LOTRIDERM

1 Dosing Considerations LOTRIDERM® should not be used with occlusive dressings. 2 Recommended Dose and Dosage Adjustment Based on the available data, Health Canada has not authorized the use of LOTRIDERM® Cream in children below 12 years of age (See INDICATIONS).

3 Administration A thin film of LOTRIDERM® Cream should be applied to cover completely the affected and surrounding skin areas twice daily, in the morning and at night, for two weeks in tinea cruris and tinea corporis, and for four weeks in tinea pedis.

The use of LOTRIDERM® Cream for longer than four weeks is not recommended. Clinical improvement, with relief of erythema and pruritus, usually occurs within three to five days of treatment. If a patient with tinea cruris and tinea corporis shows no clinical improvement after one week of treatment with LOTRIDERM® Cream, the diagnosis should be reviewed.

In tinea pedis, the treatment should be applied for two weeks prior to making that decision. Treatment with LOTRIDERM® Cream should be discontinued if the condition persists after two weeks in tinea cruris and tinea corporis and after four weeks in tinea pedis.

Alternate therapy may then be instituted, if indicated, with an appropriate antifungal preparation. 4 MISSED DOSE If a dose is missed, the patient can resume treatment with the next scheduled application.

37%) patients. Adverse reactions reported with the use of clotrimazole are as follows: erythema, stinging, blistering, peeling, edema, pruritis, 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.

Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids. LOTRIDERM® Cream (Clotrimazole and Betamethasone Dipropionate Cream, Organon Standard) Page 8 of 17

General Patients should be advised to inform subsequent physicians of the prior use of corticosteroids. Occlusive dressings should not be used, as this may result in an increase in the systemic absorption of topical corticosteroids or clotrimazole.

If irritation or hypersensitivity develops with the use of LOTRIDERM® (betamethasone dipropionate and clotrimazole) Cream, treatment should be discontinued, and appropriate therapy instituted. Endocrine and Metabolism 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.

Systemic absorption of topical corticosteroid agents will be increased with the use of more potent corticosteroid agents, with prolonged usage or if extensive body surface areas are treated. Therefore, patients receiving large doses of potent topical corticosteroids, applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression.

If HPA axis suppression occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute with a less potent corticosteroid agent. 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 corticotherapy. 0% cetostearyl alcohol, liquid paraffin, macrogol cetostearyl ether, propylene glycol, sodium dihydrogen phosphate dihydrate, phosphoric acid and white soft paraffin; benzyl alcohol as preservative.

Sodium hydroxide to adjust pH LOTRIDERM® Cream (Clotrimazole and Betamethasone Dipropionate Cream, Organon Standard) Page 6 of 17 Monitoring and Laboratory Tests If there is a lack of response to LOTRIDERM® Cream, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy.

LOTRIDERM® Cream is contraindicated in:  patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.

 patients who are sensitive to other corticosteroids or imidazoles.  untreated bacterial and tubercular infections involving the skin and in certain viral diseases such as herpes simplex, chicken pox and vaccinia.