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Desonate
Overview
What is Desonate?
Desonate Gel contains desonide (pregna-1,4-diene-3, 20-dione,11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-, (11ß,16α)- a synthetic nonfluorinated corticosteroid for topical dermatologic use. Chemically, desonide is CHO. It has the following structural formula:
Desonide has the molecular weight of 416.52. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water.
Each gram of Desonate Gel contains 0.5 mg of desonide in an aqueous gel base of purified water, glycerin, propylene glycol, edetate disodium dihydrate, methylparaben, propylparaben, sodium hydroxide, and Carbopol 981.
What does Desonate look like?
What are the available doses of Desonate?
Sorry No records found.
What should I talk to my health care provider before I take Desonate?
Sorry No records found
How should I use Desonate?
Desonate Gel is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Patients should be instructed to use Desonate Gel for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonate Gel to suppress the hypothalamic-pituitary-adrenal (HPA) axis (see). Treatment should not exceed 4 consecutive weeks.
Desonate Gel should be applied as a thin layer to the affected areas two times daily and rubbed in gently. Therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended.
Desonate Gel should not be used with occlusive dressings.
What interacts with Desonate?
Desonate Gel is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
What are the warnings of Desonate?
Sorry No Records found
What are the precautions of Desonate?
General
The safety of Desonate Gel has not been established beyond 4 weeks of use.
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.
Conditions which augment systemic absorption include the application of topical corticosteroids, over large body surface areas, prolonged use, or the addition of occlusive dressings. Therefore, patients applying a topical corticosteroid to a large body surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression (see).
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.
The effect of Desonate Gel on HPA axis function was investigated in pediatric subjects, 6 months to 6 years old, with atopic dermatitis covering at least 35% of their body, who were treated with Desonate Gel twice daily for 4 weeks. One of 37 subjects (3%) displayed adrenal suppression after 4 weeks of use, based on the cosyntropin stimulation test. As follow-up evaluation of the subject’s adrenal axis was not performed, it is unknown whether the suppression was reversible.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see).
If irritation develops, Desonate Gel should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing 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 Desonate Gel should be discontinued until the infection has been adequately controlled.
Information for Patients
Patients using topical corticosteroids should receive the following information and instructions:
Laboratory Tests
The cosyntropin (ACTH) stimulation test may be helpful in evaluating patients for HPA axis suppression.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic or photoco-carcinogenic potential of Desonate Gel or the effect on fertility of desonide.
Desonide revealed no evidence of mutagenic potential based on the results of an genotoxicity test (Ames assay) and an genotoxicity test (mouse micronucleus assay). Desonide was positive without S9 activation and was equivocal with S9 activation in an mammalian cell mutagenesis assay (L5178Y/TK mouse lymphoma assay). A dose response trend was not noted in this assay.
Pregnancy
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.
There are no adequate and well-controlled studies in pregnant women. Therefore, Desonate Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
No reproductive studies in animals have been performed with Desonate Gel. Dermal embryofetal development studies were conducted in rats and rabbits with a desonide cream, 0.05% formulation. Topical doses of 0.2, 0.6, and 2.0 g cream/kg/day of a desonide cream, 0.05% formulation or 2.0 g/kg of the cream base were administered topically to pregnant rats (gestational days 6-15) and pregnant rabbits (gestational days 6 18). Maternal body weight loss was noted at all dose levels of the desonide cream, 0.05% formulation in rats and rabbits. Teratogenic effects characteristic of corticosteroids were noted in both species. The desonide cream, 0.05% formulation was teratogenic in rats at topical doses of 0.6 and 2.0 g cream/kg/day and in rabbits at a topical dose of 2.0 g cream/kg/day. No teratogenic effects were noted for the desonide cream, 0.05% formulation at a topical dose of 0.2 g cream/kg/day in rats and 0.6 g cream/kg/day in rabbits. These doses (0.2 g cream/kg/day and 0.6 g cream/kg/day) are similar to the maximum recommended human dose based on body surface area comparisons.
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 Desonate Gel is administered to a nursing woman.
Pediatric Use
Safety and effectiveness of Desonate Gel in pediatric patients less than 3 months of age have not been evaluated, and therefore its use in this age group is not recommended.
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.
The effect of Desonate Gel on HPA axis function was investigated in pediatric subjects, 6 months to 6 years old, with atopic dermatitis covering at least 35% of their body, who were treated with Desonate Gel twice daily for 4 weeks. One of 37 subjects (3%) displayed adrenal suppression after 4 weeks of use based on the cosyntropin stimulation test. As follow-up evaluation of the subject’s adrenal axis was not performed; it is unknown whether the suppression was reversible.
