Drug: Derma-Smoothe Scalp/FS

Derma-Smoothe/FS Topical® Oil contains fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(l-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® 0.01% fluocinolone acetonide 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 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 . Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.

Source: http://www.rxlist.com

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 Derma-Smoothe/FS®. A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of Derma-Smoothe/FS® 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‡ AnyAE 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 Read the Derma-Smoothe Scalp/FS (fluocinolone acetonide) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

Derma-Smoothe/FS® 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 Derma-Smoothe/FS® 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.

Source: http://www.rxlist.com

No information provided. Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Derma-Smoothe/FS® is a low to medium potency corticosteroid indicated: In adult patients for the treatment of psoriasis of the scalp (Scalp Oil).

Source: http://www.rxlist.com

Derma-Smoothe/FS® 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). Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Topically applied Derma-Smoothe/FS® can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Source: http://www.rxlist.com

Derma-Smoothe/FS® is supplied in bottles containing 4 fluid ounces. It is labeled as Scalp Oil (NDC # 28105-149-04). Scalp Oil is supplied with 2 shower caps. Keep tightly closed. Store at 25°C (68° to 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. Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Infrequently, signs and symptoms of glucocorticoid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS - Pediatric use) Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than noting a clinical exacerbation, which may occur with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic testing. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with Derma-Smoothe/FS® (see Clinical Studies section). If wheal and flare type reactions (which may be limited to pruritus) or other manifestations of hypersensitivity develop, Derma-Smoothe/FS® should be discontinued immediately and appropriate therapy instituted. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Derma-Smoothe/ FS® should be discontinued until the infection has been adequately controlled. Derma-Smoothe/FS® is formulated with 48% refined peanut oil NF. Peanut oil used in this product is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million (ppm). Physicians should use caution in prescribing Derma-Smoothe/FS® for peanut sensitive individuals. Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test
A.M. plasma cortisol test Urinary free cortisol test Carcinogenesis, mutagenesis, and 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). Pregnancy Teratogenic effects - 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 Derma-Smoothe/FS® may be used twice daily for up to 4 weeks in pediatric patients 2 years and older with moderate to severe atopic dermatitis. Derma-Smoothe/FS® should not be applied to the diaper area. Application to intertriginous areas should be avoided due to the increased possibility of local adverse events such as striae, atrophy, and telangiectasia, which may be irreversible. The smallest amount of drug needed to cover the affected areas should be applied. Long term safety in the pediatric population has not been established. Derma-Smoothe/FSR is not recommended for use on the face (see ADVERSE REACTIONS section). Because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of HPA-axis-suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. (See PRECAUTIONS). HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Derma-Smoothe/FS® is formulated with 48% refined peanut oil NF. Peanut oil used in this product is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million (ppm). Physicians should use caution in prescribing Derma-Smoothe/FS® for peanut sensitive individuals. Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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