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Betamethasone and Clotrimazole

Pronunciation

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

Index Terms

  • Clotrimazole and Betamethasone

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream: Betamethasone dipropionate 0.05% (base) and clotrimazole 1% (15 g, 45 g)

Lotrisone: Betamethasone dipropionate 0.05% (base) and clotrimazole 1% (15 g, 45 g) [contains benzyl alcohol]

Lotion: Betamethasone dipropionate 0.05% (base) and clotrimazole 1% (30 mL)

Lotrisone: Betamethasone dipropionate 0.05% (base) and clotrimazole 1% (30 mL) [contains benzyl alcohol]

Brand Names: U.S.

  • Lotrisone

Pharmacologic Category

  • Antifungal Agent, Topical
  • Corticosteroid, Topical

Pharmacology

Betamethasone: A corticosteroid which controls the rate of protein synthesis; depresses the migration of polymorphonuclear leukocytes, fibroblasts; reverses capillary permeability and lysosomal stabilization at the cellular level to prevent or control inflammation.

Clotrimazole: An antifungal agent that binds to phospholipids in the fungal cell membrane altering cell wall permeability resulting in loss of essential intracellular elements.

Use: Labeled Indications

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.

Contraindications

Cream: There are no contraindications listed in the manufacturer's labeling

Lotion: Hypersensitivity to betamethasone, clotrimazole, other corticosteroids or imidazoles, or any component of the formulation

Dosing: Adult

Tinea corporis, tinea cruris: Topical:

Cream: Massage into affected area twice daily, morning and evening for 1 week; re-evaluate after 1 week if no clinical improvement; maximum dose: 45 g cream per week; maximum duration: 2 weeks.

Lotion: Massage into affected area twice daily, morning and evening; re-evaluate after 1 week if no clinical improvement; maximum dose: 45 mL lotion per week; maximum duration: 2 weeks.

Tinea pedis: Topical:

Cream: Massage into affected area twice daily, morning and evening for 2 weeks; re-evaluate after 2 weeks if no clinical improvement; maximum dose: 45 g cream per week; maximum duration: 4 weeks.

Lotion: Massage into affected area twice daily, morning and evening; re-evaluate after 2 weeks if no clinical improvement; maximum dose: 45 mL lotion per week; maximum duration: 4 weeks.

Dosing: Pediatric

Adolescents ≥17 years: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Administration

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

Storage

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).

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Avoid combination

Sirolimus: Clotrimazole (Topical) may increase the serum concentration of Sirolimus. Monitor therapy

Tacrolimus (Systemic): Clotrimazole (Topical) may increase the serum concentration of Tacrolimus (Systemic). Monitor therapy

Test Interactions

See individual agents.

Adverse Reactions

Also see individual agents.

1% to 10%:

Dermatologic: Xeroderma (2%)

Central nervous system: Localized burning (2%), paresthesia (2%)

<1% (Limited to important or life-threatening): Cushing's syndrome (HPA axis suppression; children), dermal ulcer (rare), edema, growth suppression (children), pseudotumor cerebri (children), secondary infection, skin atrophy (children), skin rash, stinging of the skin

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercorticism 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.

Monitoring Parameters

Growth (children and adolescents); signs/symptoms of HPA axis suppression/adrenal insufficiency; signs of skin infection

Pregnancy Risk Factor

C

Pregnancy Considerations

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

Patient Education

• 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.

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