DRUGS & SUPPLEMENTS

Fluocinonide

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Fluocinonide uses


1INDICATIONS AND USAGE

Fluocinonide Cream 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:

  • Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1)
  • Avoid use on the face, groin, or axillae. (1.2)
  • Avoid use in perioral dermatitis or rosacea. (1.2)

1.1 Indications

VANOS® (fluocinonide) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see Use in Specific Populations (8.4) ].

1.2 Limitation of Use

Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Fluocinonide Cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week.

Fluocinonide Cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

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2DOSAGE AND ADMINISTRATION

For topical use only. Fluocinonide Cream is not for ophthalmic, oral, or intravaginal use.

For psoriasis, apply a thin layer of Fluocinonide Cream 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 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 [see Clinical Studies (14) ].

For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Fluocinonide Cream once or twice daily to the affected areas as directed by a physician.

For topical use only. Fluocinonide Cream is not for ophthalmic, oral, or intravaginal use. (2)

Psoriasis: apply a thin layer once or twice daily to the affected skin areas. (2)

Atopic Dermatitis: apply a thin layer once daily to the affected skin areas. (2)

Corticosteroid Responsive Dermatoses, other than psoriasis or atopic dermatitis: apply a thin layer once or twice daily to the affected areas. (2)

3DOSAGE FORMS AND STRENGTHS

Cream, 0.1%.

Each gram of Fluocinonide Cream contains 1 mg of Fluocinonide in a white to off-white cream base.

Cream, 0.1% (3)

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4CONTRAINDICATIONS

None.

None (4)

5WARNINGS AND PRECAUTIONS

  • Fluocinonide Cream has been shown to suppress the HPA axis. Systemic absorption of Fluocinonide Cream may produce reversible hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, hyperglycemia and unmask latent diabetes. (5.1)
  • Systemic absorption may require evaluation for HPA-axis suppression. (5.1)
  • Modify use should HPA-axis suppression develop. (5.1)
  • Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption. (5.3)
  • Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely to occur with occlusive use or more potent corticosteroids. (5.3)
  • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4)

5.1 Effect on Endocrine System

Systemic absorption of topical corticosteroids, including Fluocinonide Cream, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In addition, the use of Fluocinonide Cream for longer than 2 weeks may suppress the immune system [see Nonclinical Toxicology (13.1) ].

HPA-axis suppression has been observed with Fluocinonide Cream, 0.1% applied once or twice daily in 2 out of 18 adult patients with plaque-type psoriasis, 1 out of 31 adult patients with atopic dermatitis, and 4 out of 123 pediatric patients with atopic dermatitis [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2)].

Because of the potential for systemic absorption, use of topical corticosteroids, including Fluocinonide Cream, may require that patients be periodically evaluated for HPA-axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA-axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An adrenocorticotropic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA-axis suppression. If HPA-axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA-axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic absorption of topical corticosteroids.

Studies conducted in pediatric patients demonstrated reversible HPA-axis suppression after use of Fluocinonide Cream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Fluocinonide Cream due to their larger skin surface-to-body-mass ratios [see Use in Specific Populations (8.4) ].

5.2 Local Adverse Reactions with Topical Corticosteroids

Local adverse reactions may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasis, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

5.3 Concomitant Skin Infections

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Fluocinonide Cream should be discontinued until the infection has been adequately controlled.

5.4 Allergic Contact Dermatitis

If irritation develops, Fluocinonide Cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

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6ADVERSE REACTIONS

The most commonly reported adverse reactions were headache, application site burning, nasopharyngitis, and nasal congestion. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In clinical trials, a total of 443 adult subjects with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with Fluocinonide Cream for 2 weeks. The most commonly observed adverse reactions in these clinical trials were as follows:

Adverse Reaction Fluocinonide Cream,

once daily

(n=216)

Fluocinonide Cream,

twice daily

(n=227)

Vehicle Cream,

once or twice daily

(n=211)


Headache


8 (3.7%)


9 (4.0%)


6 (2.8%)


Application Site Burning


5 (2.3%)


4 (1.8%)


14 (6.6%)


Nasopharyngitis


2 (0.9%)


3 (1.3%)


3 (1.4%)


Nasal Congestion


3 (1.4%)


1 (0.4%)


0


Safety in patients 12 to 17 years of age was similar to that observed in adults.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Fluocinonide Cream:

Administration Site Conditions: discoloration, erythema, irritation, pruritus, swelling, pain, and condition aggravated.

