Dosing and uses of DermOtic (fluocinolone acetonide, otic)
Adult dosage forms and strengths
otic oiL
- 0.01%
Eczematous External Otitis
Instill 5 gtt into affected ear(s) twice daily for 7-14 days
Pediatric dosage forms and strengths
otic oiL
- 0.01%
Eczematous External Otitis
<2 years: Safety and efficacy not established
>2 years: Instill 5 gtt into affected ear(s) twice daily for 7-14 days
DermOtic (fluocinolone acetonide, otic) adverse (side) effects
Frequency not defined
Burning
Itching
Irritation dryness
Folliculitis
Acneiform eruption
Hypopigmentation, perioral dermatitis
Allergic contact dermatitis
Secondary infection
Skin atrophy
Striae
Miliaria
Ear infection
Warnings
Contraindications
Hypersensitivity
Contains peanut oil; contraindicated in peanut allergic individuals
Viral infections of external canal including varicella & herpes simplex infections
Cautions
Risk of HPA axis suppression especially in young children or patients receiving high doses for prolonged periods
Discontinue if ear infection occurs; may also mask infections
Contact dermatitis may occur; diagnosed as failure to heaL
Pregnancy and lactation
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.
Pharmacology of DermOtic (fluocinolone acetonide, otic)
Mechanism of action
Low-to-medium potency corticosteroid; elicits anti-inflammatory, antipruritic, and vasoconstrictive effects; induces phospholipase A2 inhibitory proteins that are thought to suppress inflammatory mediators (eg, prostaglandins, leukotrienes) by inhibiting arachidonic acid
