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). |
| Molecular Weight | 416.5 |
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 | Topical corticosteroids are generally avoided in first trimester unless necessary; limited data suggest low risk with short-term, low-potency use. |
| 2nd trimester | Use with caution; minimal systemic absorption expected with topical application. |
| 3rd trimester | Use with caution; no known fetal risk from topical use. |
Clinical note
Comprehensive clinical and safety monograph for DERMA-SMOOTHE/FS (DERMA-SMOOTHE/FS).
| Placental transfer | Minimal placental transfer due to low systemic absorption from topical application. |
| Breastfeeding | Topical corticosteroids are considered compatible with breastfeeding when applied to small areas for short duration; avoid application to breasts or large areas. |
| Lactation Rating |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to fluocinolone acetonide or any componentUntreated bacterial, fungal, or viral skin infections
| 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 |
| Food/Dietary | No known food interactions. |
| Clinical Pearls |
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| L2 |
| 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. |
| 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. |
| DERMA-SMOOTHE/FS is a topical corticosteroid (fluocinolone acetonide 0.01%) in an oil base, used for scalp psoriasis and seborrheic dermatitis. Apply sparingly to affected areas; avoid prolonged use on intertriginous areas due to increased absorption. Wash hands after application. Not for ophthalmic use. Monitor for signs of HPA axis suppression with long-term use, especially in children. |
| Patient Advice | Use only on the scalp or skin as directed; avoid contact with eyes. · Shake bottle well before each use. · Apply a small amount (a few drops) to affected area, massage gently. · Do not cover with bandages or dressings unless instructed. · Do not use longer than prescribed; overuse may cause skin thinning or adrenal suppression. · Inform your doctor if you develop signs of infection, irritation, or allergic reaction. · Keep away from heat and flame; the oil base is flammable. |