NDC 0168-0333 Fluticasone Propionate

Fluticasone Propionate

NDC Product Code 0168-0333

NDC CODE: 0168-0333

Proprietary Name: Fluticasone Propionate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Fluticasone Propionate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Fluticasone is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you maintain your normal activities and decreases time lost from work or school. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

NDC Code Structure

NDC 0168-0333-15

Package Description: 15 g in 1 TUBE

NDC 0168-0333-30

Package Description: 30 g in 1 TUBE

NDC 0168-0333-60

Package Description: 60 g in 1 TUBE

NDC Product Information

Fluticasone Propionate with NDC 0168-0333 is a a human prescription drug product labeled by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The generic name of Fluticasone Propionate is fluticasone propionate. The product's dosage form is ointment and is administered via topical form.

Labeler Name: E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Fluticasone Propionate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • FLUTICASONE PROPIONATE .05 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PARAFFIN (UNII: I9O0E3H2ZE)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Labeler Code: 0168
FDA Application Number: ANDA076300 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-14-2004 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Fluticasone Nasal Spray

Fluticasone Nasal Spray is pronounced as (floo tik' a sone)

Why is fluticasone nasal spray medication prescribed?
Fluticasone nasal spray is used to relieve sneezing, runny, stuffy, or itchy nose and itchy, watery eyes caused by hay fever or other allergies (caused by an allergy to p...
[Read More]
Fluticasone Topical

Fluticasone Topical is pronounced as (floo tik' a sone)
Why is fluticasone topical medication prescribed?
Fluticasone, a corticosteroid, is used to reduce inflammation and relieve itching, redness, dryness, and scaling associated with various skin conditions.This medication i...
[Read More]

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Fluticasone Propionate Product Label Images

Fluticasone Propionate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Fluticasone Propionate Ointment 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.

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.

Vasoconstrictor AssayStudies performed with fluticasone propionate ointment indicate that it is in the medium range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

Manufactured by:FOUGERA PHARMACEUTICALS INC.Melville, New York 1174746213019AR08/17

4 Contraindications

Fluticasone propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

5.1 Hypothalamic-Pituitary-Adrenal (Hpa) Axis Suppression And Other Adverse Endocrine Effects

Topical corticosteroids, including fluticasone propionate ointment, can produce reversible HPA axis suppression with the potential for clinical glucocorticoid insufficiency. Factors that predispose to HPA axis suppression include large treatment surface areas, prolonged use, use under occlusion, altered skin barrier, liver failure, and young age. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.If HPA axis suppression is suspected, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.Pediatric patients may be at greater risk of HPA axis suppression due to their higher skin surface area to body mass ratios [see Use in Specific Populations (8.4)].HPA axis suppression may occur during or after withdrawal of treatment. If HPA axis suppression is suspected, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Evaluation of HPA axis suppression may be done by using the cosyntropin stimulation test.

5.2 Local Adverse Reactions

Fluticasone propionate ointment may cause local adverse reactions, including skin atrophy [see Adverse Reactions (6.1 , 6.2)]. The risk is greater with use under occlusion.

5.3 Allergic Contact Dermatitis

Allergic contact dermatitis with topical corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation can be corroborated with appropriate diagnostic patch testing. Discontinue fluticasone propionate ointment if appropriate.

5.4 Skin Infections

If concomitant skin infections are present or develop, use an appropriate antimicrobial. If a favorable response does not occur promptly, discontinue use of FLUTICASONE PROPIONATE OINTMENT, 0.005% Ointment until the infection has been adequately controlled.

6 Adverse Reactions

  • The following adverse reactions are discussed in greater detail in other sections of the labeling: •HPA Axis Suppression and Other Adverse Endocrine Effects [see Warnings and Precautions (5.1)] •Local Adverse Reactions [see Warnings and Precautions (5.2)] •Concomitant Skin Infections [see Warnings and Precautions (5.3)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.In controlled clinical trials, the total incidence of adverse reactions associated with the use of FLUTICASONE PROPIONATE OINTMENT, 0.005% Ointment was approximately 4%. These adverse reactions were usually mild, self-limiting, and consisted primarily of pruritus, burning, hypertrichosis, increased erythema, urticaria, irritation, and lightheadedness. Each of these events occurred individually in less than 1% of patients.

