Derma-smoothe/fs
(Fluocinolone Acetonide)Derma-Smoothe/Fs Prescribing Information
Indication and Usage, 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.
Derma-Smoothe/FS® is a corticosteroid indicated for the
- topical treatment of atopic dermatitis in adult patients ()
1.1 Adult Patients with Atopic DermatitisDerma-Smoothe/FS®is indicated for the topical treatment of atopic dermatitis in adult patients.
- topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks ()
1.2 Pediatric Patients with Atopic DermatitisDerma-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 to cover affected areas.
Discontinue when disease is controlled. ()1.3 Limitations of UseApply 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 (6)and Use in Specific Populations (8.4)]. - Do not use in the diaper area. ()
1.3 Limitations of UseApply 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 (6)and Use in Specific Populations (8.4)]. - Do not use on the face, axillae, or groin. (,
1.3 Limitations of UseApply 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 (6)and Use in Specific Populations (8.4)].,6.2 Clinical Studies Experience: Evaluation in Pediatric Subjects 3 months to 2 years oldAn 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 (8.4)];Adverse Reactions (%), N=30Includes one subject who withdrew at Week 2 Adverse Reaction# of subjects (%)Diarrhea 1 (3) Vomiting 1 (3) Pyrexia 3 (10) Abscess 1 (3) Molluscum 1 (3) Nasopharyngitis 2 (7) URI 1 (3) Otitis media 1 (3) Cough 6 (20) Rhinorrhea 4 (13) Atopic dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Hypopigmentation 2 (7) Rash 1 (3) )8.4 Pediatric Use8.4.1 Systemic Adverse Reactions in Pediatric PatientsHPA 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 (5.1)]8.4.2 Evaluation in Peanut-Sensitive Pediatric SubjectsA 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 (11)]8.4.3 Evaluation in Pediatric Subjects 2 to 6 years oldOpen-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).
8.4.4 Evaluation in Pediatric Subjects 3 months to 2 years oldAn 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).
Derma-Smoothe/FS® is not for oral, ophthalmic, or intravaginal use.
Derma-Smoothe/FS® (fluocinolone acetonide), Topical Oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces.
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.
None.