Clotrimazole and Betamethasone Dipropionate
Generic: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Basic Information
Manufacturer
Proficient Rx LP
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
3d235926-6f17-4aa5-be82-7f1b4357e247
Indications & Usage
INDICATIONS AND USAGE Clotrimazole and Betamethasone Dipropionate Cream is 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 clotrimazole and betamethasone dipropionate cream for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis ) has not been established.
Several cases of treatment failure of clotrimazole and betamethasone dipropionate cream in the treatment of infections caused by Microsporum canis have been reported
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 clotrimazole and betamethasone dipropionate cream for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis ) has not been established.
Several cases of treatment failure of clotrimazole and betamethasone dipropionate cream in the treatment of infections caused by Microsporum canis have been reported
Adverse Reactions
ADVERSE REACTIONS Adverse reactions reported for clotrimazole and betamethasone dipropionate cream in clinical trials were paresthesia in 1 .
9% of patients, and rash, edema, and secondary infection, each 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), and sensitization (local reactions upon repeated application of product).
In the pediatric population, reported adverse events for clotrimazole and betamethasone dipropionate 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.
9% of patients, and rash, edema, and secondary infection, each 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), and sensitization (local reactions upon repeated application of product).
In the pediatric population, reported adverse events for clotrimazole and betamethasone dipropionate 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.