Rx Only
For Dermatologic Use Only
Not for Ophthalmic Use
DESCRIPTION
Desonide Lotion 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17 -[(1-melhylethylidene)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 C
24H
320
6. 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 Desonide Lotion contains 0.5 mg of desonide in a base of cetyl alcohol, edetate sodium, glyceryl stearate SE, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, sorbitan monostearate, and stearyl alcohol. May contain citric acid and/or sodium hydroxide for pH adjustment.
CLINICAL PHARMACOLOGY
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 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. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Studies performed with Desonide Lotion indicate that it is in the low to medium range of potency as compared with other topical corticosteroids.
INDICATION AND USAGE
Desonide
Lotion is low to medium potency corticosteroids indicated for the
relief of the Inflammatory and pruritic manifestations of
corticosteroid responsive dermatoses.
CONTRAINDICATIONS
Desonide lotion is contraindicated in those patients with a history of
hypersensitivity to any of the components of the preparations.
PRECAUTIONS
General: Systemic absorption of topical
corticosteroids can produce reversible hypothalamic-pituitary-adrenal
(HPA) axis suppression with the potential for glucocorticosteroid
insufficiency after withdrawal of treatment. Manifestations of
Cushing's syndrome, hyperglycemia, and glucosuria can also be
produced in some patients by systemic absorption of topical
corticosteroids while on treatment. Patients applying a topical steroid
to a large surface area or to areas under occlusion should be evaluated
periodically for evidence of HPA axis suppression. This may be done by
using the ACTH stimulation, A.M. plasma cortisol, and urinary free
cortisol tests. Patients receiving superpotent corticosteroids should
not be treated for more than 2 weeks at a time and only small areas
should be treated at any one time due to the increased risk of HPA axis
suppression.
If HPA axis suppression is noted, an attempt should
be made to withdraw the drug, to reduce the frequency of application,
or to substitute a less potent corticosteroid. Recovery of HPA axis
function is generally prompt and complete upon discontinuation of
topical corticosteroids. Infrequently, signs and symptoms of
glucocorticosteroid insufficiency may occur requiring supplemental
systemic corticosteroids. For information on systemic supplementation,
see prescribing information for those products.
Pediatric patients
may be more susceptible to systemic toxicity from equivalent doses due
to their larger skin surface to body mass ratios. (See PRECAUTIONS: Pediatric Use).
If
irritation develops, Desonide Lotion should be discontinued and
appropriate therapy instituted. Allergic contact dermatitis with
corticosteroids is usually diagnosed by observing failure to heal
rather than noting a clinical exacerbation as with most topical
products not containing corticosteroids. Such an observation should be
corroborated with appropriate diagnostic patch testing.
If
concomitant skin infections are present or develop, an appropriate
antifungal or antibacterial agent should be used. If a favorable
response does not occur promptly, use of Desonide Lotion should be
discontinued until the infection has been adequately controlled.
Information for patients
Patients using topical corticosteroids should receive the following information and Instructions:
1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2. This medication should not be used for any disorder other than that for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or
wrapped so as to be occlusive unless directed by the physician.
4. Patients should report to their physician any signs of local adverse reactions.
Laboratory tests
The following tests may be helpful in evaluating patients for HPA axis suppression:
ACTH stimulation test
A.M. plasma cortisol test
Urinary free cortisol test
Carcinogenesis, mutagenesis, and impairment or fertility
Long-term
animal studies have not been performed to evaluate the carcinogenic
potential or the effect on reproduction with the use of Desonide Lotion.
Pregnancy
Teratogenic effects: Pregnancy category C:
Corticosteroids have been shown to be teratogenic in laboratory animals
when administered systemically at relativity low dosage levels. Some
corticosteroids have been shown to be teratogenic after dermal
application in laboratory animals. Animal reproduction studies have not
been conducted with Desonide Lotion. It is also not known whether
Desonide Lotion can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. Desonide Lotion should be
given to a pregnant woman only if clearly needed.
Nursing mothers
Systemically
administered corticosteroids appear
in human milk and could suppress growth, interfere with endogenous
corticosteroid
production, or cause other untoward effects. It is not known whether
topical administration of corticosteroids could result in sufficient
systemic absorption to produce detectable quantities in human milk.
Because many drugs are excreted in human milk, caution should be
exercised when Desonide Lotion is administered to a nursing woman.
Pediatric use
Safety and effectiveness in pediatric patients
have not been established. Because of a higher ratio of skin surface area to
body mass, pediatric patients are at a greater risk than adults of HPA axis
suppression when they are treated with topical corticosteroids. They are
therefore also at greater risk of glucocorticosteroid insufficiency after
withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects
including striae have been reported with inappropriate use of topical
corticosteroids in infants and children.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed
weight gain and intracranial hypertension have been reported in children
receiving topical corticosteroids. Manifestations of adrenal suppression in
children include low plasma cortisol levels, and absence of response to ACTH
stimulation. Manifestations of intracranial hypertension include bulging
fontanelles, headaches, and bilateral papilledema.
ADVERSE REACTIONS
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 listed in an approximate
decreasing order of occurrence: folliculitis, acneiform eruptions,
hypopigmentation, perioral dermatitis, secondary infection, skin
atrophy, striae, and miliaria.
OVERDOSAGE
Topically applied Desonide Lotion can be
absorbed in sufficient amounts to produce systemic effects (see
PRECAUTIONS)
DOSAGE AND ADMINISTRATION
Desonide
Lotion should be applied to the affected areas as a thin film two or
three times daily depending on the severity of the condition. SHAKE
LOTION 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.
Desonide Lotion should not be used with occlusive dressings.
HOW SUPPLIED
Desonide Lotion 0.05% is supplied as follows:
2 fl oz bottle - NDC 0472-0803-02
4 fl oz bottle - NDC 0472-0803-04
Storage Conditions
Store between 2° and 30°C (36° and 86°F).
Distributed by:
Actavis Mid Atlantic LLC
1877 Kawai Road
Lincolnton, NC 28092 USA
Manufactured by
DPT Laboratories, Ltd.
San Antonio, Texas 78215 USA
325097-0209 Revised: February 2009
Desonide Lotion 0.05% 4 fl oz - Front Label
Desonide Lotion 0.05% 4 fl oz - Back Label
Desonide Lotion 0.05% 2 fl oz - Front Label
Desonide Lotion 0.05% 2 fl oz - Back Label