6.2 Postmarketing Experience

The following local adverse reactions have been identified during post-approval use of fluticasone propionate ointment: acneiform dermatitis, edema, rash, hypoaesthesia, pustular psoriasis, skin atrophy.The following systemic adverse reactions have been identified during post-approval use of fluticasone propionate ointment cream and fluticasone propionate ointment: immunosuppression/Pneumocystis jirovecii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling).The following local adverse reactions have also been reported with the use of topical corticosteroids: telangiectasia, striae, dryness, folliculitis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria.Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Teratogenic Effects

Pregnancy Category CThere are no adequate and well-controlled studies in pregnant women. Therefore, fluticasone propionate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Systemic embryofetal development studies were conducted in mice, rats and rabbits.Subcutaneous doses of 15, 45 and 150 μg/kg/day of fluticasone propionate were administered to pregnant female mice from gestation days 6 to 15. A teratogenic effect characteristic of corticosteroids (cleft palate) was noted after administration of 45 and 150 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 15μg/kg/day (less than the MRHD in adults based on body surface area comparisons).Subcutaneous doses of 10, 30 and 100 μg/kg/day of fluticasone propionate were administered to pregnant female rats in two embryofetal development studies (one study administered fluticasone propionate from gestation days 6 to 15 and the other study from gestation days 7 to 17). In the presence of maternal toxicity, fetal effects noted at 100 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) included decreased fetal weights, omphalocele, cleft palate, and retarded skeletal ossification. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 10 μg/kg/day (less than the MRHD in adults based on body surface area comparisons). Subcutaneous doses of 0.08, 0.57 and 4 μg/kg/day of fluticasone propionate were administered to pregnant female rabbits from gestation days 6 to 18. Fetal effects noted at 4 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) included decreased fetal weights, cleft palate and retarded skeletal ossification. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 0.57 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).Oral doses of 3, 30 and 300 μg/kg/day fluticasone propionate were administered to pregnant female rabbits from gestation days 8 to 20. No fetal or teratogenic effects were noted at oral doses up to 300 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study. However, no fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration.Fluticasone propionate crossed the placenta following administration of a subcutaneous or an oral dose of 100 μg/kg tritiated fluticasone propionate to pregnant rats.

8.3 Nursing Mothers

Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when fluticasone propionate ointment is administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of fluticasone propionate ointment have not been established in pediatric patients. Use of fluticasone propionate ointment in pediatric patients is not recommended.Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic effects when treated with topical drugs. They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids [see Warnings and Precautions (5.1)].In a trial of 35 pediatric subjects treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 subjects who had normal testing prior to treatment. It is not known if these subjects had recovery of adrenal function because follow-up testing was not performed. The decreased responsiveness of cosyntropin testing was not correlated to age of subject, amount of fluticasone propionate ointment used, or serum levels of fluticasone propionate.In the above trial, telangiectasia on the face was noted in one subject on the eighth day of a 4-week treatment period. Facial use was discontinued and the telangiectasia resolved.HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids.

8.5 Geriatric Use

A limited number of patients above 65 years of age (n = 203) have been treated with fluticasone propionate ointment in US and non-US clinical trials. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

11 Description

Fluticasone propionate ointment, 0.005% contains fluticasone propionate [S-Fluoromethyl 6α, 9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate], a synthetic fluorinated corticosteroid, for topical use.Chemically, fluticasone propionate is C25H31F3O5S. 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.

12.1 Mechanism Of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of fluticasone propionate ointment in corticosteroid-responsive dermatoses is unknown.

