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What is DIPROLENE?
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 CHFO, 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.
What does DIPROLENE look like?
What are the available doses of DIPROLENE?
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.
What should I talk to my health care provider before I take DIPROLENE?
How should I use DIPROLENE?
DIPROLENE Lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.
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. .
DIPROLENE Lotion should not be used with occlusive dressings unless directed by a physician
Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
Avoid contact with eyes. Wash hands after each application.
DIPROLENE Lotion is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
What interacts with DIPROLENE?
Sorry No Records found
What are the warnings of DIPROLENE?
Sorry No Records found
What are the precautions of DIPROLENE?
Sorry No Records found
What are the side effects of DIPROLENE?
Sorry No records found
What should I look out for while using DIPROLENE?
DIPROLENE Lotion is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
What might happen if I take too much DIPROLENE?
Sorry No Records found
How should I store and handle DIPROLENE?
StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from light.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from light.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.
Chemical StructureNo Image found
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of DIPROLENE Lotion in corticosteroid responsive dermatoses is unknown.
Non-Clinical ToxicologyDIPROLENE Lotion is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
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 .
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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