Geriatric Use
Clinical studies of Desonate Gel did not include patients aged 65 and older to determine if they respond differently than younger patients. Treatment of this patient population should reflect the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
What are the side effects of Desonate?
In controlled clinical studies of 425 Desonate Gel treated subjects and 157 Vehicle-treated subjects, adverse events occurred at the application site in 3% of subjects treated with Desonate Gel and the incidence rate was not higher compared with vehicle-treated subjects. The most common local adverse events in Desonate Gel- treated subjects were application site burning in 1% (4/425) and rash in 1% (3/425) followed by application site pruritus in <1% (2/425) .
Adverse events that resulted in premature discontinuation of study drug in Desonate Gel treated subjects were telangiectasia and worsening of atopic dermatitis in one subject each. Additional adverse events observed during clinical trials for patients treated with Desonate Gel included headache in 2% (8/425) compared with 1% (2/157) in those treated with vehicle.
The following additional local adverse reactions have been reported infrequently with topical corticosteroids. 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.
What should I look out for while using Desonate?
Desonate Gel is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
What might happen if I take too much Desonate?
Topically applied Desonate Gel can be absorbed in sufficient amounts to produce systemic effects (See).
How should I store and handle Desonate?
Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Desonate Gel is supplied in:3.5g Sample-Not for Sale (NDC 67402-050-03)60g (NDC 67402-050-60) tubesSTORAGE CONDITIONS: Avoid contact with eyes or other mucous membranesKeep out of reach of childrenCAUTION: Federal law prohibits dispensing without a prescription.________________________________________________________________________Manufactured by:CPL,Buffalo, New York 14213Distributed by:SkinMedicaCarlsbad, CA 92010866-867-0110; www.skinmedica.comThe Hydrogel Technology logo is a trademark of Dow Pharmaceutical Sciences, Inc.Desonate is a trademark of SkinMedica.03-6083 (flat)03-6082 (folded)10/2006Desonate Gel is supplied in:3.5g Sample-Not for Sale (NDC 67402-050-03)60g (NDC 67402-050-60) tubesSTORAGE CONDITIONS: Avoid contact with eyes or other mucous membranesKeep out of reach of childrenCAUTION: Federal law prohibits dispensing without a prescription.________________________________________________________________________Manufactured by:CPL,Buffalo, New York 14213Distributed by:SkinMedicaCarlsbad, CA 92010866-867-0110; www.skinmedica.comThe Hydrogel Technology logo is a trademark of Dow Pharmaceutical Sciences, Inc.Desonate is a trademark of SkinMedica.03-6083 (flat)03-6082 (folded)10/2006Desonate Gel is supplied in:3.5g Sample-Not for Sale (NDC 67402-050-03)60g (NDC 67402-050-60) tubesSTORAGE CONDITIONS: Avoid contact with eyes or other mucous membranesKeep out of reach of childrenCAUTION: Federal law prohibits dispensing without a prescription.________________________________________________________________________Manufactured by:CPL,Buffalo, New York 14213Distributed by:SkinMedicaCarlsbad, CA 92010866-867-0110; www.skinmedica.comThe Hydrogel Technology logo is a trademark of Dow Pharmaceutical Sciences, Inc.Desonate is a trademark of SkinMedica.03-6083 (flat)03-6082 (folded)10/2006Desonate Gel is supplied in:3.5g Sample-Not for Sale (NDC 67402-050-03)60g (NDC 67402-050-60) tubesSTORAGE CONDITIONS: Avoid contact with eyes or other mucous membranesKeep out of reach of childrenCAUTION: Federal law prohibits dispensing without a prescription.________________________________________________________________________Manufactured by:CPL,Buffalo, New York 14213Distributed by:SkinMedicaCarlsbad, CA 92010866-867-0110; www.skinmedica.comThe Hydrogel Technology logo is a trademark of Dow Pharmaceutical Sciences, Inc.Desonate is a trademark of SkinMedica.03-6083 (flat)03-6082 (folded)10/2006Desonate Gel is supplied in:3.5g Sample-Not for Sale (NDC 67402-050-03)60g (NDC 67402-050-60) tubesSTORAGE CONDITIONS: Avoid contact with eyes or other mucous membranesKeep out of reach of childrenCAUTION: Federal law prohibits dispensing without a prescription.________________________________________________________________________Manufactured by:CPL,Buffalo, New York 14213Distributed by:SkinMedicaCarlsbad, CA 92010866-867-0110; www.skinmedica.comThe Hydrogel Technology logo is a trademark of Dow Pharmaceutical Sciences, Inc.Desonate is a trademark of SkinMedica.03-6083 (flat)03-6082 (folded)10/2006Desonate Gel is supplied in:3.5g Sample-Not for Sale (NDC 67402-050-03)60g (NDC 67402-050-60) tubesSTORAGE CONDITIONS: Avoid contact with eyes or other mucous membranesKeep out of reach of childrenCAUTION: Federal law prohibits dispensing without a prescription.