fluticasone topical (Rx)

1-10%

Pruritus (2.9%)

Dryness (1.2%)

Skin irritation: (3%)

Eczema (1%)

Telangiectasia (2-5%)

Numbness of fingers (1%)

<1%

Burning

Folliculitis

Acneiform lesions

Urticaria

Hypertrichosis

Lightheadedness

Viral

Warts

Impetigo

Skin infection

Frequency Not Defined

Striae

Pigmentation changes

HPA suppression (with higher potency used >2 wk)

Erythema

Cushing syndrome

Sepsis

Hemorrhage reported

Edema/swelling

Contraindications

Hypersensitivity

Underlying infection

Skin atrophy

Perioral dermatitis

Rosacea

Ophthalmic use

Cautions

Safety/efficacy in peds use longer than 4 wk not established

Ointment not indicated for atopic dermatitis

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

Use low potency for chronic therapy

Reversible HPA axis suppression and resulting clinical glucocorticoid insufficiency can occur during or after withdrawal of treatment; risk factors include use over large surface area, prolonged use, use under occlusion, altered skin barrier, liver failure, and young age; children may exhibit greater susceptibility to corticosteroid-induced HPA axis suppression and Cushing's syndrome due to larger skin surface area to body weight ratio; modify use if HPA axis suppression is suspected;

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)

Contains imidurea as excipient which releases formaldehyde as a breakdown product; may cause allergic sensitization or irritation upon contact

May cause irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, hypertrichosis, and miliaria; especially with high-potency or occlusive dressings

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

Absorption: 6% (animal studies; 5% systemic, 1% in skin)