Fluocinolone Acetonide (17 brand names, 9 dosage forms, 3 routes)
Available dosage forms: CREAM, IMPLANT, OIL, SOLUTION, OINTMENT, OIL/DROPS, SOLUTION/DROPS, GEL, SHAMPOO.
Routes of administration: TOPICAL, INTRAVITREAL, OTIC.
Brand Names
- CAPEX
- DERMA-SMOOTHE/FS
- DERMOTIC
- FLAC
- FLUOCET
- FLUOCINOLONE ACETONIDE
- FLUOCINONIDE ACETONIDE
- FLUONID
- FLUOTREX
- ILUVIEN
- NEO-SYNALAR
- OTOVEL
- RETISERT
- SYNALAR
- SYNALAR-HP
- TRI-LUMA
- YUTIQ
Indications and Usage
Fluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated: In adult patients for the treatment of psoriasis of the scalp (scalp oil).
Dosage and Administration
Fluocinolone acetonide topical oil, 0.01% for scalp psoriasis in adults (scalp oil): For the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. Apply a thin film of fluocinolone acetonide topical oil, 0.01% on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours before washing off. Wash hair with regular shampoo and rinse thoroughly.
Contraindications
Fluocinolone acetonide topical oil, 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product contains refined peanut oil NF (see PRECAUTIONS section).
Adverse Reactions
The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide topical oil, 0.01%. A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of fluocinolone acetonide topical oil, 0.01% when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see Table of Incidence of Adverse Events). Incidence of Adverse Events (%) N=58 Adverse Event (AE)* # of patients (%) Day 14 Day 28† Day 56‡ * The number of individual adverse events reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse event. † End of Treatment ‡ Four Weeks Post Treatment Any AE 15 (25.9) 6 (10.3) 7 (12.1) 7 (12.1) Telangiectasia 5 (8.6) 3 (5.2) 4 (6.9) 2 (3.5) Erythema 3 (5.2) 3 (5.2) Itching 3 (5.2) 3 (5.2) Irritation 3 (5.2) 3 (5.2) Burning 3 (5.2) 3 (5.2) Hypopigmentation 2 (3.5) 2 (3.5) Shiny skin 1 (1.7) 1 (1.7) Secondary atopic dermatitis 1 (1.7) 1 (1.7) Papules and pustules 1 (1.7) 1 (1.7) Keratosis pilaris 1 (1.7) 1 (1.7) Folliculitis 1 (1.7) 1 (1.7) Facial herpes simplex 1 (1.7) 1 (1.7) Acneiform eruption 1 (1.7) 1 (1.7) Ear infection 1 (1.7) 1 (1.7) To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Overdosage
Topically applied fluocinolone acetonide topical oil, 0.01% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).