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

There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; observational studies suggest an increased risk of low birth weight infants with use of greater than 300 grams of potent or very potent topical corticosteroids during pregnancy; advise pregnant women that therapy may increase risk of having a low birth weight infant and to use drug on smallest area of skin and for shortest duration possible

Animal data

• In animal reproduction studies, subcutaneous administration to pregnant mice, rats, and rabbits during organogenesis caused malformations characteristic of corticosteroids in each species; available data do not allow calculation of relevant comparisons between systemic exposure of fluticasone propionate observed in animal studies to systemic exposure that would be expected in humans after topical use

Lactation

There are no data on presence of drug in human milk, its effects on breastfed infant, or on milk production; not known whether topical administration could result in sufficient systemic absorption to produce detectable quantities in human milk

Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

To minimize potential exposure to breastfed infant via breast milk, use on smallest area of skin and for shortest duration possible while breastfeeding; advise breastfeeding women not to apply drug directly to nipple and areola prior to breastfeeding to avoid direct infant exposure

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)