betamethasone topical (Rx)

Frequency Not Defined

Skin atrophy

Striae

Allergic dermatitis

Burning

Dry skin

Erythema folliculitis

Hypertrichosis

Irritation

Miliaria

Vesiculation

Acneform lesions

Pigmentation changes

HPA suppression (with higher potency used >2 wk)

Postmarketing Reports

Ophthalmic: Cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy

Pruritus, bullous dermatitis, and erythematous rash

Contraindications

Underlying infection present

Hypersensitivity

Ophthalmic use

Cautions

Chronic topical corticosteroid therapy may interfere with growth and development in children

Prolonged treatment with corticosteroids is associated with Kaposi sarcoma (consider discontinuation of therapy if diagnosed)

Discontinue if contact dermatitis occurs; not for use in patients with decreased skin circulation

Manifestations of Cushing syndrome, hyperglycemia, or glycosuria occur, especially if occlusive dressings are used

May increase risk of posterior subcapsular cataracts and glaucoma; cataracts and glaucoma reported postmarketing with use of topical corticosteroid products, including ointment

Use may increase risk of posterior subcapsular cataracts and glaucoma; 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 ointment use in pregnant women to identify a 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 the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy; advise pregnant women that the ointment may increase risk of having a low birthweight infant and to use it on the smallest area of skin and for the shortest duration possible

Animal data

• In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration to pregnant rabbits; the available data do not allow calculation of relevant comparisons between systemic exposure in animal studies to systemic exposure that would be expected in humans after topical use of the ointment

Lactation

There are no data regarding the presence of drug in human milk, effects on breastfed infant, or on milk production after topical ointment application to women who are breastfeeding

It is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant drug or from underlying maternal condition

To minimize potential exposure to breastfed infant via breast milk, use ointment on smallest area of skin and for shortest duration possible while breastfeeding; advise breastfeeding women not to apply ointment 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

Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes, inhibiting macrophage accumulation in inflamed areas, reducing leukocyte adhesion to capillary endothelium, reducing capillary wall permeability and edema formation, decreasing complement components, antagonizing histamine activity and release of kinin from substrates, and reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation

Absorption

Yes

Topical Administration

Use medium to very high potency for less than 2 weeks to reduce local and systemic side effects

Use low potency for chronic therapy

Avoid medium to very high potency on face, folds, and groin, because use in these areas can increase steroid absorption

Use lower potency for children (ie, increased BSA/kg, therefore increased systemic absorption)