clotrimazole/betamethasone (Rx)

1-10%

Dry skin (2%)

Paresthesia (2%)

Local burning (2%)

<1%

Edema

Rash

Skin atrophy

Secondary infection

Skin ulceration

Acneiform eruption

Bruising

Folliculitis

Striae

Clotrimazole

Erythema

Stinging

Blistering

Peeling

Edema

Pruritus

Urticaria

General skin irritation

Postmarketing reports

• Blurred vision, cataracts, glaucoma, increased intraocular pressure

Betamethasone

Burning

Itching

Irritation

Dryness

Folliculitis

Hypertrichosis

Acneiform eruptions

Hypopigmentation

Perioral dermatitis

Allergic contact dermatitis

Skin maceration

Skin atrophy

Striae

Miliaria

HPA suppression (with higher potency used >2 wk)

Contraindications

Documented hypersensitivity

Cautions

Do not use with occlusive dressing; systemic absorptioin of topical corticosteroids may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal axis

Prolonged treatment with corticosteroids associated with development of Kaposi sarcoma

Occlusive dressings, prolonged use, application to denuded skin or to large surface aread may increase absorption and result in hyperglycemia, glycosuria, or Cushing syndrome

Not for use in the treatment of diaper dermatitis in any age group; significant adverse reactions associated with corticosteroids reported

Use of topical corticosteroids may increase risk of posterior subcapsular cataracts and glaucoma; cataracts and glaucoma reported in postmarketing experience with use of topical corticosteroid products, including topical betamethasone products; avoid contact with eyes; advise patients to report any visual symptoms and consider referral to ophthalmologist for evaluation

Pregnancy

There are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; observational studies suggest an increased risk of low birthweight infants with use of potent or very potent topical corticosteroid during pregnancy

Advise pregnant women that therapy may increase risk of having a low birthweight infant and to use drug on the smallest area of skin and for shortest duration possible

Animal data

• In an animal reproduction study, betamethasone dipropionate caused malformations (ie, umbilical hernias, cephalocele, and cleft palate) in pregnant rabbits when given by intramuscular route during organogenesis
• The available data do not allow calculation of relevant comparisons between systemic exposure of clotrimazole and/or betamethasone dipropionate observed in animal studies to systemic exposure that would be expected in humans after topical use of drug

Lactation

Advise a woman to apply drug to smallest area of skin and for shortest duration possible while breastfeeding; advise breastfeeding women not to apply drug directly to nipple and areola to avoid direct infant exposure

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Betamethasone: Decreases inflammation by stabilizing leukocyte lysosomal membranes

Clotrimazole: Binds to phospholipids in fungal cell membrane, which alters cell wall permeability and results in the loss of intracellular elements; fungistatic and fungicidal