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Betamethasone Dipropionate (Diprolene)

Trade Name : DIPROLENE

Merck Sharp & Dohme Corp.

OINTMENT

Strength 0.5 mg/g

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

Delivery Process

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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) which is also known as DIPROLENE and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 0.5 mg/g per ml. Read more

Betamethasone Dipropionate (Diprolene) 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 Ointment 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 Ointment 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 Ointment to the affected skin areas once or twice daily.
  • Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. DIPROLENE Ointment is a super-high-potency topical corticosteroid. Treatment with DIPROLENE Ointment should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis .
  • DIPROLENE Ointment 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 Ointment 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. ()
  • Limit therapy to no more than 2 consecutive weeks. ()
  • 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. ()
  • Ointment, 0.05%. Each gram of DIPROLENE Ointment, 0.05% contains 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a white to off-white ointment base.
  • Ointment, 0.05% ()
  • DIPROLENE Ointment 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 Ointment 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 Ointment may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ()
  • Most common adverse reactions (<1%) are: erythema, folliculitis, pruritus, and vesiculation. ()
  • 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 .
  • No data
  • DIPROLENE (augmented betamethasone dipropionate) Ointment, 0.05% 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-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:
  • 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 Ointment, 0.05% contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone), in a white ointment base of propylene glycol; propylene glycol stearate; 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 Ointment for the treatment of corticosteroid-responsive dermatoses, psoriasis and atopic dermatitis, have been evaluated in three randomized active-controlled trials, two in psoriasis and one in atopic dermatitis. A total of 378 subjects, of whom 152 received DIPROLENE Ointment, were included in these trials. These trials evaluated DIPROLENE Ointment applied twice daily, for 14 days. DIPROLENE Ointment was shown to be effective in relieving signs and symptoms of psoriasis and atopic dermatitis.
  • DIPROLENE Ointment 0.05% is a white ointment supplied in 15-g (NDC 0085-0575-02) and 50-g (NDC 0085-0575-05) 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 1983-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • uspi-mk1460-ot-1905r007
  • No data
  • NDC 0085-0575-02
  • 15
  • Arrayn- Diprolenen- u00ae
  • (augmentedbetamethasonedipropionate)
  • Ointment, 0.05%
  • *Strength expressedas betamethasone
  • For topicaluse only.
  • Not for oral,ophthalmic, orintravaginal use.
  • Rx only

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