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Fluticasone Propionate (Fluticasone Propionate)

Trade Name : FLUTICASONE PROPIONATE

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

LOTION

Strength 0.5 mg/mL

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/mL 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

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
  • Indications and Usage ()
  • Fluticasone propionate lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age or older.
  • Fluticasone propionate lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age and older. ()
  • Apply a thin film of fluticasone propionate lotion to the affected skin areas once daily. Rub in gently.
  • Discontinue use when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
  • The safety and efficacy of fluticasone propionate lotion have not been established beyond 4 weeks of use.
  • Avoid use with occlusive dressings or application to the diaper area [].
  • Fluticasone propionate lotion is for topical use only, and not for ophthalmic, oral, or intravaginal use.
  • .
  • Lotion, 0.05%. Each gram of fluticasone propionate lotion contains 0.5 mg fluticasone propionate in a white to off-white lotion base. Fluticasone propionate lotion is supplied in 60 mL and 120 mL bottles.
  • u2022
  • 3
  • None.
  • u2022
  • 4
  • No data
  • 5.1n- 8.4
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • 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
  • Fluticasone propionate lotion, 0.05% contains fluticasone propionate [S-Fluoromethyl 6u03b1, 9u03b1-difluoro-11u03b2-hydroxy-16u03b1-methyl-3-oxo-17u03b1-propionyloxyandrosta-1,4-diene-17u03b2-carbothioate], a synthetic fluorinated corticosteroid, for topical 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 has a molecular weight of 500.6. It is a white to off-white powder and is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.
  • Each gram of fluticasone propionate lotion contains 0.5 mg fluticasone propionate in a white to off white lotion base of cetomacrogol 1000, cetostearyl alcohol, citric acid monohydrate, dimethicone 350, imidurea, isopropyl myristate, methylparaben, propylene glycol, propylparaben, purified water, and sodium citrate.
  • No data
  • In an oral (gavage) mouse carcinogenicity study, doses of 0.1, 0.3 and 1 mg/kg/day fluticasone propionate were administered to mice for 18 months. Fluticasone propionate demonstrated no tumorigenic potential at oral doses up to 1 mg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study.
  • In a dermal mouse carcinogenicity study, 0.05% fluticasone propionate ointment (40 u03bcl) was topically administered for 1, 3 or 7 days/week for 80 weeks. Fluticasone propionate demonstrated no tumorigenic potential at dermal doses up to 6.7 u03bcg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study.
  • Fluticasone propionate revealed no evidence of mutagenic or clastogenic potential based on the results of five in vitro genotoxicity tests (Ames assay, E. coli fluctuation test, S. cerevisiae gene conversion test, Chinese hamster ovary cell chromosome aberration assay and human lymphocyte chromosome aberration assay) and one in vivo genotoxicity test (mouse micronucleus assay).
  • No evidence of impairment of fertility or effect on mating performance was observed in a fertility and general reproductive performance study conducted in male and female rats at subcutaneous doses up to 50 u03bcg/kg/day (less than the MRHD in adults based on body surface area comparisons).
  • Fluticasone propionate lotion applied once daily was superior to vehicle in the treatment of atopic dermatitis in two clinical trials. The two trials enrolled 438 subjects with atopic dermatitis aged 3 months and older, of which 169 subjects were selected as having clinically significant signs of erythema, infiltration/papulation, and erosion/oozing/crusting at baseline. Clinically significant was defined as having moderate or severe involvement for at least two of the three signs (erythema, infiltrations/papulation, or erosion/oozing/crusting), in at least 2 body regions. Subjects who had moderate to severe disease in a single body region were excluded from the analysis.
  • Table 3 presents the percentage of subjects who completely cleared of erythema, infiltration/papulation and erosion/oozing/crusting at Week 4 out of those subjects with clinically significant baseline signs.
  • Fluticasone propionate lotion, 0.05% is white to off-white in color, and supplied as follows:
  • 60 mL bottle NDC 0168-0434-60120 mL bottle NDC 0168-0434-04
  • Store between 15u00b0 and 30u00b0C (59u00b0 and 86u00b0 F).
  • Do not refrigerate, and keep container tightly closed.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Administration Instructionsn- see Warnings and Precautions ()n- see Warnings and Precautions ()
  • Local Adverse Reactionsn- see Warnings and Precautions ()
  • 46166797A/46166798A Revised: 07/2015 #302
  • Patent No. 7300669
  • Important: Fluticasone propionate lotion is for use on skin only (topical).
  • Read this Patient Information before you start using fluticasone propionate lotion and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
  • What is Fluticasone propionate lotion?
  • Before using fluticasone propionate lotion, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take,
  • How should I use fluticasone propionate lotion?
  • What are possible side effects with fluticasone propionate lotion? n- Fluticasone propionate lotion may cause serious side effects, including:
  • The most common side effects of fluticasone propionate lotion
  • How should I store fluticasone propionate lotion?
  • Keep fluticasone propionate lotion and all medicines out of the reach of children.
  • General information about the safe and effective use of fluticasone propionate lotion.
  • What are the ingredients in fluticasone propionate lotion?n- Active ingredient:n- Inactive ingredients:
  • Manufactured by:n n For more information call 1-800-645-9833.n This Patient Information has been approved by the U.S. Food and Drug Administration
  • 46166797A/46166798A Revised: 07/2015 #302n n n
  • NDC
  • FLUTICASONEn- PROPIONATEn- LOTION, 0.05%
  • Rx only
  • For topical use only u2013n- Not for ophthalmic, oraln- or intravaginal use.
  • 60 mL
  • NDC
  • FLUTICASONEn- PROPIONATEn- LOTION, 0.05%
  • Rx only
  • For topical use only u2013n- Not for ophthalmic, oraln- or intravaginal use.
  • 60 mL

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