DERMA-SMOOTHE/FS
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DERMA-SMOOTHE/FS (DERMA-SMOOTHE/FS).
Fluocinolone acetonide is a corticosteroid that binds to glucocorticoid receptors, modulating gene transcription to inhibit pro-inflammatory cytokines and reduce inflammation, vasodilation, and edema.
| Metabolism | Hepatic and renal metabolism via CYP3A4; fluocinolone acetonide is metabolized to inactive metabolites. |
| Excretion | Primarily renal (90%) as inactive metabolites; <5% unchanged. Biliary/fecal excretion accounts for <10%. |
| Half-life | Terminal elimination half-life: 24-36 hours (systemic absorption after topical application); clinical context: prolonged with hepatic impairment. |
| Protein binding | 90-95% bound to albumin and corticosteroid-binding globulin. |
| Volume of Distribution | Not well defined for topical; systemic absorption Vd ~0.5 L/kg for corticosteroids, indicating distribution into total body water. |
| Bioavailability | Topical: <1% systemic absorption through intact skin; higher (up to 5-10%) with occlusive dressings or inflamed skin. |
| Onset of Action | Topical: pruritus relief within 2-3 days; intralesional: within 24-48 hours. |
| Duration of Action | Topical: 1-2 weeks after treatment cessation; clinical notes: duration depends on disease severity and formulation (oil vs. cream). |
Apply topically as a thin film to affected areas twice daily. Maximum weekly dose should not exceed 60 g.
| Dosage form | OIL |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established; use is not recommended in children under 12 years of age. |
| Geriatric use | Use with caution in elderly patients due to increased risk of skin atrophy and systemic absorption; apply minimal amounts for shortest duration necessary. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DERMA-SMOOTHE/FS (DERMA-SMOOTHE/FS).
| Breastfeeding | Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when fluocinolone acetonide topical is administered to a nursing woman. The milk-to-plasma ratio (M/P) is not specifically reported for this formulation. |
| Teratogenic Risk | Fluocinolone acetonide topical, as a corticosteroid, is categorized as FDA Pregnancy Category C. In animal studies, corticosteroids have been shown to be teratogenic (cleft palate, skeletal abnormalities) with systemic administration at relatively low doses. Topical application, especially with occlusive dressings, may result in sufficient systemic absorption to produce fetal harm. The risk is considered low with brief, small-area use, but chronic high-dose or extensive use should be avoided during pregnancy. There are no adequate and well-controlled studies in pregnant women. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to fluocinolone acetonide or any component","Viral or fungal skin infections","Impaired circulation","Ocular herpes simplex","Not for ophthalmic use"]
| Precautions | ["May cause reversible HPA axis suppression with prolonged or extensive use","Systemic effects including Cushing's syndrome and hyperglycemia","Local skin reactions including atrophy, striae, and telangiectasia","Avoid use on face, groin, or axillae unless directed","Protect from light and excessive heat"] |
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| Fetal Monitoring | Monitor for maternal signs of systemic corticosteroid effects (e.g., hyperglycemia, adrenal suppression, hypertension) if large areas are treated or occlusive dressings are used. In the fetus, consider monitoring for growth restriction if prolonged high-dose use occurs. No specific fetal monitoring is routinely required for topical use. |
| Fertility Effects | No studies have been conducted on the effects of topical fluocinolone acetonide on human fertility. Animal studies with corticosteroids have shown impairment of fertility at high systemic doses; it is not known if topical application at recommended doses poses a risk. |