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Halobetasol Propionate (Halobetasol Propionate)

Trade Name : Halobetasol Propionate

E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.

CREAM

Strength 0.5 mg/g

HALOBETASOL 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 Halobetasol Propionate (Halobetasol Propionate) which is also known as Halobetasol Propionate 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

Halobetasol Propionate (Halobetasol 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

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
  • Rx Only
  • FOR DERMATOLOGICAL USE ONLY.
  • NOT FOR OPHTHALMIC USE.
  • Halobetasol Propionate Cream, 0.05% contains halobetasol propionate, USP a synthetic corticosteroid for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and antipruritic agent.
  • Chemically halobetasol propionate is 21-chloro-6u03b1,9-difluoro-11u03b2,17-dihydroxy-16u03b2-methylpregna-1,4-diene-3-20-dione,17-propionate, CHClFO . It has the following structural formula:
  • Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in water. Each gram of Halobetasol Propionate Cream contains 0.5 mg/g of halobetasol propionate, USP in a cream base of cetyl alcohol, glycerin, isopropyl isostearate, isopropyl palmitate, steareth-21, diazolidinyl urea, methylchloroisothiazolinone, (and) methylisothiazolinone and water.
  • Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, 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 .
  • Pharmacokinetics
  • Studies performed with Halobetasol Propionate Cream indicate that it is in the super-high range of potency as compared with other topical corticosteroids.
  • Halobetasol Propionate Cream, 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two 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 children under 12 years of age is not recommended.
  • 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 the diagnosis may be necessary.
  • Halobetasol Propionate Cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
  • No data
  • In controlled clinical trials, the most frequent adverse events reported for Halobetasol Propionate Cream included stinging, burning or itching in 4.4% of the patients. Less frequently reported adverse reactions were: dry skin, erythema, skin atrophy, leukoderma, vesicles and rash. The following additional local adverse reactions are reported infrequently with topical corticosteroids, and they may occur more frequently with high potency corticosteroids, such as Halobetasol Propionate Cream. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.
  • Topically applied Halobetasol Propionate Cream can be absorbed in sufficient amounts to produce systemic effects
  • (see ).
  • Apply a thin layer of Halobetasol Propionate Cream to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely. Halobetasol Propionate Cream is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary. Halobetasol Propionate Cream should not be used with occlusive dressings.
  • Halobetasol Propionate Cream, 0.05% is supplied in the following tube sizes:
  • u00a015 g NDC 0168-0355-15u00a050 g NDC 0168-0355-50
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F), excursions permitted 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F). [See USP Controlled Room Temperature].
  • To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • E. FOUGERA & CO.
  • 46254615A
  • R 01/2020#49
  • NDC 0168-0355-15
  • FOUGERAn
  • HALOBETASOLn- PROPIONATEn- CREAM, 0.05%
  • Rx only
  • FOR DERMATOLOGICAL n- USE ONLY. n- NOT FOR OPHTHALMIC USE.
  • Warning: Keep out of then- reach of children.
  • NET WT 15 grams
  • NDC 0168-0355-15
  • FOUGERAn
  • HALOBETASOL PROPIONATE n- CREAM, 0.05%
  • Rx only
  • FOR DERMATOLOGICAL USE ONLY. n- NOT FOR OPHTHALMIC USE.
  • Warning: Keep out of n- reach of children.
  • NET WT 15 grams

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