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Fluocinonide Drug Information Provided by Lexi-Comp

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Medication Safety Issues

Sound-alike/look-alike issues:

Fluocinonide may be confused with flunisolide, fluocinolone

Lidex® may be confused with Lasix®, Videx®, Wydase®

Pronunciation

(floo oh SIN oh nide)

U.S. Brand Names

  • Vanos™

Index Terms

  • Lidex

Generic Available

Yes

Canadian Brand Names

  • Lidemol®
  • Lidex®
  • Lyderm®
  • Tiamol®
  • Topactin
  • Topsyn®

Pharmacologic Category

  • Corticosteroid, Topical

Pharmacologic Category Synonyms

  • Steroid, Topical
  • Topical Corticosteroid

Use: Labeled Indications

Anti-inflammatory, antipruritic; treatment of plaque-type psoriasis (up to 10% of body surface area) [high-potency topical corticosteroid]

Use: Dental

Relief of inflammatory and pruritic manifestations (high potency topical corticosteroid)

Pregnancy Risk Factor

C

Contraindications

Hypersensitivity to fluocinonide or any component of the formulation; viral, fungal, or tubercular skin lesions, herpes simplex

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypothalamic-pituitary-adrenal (HPA) axis suppression (reversible) particularly in younger children. HPA axis suppression may lead to adrenal crisis. Risk is increased when used over large surface areas, for prolonged periods, or with occlusive dressings.

• Contact dermatitis: Allergic contact dermatitis can occur, it is usually diagnosed by failure to heal rather than clinical exacerbation.

• Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered.

• Systemic effects: Adverse systemic effects including hyperglycemia, glycosuria, fluid and electrolyte changes, and HPA suppression may occur when used on large surface areas, for prolonged periods, or with an occlusive dressing.

Special populations:

• Pediatrics: Use of the 0.1% cream in children <12 years of age is not recommended. Chronic use of corticosteroids in children may interfere with growth and development.

Other warnings/precautions:

• Application site: Lower-strength cream (0.05%) may be used cautiously on face or opposing skin surfaces that may rub or touch (eg, skin folds of the groin, axilla, and breasts); higher-strength (0.1%) should not be used on the face, groin, or axillae.

• Duration of therapy: Use of the 0.1% cream for >2 weeks is not recommended.

Adverse Reactions

Frequency not defined.

Cardiovascular: Intracranial hypertension

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

Endocrine & metabolic: Cushing's syndrome, growth retardation, HPA suppression, hyperglycemia

Local: Burning, irritation

Renal: Glycosuria

Miscellaneous: Secondary infection

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy

Mechanism of Action

Fluorinated topical corticosteroid considered to be of high potency. The mechanism of action for all topical corticosteroids is not well defined, however, is felt to be a combination of three important properties: anti-inflammatory activity, immunosuppressive properties, and antiproliferative actions.

Pharmacodynamics/Kinetics

Absorption: Dependent on strength of product, amount applied, and nature of skin at application site; ranges from ?1% in areas of thick stratum corneum (palms, soles, elbows, etc) to 36% in areas of thin stratum corneum (face, eyelids, etc); increased in areas of skin damage, inflammation, or occlusion

Distribution: Throughout local skin; absorbed drug into muscle, liver, skin, intestines, and kidneys

Metabolism: Primarily in skin; small amount absorbed into systemic circulation is primarily hepatic to inactive compounds

Excretion: Urine (primarily as glucuronide and sulfate, also as unconjugated products); feces (small amounts as metabolites)

Dosage

Children and Adults: Pruritus and inflammation: Topical (0.05% cream): Apply thin layer to affected area 2-4 times/day depending on the severity of the condition. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

Children ?12 years and Adults: Plaque-type psoriasis (Vanos™): Topical (0.1% cream): Apply a thin layer once or twice daily to affected areas (limited to <10% of body surface area). Note: Not recommended for use >2 consecutive weeks or >60 g/week total exposure. Discontinue when control is achieved.

