Derma-Smoothe FS
(fluocinolone acetonide)Derma-Smoothe FS Prescribing Information
Fluocinolone Acetonide 0.01% Topical Oil is a low to medium potency corticosteroid indicated:
In adult patients for the treatment of psoriasis of the scalp (Scalp Oil).
Fluocinolone Acetonide 0.01% Topical Oil 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 0.01% Topical Oil 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.
Fluocinolone Acetonide 0.01% Topical Oil 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).
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 malaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide oil 0.01%.
A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of fluocinolone acetonide 0.01% topical oil 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*** |
| 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) | ||
*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
Fluocinolone Acetonide 0.01 % Topical Oil contains fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid for topical use dermatologic use. This formulation is also marketed as Fluocinolone Acetonide 0.01% Topical Oil for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula:
Fluocinolone acetonide in Fluocinolone Acetonide 0.01% Topical Oil has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270ºC with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.
Each gram of Fluocinolone Acetonide 0.01% Topical Oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil NF.
Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.
Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusion of topical corticosteroids can enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Also, inflammation and/or other disease processes in the skin can increase percutaneous absorption.
Fluocinolone Acetonide 0.01% Topical Oil is in the low to medium range of potency as compared with other topical corticosteroids.
Fluocinolone Acetonide 0.01% Topical Oil is supplied in a 4 fluid ounce bottle with a net content of 118.28 mL. It is labeled as Scalp Oil (NDC 65162-703-86). Scalp Oil is supplied with 2 shower caps.
Keep tightly closed. Store upright at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or www.amneal.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
CAUTION: Rx only
Distributed by:
Amneal Pharmaceuticals
Bridgewater, NJ 08807
Rev. 08-2015-00