Desonide

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    DESONIDE TOPICAL
                        USP 0.05%
                                                                                                             By:Zeeshan Dawood
                                                                                                                  Pharmacist

Available Dosage Forms: Cream , Ointment & Lotion

Indications: Mild to moderate steroid responsive dermatosis including:

1-Dermal Drug Eruptions

2-Infantile Dermatosis

3-Atopic Dermatitis

4-Contact Dermatitis

5-seborrheic dermatoses

6-Psoriasis

7- Skin Rash

               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

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, LoKara™ Lotion (desonide lotion 0.05%) 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 LoKara™ Lotion (desonide lotion 0.05%) should be discontinued until the infection has been adequately controlled.

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions:

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. This medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician. 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, 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 desonide 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 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. LoKara™ Lotion (desonide lotion 0.05%) 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 LoKara™ Lotion (desonide lotion 0.05%) 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 effects:

Adverse events associated with the use of Desonide Topical may include, but are not limited to , the following:

1-Upper respiratory tract infection Cough 2-Application site burning 3-Application site reaction 4-Viral infection 5-Irritability 6-Asthma

Frequency Of Adminstration:

Patients apply desonide two or three times a day. Systemic absorption occurs, so continuous treatment is limited to a maximum of eight weeks.

Clinical Results FDA Approval

FDA approval of Desonate was based on the results of two clinical trials. These multi-center, randomized, double-blind, placebo-controlled studies enrolled a combined 582 pediatric patients (ages 3 months to 18 years), who received topical administration of the drug or placebo (vehicle gel) twice daily for 4 weeks. Treatment success was defined as achieving clear or almost clear on the Investigator’s Global Severity Score (IGSS) with at least a 2 point change (decrease) from the subject’s baseline IGSS when compared to the Week 4 IGSS. Results revealed that in clinical trial 1, treatment success was achieved by 44% of the subjects treated with Desonate versus 14% of the subjects treated with placebo. In clinical trial 2, success was achieved by 28% of the subjects treated with Desonate versus 6% of the subjects treated with placebo.

Drug-Disease Contraindications

Possibly Significant

Administration Site Infection, Adrenocortical Insufficiency, Peripheral Vascular Disease, Skin Atrophy, Telangiectasia

References:

1- American journal Of Dermtology July 1995 Vol-1 number33 page74-77(Study) 2- Pediatr dermatol 2007 May-jun;289-95(INFANTS) 3- Tolerance)> J drugs dermatol 2007 Feb;6(20:175-81 4- Br med j2000;321:1-7 5- Novel Addition(J Am Acad Dermatol feb 2007 P718:AB 72 6- J Am Acad Dermatol march 2005,p- 61.