Corticosteroid

Fluocinolone Acetonide

Approved 25 Apr 2016EarOil/drops

The FDA lists this product in 56 strengths and forms.

Indications

Fluocinolone acetonide oil is indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older. Fluocinolone acetonide oil is a corticosteroid indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older. ( 1 )

Contraindications

None. None. ( 4 )

Warnings and precautions

Endocrine System Adverse Reactions: o Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, hyperglycemia, and glucosuria. (5.1) o Pediatric patients may be more susceptible to systemic toxicity from equivalent doses. (5.1,8.4) o Systemic absorption may require evaluation for 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 ). 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, 6.1) Ophthalmic Adverse Reactions: May increase the risks of glaucoma and posterior subcapsular cataract. Avoid contact of fluocinolone acetonide oil with eyes.

Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. (5.3)

5.1Endocrine System Adverse Reactions

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 pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation.

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 (5.1 ), Use in Specific Populations (8.4)]
Local Adverse Reactions [see Warnings and Precautions (5.2 )]
Ophthalmic Adverse Reactions [ see Warnings and Precautions (5.3) ] The most commonly reported adverse reactions (≥ 1%) were headache (3%), URI (2%), cough (2%), eczematous otitis (1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience

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. In trials that enrolled 154 subjects (adults and pediatric subjects 2 years and older) with chronic eczematous external otitis who were treated with five drops per ear of fluocinolone acetonide oil twice daily for a maximum 14 days of treatment, the following adverse reactions were reported: Table 1: Adverse Reactions in ≥1% of Fluocinolone Acetonide Oil - Treated Adult and Pediatric Subjects 2 Years of Age and Older with Chronic Eczematous External Otitis, N=154 Adverse Reaction n (%) Headache 4 (3) URI 3 (2) Cough 3 (2) Eczematous otitis 2 (1)

6.2Postmarketing Experience

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 [see Use in Specific Populations (8.4) ] Eye Disorders : glaucoma and cataracts [see Warnings and Precautions (5.3) ] Nervous System Disorders: intracranial hypertension including bulging fontanelles, headaches, and bilateral papilledema [see Use in Specific Populations (8.4) ]

Fluocinolone Acetonide

Indications

Contraindications

Warnings and precautions

5.1Endocrine System Adverse Reactions

Two medicines in one question?

5.2Local Adverse Reactions

5.3Ophthalmic Adverse Reactions Use

5.4Allergic Contact Dermatitis Use

5.5Concomitant Skin Infections Use

5.6Use in Peanut Sensitive Individuals

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Studies Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance

Guidelines