DERMOTIC
Generic: FLUOCINOLONE ACETONIDE
Basic Information
Manufacturer
Royal Pharmaceuticals
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
AURICULAR (OTIC)
FDA Set ID
eb00f222-8105-4e05-90e8-bbd129784364
Indications & Usage
1 INDICATIONS AND USAGE DERMOTIC ® 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 ) DermOtic ® Oil is indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older.
( 1 ) DermOtic ® Oil is indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older.
Adverse Reactions
6 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 Hill Dermaceuticals, Inc.
at 1-800-344-5707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical 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 DERMOTIC OIL twice daily for a maximum 14 days of treatment, the following adverse reactions were reported: Table 1: Adverse Reactions in ≥ 1% of DERMOTIC 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) 6.2 Postmarketing 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) ]
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hill Dermaceuticals, Inc.
at 1-800-344-5707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical 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 DERMOTIC OIL twice daily for a maximum 14 days of treatment, the following adverse reactions were reported: Table 1: Adverse Reactions in ≥ 1% of DERMOTIC 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) 6.2 Postmarketing 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) ]