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Betamethasone Dipropionate (Diprolene)

Trade Name : DIPROLENE

Merck Sharp & Dohme Corp.

LOTION

Strength 0.5 mg/mL

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) which is also known as DIPROLENE and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 0.5 mg/mL 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 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.
  • 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 and 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. 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 nttttttt.
  • DIPROLENE Lotion should not be used with occlusive dressings unless directed by a physiciann
  • 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.
  • Apply a few drops to the affected skin areas once or twice daily and massage lightly until the lotion disappears. ()
  • Discontinue therapy when control is achieved. ()
  • Limit therapy to no more than 2 consecutive weeks. ()
  • Use no more than 50 mL 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. ()
  • 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.
  • Lotion, 0.05% ()
  • DIPROLENE Lotion 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 Lotion 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 Lotion 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 www.fda.gov/medwatch.
  • No data
  • 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-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 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.
  • 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 Lotion for the treatment of corticosteroid-responsive dermatoses have been evaluated in two randomized vehicle controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. A total of 263 subjects, of whom 131 received DIPROLENE Lotion, were included in these trials. These trials evaluated DIPROLENE Lotion applied once daily for 21 days.
  • DIPROLENE Lotion was shown to be effective in relieving the signs and symptoms of corticosteroid responsive dermatoses.
  • 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 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 of n Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 1988-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • uspi-mk1460-lt-1905r006
  • No data
  • 30n- 0962
  • Diprolenen- Arrayn- 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

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