CONTRAINDICATIONS
Betamethasone diproprionate products is contraindicated in patients who are
hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any
ingredient in these preparations.
PRECAUTIONS
General
Augmented betamethasone dipropionate lotion is a highly potent topical corticosteroid
that has been shown to suppress HPA axis at 7 ml per day.
Systemic absorption of topical corticosteroids has produced reversible HPA axis
suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in
some patients.
Conditions which augment systemic absorption include the application of the more potent
corticosteroids such as betamethasone diproprionate, use over large surface areas,
prolonged use, and the addition of occlusive dressings (see DOSAGE AND
ADMINISTRATION).
Therefore, patients receiving large doses of potent topical steroid applied to a large
surface area should be evaluated periodically for evidence of HPA axis suppression by
using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is
noted, an attempt should be made to withdraw the drug, to reduce the frequency of
application, or to substitute with a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of
the drug. Infrequently, signs and symptoms of steroid withdrawal many occur, requiring
supplemental systemic corticosteroids.
Children may absorb proportionally large amounts of topical corticosteroids and thus be
more susceptible to systemic toxicity (see Pediatric Use).
If irritation develops, topical corticosteroids should be discontinued and appropriate
therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or
antibacterial agent should be instituted. If a favorable response does not occur promptly,
the corticosteroid should be discontinued until the infection has been adequately
controlled.
Information for the Patient
Patients using topical corticosteroids should receive the following information and
instructions. This information is intended to aid in the safe and effective use of this
medication. It is not a disclosure of all possible adverse or intended effects.
1. This medication is to be used as directed by the physician and should not be
used longer than the prescribed time period. It is for external use only. Avoid
contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other than
that for which it was prescribed.
3. The treated skin areas should be not bandaged or otherwise covered or
wrapped so as to be occlusive (see DOSAGE AND ADMINISTRATION).
4. Patients should report any sign of local adverse reactions.
5. Parents of pediatric patients should be advised not to use tight- fitting diapers or
plastic pants on a child being treated in the diaper area, as these garments may
constitute occlusive dressing (see DOSAGE AND ADMINISTRATION).
Laboratory Tests
The following tests may be helpful in evaluating HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential
or the effect on fertility of topically applied corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed
negative results.
Pregnancy Category C
Corticosteroids are generally teratogenic in laboratory animal when administered
systemically at relatively low dosage levels. The more potent corticosteroids have been
shown to be teratogenic after dermal application in laboratory animals. Betamethasone
dipropionate has not been tested for teratogenicity by this route; however, it appears to
be fairly well-absorbed percutaneously. There are no adequate and well-controlled
studies of the teratogenic effects of topically applied corticosteroids in pregnant women.
Therefore, topical corticosteroids should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus. Drugs of this class should not be used
extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Nursing Mothers
It is not known whether topical administration of corticosteroids can result in sufficient
systemic absorption to produce detectable quantities in breast milk. Systemically
administered corticosteroids are secreted into breast milk in quantities not likely to have
deleterious effect on the infant. Nevertheless, a decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account the importance of the
drug to the mother.
Pediatric Use
The safety and efficacy of betamethasone diproprionate products when used in children
12 years of age have not been established.
Pediatric patients may demonstrate greater susceptibility to topical
corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature
patients because of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and
intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include linear growth retardation,
delayed weight gain, low plasma cortisol levels, and absence of response to ACTH
stimulation. Manifestations of intracranial hypertension include bulging fontanelles,
headaches, and bilateral papilledema.
Administration of topical corticosteroids to children should be limited to the least amount
compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may
interfere with the growth and development of children.
Additional Information for the Topical Aerosol
The spray should be kept away from the eyes or other mucous membranes.
Avoid freezing tissues by not spraying for more than three seconds, at a distance
of not less than six inches between the nozzle and skin.
Use only as directed; intentional misuse by deliberately concentrating and inhaling
the container contents can be harmful or fatal.
The container contents are under pressure; do not puncture the container.
The container mixture is flammable; do not use or store the container near heat or
an open flame; exposure to temperature above 120°F may cause bursting; never
throw container into a fire or incinerator.
Keep out of reach of children