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| Product NDC Code | 0299-5770 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Desowen |
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| Type | Brand | ||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 197572, 205529, 205534, 349351 |
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| Application Number | NDA019048 | ||||||
| Labeler Name | Galderma Laboratories, L.P. | ||||||
| Packages |
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Overdosage of DesOwen
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE: Topically applied DesOwen ® (desonide cream and lotion) Cream and Lotion can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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 DesOwen ® (desonide cream and lotion) Cream and Lotion indicate that they are in the low to medium range of potency as compared with other topical corticosteroids.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.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 ® (desonide cream and lotion) Cream and Lotion indicate that they are in the low to medium range of potency as compared with other topical corticosteroids.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS: DesOwen ® Cream and Lotion are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION: DesOwen ® Cream 0.05% and Lotion 0.05% contain 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 C 24 H 32 O 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 DesOwen ® Cream contains 0.5 mg of desonide in a base of citric acid, emulsifying wax, isopropyl palmitate, polysorbate 60, potassium sorbate, propyl gallate, propylene glycol, purified water, sodium hydroxide, sorbic acid, stearic acid, and synthetic beeswax. Each gram of DesOwen ® 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. desowen-structure-01
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION: DesOwen ® Cream 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 ® Cream and Lotion should not be used with occlusive dressings.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE: DesOwen ® Cream and Lotion are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Spl product data elements
Usually a list of ingredients in a drug product.DesOwen desonide Desonide Desonide ANHYDROUS CITRIC ACID Isopropyl palmitate Polysorbate 60 Potassium sorbate Propyl gallate Propylene glycol Water Sodium hydroxide Sorbic Acid Stearic Acid DesOwen desonide Desonide Desonide Cetyl alcohol Edetate sodium Glyceryl Monostearate Light Mineral Oil Methylparaben Propylene glycol Propylparaben Water Sodium lauryl sulfate Sorbitan monostearate Stearyl alcohol ANHYDROUS CITRIC ACID Sodium hydroxide P53307-0-deswoen-cream-carton-image P53311-0-desowen-lotion-carton-image
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.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 DesOwen ® Cream and Lotion.
Laboratory tests
Information on laboratory tests helpful in following the patient’s response to the drug or in identifying possible adverse reactions. If appropriate, information may be provided on such factors as the range of normal and abnormal values expected in the particular situation and the recommended frequency with which tests should be performed before, during, and after therapy.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
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL - Desowen Cream NDC 0299-5770-60 Rx Only For Topical Use Only. Not for Ophthalmic Use. DesOwen ® (desonide cream) Cream 0.05% NET WT. 60 g GALDERMA Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA All trademarks are the property of their respective owners. Made in Canada P53307-0 Store between 2° and 30°C (35° and 86°F). Usual dosage: Apply a small amount to affected areas 2 or 3 times daily. See package insert for complete prescribing information. Each gram contains 0.5 mg of the active ingredient desonide in a cream base consisting of the inactive ingredients citric acid, emulsifying wax, isopropyl palmitate, polysorbate 60, potassium sorbate, propyl gallate, propylene glycol, purified water, sodium hydroxide, sorbic acid, stearic acid and synthetic beeswax. See carton closure for lot number and expiration date.
PACKAGE Label - Desown Lotion Rx Only NDC 0299-5765-04 DesOwen® (desonide lotion) LOTION 0.05% 4 FL OZ (118 mL) For Topical Use Only. Not for ophthalmic Use GALDERMA SHAKE WELL BEFORE USING. Usual dosage: Apply a small amount to affected areas 2 or 3 times daily. See package insert for complete prescribing information. Contains: Active: desonide 0.05% w/w (0.5 mg/g). Inactive: 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. Lot number and expiration date on bottom of carton. STORE BETWEEN 2° AND 30° C (36° AND 86°F) Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA Made in Canada. All trademarks are the property of their respective owners. P53311-0
DesOwen: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.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.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.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 ® Cream or Lotion is administered to a nursing woman.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.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.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)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® Cream or Lotion. It is also not known whether DesOwen® Cream or Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DesOwen® Cream and Lotion should be given to a pregnant woman only if clearly needed.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED: DesOwen ® (desonide cream) Cream 0.05% is supplied in a tube containing: 60 g NDC 0299-5770-60 15 g NDC 0299-5770-15 DesOwen ® (desonide lotion) Lotion 0.05% is supplied in bottles containing: 2 fl oz NDC 0299-5765-02 4 fl oz NDC 0299-5765-04 Storage Conditions: Store between 2° and 30°C (36° and 86°F). Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177, USA All trademarks are the property of their respective owners. Made in Canada P53306-0 Revised: April 2017
General precautions
Information about any special care to be exercised for safe and effective use of the drug.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 ® Cream 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 and lotion) Cream or Lotion should be discontinued until the infection has been adequately controlled.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.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 ® Cream 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 and lotion) Cream 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: 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 DesOwen ® Cream 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® Cream or Lotion. It is also not known whether DesOwen® Cream or Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DesOwen® Cream 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 ® Cream 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API