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Betamethasone Dipropionate (Diprolene Af)

Trade Name : DIPROLENE AF

Merck Sharp & Dohme Corp.

CREAM

Strength 0.5 mg/g

BETAMETHASONE DIPROPIONATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Betamethasone Dipropionate (Diprolene Af) which is also known as DIPROLENE AF and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 0.5 mg/g per ml. Read more

Betamethasone Dipropionate (Diprolene Af) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • 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.
  • 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 and 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 n
  • 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.
  • Apply a thin film to the affected skin areas once or twice daily. ()
  • Discontinue therapy when control is achieved. ()
  • Use no more than 50 g per week. ()
  • Do not use 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. ()
  • Not for oral, ophthalmic, or intravaginal use. ()
  • 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.
  • Cream, 0.05% ()
  • DIPROLENE AF Cream is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
  • Hypersensitivity to any component of this medicine. ()
  • No data
  • Effects on endocrine system: DIPROLENE AF Cream can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factor(s) include the use of high-potency topical corticosteroids, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. (, )
  • Ophthalmic Adverse Reactions: DIPROLENE AF Cream may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or n n
  • The most common adverse reaction reported in 0.4% of adult patients is stinging. ()
  • The most common adverse reactions reported in 10% of pediatric patients are signs of skin atrophy, telangiectasia, bruising, shininess. (, )
  • No data
  • 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-11u03b2,17,21-trihydroxy-16u03b2-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.
  • No data
  • Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.
  • Betamethasone was negative in the bacterial mutagenicity assay and , and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the human lymphocyte chromosome aberration assay, and equivocal in the mouse bone marrow micronucleus assay.
  • Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.
  • The safety and efficacy of DIPROLENE AF Cream for the treatment of corticosteroid-responsive dermatoses have been established in two randomized and active controlled trials in subjects with chronic plaque psoriasis. A total of 81 subjects who received DIPROLENE AF Cream were included in these trials. These trials evaluated DIPROLENE AF Cream applied once or twice daily for 14 and 21 days, respectively, on bilateral paired psoriatic lesions. DIPROLENE AF Cream was shown to be effective in relieving the signs and symptoms of chronic plaque psoriasis.
  • 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.
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F) [see USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Inform patients of the following:
  • Distributed by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 1987-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • uspi-mk1460-cr-1905r006
  • No data
  • NDC 0085-0517-01
  • 15
  • Diprolenen- AFn- Cream, 0.05%
  • *Strength expressedas betamethasone
  • For topicaluse only.
  • Rx only

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