Diprolene Lotion

Apply a few drops of Diprolene Lotion to the affected skin areas once or twice daily and massage lightly until the lotion disappears.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Diprolene Lotion is a super-high-potency topical corticosteroid. Treatment with Diprolene Lotion should be limited to 2 consecutive weeks and amounts should not exceed 50 mL per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Diprolene Lotion should not be used with occlusive dressings unless directed by a physician.

Diprolene Lotion is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

Lotion, 0.05%. Each gram of Diprolene Lotion, 0.05% contains 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a colorless, clear to translucent lotion.

Diprolene Lotion is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

Effects on Endocrine System

Diprolene Lotion can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. 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.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a trial evaluating the effects of Diprolene Lotion on the HPA axis, Diprolene Lotion was applied once daily at 7 mL per day for 21 days to diseased scalp and body skin in subjects with scalp psoriasis, Diprolene Lotion was shown to lower plasma cortisol levels below normal limits in 2 out of 11 subjects. HPA axis suppression in these subjects was transient and returned to normal within a week. In one of these subjects, plasma cortisol levels returned to normal while treatment continued.

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Cushing's syndrome and hyperglycemia may also occur with topical corticosteroids. These events are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].

Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

DIPROLENE (augmented betamethasone dipropionate) Lotion contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. 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-11β,17,21- trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:

It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol.

Each gram of Diprolene Lotion 0.05% contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone), in a colorless, clear to translucent lotion base of hydroxypropyl cellulose; isopropyl alcohol (30%); phosphoric acid used to adjust the pH; propylene glycol; purified water; and sodium phosphate monobasic monohydrate.

Diprolene Lotion 0.05% is a colorless, clear to translucent lotion supplied in 30-mL (29 g) (NDC 0085-0962-01) and 60-mL (58 g) (NDC 0085-0962-02) plastic bottles.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Inform patients of the following:

• Discontinue therapy when control is achieved, unless directed otherwise by the physician.
• Use no more than 50 mL per week of Diprolene Lotion and for no longer than 2 consecutive weeks.
• Avoid contact with the eyes.
• Avoid use of Diprolene Lotion on the face, underarms, or groin areas unless directed by the physician.
• Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
• Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by: Bayer Inc.
Pointe Claire, Quebec H9R 1B4, Canada

For patent information: www.merck.com/product/patent/home.html

Copyright © 1988, 2004, 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-mk1460-lt-1509r004

30 mL (29 g)
NDC 0085-0962-01

Diprolene®
(augmented
betamethasone dipropionate)
Lotion, 0.05%*

*Strength expressed
as betamethasone

For topical
use only.

Not for oral,
ophthalmic, or
intravaginal use.

DO NOT USE IN EYES

Rx only