Betamethasone and Clotrimazole

(bay ta METH a sone & kloe TRIM a zole)

Fungal infections: Topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, T. mentagrophytes, and Epidermophyton floccosum in patients ≥17 years

Limitations of use: Efficacy in the treatment of zoophilic dermatophytes (eg, Microsporum canis) has not been established.

Adolescents ≥17 years: Refer to adult dosing.

For topical use only; not for oral, ophthalmic, or intravaginal use. Do not cover with occlusive dressings. Shake lotion well prior to use.

Cream: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Lotion: Store at 25°C (77°F) in the upright position only; excursions are permitted between 15°C and 30°C (59°F and 86°F).

Concerns related to adverse effects:

• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, prolonged use, or application to large surface areas.

Disease-related concerns:

• Diaper dermatitis: Do not use for diaper dermatitis in any age group; adverse reactions associated with corticosteroids have occurred.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use topical corticosteroids with caution in the elderly; skin atrophy and, rarely, skin ulcerations have been reported.

• Pediatric: Skin atrophy, including striae, has been reported with topical corticosteroid use in pediatric patients. Children may absorb proportionally larger amounts of corticosteroids after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in pediatric patients receiving topical corticosteroids. Prolonged use may affect growth velocity and delay weight gain; growth should be routinely monitored in pediatric patients.

Other warnings/precautions:

• Appropriate use: For topical use only; do not use intravaginally. Avoid contact with eyes or mouth. Do not use occlusive dressings; discontinue use if irritation occurs.

Animal reproduction studies have not been conducted with this combination. See individual agents.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dry skin or burning. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of Cushing's Disease (moon face; severe headache; or slow healing), signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), signs of skin changes (acne, stretch marks, slow healing, or hair growth), skin discoloration, vision changes, or severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.