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 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 is formulated with 48% refined peanut oil NF. The peanut oil used in Derma-Smoothe/FS 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® is indicated for the topical treatment of atopic dermatitis in adult patients.

Pediatric Patients with Atopic Dermatitis

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

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

Derma-Smoothe/FS 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].

Derma-Smoothe/FS is not for oral, ophthalmic, or intravaginal use.

The dosing of Derma-Smoothe/FS is different for adult and pediatric patients.

Adult Patients with Atopic Dermatitis

Apply Derma-Smoothe/FS as a thin film to the affected areas three times daily.

Pediatric Patients with Atopic Dermatitis

Moisten skin and apply Derma-Smoothe/FS as a thin film to the affected areas twice daily for up to four weeks.

Dosage Forms And Strengths

Derma-Smoothe/FS® (fluocinolone acetonide), Topical Oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces.

Derma-Smoothe/FS is supplied in bottles containing 4 fluid ounces. It is labeled as Body Oil (NDC # 28105-150-04).

Storage:

Store at 25°C (68°-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773. Date: 12/2007. FDA Rev date: 12/12/2007

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® 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 twice daily for 4 weeks. The following adverse reactions were reported in the study [See Use in Specific Populations]:

Adverse Reactions (%)
N=30*

No information provided.

Included as part of the PRECAUTIONS section.

Hypothalamic-Pituitary-Adrenal Axis Suppression

Systemic absorption of topical corticosteroids can produce reversible hypothalamic- pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Cushing's syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroids.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. The ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.

If HPA axis suppression is documented, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, and use of occlusive dressings. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.

Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. [See Use in Specific Populations]

Local Adverse Reactions with Topical Corticosteroids

Local adverse reactions may occur with use of topical corticosteroids and may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Some local adverse reactions may be irreversible. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. [See ADVERSE REACTIONS]

Allergic Contact Dermatitis with Topical Corticosteroids

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

Concomitant Skin Infections

Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists unchanged, Derma-Smoothe/FS® should be discontinued until the infection has been adequately treated.

Use in Peanut-Sensitive Individuals

Physicians should use caution in prescribing Derma-Smoothe/FS for peanut-sensitive individuals. [See DESCRIPTION]

Should signs of hypersensitivity present (wheal and flare reactions, pruritus, or other manifestations), or should disease exacerbations occur, Derma-Smoothe/FS should be discontinued immediately and appropriate therapy instituted.

Nonclinical Toxicology

Carcinogenesis, mutagenesis, impairment of fertility:

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of Derma-Smoothe/FS. Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active ingredient in Derma- Smoothe/FS. Some corticosteroids have been found to be genotoxic in various genotoxicity tests (i.e. the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micronucleus assay, the Chinese hamster micronucleus test and the in vitro mouse lymphoma gene mutation assay).

Use In Specific Populations

Pregnancy

Pregnancy Category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from Derma-Smoothe/FS. Therefore, Derma-Smoothe/FS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Derma-Smoothe/FS is administered to a nursing woman.

Pediatric Use

Systemic Adverse Reactions in Pediatric Patients

HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Because of a higher ratio of skin surface area to body mass, children are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids. [See Warnings and PRECAUTIONS]

Evaluation in Peanut-Sensitive Pediatric Subjects

A clinical study was conducted to assess the safety of Derma-Smoothe/FS, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 subjects with atopic dermatitis, 6 to 17 years of age. Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the subjects' responses to both prick test and patch test utilizing peanut oil NF, Derma-Smoothe/FS and histamine/saline controls. Subjects were also treated with Derma- Smoothe/FS twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to Derma-Smoothe/FS and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of Derma-Smoothe/FS. The bulk peanut oil NF, used in Derma-Smoothe/FS is heated at 475°F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins. [See DESCRIPTION]

Evaluation in Pediatric Subjects 2 to 6 years old

Open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. Subjects were treated with Derma-Smoothe/FS twice daily for 4 weeks. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. Morning pre-stimulation cortisol and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL).

Evaluation in Pediatric Subjects 3 months to 2 years old

An open-label safety study was conducted in 29 children (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months and 15 subjects ages > 12 months to 2 years of age) to assess the HPA axis by ACTH stimulation testing following use of Derma-Smoothe/FS twice daily for 4 weeks. All subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area. Baseline body surface area involvement was 50% to 75% in 11 subjects and greater than 75% in 7 subjects. Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. All subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL).

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects, including under conditions of normal use. [See Warnings and PRECAUTIONS and Use in Specific Populations].

None

Mechanism of Action

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

Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

Derma-Smoothe/FS is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies.

Instructions

• Derma-Smoothe/FS 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 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 should not be applied under occlusion unless directed by the physician. Derma-Smoothe/FS should not be applied to the diaper area as diapers or plastic pants may constitute occlusive use.
• Derma-Smoothe/FS 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 without first consulting your physician.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

FLUOCINOLONE (ECZEMA) OIL - TOPICAL

(FLOO-oh-SIN-oh-lone)

COMMON BRAND NAME(S): Derma-Smoothe/FS

USES: This medication is used to treat eczema, a skin condition which causes red, irritated, and itchy skin. Fluocinolone reduces these symptoms. This medication is a low- to medium-strength corticosteroid.

HOW TO USE: Shake well before each use. Use this medication on the skin only. However, do not use it on the face, groin, or underarms unless directed to do so by your doctor. Do not apply this medication to the diaper area.

Wash and dry your hands before using. Clean and dry the affected area. Apply a thin film of medication to the affected area and gently rub in, usually 3 times daily or as directed by your doctor. Do not bandage, cover, or wrap the area unless directed to do so by your doctor.

After applying the medication, wash your hands unless you are using this medication to treat the hands. Avoid getting this medication in the eyes, nose, or mouth. If you get the medication in these areas, rinse with plenty of water.

Use this medication only for the condition for which it was prescribed. Do not use it for longer than prescribed.

Inform your doctor if your condition persists or worsens after 2 weeks.

SIDE EFFECTS: Stinging, burning, irritation, dryness, or redness at the application site may occur. Acne, excessive hair growth, "hair bumps" (folliculitis), skin thinning/discoloration, or stretch marks may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using fluocinolone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or to peanuts; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history.

Do not use if there is an infection or sore in the area to be treated. Skin infections can become worse when this medication is used. Notify your doctor promptly if redness, swelling, or irritation does not improve.

Though very unlikely, it is possible this medication will be absorbed into your bloodstream. This may have undesirable consequences that may require additional corticosteroid treatment. This is especially true for children and those who have used this drug for an extended time, especially if they also have serious medical problems such as serious infections, injuries, or surgeries. This precaution applies for up to one year after stopping use of this drug. Tell your doctor immediately if any of the following side effects occur: vision problems, persistent headache, increased thirst/urination, unusual weakness, unusual weight loss, dizziness.

Consult your doctor or pharmacist for more details, and inform them that you use or have used this medication.

Children may be more sensitive to the effects of too much steroid hormone. Though it is unlikely to occur with corticosteroids applied to the skin, this medication may affect growth in infants and children if used for long periods. Monitor your child's height and rate of growth from time to time.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other corticosteroids (e.g., hydrocortisone, prednisone).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Inform all your doctors you use (or have used) this medication.

Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store in a tightly closed container at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.