________________________________________________________________________Manufactured by:CPL,Buffalo, New York 14213Distributed by:SkinMedicaCarlsbad, CA 92010866-867-0110; www.skinmedica.comThe Hydrogel Technology logo is a trademark of Dow Pharmaceutical Sciences, Inc.Desonate is a trademark of SkinMedica.03-6083 (flat)03-6082 (folded)10/2006Desonate Gel is supplied in:3.5g Sample-Not for Sale (NDC 67402-050-03)60g (NDC 67402-050-60) tubesSTORAGE CONDITIONS: Avoid contact with eyes or other mucous membranesKeep out of reach of childrenCAUTION: Federal law prohibits dispensing without a prescription.________________________________________________________________________Manufactured by:CPL,Buffalo, New York 14213Distributed by:SkinMedicaCarlsbad, CA 92010866-867-0110; www.skinmedica.comThe Hydrogel Technology logo is a trademark of Dow Pharmaceutical Sciences, Inc.Desonate is a trademark of SkinMedica.03-6083 (flat)03-6082 (folded)10/2006Desonate Gel is supplied in:3.5g Sample-Not for Sale (NDC 67402-050-03)60g (NDC 67402-050-60) tubesSTORAGE CONDITIONS: Avoid contact with eyes or other mucous membranesKeep out of reach of childrenCAUTION: Federal law prohibits dispensing without a prescription.________________________________________________________________________Manufactured by:CPL,Buffalo, New York 14213Distributed by:SkinMedicaCarlsbad, CA 92010866-867-0110; www.skinmedica.comThe Hydrogel Technology logo is a trademark of Dow Pharmaceutical Sciences, Inc.Desonate is a trademark of SkinMedica.03-6083 (flat)03-6082 (folded)10/2006Desonate Gel is supplied in:3.5g Sample-Not for Sale (NDC 67402-050-03)60g (NDC 67402-050-60) tubesSTORAGE CONDITIONS: Avoid contact with eyes or other mucous membranesKeep out of reach of childrenCAUTION: Federal law prohibits dispensing without a prescription.________________________________________________________________________Manufactured by:CPL,Buffalo, New York 14213Distributed by:SkinMedicaCarlsbad, CA 92010866-867-0110; www.skinmedica.comThe Hydrogel Technology logo is a trademark of Dow Pharmaceutical Sciences, Inc.Desonate is a trademark of SkinMedica.03-6083 (flat)03-6082 (folded)10/2006
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Topical corticosteroids share 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 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.
Non-Clinical Toxicology
Desonate Gel is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.The safety of Desonate Gel has not been established beyond 4 weeks of use.
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.
Conditions which augment systemic absorption include the application of topical corticosteroids, over large body surface areas, prolonged use, or the addition of occlusive dressings. Therefore, patients applying a topical corticosteroid to a large body surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression (see).
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.
The effect of Desonate Gel on HPA axis function was investigated in pediatric subjects, 6 months to 6 years old, with atopic dermatitis covering at least 35% of their body, who were treated with Desonate Gel twice daily for 4 weeks. One of 37 subjects (3%) displayed adrenal suppression after 4 weeks of use, based on the cosyntropin stimulation test. As follow-up evaluation of the subject’s adrenal axis was not performed, it is unknown whether the suppression was reversible.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see).
If irritation develops, Desonate Gel should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing 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 Desonate Gel should be discontinued until the infection has been adequately controlled.
In controlled clinical studies of 425 Desonate Gel treated subjects and 157 Vehicle-treated subjects, adverse events occurred at the application site in 3% of subjects treated with Desonate Gel and the incidence rate was not higher compared with vehicle-treated subjects. The most common local adverse events in Desonate Gel- treated subjects were application site burning in 1% (4/425) and rash in 1% (3/425) followed by application site pruritus in <1% (2/425) .
Adverse events that resulted in premature discontinuation of study drug in Desonate Gel treated subjects were telangiectasia and worsening of atopic dermatitis in one subject each. Additional adverse events observed during clinical trials for patients treated with Desonate Gel included headache in 2% (8/425) compared with 1% (2/157) in those treated with vehicle.
The following additional local adverse reactions have been reported infrequently with topical corticosteroids. 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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