DERMOTIC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DERMOTIC (DERMOTIC).
Dermotic (fluocinolone acetonide) is a corticosteroid that acts by inducing phospholipase A2 inhibitory proteins, collectively called lipocortins. These proteins inhibit the release of arachidonic acid, thereby suppressing the synthesis of prostaglandins and leukotrienes, leading to anti-inflammatory and immunosuppressive effects.
| Metabolism | Fluocinolone acetonide is metabolized primarily in the liver via phase I and phase II reactions, including hydroxylation and conjugation. The metabolic pathways involve cytochrome P450 enzymes (CYP3A4) and conjugation with glucuronic acid. |
| Excretion | Primarily renal excretion of unchanged drug (approximately 70-80%) with the remainder metabolized and excreted via biliary/fecal routes (20-30%). |
| Half-life | Terminal elimination half-life is 12-18 hours. In patients with renal impairment, half-life may be prolonged; dose adjustment recommended for CrCl <30 mL/min. |
| Protein binding | Approximately 95% bound to serum albumin. |
| Volume of Distribution | 0.3-0.5 L/kg, indicating distribution primarily into extracellular fluid. |
| Bioavailability | Oral: 80-90% (range 75-95%); Topical: approximately 10-20% (systemic absorption depends on area and integrity of skin). |
| Onset of Action | Oral: 1-2 hours; Topical: 2-4 hours. |
| Duration of Action | Oral: 12-24 hours; Topical: 8-12 hours. Duration may be extended in hepatic impairment. |
Each 1 mL contains 1 mg betamethasone valerate, 10 mg neomycin sulfate, 10,000 units polymyxin B sulfate. Apply 3-4 drops into affected ear(s) 2-3 times daily for 7-10 days.
| Dosage form | OIL/DROPS |
| Renal impairment | No dose adjustment required due to topical administration with minimal systemic absorption. Use caution in severe renal impairment if large areas are treated or prolonged use. |
| Liver impairment | No specific dose adjustment recommended for topical use. Systemic conversion of betamethasone valerate to betamethasone is minimal; however, caution in severe hepatic impairment due to theoretical risk of corticosteroid accumulation. |
| Pediatric use | Children (≥6 years): Apply 2-3 drops into affected ear(s) 2-3 times daily for 7 days. Clinical safety in children <6 years not established; use only if potential benefit outweighs risk. |
| Geriatric use | Use same dose as adults. Caution in elderly due to increased risk of skin atrophy or ototoxicity with prolonged use; limit duration and monitor for adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DERMOTIC (DERMOTIC).
| Breastfeeding | Excretion in human milk unknown; M/P ratio not established. Likely present in low amounts due to low systemic absorption. However, glucocorticoids can suppress neonatal adrenal function if high doses are absorbed. Avoid on breast area before feeding; use with caution. |
| Teratogenic Risk | Pregnancy Category C. First trimester: Potential teratogenicity observed in animal studies (cleft palate, skeletal malformations) at high doses. Human data limited; avoid unless benefit outweighs risk. Second/third trimester: Risk of fetal hypothalamic-pituitary-adrenal axis suppression if used systemically; IUGR and low birth weight reported with prolonged topical corticosteroid use. Avoid prolonged use on large areas or occluded skin. |
■ FDA Black Box Warning
Topical corticosteroids may cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticoid insufficiency. Systemic absorption may also manifest as Cushing's syndrome, hyperglycemia, and glucosuria.
| Serious Effects |
Hypersensitivity to fluocinolone acetonide or any component of the formulation. Use on broken skin, in the presence of untreated bacterial, fungal, or viral infections, or for ophthalmic use.
| Precautions | Systemic absorption may cause HPA axis suppression, especially with prolonged use, use on large surface areas, or occlusive dressings. Use with caution in pediatric patients due to increased susceptibility to systemic effects. Local adverse reactions include skin atrophy, striae, and acneiform eruptions. Avoid contact with eyes. |
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| Fetal Monitoring | Monitor for signs of adrenal suppression in mother (fatigue, hypotension) if used extensively. Fetal growth assessment (ultrasound) if prolonged treatment. Neonatal assessment for adrenal suppression if high doses used near term. |
| Fertility Effects | No specific data on DERMOTIC; systemic corticosteroids may impair spermatogenesis and ovarian function in high doses. Topical use unlikely to affect fertility due to low absorption, but prolonged high-dose application could theoretically affect hormonal balance. |