Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Lotrisone: Betamethasone dipropionate 0.05% (base) and clotrimazole 1% (15 g, 45 g) [contains benzyl alcohol]
Generic: Betamethasone dipropionate 0.05% (base) and clotrimazole 1% (15 g, 45 g)
Lotion, External:
Generic: Betamethasone dipropionate 0.05% (base) and clotrimazole 1% (30 mL)
Pharmacology
Mechanism of Action
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
Canadian labeling: Additional contraindications (not in US labeling): Cream: Hypersensitivity to betamethasone, clotrimazole, other corticosteroids or imidazoles, or any component of the formulation; untreated bacterial and tubercular skin infections; viral diseases (eg, herpes simplex, chicken pox, vaccinia)
Dosage and Administration
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.
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
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
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
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%, postmarketing, and/or case reports: 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 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).
- Ocular effects: Topical corticosteroids, including betamethasone, may increase the risk of posterior subcapsular cataracts and glaucoma. Monitor for ocular changes. Avoid contact with eyes.
- 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; ocular changes
Pregnancy
Pregnancy Considerations
Use of this combination product in large amounts and use over prolonged periods of time should be avoided during pregnancy. Also see individual monographs for additional information.
Patient Education
What is this drug used for?
- It is used to treat fungal infections of the skin.
Frequently reported side effects of this drug
- Skin tingling
- Burning
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit
- Cushing syndrome like moon face; severe headache; or slow healing
- Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss
- Skin changes like acne, stretch marks, slow healing, or hair growth
- Skin discoloration
- Skin thinning
- Vision changes
- Severe skin irritation
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
