DESONIDE
DESCRIPTION:
FOR DERMATOLOGIC USE ONLY-
NOT FOR OPHTHALMIC USE-
DESOWEN(R) Cream 0.05%, Ointment 0.05%, and Lotion 0.05% contain desonide
(Pregna-1,4-diene- 3,20-dione,11, 21-dihydroxy- 16,17-((1-
methylethylidene)bis(oxy))-,(11beta, 16alpha-) 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.
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 DESOWEN(R) Cream contains 0.5 mg of desonide in a base of purified
water, emulsifying wax, propylene glycol, stearic acid, isopropyl palmitate,
synthetic beeswax, polysorbate 60, potassium sorbate, sorbic acid, propyl
gallate, citric acid, and sodium hydroxide.
Each gram of DESOWEN(R) Ointment contains 0.5 mg of desonide in a base of
mineral oil and polyethylene.
Each gram of DESOWEN(R) Lotion 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 and purified water. May contain citric acid and/or sodium
hydroxide for pH adjustment.
ACTIONS/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 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.
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 DESOWEN(R) (desonide cream, ointment and lotion) Cream,
Ointment, and Lotion indicate that they are in the low to medium range of
potency as compared with other topical corticosteroids.
INDICATIONS AND USAGE:
DESOWEN(R) Cream, Ointment and Lotion are low to medium potency corticosteroids
indicated for the relief of the inflammatory and pruritic manifestations of
corticosteroid responsive dermatoses.
CONTRAINDICATIONS:
DESOWEN(R) Cream, Ointment and Lotion are 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, DESOWEN(R) Cream, Ointment or 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 DESOWEN (desonide cream, ointment and lotion) Cream, Ointment
or 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 OF FERTILITY: Long-term animal
studies have not been performed to evaluate the carcinogenic potential or the
effect on reproduction with the use of DESOWEN(R) Cream, Ointment, and Lotion.
PREGNANCY: Teratogenic Effects: Pregnancy Category C:
Corticosteroids have been shown to be teratogenic in laboratory animals when
administered systemically at relatively 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 DESOWEN(R)
Cream, Ointment or Lotion. It is also not known whether DESOWEN(R) Cream,
Ointment or Lotion can cause fetal harm when administered to a pregnant woman or
can affect reproduction capacity. DESOWEN(R) Cream, Ointment and 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 DESOWEN(R) Cream, Ointment or 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 DESOWEN(R) (desonide cream, ointment, and lotion) Cream,
Ointment and Lotion can be absorbed in sufficient amounts to produce systemic
effects (See PRECAUTIONS).
DOSAGE AND ADMINISTRATION:
DESOWEN(R) Cream, Ointment or 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.
DESOWEN(R) Cream, Ointment and Lotion should not be used with occlusive
dressings.
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