LoKara™ Lotion
(desonide lotion 0.05%)

Rx only

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

LoKara^™ Lotion (desonide lotion 0.05%) contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α-) a synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents.

Chemically, desonide is C₂₄H₃₂O₆. It has the following structural formula:

Desonide has the molecular weight of 416.51. It is a white to off white odorless powder which is soluble in methanol and practically insoluble in water.

Each gram of LoKara^™ Lotion (desonide lotion 0.05%) contains 0.5 mg of desonide in a base of sodium lauryl sulfate, light mineral oil, cetyl alcohol, stearyl alcohol, propylene glycol, methylparaben, propylparaben, sorbitan monostearate, glyceryl stearate SE, edetate sodium, citric acid anhydrous and purified water. May also contain additional citric acid and/or sodium hydroxide for pH adjustment.

Like other topical corticosteroids, desonide 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.

LoKara^™ Lotion (desonide lotion 0.05%) is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

LoKara^™ Lotion (desonide lotion 0.05%) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide was approximately 8%. These were: stinging and burning approximately 3%, irritation, contact dermatitis, condition worsened, peeling of skin, itching, intense transient erythema, and dryness/scaliness, each less than 2%.

The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are uled in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Topically applied LoKara^™ Lotion (desonide lotion 0.05%) can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

LoKara^™ Lotion (desonide lotion 0.05%) should be applied to the affected areas as a thin film two or three times daily depending on the severity of the condition.

SHAKE WELL BEFORE USING.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

LoKara^™ Lotion (desonide lotion 0.05%) should not be used with occlusive dressings.

LoKara^™ Lotion (desonide lotion 0.05%) is supplied in bottles as follows:

59 mL (2 fl oz) NDC 0462-0392-02
118 mL (4 fl oz) NDC 0462-0392-04

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

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

I8392B/IF8392B
#118
R3/06