Product Elements:
Fluocinolone acetonide fluocinolone acetonide fluocinolone acetonide fluocinolone acetonide isopropyl alcohol anhydrous citric acid isopropyl myristate oleth-2 peanut oil light mineral oil
Indications and Usage:
Indications and usage fluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated: in adult patients for the treatment of psoriasis of the scalp (scalp oil).
Dosage and Administration:
Dosage and administration fluocinolone acetonide topical oil, 0.01% for scalp psoriasis in adults (scalp oil): for the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. apply a thin film of fluocinolone acetonide topical oil, 0.01% on the scalp, massage well and cover scalp with the supplied shower cap. leave on overnight or for a minimum of 4 hours before washing off. wash hair with regular shampoo and rinse thoroughly.
Contraindications:
Contraindications fluocinolone acetonide topical oil, 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. this product contains refined peanut oil (see precautions section).
Adverse Reactions:
Adverse reactions the following local adverse reactions have been reported infrequently with topical corticosteroids. they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. these reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. one peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide topical oil, 0.01%. a post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of fluocinolone acetonide topical oil, 0.01% when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see table of incidence of adverse events). incidence of adverse ev
Read more...ents (%) n=58 *the number of individual adverse events reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reportings of an adverse event. **end of treatment ***four weeks post treatment adverse event (ae)* # of patients (%) day 14 day 28** day 56*** any ae 15 (25.9) 6 (10.3) 7 (12.1) 7 (12.1) telangiectasia 5 (8.6) 3 (5.2) 4 (6.9) 2 (3.5) erythema 3 (5.2) 3 (5.2) itching 3 (5.2) 3 (5.2) irritation 3 (5.2) 3 (5.2) burning 3 (5.2) 3 (5.2) hypopigmentation 2 (3.5) 2 (3.5) shiny skin 1 (1.7) 1 (1.7) secondary atopic dermatitis 1 (1.7) 1 (1.7) papules and pustules 1 (1.7) 1 (1.7) keratosis pilaris 1 (1.7) 1 (1.7) folliculitis 1 (1.7) 1 (1.7) facial herpes simplex 1 (1.7) 1 (1.7) acneiform eruption 1 (1.7) 1 (1.7) ear infection 1 (1.7) 1 (1.7)
Adverse Reactions Table:
| *The number of individual adverse events reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reportings of an adverse event. |
| **End of Treatment |
| ***Four Weeks Post Treatment |
| Adverse Event (AE)* | # of patients (%) | Day 14 | Day 28** | Day 56*** |
| Any AE | 15 (25.9) | 6 (10.3) | 7 (12.1) | 7 (12.1) |
| Telangiectasia | 5 (8.6) | 3 (5.2) | 4 (6.9) | 2 (3.5) |
| Erythema | 3 (5.2) | | | 3 (5.2) |
| Itching | 3 (5.2) | | | 3 (5.2) |
| Irritation | 3 (5.2) | | | 3 (5.2) |
| Burning | 3 (5.2) | | | 3 (5.2) |
| Hypopigmentation | 2 (3.5) | 2 (3.5) | | |
| Shiny skin | 1 (1.7) | | 1 (1.7) | |
| Secondary atopic dermatitis | 1 (1.7) | | | 1 (1.7) |
| Papules and pustules | 1 (1.7) | | | 1 (1.7) |
| Keratosis pilaris | 1 (1.7) | | | 1 (1.7) |
| Folliculitis | 1 (1.7) | | 1 (1.7) | |
| Facial herpes simplex | 1 (1.7) | 1 (1.7) | | |
| Acneiform eruption | 1 (1.7) | | 1 (1.7) | |
| Ear infection | 1 (1.7) | | 1 (1.7) | |
Overdosage:
Overdosage topically applied fluocinolone acetonide topical oil, 0.01% can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description fluocinolone acetonide topical oil, 0.01% contains fluocinolone acetonide, usp (6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene) bis-(oxy)]-pregna-1,4-diene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. this formulation is also marketed as fluocinolone acetonide topical oil, 0.01%, fluocinolone acetonide for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older and as fluocinolone acetonide oil, 0.01% for chronic eczematous external otitis. chemically, fluocinolone acetonide, usp is c 24 h 30 f 2 o 6 . it has the following structural formula: fluocinolone acetonide, usp in fluocinolone acetonide topical oil, 0.01% has a molecular weight of 452.49. it is a white to almost white, crystalline powder and melts at about 270°c with decomposition; practically insoluble in water and heptane, soluble in methanol, anhydrous ethanol and acetone, slightly soluble in ether and chloroform. each gram of fluocinolone acetonide topical oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide, usp in a blend of oils, which contains anhydrous citric acid, isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil. each packaged product contains 2 shower caps. the shower cap is made of low density polyethylene material with rubber elastic. chemical-structure
