Drugs Details

Drugs Info of Delonide, Desonate, DesOwen, DesOwen 2 oz, DesOwen Lotion 4 oz Kit, LoKara, Tridesilon, Verdeso
Drugs Details
  • Drugs Type  : Multum
  • Date : 15th Jan 2015 10:38 pm
  • Brand Name : Delonide, Desonate, DesOwen, DesOwen 2 oz, DesOwen Lotion 4 oz Kit, LoKara, Tridesilon, Verdeso
  • Generic Name :  desonide topical (Pronunciation: DES oh nide)
Descriptions

Desonate contains 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. Chemically, desonide is C24H32O6. It has the following structural formula:

 

DESONATE® (desonide) Structural Formula Illustration

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 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 are the possible side effects of desonide topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing desonide topical through your skin, such as:

  • blurred vision, or seeing halos around lights;
  • mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face; or
  • muscle weakness, feeling tired.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Desonate »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Desonate 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 for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonate to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see WARNINGS AND PRECAUTIONS]. Treatment should not exceed 4 consecutive weeks [see DOSAGE AND ADMINISTRATION].

Dosage Administration

Apply a thin layer to the affected areas two times daily and rub in gently. Discontinue use 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. Do not use with occlusive dressings. Avoid contact with eyes or other mucous membranes.

For topical use only. Not for oral, ophthalmic, or intravaginal use.

How Supplied

Dosage Forms And Strengths

Gel, 0.05%; (0.5mg/g) desonide in a translucent to opaque gel

Storage And Handling

Desonate is a translucent to opaque gel supplied in 60g tubes in cartons containing 1x 60g tube (NDC 50419-828-06), or a 2 x 60g tube TwinPack (NDC 50419-828-12).

Storage

Store at 25°C (77°F); excursions permitted to15-30°C (59-86°F) [See USP Controlled Room Temperature].

Keep out of reach of children.

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981 Manufactured in Canada. Rev. 07/2014


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled clinical studies of 425 Desonate-treated subjects and 157 Vehicle-treated subjects, adverse events occurred at the application site in 3% of subjects treated with Desonate and the incidence rate was not higher compared with vehicle-treated subjects. The most common local adverse events in Desonate 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 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 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.

Read the Desonate (desonide gel) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Effects On Endocrine System

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

The effect of Desonate 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 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 [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Desonate due to their larger skin surface-to-body mass ratios [see Use In Specific Populations].

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Local Adverse Reactions With Topical Corticosteroids

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include skin atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

Concomitant Skin Infections

If concomitant skin infections are present or develop during treatment, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Desonate should be discontinued until the infection is adequately controlled.

Skin Irritation

If irritation develops, Desonate 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of desonide or its effect on fertility. In a 26-week dermal carcinogenicity study conducted in transgenic (Tg.AC) mice, once daily application of 0.005% to 0.05% Desonate Gel significantly increased the incidence of papillomas at the treatment site in males and females compared to their respective control animals. The clinical relevance of these findings in animals to humans is not clear.

Desonide revealed no evidence of mutagenic potential based on the results of an in vitro genotoxicity test (Ames assay) and an in vivo genotoxicity test (mouse micronucleus assay). Desonide was positive without S9 activation and was equivocal with S9 activation in an in vitro mammalian cell mutagenesis assay (L5178YITK+ mouse lymphoma assay). A dose response trend was not noted in this assay.

Use In Specific Populations

Pregnancy

Teratogenic effects

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Therefore, Desonate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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.

No reproductive studies in animals have been performed with Desonate. 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 is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Desonate in pediatric patients less than 3 months of age have not been evaluated, and therefore its use in this age group is not recommended.

The effect of Desonate on HPA axis function was investigated in pediatric subjects, with atopic dermatitis covering at least 35% of their body, who were treated with Desonate twice daily for 4 weeks. One of 37 subjects (3%) displayed adrenal suppression after 4 weeks of use, based on the cosyntropin stimulation test [see WARNINGS AND PRECAUTIONS].

In controlled clinical studies in subjects 3 months to 18 years of age, 425 subjects were treated with Desonate and 157 subjects were treated with vehicle [see ADVERSE REACTIONS and Clinical Studies].

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.

