fluocinolone (Rx)

Frequency Not Defined

Skin atrophy

Striae

Intracranial hypertension

Telangiectasia

Acneiform eruptions

Ketatosis pilaris

Papules

Pustules

Burning

Dryness

Erythema

Pigmentation changes

HPA suppression (with higher potency used >2 wk)

Contraindications

Hypersensitivity

Cautions

Chronic topical corticosteroid therapy may interfere with growth & development in pediatric patients

Use med to very high potency for <2 wk to reduce local and systemic side effects

Use low potency for chronic therapy

Kaposi's sarcoma reported with prolonged corticosteroid therapy; if noted, consider discontinuing therapy

Avoid medium to very high potency on face, folds, groin because can increase steroid absorption

Use lower potency for children (ie, increase BSA/kg, therefore increase systemic absorption)

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted

Contact dermatitis may occur; may be diagnosed as failure to heal rather than clinical exacerbation

As with any topical corticosteroid product, prolonged use may produce atrophy of skin and subcutaneous tissues; when used on intertriginous or flexor areas, or on face, this may occur even with short-term use

In presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted; if a favorable response does not occur promptly, the corticosteroid should be discontinued until infection has been adequately controlled

Avoid contact with the eyes

Patients should be advised not to use this medication for any disorder other than that for which it was prescribed

Shampoo only proven effective in corticosteroid-responsive dermatoses, other than seborrheic dermatitis of the scalp

HPA axis suppression

• Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients
• Conditions that augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings
• Patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests
• If HPA axis suppression is noted, an attempt should be made to withdraw drug, reduce frequency of application, or substitute a less potent steroid
• Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug
• Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids
• Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity

Pregnancy Category: C

Lactation: excretion in milk unknown; use with caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation

Pharmacokinetics

Excretion: Urine (primarily); feces (minimal)

Distribution: Throughout local skin

Absorption: Minimal (~1%); nature of skin at application; occlusion and inflammation may increase absorption