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Betamethasone Dipropionate (Betamethasone Dipropionate)

Trade Name : Betamethasone Dipropionate

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

OINTMENT, AUGMENTED

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 (Betamethasone Dipropionate) which is also known as Betamethasone Dipropionate and Manufactured by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. It is available in strength of 0.5 mg/g per ml. Read more

Betamethasone Dipropionate (Betamethasone Dipropionate) 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
  • Warnings and Precautions Ophthalmic Adverse Reactions () 05/2019
  • Betamethasone dipropionate ointment (augmented), 0.05% 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.
  • Betamethasone dipropionate ointment (augmented), 0.05% 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 betamethasone dipropionate ointment (augmented), 0.05% 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. Betamethasone dipropionate ointment (augmented), 0.05% is a super-high-potency topical corticosteroid. Treatment with betamethasone dipropionate ointment (augmented), 0.05% should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis .
  • Betamethasone dipropionate ointment (augmented), 0.05% 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.
  • Betamethasone dipropionate ointment (augmented), 0.05% is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
  • Ointment, 0.05%. Each gram of betamethasone dipropionate ointment USP (augmented), 0.05% contains 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a white to off-white ointment base.
  • u2022
  • 3
  • Betamethasone dipropionate ointment (augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
  • u2022
  • 4
  • No data
  • 5.1n- 8.4
  • Most common adverse reactions (<1%) are: erythema, folliculitis, pruritus, and vesiculation. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Betamethasone dipropionate ointment USP (augmented), 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 molecular formula CHFO, a molecular weight of 504.6 and the following structural formula:
  • Betamethasone dipropionate 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 betamethasone dipropionate ointment USP (augmented), 0.05% contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a white to off-white ointment base of propylene glycol, propylene glycol monostearate, beeswax and white petrolatum.
  • 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 betamethasone dipropionate ointment (augmented), 0.05% 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 betamethasone dipropionate ointment (augmented), 0.05% were included in these trials. These trials evaluated betamethasone dipropionate ointment (augmented), 0.05% applied twice daily, for 14 days. Betamethasone dipropionate ointment (augmented), 0.05% was shown to be effective in relieving signs and symptoms of psoriasis and atopic dermatitis.
  • Betamethasone Dipropionate Ointment USP (Augmented), 0.05%
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Inform patients of the following:
  • No data
  • E. FOUGERA & CO.n- Fougera
  • 46251221A R05/19 #240
  • This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 05/2019
  • NDC
  • Fougera
  • Rx only
  • NET WT 15 grams
  • NDC
  • Fougera
  • Rx only
  • For topical use only.
  • KEEP OUT OF THE REACHn- OF CHILDREN.
  • NET WT 15 grams

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