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DIPROLENE AF

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Overview

What is DIPROLENE AF?

DIPROLENE AF (augmented betamethasone dipropionate) Cream 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a cream 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-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:

Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.

Each gram of DIPROLENE AF Cream 0.05% contains: 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a white cream base of carbomer 940; ceteareth-30; chlorocresol; cyclomethicone; glyceryl oleate/propylene glycol; propylene glycol; purified water; sodium hydroxide; sorbitol solution; white petrolatum; and white wax.



What does DIPROLENE AF look like?



What are the available doses of DIPROLENE AF?

Cream, 0.05%. Each gram of DIPROLENE AF Cream, 0.05% contains 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a white cream base.

What should I talk to my health care provider before I take DIPROLENE AF?

How should I use DIPROLENE AF?

DIPROLENE AF Cream 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 thin film of DIPROLENE AF Cream to the affected skin areas once or twice daily.

Therapy should be discontinued when control is achieved. DIPROLENE AF Cream is a high-potency corticosteroid. Treatment with DIPROLENE AF Cream should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis

DIPROLENE AF Cream should not be used with occlusive dressings unless directed by a physician.

Avoid contact with eyes. Wash hands after each application.

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

DIPROLENE AF Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.


What interacts with DIPROLENE AF?

Sorry No Records found


What are the warnings of DIPROLENE AF?

Sorry No Records found


What are the precautions of DIPROLENE AF?

Sorry No Records found


What are the side effects of DIPROLENE AF?

Sorry No records found


What should I look out for while using DIPROLENE AF?

DIPROLENE AF Cream 0.05% 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 AF?

Sorry No Records found


How should I store and handle DIPROLENE AF?

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 AF Cream 0.05% is a white cream supplied in 15-g (NDC 0085-0517-01) and 50-g (NDC 0085-0517-04) tubes.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of DIPROLENE AF Cream in corticosteroid responsive dermatoses is unknown.

Non-Clinical Toxicology
DIPROLENE AF Cream 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

(See and .) DIFLUCAN is a potent inhibitor of cytochrome P450 (CYP) isoenzyme 2C9 and 2C19, and a moderate inhibitor of CYP3A4. In addition to the observed /documented interactions mentioned below, there is a risk of increased plasma concentration of other compounds metabolized by CYP2C9, CYP2C19, and CYP3A4 coadministered with fluconazole. Therefore, caution should be exercised when using these combinations and the patients should be carefully monitored. The enzyme inhibiting effect of fluconazole persists 4 to 5 days after discontinuation of fluconazole treatment due to the long half-life of fluconazole. Clinically or potentially significant drug interactions between DIFLUCAN and the following agents/classes have been observed. These are described in greater detail below:

Oral hypoglycemicsCoumarin-type anticoagulantsPhenytoinCyclosporineRifampinTheophyllineTerfenadineCisaprideAstemizoleRifabutinVoriconazoleTacrolimusShort-acting benzodiazepinesTofacitinibTriazolamOral ContraceptivesPimozideQuinidineHydrochlorothiazideAlfentanilAmiodaroneAmitriptyline, nortriptylineAmphotericin BAzithromycinCarbamazepineCalcium Channel BlockersCelecoxibCyclophosphamideFentanylHalofantrineHMG-CoA reductase inhibitorsLosartanMethadoneNon-steroidal anti-inflammatory drugsPrednisoneSaquinavirSirolimusVinca AlkaloidsVitamin AZidovudine

DIPROLENE AF Cream 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.

DIPROLENE AF Cream 0.05% was applied once daily at 7 grams per day for 1 week to diseased skin, in adult subjects with psoriasis or atopic dermatitis, to study its effects on the HPA axis. The results suggested that the drug lowered adrenal corticosteroid secretion, although plasma cortisol levels did not go below the lower limit of the normal range.

In an open-label pediatric trial of 60 evaluable subjects (3 months to 12 years of age), 19 subjects showed evidence of HPA axis suppression. Four (4) subjects were tested 2 weeks after discontinuation of DIPROLENE AF Cream 0.05%, and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group.

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 .

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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