Clinical Pharmacology:
Clinical pharmacology 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 a 2 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 a 2 . pharmacokinetics: the extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. occlusion of topical corticosteroids can enhance penetration. topical corticosteroids can be absorbed from normal intact skin. also, inflammation and
Read more.../or other disease processes in the skin can increase percutaneous absorption. fluocinolone acetonide topical oil, 0.01% is in the low to medium range of potency as compared with other topical corticosteroids.
Clinical Studies:
Clinical studies in a vehicle-controlled study for the treatment of psoriasis of the scalp in adults, after 21 days of treatment, 60% of patients on active treatment and 21% of patients on the drug vehicle had excellent to cleared clinical response. open-label safety studies on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis, and baseline body surface area involvement greater than 75% in 18 patients, and 50% to 75% in 15 patients, were treated with fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. morning pre-stimulation cortisol level and post-cortrosyn stimulation cortisol level were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. at the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 mcg/dl; normal: cortisol > 7mcg/dl) but all had normal responses to 0.25 mg of cortrosyn stimulatio
Read more...n (cortisol > 18 mcg/dl). a clinical study was conducted to assess the safety of fluocinolone acetonide topical oil, 0.01%, which contains refined peanut oil, on subjects with known peanut allergies. the study enrolled 13 patients with atopic dermatitis, 6 to 17 years of age. of the 13 patients, 9 were radioallergosorbent test (rast) positive to peanuts and 4 had no peanut sensitivity (controls). the study evaluated the responses to both prick test and patch test utilizing peanut oil nf, fluocinolone acetonide topical oil, 0.01% and histamine/saline controls, on the 13 individuals. these subjects were also treated with fluocinolone acetonide topical oil, 0.01% twice daily for 7 days. prick test and patch test results for all 13 patients were negative to fluocinolone acetonide topical oil, 0.01% and the refined peanut oil. one of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of fluocinolone acetonide topical oil, 0.01%. importantly, the bulk peanut oil nf, used in fluocinolone acetonide topical oil, 0.01% is heated at 475° f for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.
How Supplied:
How supplied fluocinolone acetonide topical oil, 0.01% is supplied in bottles containing 4 fluid ounces. it is labeled as scalp oil (ndc # 68462-590-89). scalp oil is supplied with 2 shower caps. keep tightly closed. store at 20ºc to 25ºc (68° to 77°f); excursions permitted to 15ºc to 30ºc (59° to 86°f) [see usp controlled room temperature]. caution: rx only manufactured by: glenmark pharmaceuticals ltd. village kishanpura, baddi nalagarh road, district: solan, himachal pradesh â 173205, india manufactured for: glenmark pharmaceuticals inc., usa mahwah, nj 07430 questions? 1(888)721-7115 www.glenmarkpharma.com/usa november 2018 glenmark-logo
Package Label Principal Display Panel:
Package/label display panel ndc 68462-590-89 fluocinolone acetonide topical oil 0.01%-carton label (scalp oil) fluocinolone-scalp-oil-carton
Package/label display panel ndc 68462-590-89 fluocinolone acetonide topical oil 0.01%-bottle label (scalp oil) fluocinolone-bottle-label