Fluocinolone acetonide
Generic: FLUOCINOLONE ACETONIDE
Basic Information
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
7f8512d9-b4a4-43c6-bac6-3e75dc451db2
Indications & Usage
1 INDICATIONS AND USAGE Fluocinolone acetonide topical oil is indicated for the treatment of psoriasis of the scalp in adults.
Fluocinolone acetonide topical oil is a corticosteroid indicated for the treatment of psoriasis of the scalp in adults.
( 1 )
Fluocinolone acetonide topical oil is a corticosteroid indicated for the treatment of psoriasis of the scalp in adults.
( 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 )] • Local Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5.3 )] 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%).
( 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 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 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 • Eye Disorders: glaucoma and cataracts • Nervous System Disorders: intracranial hypertension including bulging fontanelles, headaches, and bilateral papilledema
( 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 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 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 • Eye Disorders: glaucoma and cataracts • Nervous System Disorders: intracranial hypertension including bulging fontanelles, headaches, and bilateral papilledema