Dental Usual Dosing

Pruritus and inflammation: Children and Adults: Topical (0.05% cream): Apply thin layer to affected area 2-4 times/day depending on the severity of the condition. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

Patient Education

For external use only. Do not use for eyes, mucous membranes, or open wounds. Use exactly as directed and for no longer than the period prescribed. Before using, wash and dry area gently. Apply in a thin layer (may rub in lightly). Apply light dressing (if necessary) to area being treated. Do not use occlusive dressing unless so advised by prescriber. Avoid prolonged or excessive use around sensitive tissues, genital, or rectal areas. Avoid exposing treated area to direct sunlight. Inform prescriber if condition worsens (redness, swelling, irritation, signs of infection, or open sores) or fails to improve. Pregnancy precaution: Inform prescriber if you are or intend to become pregnant

Geriatric Considerations

Due to age-related changes in skin, limit use of topical glucocorticosteroids.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

None reported

Mental Health: Effects on Psychiatric Treatment

None reported

Nursing: Physical Assessment/Monitoring

Assess potential for interactions with other prescriptions, OTC medications, or herbal products patient may be taking. Assess patient response. Teach patient proper use (according to formulation), side effects/appropriate interventions, and symptoms to report.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, anhydrous, emollient: 0.05% (15 g, 30 g, 60 g, 120 g)

Cream, aqueous, emollient: 0.05% (15 g, 30 g, 60 g)

Cream:

Vanos™: 0.1% (30 g, 60 g)

Gel: 0.05% (15 g, 30 g, 60 g)

Ointment: 0.05% (15 g, 30 g, 60 g)

Solution: 0.05% (20 mL, 60 mL)

Pricing: U.S. (www.drugstore.com)

Cream (Fluocinonide)

0.05% (15): $11.99

0.05% (30): $12.99

0.05% (60): $14.99

Cream (Fluocinonide-E)

0.05% (15): $14.99

0.05% (30): $15.99

0.05% (60): $17.99

Cream (Vanos)

0.1% (30): $134.20

0.1% (60): $240.50

Gel (Fluocinonide)

0.05% (15): $16.99

0.05% (30): $23.99

0.05% (60): $35.99

Ointment (Fluocinonide)

0.05% (15): $19.99

0.05% (30): $23.99

0.05% (60): $33.99

Solution (Fluocinonide)

0.05% (20): $19.99

0.05% (60): $22.99

References

Goedert JJ, Vitale F, Lauria C, et al, “Risk Factors for Classical Kaposi's Sarcoma,” J Natl Cancer Inst, 2002, 94(22):1712-8.

International Brand Names

  • Acderma (JP)
  • Biscosal (JP)
  • Delipo (JP)
  • Etonalin F (JP)
  • Flu-21 (IT)
  • Flubiol (JP)
  • Glycobase (JP)
  • Hakelon (JP)
  • KC-F (JP)
  • Klariderm (ES)
  • Lidemol (PH)
  • Lidex (BE, GR, KP, LU, PH)
  • Medrexim (JP)
  • Metosyn (BB, BF, BJ, BM, BS, BZ, CI, CZ, DK, ET, GB, GH, GM, GN, GY, IE, JM, KE, LR, MA, ML, MR, MU, MW, MY, NE, NG, NO, PR, SC, SD, SL, SN, SR, TN, TT, TZ, UG, ZA, ZM, ZW)
  • Murukos F (JP)
  • Novoter (MY)
  • Rauracid (JP)
  • Rufull (JP)
  • Simaron (JP)
  • Solunim (JP)
  • Tohsino (JP)
  • Topsym (AE, AT, BH, CH, CY, DE, EC, EG, IL, IQ, IR, JO, JP, KW, LB, LY, OM, PE, PT, QA, SA, SY, TW, YE)
  • Topsym F (AT)
  • Topsym Polyol (PY)
  • Topsyn (IT, MX)
  • Topsyne (FR, NL)
  • Trappen (JP)

Lexi-Comp.com

Last full review/revision December 2009

Content last modified December 2009

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