Immune System Disorders: hypersensitivity.

Nervous System Disorders: headache and dizziness.

Skin and Subcutaneous Tissue Disorders: acne, dry skin, rash, skin exfoliation, and skin tightness.

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.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Therefore, Fluocinonide Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

8.3 Nursing Mothers

Systemically administered corticosteroids appear in human milk and could 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 breast milk. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

Safety and efficacy of Fluocinonide Cream in pediatric patients younger than 12 years of age have not been established; therefore, use in pediatric patients younger than 12 years of age is not recommended.

HPA-axis suppression was studied in four sequential cohorts of pediatric patients with atopic dermatitis covering at least 20% of the body surface area, treated once daily or twice daily with Fluocinonide Cream. The first cohort of 31 patients (mean 36.3% BSA) 12 to <18 years old; the second cohort included 31 patients (mean 39.0% BSA) 6 to <12 years old; the third cohort included 30 patients (mean 34.6% BSA) 2 to <6 years old; the fourth cohort included 31 patients (mean 40.0% BSA) 3 months to <2 years old. Fluocinonide Cream caused HPA-axis suppression in 1 patient in the twice-daily group in Cohort 1, 2 patients in the twice-daily group in Cohort 2, and 1 patient in the twice-daily group in Cohort 3. Follow-up testing 14 days after treatment discontinuation, available for all 4 suppressed patients, demonstrated a normally responsive HPA axis. Signs of skin atrophy were present at baseline and severity was not determined, making it difficult to assess local skin safety. Therefore, the safety of Fluocinonide Cream in patients younger than 12 years of age has not been demonstrated [see Warnings and Precautions (5.2) ].

HPA-axis suppression has not been evaluated in patients with psoriasis who are less than 18 years of age.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA-axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA-axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to cosyntropin (ACTH1–24) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

8.5 Geriatric Use

Clinical studies of Fluocinonide Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

10OVERDOSAGE

Topically applied Fluocinonide Cream can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1) ].

11DESCRIPTION

Fluocinonide (fluocinonide) Cream, 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 C26H32F2O7 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 contains 1 mg micronized Fluocinonide in a cream base of anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP.

Chemical Structure

12CLINICAL PHARMACOLOGY

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 Fluocinonide Cream in corticosteroid responsive dermatoses is unknown.

12.2 Pharmacodynamics

Vasoconstrictor studies performed with Fluocinonide Cream in healthy subjects indicate that it is in the super-high range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

Application of Fluocinonide Cream twice daily for 14 days in 18 adult subjects with plaque-type psoriasis and 31 adult subjects (17 treated once daily; 14 treated twice daily) with atopic dermatitis (2–10% BSA, mean 5% BSA) showed demonstrable HPA-axis suppression in 2 subjects with psoriasis (with 12% and 25% BSA) and 1 subject with atopic dermatitis (treated once daily, 4% BSA) where the criterion for HPA-axis suppression is a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (ACTH1–24) [see Warnings and Precautions (5.1) ].

HPA-axis suppression following application of Fluocinonide Cream, 0.1% (once or twice daily) was also evaluated in 123 pediatric patients from 3 months to <18 years of age with atopic dermatitis (mean BSA range 34.6%-40.0%). HPA-axis suppression was observed in 4 patients in the twice-daily groups. Follow-up testing 14 days after treatment discontinuation demonstrated a normally responsive HPA axis in all 4 suppressed patients [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ].

12.3Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

13NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Fluocinonide Cream 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 in vitro genotoxicity tests (Ames test and chromosomal aberration assay using human lymphocytes). However, Fluocinonide was positive for clastogenic potential when tested in the in vivo 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 ultraviolet radiation (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 photocarcinogenicity 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 would not enhance photocarcinogenesis.

14CLINICAL STUDIES

Two adequate and well-controlled efficacy and safety studies of Fluocinonide Cream have been completed, one in adult subjects with plaque-type psoriasis (Table 2), and one in adult subjects with atopic dermatitis (Table 3). 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 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.

