Fluocinonide

FLUOCINONIDE- fluocinonide cream
Preferred Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

1.1 Indication

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, 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, 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.

2 DOSAGE AND ADMINISTRATION

For topical use only. Fluocinonide Cream, 0.1% is not for ophthalmic, oral, or intravaginal use.

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

For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Fluocinonide Cream, 0.1% once or twice daily to the affected areas as directed by a physician.

3 DOSAGE FORMS AND STRENGTHS

Cream, 0.1%.

Each gram of Fluocinonide Cream, USP 0.1% contains 1 mg of fluocinonide, USP in a white to off-white cream base free from any foreign particles.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

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 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.

6 ADVERSE REACTIONS

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:

Table 1: Most Commonly Observed Adverse Reactions (≥1%) in Adult Clinical Trials

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.

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