fluocinonide

Fluocinonide is a corticosteroid medication topically applied to treat inflammatory skin conditions such as atopic dermatitis, psoriasis, and other skin conditions that respond to corticosteroid treatment. Fluocinonide relieves dryness, redness, itching, scaling, crusting, and other discomforts associated with inflammatory skin conditions.

Fluocinonide is a highly potent anti-inflammatory agent that suppresses inflammation by inducing the synthesis of lipocortins. Lipocortins are proteins that inhibit phospholipase 2 enzyme that initiates inflammatory activity. Fluocinonide binds to glucocorticoid receptors, protein molecules on cell membranes and activates multiple processes that help reduce inflammation, including:

• Inhibition of the release of proinflammatory substances such as prostaglandin, histamine, and kinins
• Stabilization of the membranes of leukocytes and lysosomes, organelles inside leukocytes, preventing the release of destructive chemicals
• Prevention of migration and aggregation of inflammatory cells to the inflamed area
• Reducing capillary permeability to prevent the leakage of inflammatory cells and proteins (cytokines) into the inflammation site
• Preventing migration of fibroblasts, cells that form extracellular matrix, the supportive structure of tissue, and preventing scar tissue formation

• Do not use in patients with hypersensitivity to fluocinonide or any of its components.
• Systemic absorption from topical fluocinonide can cause reversible suppression of hypothalamic-pituitary-adrenal (HPA) axis with the potential for adrenal insufficiency, particularly in young children.
• Systemic absorption can also cause Cushing’s syndrome, hyperglycemia and glycosuria.
• Risk factors for increased systemic absorption include use of high potency steroids, use over large skin areas, use for prolonged periods, use with occlusive bandage, and use on compromised skin.
• Monitor patients for symptoms of HPA axis suppression with periodic tests, and if symptoms develop, use less potent steroid, reduce frequency of application or withdraw the drug.
• HPA axis function generally returns to normal with discontinuation of corticosteroid. Symptoms of adrenal insufficiency may require supplemental systemic corticosteroids.
• Prolonged topical corticosteroid therapy may interfere with growth and development in children. Growth should be regularly monitored in young children.
• Use of high potency corticosteroid should be limited for a period of less than 2 weeks and a lower potency should be used if treatment continues for a longer period.
• Avoid using medium or high potency corticosteroids on face, skin folds and groin, it can increase systemic absorption.
• Prolonged use, occlusive use or use of high potency corticosteroids can cause local adverse reactions including skin atrophy. Even short-term use can cause skin reactions when used in the face or in skin folds.
• Prolonged treatment with corticosteroid is associated with Kaposi sarcoma, a type of cancer.
• If simultaneous skin infections occur, appropriate antifungal or antibacterial drug should be used. If the infection is not immediately controlled, fluocinonide should be discontinued until infection is adequately controlled.

Common side effects of fluocinonide include:

• Application site reactions including:
  • Irritation
  • Itching (pruritus)
  • Pain
  • Burning
  • Swelling
  • Redness
  • Discoloration
  • Aggravation of the condition treated
• Pimples/zits (acne vulgaris)
• Allergic dermatitis
• Contact dermatitis
• Dermatitis around the mouth (perioral dermatitis)
• Thinning of the skin (atrophy)
• Stretch marks (striae)
• Inflammation of follicles (folliculitis)
• Excessive hair growth (hypertrichosis)
• Loss of skin color (hypopigmentation)
• Softening and breakdown of skin (maceration)
• Prickly heat/sweat rash (miliaria)
• Dry skin (xeroderma)
• Spider veins (telangiectasis)
• Rash
• Pruritus
• Skin peeling (exfoliation)
• Skin tightness
• Hypersensitivity reactions
• Headache
• Dizziness
• High blood pressure inside the skull (intracranial hypertension)
• Secondary infection
• Hypothalamus-pituitary-adrenal axis suppression
• Growth suppression in children
• Cushing’s syndrome, a disorder that causes excessive production of the stress hormone cortisol with symptoms such as moon face and abnormal fat deposits on the neck
• High blood sugar levels (hyperglycemia)
• Sugar in urine (glycosuria)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Cream, External

• Vanos: 0.1%
• Generic: 0.05%, 0.1%

Ointment/Gel/Topical Solution

• Generic: 0.05%

Adult:

Corticosteroid Responsive Dermatoses

• Apply thin layer topically once daily or every 12 hours to affected areas

Psoriasis

• Apply thin layer topically once daily or every 12 hours to affected areas

Atopic Dermatitis

• Apply thin layer topically once daily to affected areas

Pediatric:

Corticosteroid Responsive Dermatoses

Cream, gel, ointment, topical solution (0.05%):

Children and adolescents:

• Topical: Apply thin layer to affected area 2 to 4 times daily depending on the severity of the condition; may use occlusive dressings to manage psoriasis or recalcitrant conditions

Cream (0.1%):

Children 12 years and above and adolescents:

• Apply a thin layer once or twice daily to affected areas.
• Not recommended for use for longer than 2 consecutive weeks or more than 60 g/week total exposure.
• Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassess diagnosis.

Atopic Dermatitis

Cream, gel, ointment, topical solution (0.05%):

Children and adolescents:

• Apply thin layer to affected area 2 to 4 times daily depending on the severity of the condition.
• Note: In children below 12 years, NICE guidelines recommend applying only once or twice daily (NICE 2007).

Cream (0.1%):

Children 12 years and above and adolescents:

• Apply a thin layer once daily to affected areas.
• Not recommended for use for longer than 2 consecutive weeks or more than 60 g/week total exposure.
• Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassess diagnosis.

Overdose

• Topical overdose of fluocinonide can cause skin eruptions, skin inflammation, burning, itching and other skin reactions.
• Topical overdose can cause sufficient absorption to produce systemic effects which can suppress the hypothalamus-pituitary-adrenal axis, leading to adrenal insufficiency. Symptoms usually resolve with withdrawal of the drug.
• Overdose treatment includes tapering and withdrawing fluocinonide and symptomatic care.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of fluocinonide includes:
  • aldesleukin
• Fluocinonide has no known serious, moderate or mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There are no adequate and well-controlled studies on the safety of topical fluocinonide use in pregnant women. Animal studies indicate topical application of some corticosteroids can cause fetal harm. Use fluocinonide during pregnancy only if potential benefits outweigh potential risks to the fetus.
• Systemic corticosteroids are present in breast milk and can suppress growth, interfere with natural corticosteroid production and cause other adverse effects in the breastfed infant. It is not known if topical administration can result in sufficient systemic absorption for the drug to appear in milk. Decision should be made to discontinue the drug or nursing depending on the importance of the drug to the mother.

• Use fluocinonide exactly as prescribed, do not apply on larger skin areas or more frequently than recommended.
• Store safely out of reach of children.
• In case of overdose, contact your physician or Poison Control.