Fluocinolone Acetonide

FLUOCINOLONE ACETONIDE — fluocinolone acetonide oil
Physicians Total Care, Inc.

1 INDICATIONS AND USAGE

1.1. Adult Patients with Atopic Dermatitis

Fluocinolone Acetonide 0.01% Topical Oil is indicated for the topical treatment of atopic dermatitis in adult patients.

1.2. Pediatric Patients with Atopic Dermatitis

Fluocinolone Acetonide 0.01% Topical Oil 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 Fluocinolone Acetonide 0.01% Topical Oil needed to cover the affected areas. As with other corticosteroids, Fluocinolone Acetonide 0.01% Topical Oil should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks.

Fluocinolone Acetonide 0.01% Topical Oil should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use.

Fluocinolone Acetonide 0.01% Topical Oil 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

Fluocinolone acetonide 0.01% topical oil is not for oral, ophthalmic, or intravaginal use.

The dosing of fluocinolone acetonide 0.01% topical oil is different for adult and pediatric patients.

2.1. Adult Patients with Atopic Dermatitis

Apply fluocinolone acetonide 0.01% topical oil as a thin film to the affected areas three times daily.

2.2. Pediatric Patients with Atopic Dermatitis

Moisten skin and apply fluocinolone acetonide 0.01% topical oil as a thin film to the affected areas twice daily for up to four weeks.

3 DOSAGE FORMS AND STRENGTHS

Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) is supplied in 4 fluid ounce bottles with a net content of 118.28 mL.

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, fluocinolone acetonide topical oil 0.01% should be discontinued until the infection has been adequately treated.

5.5. Use in Peanut-Sensitive Individuals

Physicians should use caution in prescribing fluocinolone acetonide 0.01% topical oil 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, fluocinolone acetonide 0.01% topical oil 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 of another drug and may not reflect the rates observed in practice.

6.1. 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 fluocinolone acetonide 0.01% topical oil when applied to the face twice daily for 4 weeks. The following adverse reactions were reported:

Incidence of Adverse Reaction (%)N=58
* The number of individual adverse reactions reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse reaction.
** End of Treatment
*** Four Weeks Post Treatment
Adverse Reaction (AR) * # of subjects (%) Day 14 Day 28 ** Day 56 ***
Any AE 15 (26) 6 (10) 7 (12) 7 (12)
Telangiectasia 5 (9) 3 (5) 4 (7) 2 (4)
Erythema 3 (5) 3 (5)
Itching 3 (5) 3 (5)
Irritation 3 (5) 3 (5)
Burning 3 (5) 3 (5)
Hypopigmentation 2 (4) 2 (4)
Shiny Skin 1 (2) 1 (2)
Secondary atopic dermatitis 1 (2) 1 (2)
Papules and pustules 1 (2) 1 (2)
Keratosis pilaris 1 (2) 1 (2)
Follicuitis 1 (2) 1 (2)
Facial herpes simplex 1 (2) 1 (2)
Acneiform eruption 1 (2) 1 (2)
Ear infection 1 (2) 1 (2)
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