Product Description.:
PAD 0107
tablet , white , round round
Debossed
LOTRISONE? Cream and Lotion contain combinations of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic use.
Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol.
Each gram of LOTRISONE Cream contains 10 mg clotrimazole and 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of purified water, mineral oil, white petrolatum, cetyl alcohol plus stearyl alcohol, ceteareth-30, propylene glycol, sodium phosphate monobasic monohydrate, and phosphoric acid benzyl alcohol as preservative.
LOTRISONE Cream may contain sodium hydroxide. LOTRISONE Cream is smooth, uniform, and white to off-white in color.
Each gram of LOTRISONE Lotion contains 10 mg clotrimazole and 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in a hydrophilic base of purified water, mineral oil, white petrolatum, cetyl alcohol plus stearyl alcohol, ceteareth-30, propylene glycol, sodium phosphate monobasic monohydrate, and phosphoric acid benzyl alcohol as a preservative.
LOTRISONE Lotion may contain sodium hydroxide. LOTRISONE Lotion is opaque and white in color.
INDICATIONS
LOTRISONE? Cream and Lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of LOTRISONE Cream or Lotion for the treatment of infections caused by zoophilic dermatophytes (eg, Microsporum canis) has not been established. Several cases of treatment failure of LOTRISONE Cream in the treatment of infections caused by Microsporum canis have been reported.
DOSAGE AND ADMINISTRATION
Gently massage sufficient LOTRISONE? Cream or Lotion into the affected skin areas twice a day, in the morning and evening.
LOTRISONE Cream or Lotion should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 g per week of LOTRISONE Cream or amounts greater than 45 mL per week of LOTRISONE Lotion should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after 1 week of treatment with LOTRISONE Cream or Lotion, the diagnosis should be reviewed.
LOTRISONE Cream or Lotion should not be used longer than 4 weeks in the treatment of tinea pedis and amounts greater than 45 g per week of LOTRISONE Cream or amounts greater than 45 mL per week of LOTRISONE Lotion should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with LOTRISONE Cream or Lotion, the diagnosis should be reviewed.
LOTRISONE Cream or Lotion should not be used with occlusive dressings.
SIDE EFFECTS
Adverse reactions reported for LOTRISONE? Cream in clinical trials were paresthesia in 1.9% of patients, and rash, edema, and secondary infection, each in less than 1% of patients.
Adverse reactions reported for LOTRISONE? Lotion in clinical trials were burning and dry skin in 1.6% of patients and stinging in less than 1% of patients.
The following local adverse reactions have been reported with topical corticosteroids and may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria, capillary fragility (ecchymoses), telangiectasia, and sensitization (local reactions upon repeated application of product). In the pediatric population, reported adverse events for LOTRISONE Cream include growth retardation, benign intracranial hypertension, Cushing's syndrome (HPA axis suppression), and local cutaneous reactions, including skin atrophy.
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.
Adverse reactions reported with the use of clotrimazole are as follows: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin.
