Product Description.:
1.1 Adult Patients with Atopic Dermatitis
Derma-Smoothe/FS? is indicated for the topical
treatment of atopic dermatitis in adult patients.
1.2 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.
1.3 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 (6) and Use in Specific Populations (8.4)].
2 DOSAGE AND ADMINISTRATION
Derma-Smoothe/FS is not for oral, ophthalmic, or
intravaginal use.
The dosing of Derma-Smoothe/FS is different for
adult and pediatric patients.
2.1 Adult Patients with Atopic Dermatitis
Apply Derma-Smoothe/FS as a thin film to the
affected areas three times daily.
2.2 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.
3 DOSAGE FORMS AND STRENGTHS
Derma-Smoothe/FS? (fluocinolone acetonide),
Topical Oil, 0.01% (Body Oil) is supplied in bottles
containing 4 fluid ounces.
4 CONTRAINDICATIONS
None
5 WARNINGS AND PRECAUTIONS
5.1 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 (8.4)]
5.2 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 (6.1)]
5.3 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.
5.4 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.
5.5 Use in Peanut-Sensitive Individuals
Physicians should use caution in prescribing Derma-Smoothe/FS for peanut-sensitive individuals. [See Description (11)]
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.
6 ADVERSE REACTIONS
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