12.3 Pharmacokinetics

AbsorptionThe extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.In a study of 6 healthy subjects applying 25 g of fluticasone propionate ointment 0.005% twice daily to the trunk and legs for up to 5 days under occlusion, plasma levels of fluticasone ranged from 0.08 to 0.22 ng/mL.DistributionThe percentage of fluticasone propionate bound to human plasma proteins averaged 91%. Fluticasone propionate is weakly and reversibly bound to erythrocytes. Fluticasone propionate is not significantly bound to human transcortin.MetabolismNo metabolites of fluticasone propionate were detected in an in vitro study of radiolabeled fluticasone propionate incubated in a human skin homogenate.Fluticasone propionate is metabolized in the liver by cytochrome P450 3A4-mediated hydrolysis of the 5-fluoromethyl carbothiolate grouping. This transformation occurs in 1 metabolic step to produce the inactive 17β-carboxylic acid metabolite, the only known metabolite detected in man. This metabolite has approximately 2000 times less affinity than the parent drug for the glucocorticoid receptor of human lung cytosol in vitro and negligible pharmacological activity in animal studies. Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

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 μl) 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 μg/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 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).

16 How Supplied/Storage And Handling

Fluticasone Propionate Ointment, 0.005% is a white to off-white translucent ointment supplied as follows: supplied as follows:15 gram tubes NDC 0168-0333-1530 gram tubes NDC 0168-0333-3060 gram tubes NDC 0168-0333-60

Storage And Handling

Store between 2° and 30°C (36° and 86° F).

17 Patient Counseling Information

  • Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise the patient: •Avoid contact with the eyes. •Do not bandage the treated skin area, or cover or wrap it to cause occlusion unless directed by the healthcare provider. •Report any signs of local adverse reaction to their healthcare provider. •Do not use on the face, underarms, or groin areas unless directed by the healthcare provider.

Patient Information Fluticasone Propionate Ointment, 0.005%

  • Important: Fluticasone Propionate Ointment is for use on skin only (topical). Do not get Fluticasone Propionate Ointment near or in your eyes, mouth, or vagina.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?Fluticasone Propionate Ointment is a prescription corticosteroid medicine used on the skin (topical) for the relief of inflammation and itching caused by certain skin conditions in adults. 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: • have an allergy to any of the ingredients in Fluticasone Propionate Ointment • have a skin infection at the site to be treated. You may also need medicine to treat the skin infection. • have adrenal gland problems • have liver problems • have diabetes • have thinning skin (atrophy) at the site to be treated • are pregnant or plan to become pregnant. It is not known if Fluticasone Propionate Ointment will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if Fluticasone Propionate Ointment can pass into your breast milk and harm your baby.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids.How should I use Fluticasone Propionate Ointment? •Use Fluticasone Propionate Ointment exactly as your healthcare provider tells you to use it. •Apply a thin film of Fluticasone Propionate Ointment to the affected area 2 times each day. Gently rub into your skin. •Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to. •Do not use Fluticasone Propionate Ointment on your face, groin, underarms (armpits), unless your healthcare provider tells you to. •Wash your hands after applying Fluticasone Propionate Ointment, unless your hands are being treated. •Tell your healthcare provider if your symptoms get worse with Fluticasone Propionate Ointment or if your symptoms do not improve after 2 weeks of treatment.What are possible side effects with Fluticasone Propionate Ointment? Fluticasone Propionate Ointment may cause serious side effects, including: •Fluticasone Propionate Ointment can pass through your skin and may cause adrenal gland problems. This is more likely to happen if you use Fluticasone Propionate Ointment for too long, use it over a large treatment area, use it with other topical medicines that contain corticosteroids, cover the treated area, or have liver failure. Your healthcare provider may do blood tests to check your adrenal gland function during and after treatment with Fluticasone Propionate Ointment. •Skin problems, including skin reactions or thinning of your skin (atrophy), skin infections, and allergic reactions (allergic contact dermatitis) at the treatment site. Tell your healthcare provider if you get any skin reactions such as pain, tenderness, swelling, or healing problems.The most common side effects of Fluticasone Propionate Ointment include itching, burning, excessive hair growth, skin redness, hives, and lightheadedness.These are not all the possible side effects with Fluticasone Propionate Ointment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.How should I store Fluticasone Propionate Ointment? • Store Fluticasone Propionate Ointment between 36°F to 86°F (2°C to 30°C).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?Active ingredient: fluticasone propionateInactive ingredients: liquid paraffin, microcrystalline wax, propylene glycol, and sorbitan sesquioleateManufactured by:E. FOUGERA & CO.A division of FougeraPHARMACEUTICALS INC. Melville, New York 11747 This Patient Information has been approved by the U.S. Food and Drug Administration46213019AR08/17

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