Fluocinonide

Name: Fluocinonide

Uses of Fluocinonide

Fluocinonide is a prescription medication used to relieve the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions such as eczema, psoriasis, and dermatitis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

What happens if i miss a dose (fluocinonide-e, lidex, lidex-e, vanos)?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

Side effects

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 VANOS 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 VANOS Cream, once daily
(n=216)
VANOS 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.

Postmarking Experience

The following adverse reactions have been identified during post approval use of VANOS 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.

Read the entire FDA prescribing information for Vanos (Fluocinonide)

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Indications and usage

Indications

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)].

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.

Dosage forms and strengths

Cream, 0.1%.

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

Overdosage

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

Nonclinical toxicology

Carcinogenesis, 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.

Use Labeled Indications

Inflammatory and pruritic dermatologic conditions: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosing Geriatric

Refer to adult dosing.

Adverse Reactions

Frequency not defined.

Central nervous system: Intracranial hypertension, localized burning

Dermatologic: Acne vulgaris, allergic dermatitis, atrophic striae, contact dermatitis, folliculitis, hypertrichosis, hypopigmentation, maceration of the skin, miliaria, perioral dermatitis, pruritus, skin atrophy, telangiectasia, xeroderma

Endocrine & metabolic: Cushing's syndrome, glycosuria, growth suppression, HPA-axis suppression, hyperglycemia

Infection: Secondary infection

Local: Local irritation

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