Fluticasone Propionate (Fluticasone Propionate)

Trade Name : Fluticasone Propionate

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

OINTMENT

Strength 0.05 mg/g

FLUTICASONE PROPIONATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

Delivery Process

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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 0.05 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

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.

Read more
  • No data
  • Fluticasone Propionate Ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients.
  • Fluticasone propionate ointment, 0.005% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. ()
  • Apply a thin film of fluticasone propionate ointment, 0.005% to the affected skin areas twice daily. Rub in gently.
  • Avoid use with occlusive dressing.
  • Fluticasone propionate ointment, 0.005% is for topical use only; it is not for ophthalmic, oral or intravaginal use.
  • u2022
  • 2
  • Ointment, 0.005%. Each gram of Fluticasone propionate ointment contains 0.05 mg fluticasone propionate in a white to off-white translucent ointment base. Fluticasone propionate ointment is supplied in 15 g, 30 g and 60 g tubes.
  • u00a0
  • 3
  • Fluticasone propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
  • Fluticasone propionate ointment is contraindicated in those patients with a history of serious hypersensitivity to any of the components in the preparation. ()
  • No data
  • u2022
  • 5.1
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • The most common adverse reactions (<1%) were pruritus, burning, hypertrichosis, increased erythema, urticaria, irritation, and lightheadedness. ()
  • 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 ointment, 0.005% 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.
  • 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 insoluble in water.
  • Each gram of fluticasone propionate ointment contains fluticasone propionate 0.05 mg in a white to off-white translucent ointment base of liquid paraffin, microcrystalline wax, propylene glycol, and sorbitan sesquioleate.
  • 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 Ointment, 0.005% is a white to off-white translucent ointment supplied as follows: supplied as follows:
  • 15 gram tubes NDC 0168-0333-15
  • 30 gram tubes NDC 0168-0333-30
  • 60 gram tubes NDC 0168-0333-60
  • Store between 2u00b0 and 30u00b0C (36u00b0 and 86u00b0 F).
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Advise the patient:
  • Manufactured by:
  • FOUGERA PHARMACEUTICALS INC.Melville, New York 11747n
  • 46213019AR08/17
  • Important: Fluticasone Propionate Ointment is for use on skin only (topical).
  • Read this Patient Information before you start using Fluticasone Propionate Ointment 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 Ointment?
  • It is not known if Fluticasone Propionate Ointment is safe and effective in children. Fluticasone Propionate Ointment is not recommended for use in children.
  • Before using Fluticasone Propionate Ointment, 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 Ointment?
  • What are possible side effects with Fluticasone Propionate Ointment?
  • Fluticasone Propionate Ointment may cause serious side effects, including:
  • The most common side effects of Fluticasone Propionate Ointment
  • How should I store Fluticasone Propionate Ointment?
  • Keep Fluticasone Propionate Ointment and all medicines out of the reach of children.
  • General information about the safe and effective use of Fluticasone Propionate Ointment.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Fluticasone Propionate Ointment for a condition for which it was not prescribed. Do not give Fluticasone Propionate Ointment to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Fluticasone Propionate Ointment that is written for health professionals.
  • What are the ingredients in Fluticasone Propionate Ointment?n- Active ingredient:n- Inactive ingredients:
  • Manufactured by:
  • E. FOUGERA & CO.n- Fougera
  • This Patient Information has been approved by the U.S. Food and Drug Administration
  • 46213019AR08/17
  • NDC 0168-0333-15
  • Fluticasone Propionate Ointment, 0.005%n- For topical use only u2013 Not for ophthalmic use.
  • Rx only
  • 15 g
  • NDC 0168-0333-15
  • Fluticasone Propionate Ointment, 0.005%
  • For topical use only u2013 Not for ophthalmic use.
  • Rx only
  • 15 g

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