Fluocinolone Acetonide

Derma-Smoothe/FS® (fluocinolone acetonide), Topical Oil, 0.01% (Body 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 dermatologic use. This formulation is also marketed as Derma-Smoothe/FS® (fluocinolone acetonide), Topical Oil, 0.01% (Scalp Oil) 0.01% fluocinolone acetonide for use with shower caps for treatment of scalp psoriasis in adults and as fluocinolone acetonide oil, 0.01% for treatment of chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula:

Fluocinolone acetonide in Derma-Smoothe/FS (fluocinolone acetonide) has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

Each gram of Derma-Smoothe/FS contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF and fragrances.

Derma-Smoothe/FS (fluocinolone acetonide) is formulated with 48% refined peanut oil NF. The peanut oil used in Derma-Smoothe/FS (fluocinolone acetonide) is tested for peanut proteins through amino acid analysis which can detect the quantity of amino acids to below 0.5 parts per million.

Adult Patients with Atopic Dermatitis

Derma-Smoothe/FS® (fluocinolone acetonide) is indicated for the topical treatment of atopic dermatitis in adult patients.

Pediatric Patients with Atopic Dermatitis

Derma-Smoothe/FS® (fluocinolone acetonide) is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established.

Limitations of Use

Apply the least amount of Derma-Smoothe/FS® (fluocinolone acetonide) needed to cover the affected areas. As with other corticosteroids, Derma-Smoothe/FS® (fluocinolone acetonide) should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks.

Derma-Smoothe/FS (fluocinolone acetonide) should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use.

Derma-Smoothe/FS (fluocinolone acetonide) should not be used on the face, axillae, or groin unless directed by the physician. Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions. [see ADVERSE REACTIONS and Use in Specific Populations].

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Studies Experience: Evaluation of Facial Use in Pediatric Subjects

An, open-label, study was conducted in 58 children with moderate to severe atopic dermatitis (2 to 12 years old) to evaluate the safety of Derma-Smoothe/FS® (fluocinolone acetonide) when applied to the face twice daily for 4 weeks. The following adverse reactions were reported:

Incidence of Adverse Reactions (%)
N=58

Clinical Studies Experience: Evaluation in Pediatric Subjects 3 months to 2 years old

An open-label safety study was conducted in 29 children to assess the HPA axis by ACTH stimulation testing following use of Derma-Smoothe/FS (fluocinolone acetonide) twice daily for 4 weeks. The following adverse reactions were reported in the study [See Use in Specific Populations]:

Adverse Reactions (%)
N=30*

Instructions

• Derma-Smoothe/FS (fluocinolone acetonide) should be used as directed by the physician. It is for external use only. Avoid contact with the eyes. In case of contact, wash eyes liberally with water.
• Derma-Smoothe/FS (fluocinolone acetonide) should not be used for any disorder other than that for which it was prescribed.
• Patients should report any worsening of their skin condition to their physician promptly.
• Derma-Smoothe/FS (fluocinolone acetonide) should not be applied under occlusion unless directed by the physician. Derma-Smoothe/FS (fluocinolone acetonide) should not be applied to the diaper area as diapers or plastic pants may constitute occlusive use.
• Derma-Smoothe/FS (fluocinolone acetonide) should not be used on the face, axillae, or groin unless directed by the physician.
• As with other corticosteroids, therapy should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks.
• Do not use other corticosteroid-containing products while using Derma-Smoothe/FS (fluocinolone acetonide) without first consulting your physician.

SYNALAR® (fluocinolone acetonide) Topical Solution, 0.01%

60 mL Bottle with applicator tip – NDC 43538-920-60
90 mL Bottle with applicator tip – NDC 43538-920-90

Storage

Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F).

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.

Manufactured for: Medimetriks Pharmaceuticals, Inc., 363 Route 46 West, Fairfield, NJ 07004-2402 USA. Manufactured by: IGI Laboratories, Inc., Buena, NJ 08310. Revised: 11/2012

No information provided.

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (See DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

This is not a complete list of Fluocinolone Acetonidedrug interactions. Ask your doctor or pharmacist for more information.

Take fluocinolone acetonide exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Fluocinolone Acetonide dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Fluocinolone Acetonide is available in the following doses:

• Fluocinolone Ophthalmic 0.59 Mg Intraocular Implant
• Fluocinolone Otic 0.01% Otic Solution
• Fluocinolone Topical 0.01% Topical Cream
• Fluocinolone Topical 0.01% Topical Kit
• Fluocinolone Topical 0.01% Topical Lotion
• Fluocinolone Topical 0.01% Topical Oil
• Fluocinolone Topical 0.01% Topical Shampoo
• Fluocinolone Topical 0.01% Topical Solution
• Fluocinolone Topical 0.025% Topical Cream
• Fluocinolone Topical 0.025% Topical Kit
• Fluocinolone Topical 0.025% Topical Ointment
• Fluocinolone Topical 0.025% Topical Solution
• Fluocinolone Topical 0.2% Topical Cream
• Fluocinolone Topical Compounding Powder
• Fluocinolone/hydroquinone/tretinoin Topical 0.01%-4%-0.05% Topical Cream

You should not use this medication if you are allergic to fluocinolone.

To make sure fluocinolone topical is safe for you, tell your doctor if you have any type of skin infection.

Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.

FDA pregnancy category C. It is not known whether fluocinolone topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether fluocinolone topical passes into breast milk or if it could harm a nursing baby. Do not apply this medication to your chest area if you are breast-feeding a baby.

Children can absorb larger amounts of this medication through the skin and may be more likely to have side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.