fluocinolone acetonide
Generic: FLUOCINOLONE ACETONIDE
Basic Information
Manufacturer
Bryant Ranch Prepack
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
71541422-f12c-4e92-8012-dba59112070c
Indications & Usage
1 INDICATIONS AND USAGE Fluocinolone Acetonide Topical Oil, 0.01% is a corticosteroid indicated for the topical treatment of atopic dermatitis in adult patients ( 1.1 ) topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks ( 1.2 ) Limitations of Use: Apply the least amount to cover affected areas.
Discontinue when disease is controlled.
( 1.3 ) Do not use in the diaper area.
( 1.3 ) Do not use on the face, axillae, or groin.
( 1.3 , 6.2 , 8.4 ) 1.1 Adult Patients with Atopic Dermatitis Fluocinolone Acetonide Topical Oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients.
1.2 Pediatric Patients with Atopic Dermatitis Fluocinolone Acetonide Topical Oil, 0.01% is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks.
Safety and effectiveness in pediatric patients younger than 3 months of age have not been established.
1.3 Limitations of Use Apply the least amount of Fluocinolone Acetonide Topical Oil, 0.01% needed to cover the affected areas.
As with other corticosteroids, Fluocinolone Acetonide Topical Oil, 0.01% should be discontinued when control of disease is achieved.
Contact the physician if no improvement is seen within 2 weeks.
Fluocinolone Acetonide Topical Oil, 0.01% should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use.
Fluocinolone Acetonide Topical Oil, 0.01% should not be used on the face, axillae, or groin unless directed by the physician.
Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions.
[see Adverse Reactions ( 6 ) and Use in Specific Populations ( 8.4 )] .
Discontinue when disease is controlled.
( 1.3 ) Do not use in the diaper area.
( 1.3 ) Do not use on the face, axillae, or groin.
( 1.3 , 6.2 , 8.4 ) 1.1 Adult Patients with Atopic Dermatitis Fluocinolone Acetonide Topical Oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients.
1.2 Pediatric Patients with Atopic Dermatitis Fluocinolone Acetonide Topical Oil, 0.01% is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks.
Safety and effectiveness in pediatric patients younger than 3 months of age have not been established.
1.3 Limitations of Use Apply the least amount of Fluocinolone Acetonide Topical Oil, 0.01% needed to cover the affected areas.
As with other corticosteroids, Fluocinolone Acetonide Topical Oil, 0.01% should be discontinued when control of disease is achieved.
Contact the physician if no improvement is seen within 2 weeks.
Fluocinolone Acetonide Topical Oil, 0.01% should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use.
Fluocinolone Acetonide Topical Oil, 0.01% should not be used on the face, axillae, or groin unless directed by the physician.
Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions.
[see Adverse Reactions ( 6 ) and Use in Specific Populations ( 8.4 )] .
Adverse Reactions
6 ADVERSE REACTIONS 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.
The most common adverse reactions (≥ 5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%).
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Studies Experience: Evaluation of Facial Use in Pediatric Subjects An open-label study was conducted in 58 children with moderate to severe atopic dermatitis (2 to 12 years old) to evaluate the safety of fluocinolone acetonide topical oil, 0.01% when applied to the face twice daily for 4 weeks.
The following adverse reactions were reported: Incidence of Adverse Events (%) N=58 Adverse Reaction (AR)* # of subjects (%) 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 reporting of an adverse reaction.
**End of Treatment ***Four Weeks Post Treatment 6.2 Clinical Studies Experience: Evaluation in Pediatric Subjects 3 months to 2 years old An open-label safety study was conducted in 29 children to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks.
The following adverse reactions were reported in the study [See Use in Specific Populations ( 8.4 )] : Adverse Reactions (%) N=30* Adverse Reaction # of subjects (%) Diarrhea 1 (3) Vomiting 1 (3) Pyrexia 3 (10) Abscess 1 (3) Molluscum 1 (3) Nasopharyngitis 2 (7) URI 1 (3) Otitis media 1 (3) Cough 6 (20) Rhinorrhea 4 (13) Atopic dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Hypopigmentation 2 (7) Rash 1 (3) *Includes one subject who withdrew at Week 2
The most common adverse reactions (≥ 5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%).
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Studies Experience: Evaluation of Facial Use in Pediatric Subjects An open-label study was conducted in 58 children with moderate to severe atopic dermatitis (2 to 12 years old) to evaluate the safety of fluocinolone acetonide topical oil, 0.01% when applied to the face twice daily for 4 weeks.
The following adverse reactions were reported: Incidence of Adverse Events (%) N=58 Adverse Reaction (AR)* # of subjects (%) 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 reporting of an adverse reaction.
**End of Treatment ***Four Weeks Post Treatment 6.2 Clinical Studies Experience: Evaluation in Pediatric Subjects 3 months to 2 years old An open-label safety study was conducted in 29 children to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks.
The following adverse reactions were reported in the study [See Use in Specific Populations ( 8.4 )] : Adverse Reactions (%) N=30* Adverse Reaction # of subjects (%) Diarrhea 1 (3) Vomiting 1 (3) Pyrexia 3 (10) Abscess 1 (3) Molluscum 1 (3) Nasopharyngitis 2 (7) URI 1 (3) Otitis media 1 (3) Cough 6 (20) Rhinorrhea 4 (13) Atopic dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Hypopigmentation 2 (7) Rash 1 (3) *Includes one subject who withdrew at Week 2