1.1 Indication

Fluocinonide cream USP, 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 USP, 0.1% 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 USP, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

5.1 Effect on Endocrine System

Systemic absorption of topical corticosteroids, including fluocinonide cream USP, 0.1%, 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 USP, 0.1% for longer than 2 weeks may suppress the immune system [ see Nonclinical Toxicology (13.1)].

HPA axis suppression has been observed with fluocinonide cream USP, 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 Population (8.4)and Clinical Pharmacology (12.2)]. Because of the potential for systemic absorption, use of topical corticosteroids, including fluocinonide cream USP, 0.1%, 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 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 USP, 0.1%. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of fluocinonide cream USP, 0.1% 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 USP, 0.1% should be discontinued until the infection has been adequately controlled.

5.4 Allergic Contact Dermatitis

If irritation develops, fluocinonide cream USP, 0.1% 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.

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 USP, 0.1% for 2 weeks. The most commonly observed adverse reactions in these clinical trials were as follows:

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 post approval use of fluocinonide cream USP, 0.1%:

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.

8.1 Pregnancy

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 USP, 0.1% 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 4 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 USP, 0.1%. 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 USP, 0.1% 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 USP, 0.1% 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 (ACTH 1-24) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

8.5 Geriatric Use

Clinical studies of fluocinonide cream USP, 0.1% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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 USP, 0.1% in corticosteroid responsive dermatoses is unknown.

12.2 Pharmacodynamics

Vasoconstrictor studies performed with fluocinonide cream USP, 0.1% 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 USP, 0.1% twice daily for 14 days in 18 adult subjects with plaque-type psoriasis (10–50% BSA, mean 19.6% BSA) 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 (ACTH 1-24) [ see Warnings and Precautions (5.1)].

HPA-axis suppression following application of fluocinonide cream USP, 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)] .

12.3 Pharmacokinetics

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.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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 in vitrogenotoxicity tests (Ames test and chromosomal aberration assay using human lymphocytes). However, fluocinonide was positive for clastogenic potential when tested in the in vivomouse 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 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.

Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

Keep the tube tightly closed.

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.

• 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 of 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 USP, 0.1% is safe and effective in children under 12 years of age.

What should I tell my doctor before using Fluocinonide Cream USP, 0.1%?

Before using Fluocinonide Cream USP, 0.1%, 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 takeincluding prescriptions and non-prescriptions 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 USP, 0.1%?

• See " What is Fluocinonide Cream USP, 0.1%?"
• 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 USP, 0.1%?

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 USP, 0.1%isburning of your skin treated with Fluocinonide Cream USP, 0.1%.

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 TARO at 1-866-923-4914

How should I store Fluocinonide Cream USP, 0.1%?

• Store Fluocinonide Cream at 20°C to 25°C (68°F to 77°F).
• Keep the tube tightly closed.

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 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 USP, 0.1%?

Active ingredient:fluocinonide 0.1%

Inactive ingredients:carbomer 940 (carbopol 980), ceteareth-20, citric acid, diethylene glycol monoethyl ether (transcutol P), polyethylene glycol, propylene glycol, sorbitan monostearate, and trolamine.

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