Fluocinonide - Drug Monograph

Introduction

Fluocinonide is a potent synthetic fluorinated corticosteroid used topically for its anti-inflammatory, antipruritic, and vasoconstrictive properties. It belongs to the class III super-high potency topical corticosteroids according to the Vasoconstrictor Assay classification system. Fluocinonide is commercially available in various formulations including cream, ointment, gel, and solution.

Mechanism of Action

Fluocinonide exerts its therapeutic effects through binding to intracellular glucocorticoid receptors. This complex translocates to the cell nucleus where it modulates gene transcription, leading to:

• Inhibition of inflammatory cytokine production
• Suppression of inflammatory cell migration
• Reduction of vascular permeability
• Decreased synthesis of prostaglandins and leukotrienes

The fluorination at the 9-alpha position enhances its glucocorticoid receptor affinity and metabolic stability, contributing to its high potency.

Indications

FDA-approved indications:

• Inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
• Atopic dermatitis
• Contact dermatitis
• Eczema
• Psoriasis
• Lichen planus
• Lichen simplex chronicus

Off-label uses (with clinical evidence):

• Alopecia areata (intralesional injection)
• Discoid lupus erythematosus
• Granuloma annulare

Dosage and Administration

• Apply a thin film to affected area 2-4 times daily
• Occlusive dressing may be used for severe, resistant lesions

• 0.05% cream, ointment, gel, and solution

• Pediatrics: Use with caution; limit duration due to increased systemic absorption risk
• Geriatrics: Increased susceptibility to topical side effects
• Hepatic impairment: No specific dosage adjustment recommended
• Renal impairment: No specific dosage adjustment recommended

Pharmacokinetics

Contraindications

• Hypersensitivity to fluocinonide or any component of the formulation
• Viral skin infections (herpes simplex, vaccinia, varicella)
• Fungal skin infections without appropriate antifungal therapy
• Tuberculous skin lesions
• Perioral dermatitis
• Acne rosacea

Warnings and Precautions

• Systemic absorption can cause reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria
• May increase risk of local infections
• Use with caution on face, groin, and axillae due to increased absorption
• Not for ophthalmic use
• Discontinue if skin irritation develops
• Pregnancy Category C: Use only if potential benefit justifies potential risk
• Pediatric patients are more susceptible to systemic toxicity

Drug Interactions

• Increased systemic absorption when used with occlusive dressings
• Potential increased risk of HPA axis suppression when used with other systemic corticosteroids
• No known clinically significant pharmacokinetic drug interactions

Adverse Effects

• Burning sensation
• Pruritus
• Irritation
• Dryness
• Folliculitis
• Hypertrichosis
• Hypopigmentation

• Contact dermatitis
• Skin atrophy
• Striae
• Telangiectasia
• Acneiform eruptions
• Perioral dermatitis
• Secondary infections
• HPA axis suppression (with prolonged use on large areas)

Monitoring Parameters

• Clinical response to therapy
• Signs of local adverse reactions (skin atrophy, striae, telangiectasia)
• Signs of systemic absorption (edema, weight gain, hypertension)
• Signs of secondary infection
• In long-term use: periodic evaluation of HPA axis function
• Pediatric growth monitoring with prolonged use

Patient Education

• Apply thin film to clean, dry skin
• Wash hands after application unless hands are treatment area
• Do not bandage or wrap unless directed by healthcare provider
• Avoid contact with eyes, mouth, and mucous membranes

• Use only as directed; do not exceed prescribed duration
• Report any signs of skin irritation or infection
• Do not use on broken or infected skin without medical supervision
• Inform all healthcare providers about topical corticosteroid use
• Do not share medication with others
• Store at room temperature, away from moisture and heat
• Discard unused medication appropriately

• No improvement after 2 weeks of treatment
• Worsening of condition
• Signs of allergic reaction
• Symptoms of systemic absorption (unusual weight gain, fatigue, muscle weakness)

References

1. FDA Prescribing Information: Lidex (fluocinonide) cream, ointment, gel, solution 2. Wolverton SE. Comprehensive Dermatologic Drug Therapy. 4th ed. Elsevier; 2020 3. Bolognia JL, Schaffer JV, Cerroni L. Dermatology. 4th ed. Elsevier; 2017 4. Paller AS, Mancini AJ. Hurwitz Clinical Pediatric Dermatology. 6th ed. Elsevier; 2022 5. Lexicomp Online. Fluocinonide monograph. Wolters Kluwer Clinical Drug Information 6. Clinical Pharmacology [Internet]. Tampa (FL): Elsevier. Fluocinonide 7. American Academy of Dermatology Guidelines of Care for the Management of Atopic Dermatitis. J Am Acad Dermatol. 2014 8. National Psoriasis Foundation. Psoriasis Treatment Guidelines