Fluocinonide Cream,

once daily

(n=107)

Vehicle,

once daily

(n=54)

Fluocinonide Cream,

twice daily

(n=107)

Vehicle,

twice daily

(n=55)


Subjects cleared


0 (0)


0 (0)


6 (6%)


0 (0)


Subjects achieving treatment successCleared or almost cleared


19 (18%)


4 (7%)


33 (31%)


3 (5%)

Fluocinonide Cream,

once daily

(n=109)

Vehicle,

once daily

(n=50)

Fluocinonide Cream,

twice daily

(n=102)

Vehicle,

twice daily

(n=52)


Subjects cleared


11 (10%)


0 (0)


17 (17%)


0 (0)


Subjects achieving treatment successCleared or almost cleared


64 (59%)


6 (12%)


58 (57%)


10 (19%)


No efficacy studies have been conducted to compare Fluocinonide (fluocinonide) Cream, 0.1% with any other topical corticosteroid product, including Fluocinonide cream 0.05%.

16HOW SUPPLIED/STORAGE AND HANDLING

VANOS® (fluocinonide) Cream, 0.1% is white to off-white in color and is supplied in tubes as follows:

  • 30 g NDC 99207-525-30
  • 60 g NDC 99207-525-60
  • 120 g NDC 99207-525-10

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Keep the tube tightly closed.

17PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Patients using Fluocinonide Cream 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:

  • Fluocinonide Cream is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. It should not be used on the face, groin, and underarms.
  • Fluocinonide Cream should not be used for any disorder other than that for which it was prescribed.
  • The treated skin area should not be bandaged or otherwise covered or wrapped, so as to be occlusive unless directed by the physician.
  • Patients should report to their physician any signs of local adverse reactions.
  • Other corticosteroid-containing products should not be used with Fluocinonide Cream without first talking to the physician.
  • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen in 2 weeks, the patient should be instructed to contact a physician. The safety of the use of Fluocinonide Cream for longer than 2 weeks has not been established.
  • Patients should be informed to not use more than 60 g per week of Fluocinonide Cream. Do not use more than half of the 120 g tube per week.
  • Patients should inform their physicians that they are using Fluocinonide Cream if surgery is contemplated.
  • Patients should wash their hands after applying medication.

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

By:

Valeant Pharmaceuticals International, Inc.

Laval, Quebec H7L 4A8, Canada

U.S. Patent Numbers 6,765,001; 7,217,422; 7,220,424; 7,771,733; 7,794,738 and 8,232,264

Fluocinonide is a trademark of Valeant Pharmaceuticals

International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

9481801

Patient Information

VANOS® (VAN-ōs) (fluocinonide)

Cream, 0.1%

IMPORTANT: For skin use only. Do not get Fluocinonide Cream in your eyes, mouth, or vagina. Not for use on the face, groin, or underarms.

Read the Patient Information that comes with Fluocinonide Cream 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?

Fluocinonide Cream 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.

  • You should not use Fluocinonide Cream for longer than 2 weeks in a row.
  • You should not use more than 60 grams of Fluocinonide Cream or more than half of the 120 gram tube in 1 week.
  • Fluocinonide Cream should not be used:
    • if you have skin swelling or redness on the nose or face (rosacea)
    • for a scaly or bumpy rash around your mouth (perioral dermatitis)
    • on your face, underarms, or groin area

It is not known if Fluocinonide Cream is safe and effective in children under 12 years of age.

What should I tell my doctor before using Fluocinonide Cream?

Before using Fluocinonide Cream, tell your doctor if you:

  • have had irritation or other skin reaction to a steroid medicine in the past
  • adrenal gland problems
  • plan to have surgery
  • are pregnant or plan to become pregnant. It is not known if Fluocinonide Cream will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breastfeed. It is not known if Fluocinonide Cream passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Fluocinonide Cream.

Tell your doctor about all the medicine you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take a corticosteroid medicine by mouth or use other products on your skin that contain corticosteroids. Ask your doctor or pharmacist if you are not sure.

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?

  • See "What is Fluocinonide Cream?"
  • Use Fluocinonide Cream exactly as your doctor tells you.
  • This medicine is for use on the skin only. Do not use Fluocinonide Cream in your eyes, mouth, or vagina.
  • Wash your hands after you use Fluocinonide Cream.
  • Do not use Fluocinonide Cream for longer than 2 weeks in a row.
  • Talk to your doctor if your skin does not get better after 2 weeks of treatment with Fluocinonide Cream.
  • Do not bandage or cover the skin treated with Fluocinonide Cream unless your doctor tells you to.

What are the possible side effects with Fluocinonide Cream?

