CUTIVATE^®
(fluticasone propionate ointment)
Ointment, 0.005%

For Dermatologic Use Only—Not for Ophthalmic Use.

R_x Only

CUTIVATE^® (fluticasone propionate ointment) 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 CUTIVATE^® Ointment contains fluticasone propionate 0.05 mg in a base of liquid paraffin, microcrystalline wax, propylene glycol, and sorbitan sesquioleate.

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 CUTIVATE^® Ointment indicate that it is in the medium range of potency as compared with other topical corticosteroids.

CUTIVATE^® Ointment is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients.

CUTIVATE^® Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

In controlled clinical trials, the total incidence of adverse reactions associated with the use of CUTIVATE^® 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 and PRECAUTIONS: Pediatric Use). 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 uled 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.

Topically applied CUTIVATE^® Ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Apply a thin film of CUTIVATE^® Ointment to the affected skin areas twice daily. Rub in gently.

CUTIVATE^® Ointment should not be used with occlusive dressings.

CUTIVATE^® (fluticasone propionate ointment) Ointment, 0.005% is supplied in:

•  15-g tubes (NDC 0462-0333-15),
•  30-g tubes (NDC 0462-0333-30), and
•  60-g tubes (NDC 0462-0333-60).

Store between 2^°and 30^°C (36^°and 86^°F).

PharmaDerm^®
a division of ALTANA Inc
Duluth, GA 30096 USA
www.pharmaderm.com

I8333
R5/06
#144