Fluocinolone acetonide is the generic equivalent of the brand-name drug Fluocinolone Acetonide. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Fluocinolone acetonide through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Fluocinolone acetonide topical oil 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 is indicated for the topical treatment of atopic dermatitis in adult patients. 1.2 Pediatric Patients with Atopic Derm…
Mechanism of Action
12.1 Mechanism of Action Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Clinical Pharmacology
12 CINICAL PHARMACOLOGY 12.1 Mechanism of Action Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. 12.3…
Contraindications & Precautions
4 CONTRAINDICATIONS None None ( 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 Taro Ph…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Fluocinolone acetonide topical oil is not for oral, ophthalmic, or intravaginal use. The dosing of fluocinolone acetonide topical oil is different for adult and pediatric patients. Fluocinolone acetonide topical oil is not for oral, ophthalmic, or intravaginal use. ( 2 ) Adult patients: Apply to affected areas 3 times daily. ( 2.1 ) Pediatric patients: Moisten skin and apply to affected areas twice daily for up to 4 weeks. ( 2.2 ) 2.1 Adult Patients with Atopic Dermat…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION 17.1 Instructions Fluocinolone acetonide topical oil should be used as directed by the physician. It is for external use only. Avoid contact with the eyes. In case of contact, wash eyes liberally with water. Fluocinolone acetonide topical oil should not be used for any disorder other than that for which it was prescribed. Patients should report any worsening of their skin condition to their physician promptly. Fluocinolone acetonide topical oil should not be applied under occlusion unless directed by the physician. Fluocinolone acetonide topical oil should not…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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