weeks in tinea pedis. Alternate therapy may then be instituted, if indicated, with an appropriate antifungal preparation.

Lotriderm cream should not be used with occlusive dressings.

Availability And Storage: Each g of white to off-white cream contains: clotrimazole USP 10 mg and betamethasone (as dipropionate USP) 0.5 mg in a hydrophilic emollient cream. Nonmedicinal ingredients: benzyl alcohol, ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate and white petrolatum. Sodium hydroxide to adjust pH. Tubes of 15 and 50 g. Store between 2 and 30°C.

LOTRIDERM®Schering Clotrimazole – Betamethasone Dipropionate Topical Antifungal – Corticosteroid

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