Fluocinonide Cream may cause side effects, including:

  • Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment or after stopping treatment. Your doctor may do blood tests to check you for adrenal insufficiency while you are using Fluocinonide Cream. Tell your doctor if you have any of these symptoms of adrenal insufficiency:
    • tiredness that worsens and does not go away
    • nausea or vomiting
    • dizziness or fainting
    • muscle weakness
    • irritability and depression
    • loss of appetite
    • weight loss
  • Cushing's syndrome, when the body is exposed to too much of the hormone cortisol. Your doctor may do tests to check for this. Symptoms can include:
    • weight gain, especially around your upper back and midsection
    • slow healing of cuts, insect bites, and infections
    • tiredness and muscle weakness
    • depression, anxiety, and irritability
    • roundness of your face (moon face)
    • new or worsening high blood pressure

The most common side effect of Fluocinonide Cream is burning of your skin treated with Fluocinonide Cream.

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. 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 Valeant Pharmaceuticals North America LLC at 1-800-321-4576.

How should I store Fluocinonide Cream?

  • Store Fluocinonide Cream at room temperature, between 59° to 86°F (15° to 30°C).
  • Keep the tube tightly closed.

Keep Fluocinonide Cream and all medicines out of reach of children.

General information about Fluocinonide Cream

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Fluocinonide Cream for a condition for which it was not prescribed. Do not give Fluocinonide Cream 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. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about Fluocinonide Cream that is written for healthcare professionals.

What are the ingredients in Fluocinonide Cream?

Active ingredient: Fluocinonide 0.1%

Inactive ingredients: anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

By:

Valeant Pharmaceuticals International, Inc.

Laval, Quebec H7L 4A8, Canada

U.S. Patent Numbers 6,765,001; 7,217,422; 7,220,424; 7,771,733; 7,794,738 and 8,232,264

Fluocinonide is a trademark of Valeant Pharmaceuticals

International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

Rev. 05/2017

9481801

Fluocinonide pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Fluocinonide available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.

Price
Cream; Topical; Fluocinonide 0.05%
Cream; Topical; Fluocinonide 0.1%
Fluocinonide 0.05% Cream 15 gm Tube11.99 USD
Fluocinonide 0.05% Cream 30 gm Tube13.54 USD
Fluocinonide 0.05% Cream 60 gm Tube22.71 USD
Fluocinonide 0.05% Gel 15 gm Tube21.85 USD
Fluocinonide 0.05% Gel 30 gm Tube30.1 USD
Fluocinonide 0.05% Gel 60 gm Tube50.78 USD
Fluocinonide 0.05% Ointment 15 gm Tube21.88 USD
Fluocinonide 0.05% Ointment 30 gm Tube28.61 USD
Fluocinonide 0.05% Ointment 60 gm Tube50.96 USD
Fluocinonide 0.05% Solution 20ml Bottle21.99 USD
Fluocinonide 0.05% Solution 60ml Bottle27.23 USD
Fluocinonide 0.05% cream0.6 USD
Fluocinonide powder176.0 USD
Fluocinonide-E 0.05% Cream 15 gm Tube20.18 USD
Fluocinonide-E 0.05% Cream 30 gm Tube28.6 USD
Fluocinonide-E 0.05% Cream 60 gm Tube47.84 USD
Fluocinonide-e 0.05% cream1.33 USD
Fluocinonide-emol 0.05% cream0.4 USD
Gel; Topical; Fluocinonide 0.05%
Lidex 0.05% cream3.57 USD
Lyderm 0.05 % Cream0.29 USD
Lyderm 0.05 % Gel0.38 USD
Lyderm 0.05 % Ointment0.37 USD
Ointment; Topical; Fluocinonide 0.05%
Solution; Topical; Fluocinonide 0.05%
Tiamol 0.05 % Emollient Cream0.27 USD
Vanos 0.1% Cream 30 gm Tube155.34 USD
Vanos 0.1% Cream 60 gm Tube275.75 USD
Vanos 0.1% cream4.13 USD

Fluocinonide destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Fluocinonide Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Fluocinonide pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."VANOS (FLUOCINONIDE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."FLUOCINONIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "fluocinonide". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Fluocinonide?

Depending on the reaction of the Fluocinonide after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Fluocinonide not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Fluocinonide addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Fluocinonide, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Fluocinonide consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported useful

How is the drug Fluocinonide useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sDrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
Visitors%
Useful1
100.0%

Three visitors reported doses

What is the dose of Fluocinonide drug you are taking?
According to the survey conducted among sDrugs.com website users, the maximum number of people are using the following dose 1-5mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
1-5mg2
66.7%
101-200mg1
33.3%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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