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Clobetasol Propionate (Clobetasol Propionate)

Trade Name : Clobetasol Propionate

Perrigo New York Inc

GEL

Strength 0.05 mg/g

CLOBETASOL PROPIONATE 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 Clobetasol Propionate (Clobetasol Propionate) which is also known as Clobetasol Propionate and Manufactured by Perrigo New York Inc. It is available in strength of 0.05 mg/g per ml. Read more

Clobetasol Propionate (Clobetasol Propionate) 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

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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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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
  • Rx Only
  • FOR TOPICAL DERMATOLOGIC USE ONLY u2013 NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
  • Clobetasol Propionate Gel, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.
  • Chemically, clobetasol propionate is (11u00df,16u00df)-21-chloro-9-fluoro-11-hydroxy-16- methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula:
  • Clobetasol propionate has the empirical formula CHClFO and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.
  • Clobetasol Propionate Gel, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbomer homopolymer type B, propylene glycol, purified water, and sodium hydroxide.
  • Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A.
  • The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Greater absorption was observed for the clobetasol propionate gel formulation as compared to the cream formulation in human skin penetration studies.
  • Studies performed with clobetasol propionate gel, 0.05% indicate that it is in the super-high range of potency as compared with other topical corticosteroids.
  • Clobetasol Propionate Gel, 0.05% is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.
  • Clobetasol Propionate Gel, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
  • No data
  • In a controlled trial with clobetasol propionate gel, 0.05%, the only reported adverse reaction that was considered to be drug related was a report of burning sensation (1.8% of treated patients).
  • In larger controlled clinical trials with other clobetasol propionate formulations, the most frequently reported adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of fingers, skin atrophy, and telangiectasia (all less than 2%).
  • Cushingu2019s syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.
  • The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids such as Clobetasol Propionate Gel, 0.05%. These reactions are listed in approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.
  • Topically applied Clobetasol Propionate Gel, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see ).
  • Apply a thin layer of Clobetasol Propionate Gel, 0.05% to the affected skin areas twice daily and rub in gently and completely (see ).
  • Clobetasol Propionate Gel, 0.05% is a super-high potency topical corticosteroid; therefore, n
  • As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
  • Clobetasol Propionate Gel, 0.05% should not be used with occlusive dressings.
  • Clobetasol Propionate Gel, 0.05% is available as follows:
  • 15 g tube (NDC 45802--14)
  • 30 g tube (NDC 45802--94)
  • 60 g tube (NDC 45802--96)
  • Store at 20-25u00b0C (68-77u00b0F) [see USP Controlled Room Temperature].u00a0 n
  • Made in Israel
  • Manufactured By Perrigo
  • Yeruham, Israel
  • Distributed By
  • Perrigou00ae
  • Allegan, MI 49010 u2013 www.perrigo.com
  • Rev 01-19
  • : 2P100 RC J5
  • Rx Only
  • Clobetasol Propionate Gel, 0.05%
  • For Dermatologic Use Only - Not for Ophthalmic Use
  • NET WT 30 g
  • The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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