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Pronunciation:

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

U.S. Brand Names:

Lotrisone®

Synonyms:

Clotrimazole and Betamethasone

Generic Available:

Yes

Canadian Brand Names:

Lotriderm®

Use:

Topical treatment of various dermal fungal infections (including tinea pedis, cruris, and corpora in patients 17 years of age)

Pregnancy Risk Factor:

Pregnancy Implications:

There are no adequate and well-controlled studies using topical betamethasone during pregnancy. However, intrauterine growth retardation has been reported with another topical steroid. Avoid use in large amounts for long periods of time during pregnancy. Clotrimazole is poorly absorbed when used topically.

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

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

Warnings/Precautions:

Systemic absorption of topical corticosteroids may cause hypothalamic-pituitary-adrenal (HPA) axis suppression (reversible); may lead to manifestations of Cushing's syndrome, hyperglycemia, and glucosuria; risk is increased when used over large surface areas, for prolonged periods of time, or with occlusive dressings; not for use in patients <17 years of age (striae and growth retardation have been reported with use in infants and children); do not use for diaper dermatitis.

Adverse Reactions:

Also see individual agents.

1% to 10%:

Dermatologic: Dry skin (2%)

Local: Burning (2%)

Neuromuscular & skeletal: Paresthesia (2%)

<1%: Cushing's syndrome, edema, glycosuria, HPA axis suppression (higher in children), hyperglycemia, rash, secondary infection, stinging. Growth suppression, intracranial hypertension, and striae have also been reported with use in children.

Postmarketing/case reports: Skin atrophy, skin ulceration (rare)

Overdosage/Toxicology:

Acute overdose with topical administration is not likely. Signs/symptoms of HPA axis suppression may be seen when >45 g/week of cream or >45 mL/week of lotion are used; withdraw medication, reduce application frequency, or substitute a less potent corticosteroids.

Drug Interactions:

Betamethasone: Inhibits CYP3A4 (weak)

Clotrimazole: Inhibits CYP1A2 (weak), 2A6 (weak), 2B6 (weak), 2C8/9 (weak), 2C19 (weak), 2D6 (weak), 2E1 (weak), 3A4 (moderate)

Also see individual agents.

Stability:

Cream: Store between 2°C to 30°C (36°F to 86°F)

Lotion: Store upright between 15°C to 30°C (59°F to 86°F)

Mechanism of Action:

Betamethasone dipropionate is a corticosteroid. Clotrimazole is an antifungal agent.

Pharmacodynamics/Kinetics:

See individual agents.

Dosage:

Children <17 years: Do not use

Children 17 years and Adults:

Tinea corporis, tinea cruris: Topical: Massage into affected area twice daily, morning and evening; do not use for longer than 2 weeks; re-evaluate after 1 week if no clinical improvement; do not exceed 45 g cream/week or 45 mL lotion/week

Tinea pedis: Topical: Massage into affected area twice daily, morning and evening; do not use for longer than 4 weeks; re-evaluate after 2 weeks if no clinical improvement; do not exceed 45 g cream/week or 45 mL lotion/week

Elderly: Use with caution; skin atrophy and skin ulceration (rare) have been reported in patients with thinning skin; do not use for diaper dermatitis or under occlusive dressings

Administration:

For external use only; do not use on open wounds; do not cover with occlusive dressings; shake lotion well prior to use

Monitoring Parameters:

Urinary free cortisol test, morning plasma cortisol test, and ACTH stimulation test may be used to evaluate HPA axis suppression; signs of infection

Patient Education:

This medication is for topical use only. Avoid contact with the eyes or mouth. Do not use intravaginally. Do not use longer than recommended. Do not use under dressings or diapers. Shake lotion well before use. Notify prescriber if the condition does not improve or if side effects occur. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

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

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

International Brand Names:

Lotriderm® (CA)

References

Reed, BD, "Dermatologic Drugs, Pregnancy, and Lactation. A Conservative Guide,"Arch Dermatol, 1997, 133: 894-8.

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