displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Fluticasone Propionate Ointment 0.005% contains fluticasone propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:
Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water.
Each gram of fluticasone propionate ointment contains fluticasone propionate 0.05 mg in an ointment base of mineral oil, microcrystalline wax, sorbitan sesquioleate and propylene glycol.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Like other topical corticosteroids, fluticasone propionate 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.
Fluticasone propionate is lipophilic and has a strong affinity for the glucocorticoid receptor. It has weak affinity for the progesterone receptor, and virtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The therapeutic potency of glucocorticoids is related to the half-life of the glucocorticoid-receptor complex. The half-life of the fluticasone propionate-glucocorticoid receptor complex is approximately 10 hours.
Studies performed with fluticasone propionate ointment indicate that it is in the medium range of potency as compared with other topical corticosteroids.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Fluticasone propionate ointment is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Fluticasone propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
In controlled clinical trials, the total incidence of adverse reactions associated with the use of fluticasone propionate ointment was approximately 4%. These adverse reactions were usually mild, self-limiting, and consisted primarily of pruritus, burning, hypertrichosis, increased erythema, hives, irritation, and lightheadedness. Each of these events occurred individually in less than 1% of patients.
In a study of 35 pediatric patients treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 patients who had normal testing prior to treatment. It is not known if these patients had recovery of adrenal function because follow-up testing was not performed (see
PRECAUTIONS: Laboratory Tests
PRECAUTIONS: Pediatric Use
sections). Telangiectasia on the face was noted in 1 patient on the eighth day of a 4-week treatment period. Facial use was discontinued and the telangiectasia resolved.
The following additional local adverse reactions have been reported infrequently with topical corticosteroids, including fluticasone propionate, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. Also, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroid products.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Topically applied fluticasone propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Apply a thin film of fluticasone propionate ointment to the affected skin areas twice daily. Rub in gently.
Fluticasone propionate ointment should not be used with occlusive dressings.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Fluticasone Propionate Ointment, 0.005% is supplied in:
5 g tubes (physician samples, tubes only) NDC 51672-4095-5
15 g tubes NDC 51672-4095-1
30 g tubes NDC 51672-4095-2
60 g tubes NDC 51672-4095-3
PRINCIPAL DISPLAY PANEL – 60 g Tube Carton
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.