Fluticasone Propionate (Fluticasone Propionate)

Trade Name : FLUTICASONE PROPIONATE

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

CREAM

Strength 0.5 mg/g

FLUTICASONE 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 Fluticasone Propionate (Fluticasone Propionate) which is also known as FLUTICASONE 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

Fluticasone Propionate (Fluticasone 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

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Rx Only
FOR DERMATOLOGIC USE ONLYn- NOT FOR OPHTHALMIC USE

Fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP [(6u03b1,11u03b2,16u03b1,17u03b1)-6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid -fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
Chemically, fluticasone propionate is CHFOS. It has the following structural formula:
Fluticasone propionate USP has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water.
Each gram of fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water and imidurea as preservative.

Like other topical corticosteroids, fluticasone 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.
Fluticasone propionate is lipophilic and has a strong affinity for the glucocorticoid receptor. It has weak affinity for the progesterone receptor, and virtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The therapeutic potency of glucocorticoids is related to the half-life of the glucocorticoid-receptor complex. The half-life of the fluticasone propionate-glucocorticoid receptor complex is approximately 10 hours.
Studies performed with fluticasone propionate cream, 0.05% indicate that it is in the medium range of potency as compared with other topical corticosteroids.

Fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.

Fluticasone propionate cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

No data

In controlled clinical trials of twice daily administration, the total incidence of adverse reactions associated with the use of fluticasone propionate cream, 0.05% was approximately 4%. These adverse reactions were usually mild, self-limiting; and consisted primarily of pruritus, dryness, numbness of fingers, and burning. These events occurred in 2.9%, 1.2%, 1.0%, and 0.6% of patients, respectively.
Two clinical studies compared once to twice-daily administration of fluticasone propionate cream, 0.05% for the treatment of moderate to severe eczema. The local drug-related adverse events for the 491 patients enrolled in both studies are shown in . In the study enrolling both adult and pediatric patients, the incidence of local adverse events in the 119 pediatric patients ages 1 to 12 years was comparable to the 140 patients ages 13 to 62 years.
Fifty-one pediatric patients ages 3 months to 5 years, with moderate to severe eczema, were enrolled in an open-label HPA axis safety study. Fluticasone propionate cream, 0.05% was applied twice daily for 3 to 4 weeks over and arithmetic mean body surface area of 64% (range 35% to 95%).
The mean morning cortisol levels with standard deviations before treatment (pre-stimulation mean value =13.76u00b16.94 mcg/dL, post-stimulation mean value =30.53u00b17.23 mcg/dL) and at end treatment (pre-stimulation mean value =12.32u00b16.92 mcg/dL, poststimulation mean value =28.84u00b17.16 mcg/dL) showed little change. In 2 of 43 (4.7%) patients with end-treatment results, peak cortisol levels following cosyntropin stimulation testing were u226418 mcg/dL indicating adrenal suppression. Follow-up testing after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally responsive HPA axis. Local drug-related adverse events were (see ): transient burning, resolving the same day it was reported; transient urticaria, resolving the same day it was reported; erythematous rash; dusky erythema, resolving within one month after cessation of fluticasone propionate cream, 0.05%; and telangiectasia resolving within 3 months after stopping fluticasone propionate cream, 0.05%.
The following local adverse reactions have been reported infrequently with topical corticosteroids and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, hypertrichosis and miliaria. Also, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroid products.

Topically applied fluticasone propionate cream, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see ).

Fluticasone propionate cream, 0.05% may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients for more than 4 weeks of use have not been established (see ). The safety and efficacy of Fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.

No data

Fluticasone propionate cream USP, 0.05% is supplied in: 15 g tubes NDC 0168-0332-15 30 g tubes NDC 0168-0332-30 60 g tubes NDC 0168-0332-60 n n
E. FOUGERA & CO. n- Fougera
46233142AR07/18#91

NDC
Fougeran
FLUTICASONE PROPIONATE CREAM, 0.05%
Rx
NET WT 15 grams

NDC
Rx
Fougera
FLUTICASONE PROPIONATE CREAM, 0.05%
FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE WARNING: Keep out of reach of children.
NET WT 15 grams

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Fluticasone Propionate (Fluticasone Propionate)

Trade Name : FLUTICASONE PROPIONATE

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Fluticasone Propionate (Fluticasone Propionate)

Trade Name : FLUTICASONE PROPIONATE

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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