Drug profile
Betamethasone
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Apply a thin film of betamethasone dipropionate ointment USP (augmented) to the
affected skin areas once or twice daily. Therapy should be discontinued when
control is achieved. If no improvement is seen within 2 weeks, reassessment of
diagnosis may be necessary. Betamethasone dipropionate ointment USP (augmented) is
a super-high-potency topical corticosteroid.
Source: US FDA label for betamethasone (Betamethasone dipropionate), section
'dosage and administration', retrieved 2026-08-29
CHILD
- Use of betamethasone dipropionate ointment (augmented) in pediatric patients
younger than 13 years of age is not recommended due to the potential for HPA axis
suppression [see WARNINGS AND PRECAUTIONS ( 5.1 )] . In an open-label HPA axis
safety trial in subjects 3 months to 12 years of age with atopic dermatitis,
DIPROLENE AF ® Cream 0.05% was applied twice daily for 2 to 3 weeks over a mean
body surface area of 58% (range 35% to 95%).
Source: US FDA label for betamethasone (Betamethasone dipropionate), section
'pediatric use', retrieved 2026-08-29
RENAL IMPAIRMENT
- No kidney-impairment dose in this label. Not a statement that none is needed.
Source: Read and found silent: the US FDA label for betamethasone (Betamethasone
dipropionate), retrieved 2026-08-29
HEPATIC IMPAIRMENT
- Risk factor(s) include the use of high-potency topical corticosteroids, use over a
large surface area or to areas under occlusion, prolonged use, altered skin
barrier, liver failure, and use in pediatric patients.
Source: US FDA label for betamethasone (Betamethasone dipropionate), section
'warnings and cautions', retrieved 2026-08-29
- Factors that predispose to HPA axis suppression include the use of high-potency
steroids, large treatment surface areas, prolonged use, use of occlusive
dressings, altered skin barrier, liver failure, and young age.
Source: US FDA label for betamethasone (Betamethasone dipropionate), section
'warnings and cautions', retrieved 2026-08-29
PREGNANCY
- Risk Summary There are no available data on betamethasone dipropionate ointment
(augmented) use in pregnant women to identify a drug-associated risk of major
birth defects, miscarriage, or adverse maternal or fetal outcomes.
Source: US FDA label for betamethasone (Betamethasone dipropionate), section
'pregnancy', retrieved 2026-08-29
- 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.
Source: US FDA label for betamethasone (Betamethasone dipropionate), section
'pregnancy', retrieved 2026-08-29
- Advise pregnant women that betamethasone dipropionate ointment (augmented) may
increase the risk of having a low birthweight infant and to use betamethasone
dipropionate ointment (augmented) on the smallest area of skin and for the
shortest duration possible.
Source: US FDA label for betamethasone (Betamethasone dipropionate), section
'pregnancy', retrieved 2026-08-29
BREASTFEEDING
- Risk Summary There are no data regarding the presence of betamethasone
dipropionate in human milk, the effects on the breastfed infant, or the effects on
milk production after topical application of betamethasone dipropionate ointment
(augmented) to women who are breastfeeding.
Source: US FDA label for betamethasone (Betamethasone dipropionate), section
'nursing mothers', retrieved 2026-08-29
- It is possible that topical administration of betamethasone dipropionate could
result in sufficient systemic absorption to produce detectable quantities in human
milk.
Source: US FDA label for betamethasone (Betamethasone dipropionate), section
'nursing mothers', retrieved 2026-08-29
- The developmental and health benefits of breastfeeding should be considered along
with the mother's clinical need for betamethasone dipropionate ointment
(augmented) and any potential adverse effects on the breastfed infant from
betamethasone dipropionate ointment (augmented) or from the underlying maternal
condition.
Source: US FDA label for betamethasone (Betamethasone dipropionate), section
'nursing mothers', retrieved 2026-08-29