fluocinolone acetonide
Generic: FLUOCINOLONE ACETONIDE
Basic Information
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
ba20d901-f800-4edd-aac6-6c77cbfe1064
Indications & Usage
1 INDICATIONS AND USAGE Fluocinolone acetonide topical oil is indicated for the topical treatment of: • atopic dermatitis in adults • moderate to severe atopic dermatitis in pediatric patients 3 months of age and older Fluocinolone acetonide topical oil is a corticosteroid indicated for the topical treatment of: • atopic dermatitis in adults ( 1 ) • moderate to severe atopic dermatitis in pediatric patients 3 months of age and older ( 1 )
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 common adverse reactions (≥ 5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%).
( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 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.
An open-label trial was conducted in 58 pediatric subjects 2 years to 12 years of age with moderate to severe atopic dermatitis to evaluate the safety of fluocinolone acetonide topical oil when applied to the face twice daily for 4 weeks.
Adverse reactions reported by ≥2% of pediatric subjects treated with fluocinolone acetonide topical oil are shown in Table 1.
Table 1: Adverse Reactions in ≥2% of Pediatric Subjects 2 Years to 12 Years of Age with Moderate to Severe Atopic Dermatitis, Treated with Fluocinolone Acetonide Topical Oil (Body Oil), N=58 Adverse Reaction (AR)* n (%) 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) Folliculitis 1 (2) 1 (2) Facial herpes simplex 1 (2) 1 (2) Acneiform eruption 1 (2) 1 (2) Ear infection 1 (2) 1 (2) *The number of individual adverse reactions reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reports of an adverse reaction.
**End of Treatment ***Four Weeks Post Treatment An open-label safety trial was conducted in 29 pediatric subjects 3 months to 2 years of age to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil twice daily for 4 weeks.
The trial included 7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years.
All subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area (BSA).
Eleven (11) subjects had baseline BSA involvement of 50% to 75% and 7 subjects had BSA involvement of greater than 75% [see Use in Specific Populations ( 8.4 )].
The most common adverse reactions reported in the study (≥2%) are shown in Table 2.
Table 2: Adverse Reactions in ≥ 2% of Pediatric Subjects 3 Months to 2 Years of Age with Moderate to Severe Atopic Dermatitis, Treated with Fluocinolone Acetonide Topical Oil (Body 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 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 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 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.
An open-label trial was conducted in 58 pediatric subjects 2 years to 12 years of age with moderate to severe atopic dermatitis to evaluate the safety of fluocinolone acetonide topical oil when applied to the face twice daily for 4 weeks.
Adverse reactions reported by ≥2% of pediatric subjects treated with fluocinolone acetonide topical oil are shown in Table 1.
Table 1: Adverse Reactions in ≥2% of Pediatric Subjects 2 Years to 12 Years of Age with Moderate to Severe Atopic Dermatitis, Treated with Fluocinolone Acetonide Topical Oil (Body Oil), N=58 Adverse Reaction (AR)* n (%) 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) Folliculitis 1 (2) 1 (2) Facial herpes simplex 1 (2) 1 (2) Acneiform eruption 1 (2) 1 (2) Ear infection 1 (2) 1 (2) *The number of individual adverse reactions reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reports of an adverse reaction.
**End of Treatment ***Four Weeks Post Treatment An open-label safety trial was conducted in 29 pediatric subjects 3 months to 2 years of age to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil twice daily for 4 weeks.
The trial included 7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years.
All subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area (BSA).
Eleven (11) subjects had baseline BSA involvement of 50% to 75% and 7 subjects had BSA involvement of greater than 75% [see Use in Specific Populations ( 8.4 )].
The most common adverse reactions reported in the study (≥2%) are shown in Table 2.
Table 2: Adverse Reactions in ≥ 2% of Pediatric Subjects 3 Months to 2 Years of Age with Moderate to Severe Atopic Dermatitis, Treated with Fluocinolone Acetonide Topical Oil (Body 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 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 )]