Geriatric Use

Clinical studies of Desonate 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.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

Topically applied Desonate can be absorbed in sufficient amounts to produce systemic effects [see WARNINGS AND PRECAUTIONS].

ContrainDications

Desonate is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

The mechanism of action of desonide is unknown.

Pharmacodynamics

In an HPA axis suppression study, one of 37 (3%) pediatric subjects, 6 months to 6 years old, with moderate to severe atopic dermatitis covering at least 35% body surface area who applied Desonate experienced suppression of the adrenal glands following 4 weeks of therapy [see WARNINGS AND PRECAUTIONS and Use In Specific Populations]. A follow-up evaluation of the subject's adrenal axis was not performed; it is unknown whether the suppression was reversible.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolized primarily in the liver and then are excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

Clinical Studies

In two randomized vehicle-controlled clinical studies, subjects 3 months to 18 years of age with mild to moderate atopic dermatitis were treated twice daily for 4 weeks with either Desonate or vehicle. 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. The results of the 2 clinical trials are summarized in Table 1:

Table 1: Subjects Achieving Treatment Success

Clinical Trial 1
Desonate
N = 289
Vehicle
N = 92
128 (44%) 13 (14%)
Clinical Trial 2
Desonate
N = 136
Vehicle
N = 65
38 (28%) 4 (6%)


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

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.
  • Unless directed by the physician, the treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive.
  • Unless directed by a physician, this medication should not be used on the underarm or groin areas of pediatric patients.
  • Parents of pediatric patients should be advised not to use Desonate in the treatment of diaper dermatitis. Desonate should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressing [see DOSAGE AND ADMINISTRATION].
  • Patients should report to their physician any signs of local adverse reactions.
  • Other corticosteroid-containing products should not be used with Desonate without first consulting with the physician.
  • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Delonide, Desonate, DesOwen, DesOwen 2 oz, DesOwen Lotion 4 oz Kit, LoKara, Tridesilon, Verdeso

Generic Name: desonide topical (Pronunciation: DES oh nide)

  • What is desonide topical (Desonate)?
  • What are the possible side effects of desonide topical?
  • What is the most important information I should know about desonide topical?
  • What should I discuss with my healthcare provider before using desonide topical?
  • How should I use desonide topical?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using desonide topical?
  • What other drugs will affect desonide topical?
  • Where can I get more information?

What is desonide topical (Desonate)?

Desonide is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Desonide topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Desonide topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of desonide topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing desonide topical through your skin, such as:

  • blurred vision, or seeing halos around lights;
  • mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face; or
  • muscle weakness, feeling tired.

Less serious side effects may include:

  • mild skin itching, redness, burning, or peeling;
  • dryness or scaly skin;
  • thinning or softening of your skin;
  • skin rash or irritation around your mouth;
  • swollen hair follicles;
  • changes in color of treated skin;
  • blisters, pimples, or crusting of treated skin; or
  • stretch marks.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Desonate (desonide gel) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about desonide topical?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with desonide topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve after 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

Side Effects Centers
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  • Desonate
  • Verdeso
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Patient Detailed How Take

What should I discuss with my healthcare provider before using desonide topical?

Do not use this medication if you are allergic to desonide.

Before using desonide topical, tell your doctor if you are allergic to any drugs, or if you have any type of skin infection.

Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether desonide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

How should I use desonide topical?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Wash your hands before and after using desonide topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount to the affected area and rub it gently into the skin. Do not use this medication over a large area of skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with desonide topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Contact your doctor if your condition does not improve after 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection. It is important to use desonide topical regularly to get the most benefit.

To be sure this medication is not causing harmful effects with long-term use, you may need blood tests. Do not miss any scheduled appointments.

Store desonide topical at room temperature away from moisture and heat. Keep from freezing.

Side Effects Centers
  • DesOwen
  • Desonate
  • Verdeso
  • LoKara

Patient Detailed Avoid Taking

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of desonide is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using desonide topical?

Desonide topical should not be used to treat any skin condition your doctor has not prescribed it for.

Avoid getting this medication in your eyes. If contact does occur, rinse with water. Do not use desonide topical on broken or infected skin. Also avoid using this medication in open wounds.

What other drugs will affect desonide topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied desonide topical. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about desonide topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 7.02. Revision date: 12/15/2010.

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