Label: FLUOCINOLONE ACETONIDE oil

Pharmacokinetics:

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusion of topical corticosteroids can enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Also, inflammation and/or other disease processes in the skin can increase percutaneous absorption.

Fluocinolone Acetonide Topical Oil, 0.01% is in the low to medium range of potency as compared with other topical corticosteroids.

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 fluocinolone acetonide topical oil, 0.01% (see CLINICAL STUDIES section).

If wheal and flare type reactions (which may be limited to pruritus) or other manifestations of hypersensitivity develop, Fluocinolone Acetonide Topical Oil, 0.01% 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 Fluocinolone Acetonide Topical Oil, 0.01% should be discontinued until the infection has been adequately controlled.

Fluocinolone Acetonide Topical Oil, 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Topical Oil, 0.01% for peanut-sensitive individuals.

Information for Patients:

Patients using topical corticosteroids should receive the following information and instructions:

1.

This medication is to 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.

2.

This medication should not be used for any disorder other than that for which it was prescribed.

3.

Patients should promptly report to their physician any worsening of their skin condition.

4.

Parents of pediatric patients should be advised not to use Fluocinolone Acetonide Topical Oil, 0.01% in the treatment of diaper dermatitis. Fluocinolone Acetonide Topical Oil, 0.01% should not be applied to the diaper area as diapers or plastic pants may constitute occlusive dressing.

5.

This medication should not be used on the face, underarm, or groin unless directed by the physician.

6.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

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 fluocinolone acetonide topical oil, 0.01%. Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active ingredient in fluocinolone acetonide topical oil, 0.01%. 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 fluocinolone acetonide topical oil, 0.01%. Therefore, Fluocinolone Acetonide Topical Oil, 0.01% 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 Fluocinolone Acetonide Topical Oil, 0.01% is administered to a nursing woman.

Pediatric Use:

Fluocinolone Acetonide Topical Oil, 0.01% may be used twice daily for up to 4 weeks in pediatric patients 2 years and older with moderate to severe atopic dermatitis. Fluocinolone Acetonide Topical Oil, 0.01% 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.

Fluocinolone Acetonide Topical Oil, 0.01% 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.

Fluocinolone Acetonide Topical Oil, 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Topical Oil, 0.01% for peanut-sensitive individuals.