Fluocinonide (Fluocinonide)

Trade Name : fluocinonide

Fougera Pharmaceuticals Inc.

CREAM

Strength 1 mg/g

FLUOCINONIDE 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 Fluocinonide (Fluocinonide) which is also known as fluocinonide and Manufactured by Fougera Pharmaceuticals Inc.. It is available in strength of 1 mg/g per ml. Read more

Fluocinonide (Fluocinonide) 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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About GNH

No data

Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older ().
Limitation of Use:

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For topical use only. Fluocinonide cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use.
For psoriasis, apply a thin layer of fluocinonide cream USP, 0.1% once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.
For atopic dermatitis, apply a thin layer of fluocinonide cream USP, 0.1% once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [].
For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of fluocinonide cream USP, 0.1% once or twice daily to the affected areas as directed by a physician.
For topical use only. Fluocinonide cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use. ()

Cream, 0.1%.
Each gram of fluocinonide cream USP, 0.1% contains 1 mg of fluocinonide in a white to off-white cream base.
Cream, 0.1% ()

None.
None ()

No data

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The most commonly reported adverse reactions (u22651%) were headache, application site burning, nasopharyngitis, and nasal congestion. ()
To report SUSPECTED ADVERSE REACTIONS, contact Fougera at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

Topically applied fluocinonide cream USP, 0.1% can be absorbed in sufficient amounts to produce systemic effects [].

Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is CHFO and it has a molecular weight of 494.58.
It has the following chemical structure:
Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol.
Each gram of fluocinonide cream USP, 0.1% contains 1 mg fluocinonide in a cream base of propylene glycol USP, diethylene glycol monoethyl ether NF, glyceryl stearate (and) PEG-100 stearate, purified water USP, glyceryl monostearate NF, white petrolatum USP, carbomer 980 NF, diisopropanolamine, and citric acid USP.

No data

Long-term animal studies have not been performed to evaluate the carcinogenic potential of fluocinonide cream USP, 0.1% because of severe immunosuppression induced in a 13-week dermal rat study. The effects of fluocinonide on fertility have not been evaluated.
Fluocinonide revealed no evidence of mutagenic or clastogenic potential based on the results of two genotoxicity tests (Ames test and chromosomal aberration assay using human lymphocytes). However, fluocinonide was positive for clastogenic potential when tested in the mouse micronucleus assay.
Topical (dermal) application of 0.0003%-0.03% fluocinonide cream to rats once daily for 13 weeks resulted in a toxicity profile generally associated with long term exposure to corticosteroids including decreased skin thickness, adrenal atrophy, and severe immunosuppression. A NOAEL could not be determined in this study. In addition, topical (dermal) application of 0.1% fluocinonide cream plus UVR exposure to hairless mice for 13 weeks and 150-900 mg/kg/day of 0.1% fluocinonide cream to minipigs (a model which more closely approximates human skin) for 13 weeks produced glucocorticoid-related suppression of the HPA axis, with some signs of immunosuppression noted in the dermal minipig study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk for carcinogenesis.
Topical doses of 0% (fluocinonide cream vehicle), 0.0001%, 0.005% and 0.001% fluocinonide cream were evaluated in a 52 week dermal photo-carcinogenicity study (40 weeks of treatment followed by 12 weeks of observation) conducted in hairless albino mice with concurrent exposure to low level ultraviolet radiation. Topical treatment with increasing concentrations of fluocinonide cream did not have an adverse effect in this study. The results of this study suggest that topical treatment with fluocinonide cream USP, 0.1% would not enhance photo-carcinogenesis.

Two adequate and well-controlled efficacy and safety studies of fluocinonide cream USP, 0.1% have been completed, one in adult subjects with plaque-type psoriasis (), and one in adult subjects with atopic dermatitis (). In each of these studies, subjects with between 2% and 10% body surface area involvement at baseline treated all affected areas either once daily or twice daily with fluocinonide cream USP, 0.1% for 14 consecutive days. The primary measure of efficacy was the proportion of subjects whose condition was cleared or almost cleared at the end of treatment. The results of these studies are presented in the tables below as percent and number of patients achieving treatment success at Week 2.
*Cleared or almost cleared
*Cleared or almost cleared
No efficacy studies have been conducted to compare fluocinonide cream USP, 0.1% with any other topical corticosteroid product, including fluocinonide cream 0.05%.

FLUOCINONIDE CREAM USP, 0.1% is white to off-white in color and is supplied in tubes as follows:
30 g u00a0u00a0u00a0u00a0 NDC 0168-0457-30
60 g u00a0u00a0u00a0u00a0 NDC 0168-0457-60
120 gu00a0u00a0u00a0u00a0NDC 0168-0457-04
Store at 20u00b0-25u00b0C (68u00b0-77u00b0F) [see USP Controlled Room Temperature].
Keep the tube tightly closed.

[See FDA-approved patient labeling ()]
Patients using fluocinonide cream USP, 0.1% should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or unintended effects:
E. FOUGERA & CO.A division of n n PHARMACEUTICALS INC. Melville, New York 11747
400077AR08/13#216

PATIENT INFORMATION n- Fluocinoniden- Cream USP, 0.1%
Read the Patient Information that comes with fluocinonide cream USP, 0.1% before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your condition or treatment.
What is fluocinonide cream USP, 0.1%?
Fluocinonide cream USP, 0.1% is a prescription corticosteroid medicine used on the skin (topical) to treat adults and children 12 years and older with certain skin conditions that cause red, flaky, and itchy skin.
It is not known if fluocinonide cream USP, 0.1% is safe and effective in children under 12 years of age.
Arrayn- What should I tell my doctor before using fluocinonide cream USP, 0.1%?
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Tell your doctor about all the medicine you take
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.
How should I use fluocinonide cream USP, 0.1%?
What are the possible side effects with fluocinonide cream USP, 0.1%?
Fluocinonide cream USP, 0.1% may cause side effects, including:
The most common side effect of fluocinonide cream USP, 0.1% is
Talk to your doctor about any side effect that bothers you or that does not go away.
These are not all the side effects with fluocinonide cream USP, 0.1%. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Fougera at 1-800-645-9833.
How should I store fluocinonide cream USP, 0.1%?
Keep fluocinonide cream USP, 0.1% and all medicines out of the reach of children.
General information about fluocinonide cream USP, 0.1%
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use fluocinonide cream USP, 0.1% for a condition for which it was not prescribed. Do not give fluocinonide cream USP, 0.1% to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about fluocinonide cream USP, 0.1%. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about fluocinonide cream USP, 0.1% that is written for healthcare professionals.
What are the ingredients in fluocinonide cream USP, 0.1%?
Active ingredient:
Inactive ingredients:
This Patient Information has been approved by the U.S. Food and Drug Administration.
E. FOUGERA & CO.A division of n n PHARMACEUTICALS INC. Melville, New York 11747
400077AR08/13#216

NDC
Fougeran
FLUOCINONIDEn- CREAMn- USP, 0.1%
Rx only
FOR TOPICAL USE ONLY
WARNING
NET WT 30 grams

NDC
Rx only
Fougeran
FLUOCINONIDEn- CREAM USP, 0.1%
FOR TOPICAL USE ONLY
WARNING
NET WT 30 grams

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Fluocinonide (Fluocinonide)

Trade Name : fluocinonide

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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Fluocinonide (Fluocinonide)

Trade Name : fluocinonide

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

FAQ

Can’t find what you’re looking for?

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