Fluocinolone Acetonide
Fluocinolone Acetonide Prescribing Information
Fluocinolone acetonide topical oil is indicated for the treatment of psoriasis of the scalp in adults.
Fluocinolone acetonide topical oil is for topical use only. Not for oral, ophthalmic, or intravaginal use.
Wet or dampen hair and scalp thoroughly. Apply a thin film of fluocinolone acetonide topical oil on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours then wash hair with regular shampoo and rinse thoroughly. Use daily as needed.
Discontinue fluocinolone acetonide topical oil when control of disease is achieved within 2 weeks, or contact the healthcare provider if no improvement is seen within 2 weeks.
Do not use fluocinolone acetonide topical oil on the face unless directed by the healthcare provider. Do not apply to intertriginous areas due to the increased risk of local adverse reactions
The following serious adverse reactions are discussed in more detail in other sections of the labeling:
• Endocrine System Adverse Reactions[see Warnings and Precautions ]• Local Adverse Reactions[see Warnings and Precautions ]• Ophthalmic Adverse Reactions[see Warnings and Precautions ]
The most common adverse reactions in pediatric subjects treated for atopic dermatitis (≥5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%).
Because clinical trials are conducted under widely varying condition, 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.
An open-label safety study was conducted in 29 pediatric subjects 3 months to 2 years old to assess the HPA axis by ACTH stimulation testing following use of the formulation of fluocinolone acetonide topical oil twice daily for 4 weeks. Fluocinolone acetonide topical oil is not approved for use in pediatric patients for the treatment of psoriasis of the scalp. The most common adverse reactions were reported in the study:
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* Includes one subject who withdrew at Week 2
The following adverse reactions have been identified during post-approval use of products containing topical corticosteroids. Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Endocrine Disorders:HPA axis suppression and Cushing’s syndrome• Eye Disorders:glaucoma and cataracts• Nervous System Disorders:intracranial hypertension including bulging fontanelles, headaches, and bilateral papilledema
Do not apply to the diaper area; diapers or plastic pants may constitute occlusive use.
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 result from systemic absorption of topical corticosteroids.
HPA axis suppression and Cushing’s syndrome have been reported in patients receiving topical corticosteroids.
Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, use of occlusive dressings, altered skin barrier, liver failure, and young age. Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. 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. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) is a topical oil containing 0.01% fluocinolone acetonide, supplied in bottles containing 4 fluid ounces and with 2 shower caps.
Available data from case reports, case series, and observational studies on fluocinolone acetonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids may be associated with an increased risk of low birthweight infants. Advise pregnant women to use fluocinolone acetonide topical oil on the smallest area of skin and for the shortest duration possible.
Corticosteroids can cause fetal malformations in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids cause fetal malformations after dermal application in laboratory animals.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
None.
• Endocrine System Adverse Reactions:o Topical corticosteroids can produce reversible HPA axis suppression, Cushing’s syndrome, hyperglycemia, and glucosuria. ()5.1 Endocrine System Adverse ReactionsSystemic 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 result from systemic absorption of topical corticosteroids.
HPA axis suppression and Cushing’s syndrome have been reported in patients receiving topical corticosteroids.
Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, use of occlusive dressings, altered skin barrier, liver failure, and young age. Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. 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. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.
o Systemic absorption may require evaluation for hypothalamic-pituitary-adrenal (HPA) axis suppression. Potent corticosteroids use on large areas, prolonged use or occlusive use, altered skin barrier, liver failure, and young age may increase systemic absorption. Modify use should HPA axis suppression develop. ()5.1 Endocrine System Adverse ReactionsSystemic 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 result from systemic absorption of topical corticosteroids.
HPA axis suppression and Cushing’s syndrome have been reported in patients receiving topical corticosteroids.
Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, use of occlusive dressings, altered skin barrier, liver failure, and young age. Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. 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. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.
• Local Adverse Reactions:Local adverse reactions may include atrophy, striae irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis, and may be more likely with occlusive use or more potent corticosteroids. (,5.2 Local Adverse ReactionsLocal adverse reactions may occur with use of topical corticosteroids, including fluocinolone acetonide topical oil, 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 Clinical Studies ExperienceBecause clinical trials are conducted under widely varying condition, 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.
An open-label safety study was conducted in 29 pediatric subjects 3 months to 2 years old to assess the HPA axis by ACTH stimulation testing following use of the formulation of fluocinolone acetonide topical oil twice daily for 4 weeks. Fluocinolone acetonide topical oil is not approved for use in pediatric patients for the treatment of psoriasis of the scalp. The most common adverse reactions were reported in the study:
Table 1: Adverse Reactions in ≥ 2% Pediatric Subjects 3 Months to 2 Years of Age Treated with the Formulation of Fluocinolone Acetonide Topical Oil (Scalp Oil), N=30*- Adverse Reaction
- n (%)
Cough
6 (20)
Rhinorrhea
4 (13)
Pyrexia
3 (10)
Nasopharyngitis
2 (7)
Hypopigmentation
2 (7)
Abscess
1 (3)
Atopic Dermatitis
1 (3)
Eczema
1 (3)
Hyperpigmentation
1 (3)
Molluscum
1 (3)
Rash
1 (3)
Diarrhea
1 (3)
Otitis Media
1 (3)
URI
1 (3)
Vomiting
1 (3)
* Includes one subject who withdrew at Week 2
• Ophthalmic Adverse Reactions:May increase the risks of glaucoma and posterior subcapsular cataract. Avoid contact of fluocinolone acetonide topical oil with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. ()5.3 Ophthalmic Adverse ReactionsUse of topical corticosteroids may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products. Avoid contact of fluocinolone acetonide topical oil with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.