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Diprolene AF®
(betamethasone dipropionate)

Drug Uses
Diprolene AF Cream is indicated for relief
of the inflammatory and pruritic manifestations of corticosteroid-responsive
dermatoses in patients 13 years and older.
How Taken
Apply a thin film of Diprolene AF Cream to
the affected skin areas once or twice daily. Treatment with Diprolene AF Cream
should be limited to 45 g per week.
Warnings/Precautions
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. Do not use this
medication for any disorder other than that for which it was prescribed. The
treated skin area should not be bandaged or otherwise covered or wrapped as to
be occlusive.
Missed Dose
If you miss a dose, use it as soon as you
remember. If it is near the time for the next dose, skip the missed dose and
resume your usual dosing schedule. Do not double the dose to catch up.
Possible Side Effects
Adverse reactions reported to be possibly
or probably related to treatment with Diprolene AF Cream during a pediatric
clinical study include signs of skin atrophy (telangiectasia, bruising,
shininess).
Storage
Store between 2°and 30°C (36° and 86° F).
Overdose
Topically applied Diprolene AF can be
absorbed in sufficient amounts to produce systemic effects. Seek emergency
medical attention if an overdose is suspected.
More Information
Diprolene AF Cream is contraindicated for
patients who are hypersensitive to betamethasone dipropionate, to other
corticosteroids, or to any ingredient in this preparation.
DIPROLENE AF Cream contains betamethasone dipropionate, USP, a synthetic
adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone,
an analog of prednisolone, has a high degree of corticosteroid activity and a
slight degree of mineralocorticoid activity. Betamethasone dipropionate is the
17, 21 -dipropionate ester of betamethasone.
Chemically, betamethasone dipropionate is
9- fluoro-11 p, 17,21-
trihydroxy-16p-methylpregna- 1.4. diene- 3,200dione 17,21 -dipropionate,
with the empirical formula C28H27FO7, a molecular
weight of 504.6 and the following structual formula.
Betamethasone dipropionate is a white to creamy white, odorless crystalline
powder, insoluble in water.
Each gram of DIPROLENE AF Cream 0.05% contains: 0.64 mg betamethasone
dipropionate, USP (equivalent to 0.5 mg betamethasone) in an emollient cream
base of purified water, chlorocresol, propylene glycol, white petrolatum, white
wax, cyclomethicone, sorbitol solution, glyceryl monooleate, ceteareth-30,
carbomer 940 and sodium hydroxide R.
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