Drugs Details

Drugs Info of Delonide, Desonate, DesOwen, DesOwen 2 oz, DesOwen Lotion 4 oz Kit, LoKara, Tridesilon, Verdeso
Drugs Details
  • Drugs Type  : FDA
  • Date : 27th Jun 2015 05:45 am
  • 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

VERDESO (desonide) Foam, 0.05% is a white to off-white petrolatum-based emulsion aerosol foam containing the active ingredient desonide, a low-potency topical corticosteroid.

Chemically, desonide is (11β,16α)-11,21-dihydroxy-16,17-[(1-methylethylidene)- bis(oxy)]-pregna-1,4-diene-3,20-dione.

The structural formula of desonide is represented below:

 

VERDESO (desonide) Structural Formula Illustration

 

Desonide has a molecular formula of C24H32O6 and a molecular weight of 416.51. Desonide is a white powder or crystal that is practically insoluble in water, sparingly soluble in ethanol and in acetone, and soluble in chloroform. Each gram of VERDESO Foam contains 0.5 mg desonide. The foam also contains anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, potassium citrate (monohydrate), propylene glycol, purified water, sorbitan monolaurate, and phenoxyethanol as a preservative.

VERDESO Foam is dispensed from an aluminum can pressurized with ahydrocarbon (propane/butane) propellant.

 

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 Verdeso »

What are the precautions when taking desonide foam (Verdeso)?

Before using desonide, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Do not use if there is an infection or sore in the area to be treated.

Children may be more sensitive to the effects of too much corticosteroid medication. Consult your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug...

Read All Potential Precautions of Verdeso »

Indications

VERDESO® (desonide) Foam, 0.05% 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 VERDESO Foam for the minimum amount of time necessary to achieve the desired results because of the potential for VERDESO Foam to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Treatment should not exceed 4 consecutive weeks.

Dosage Administration

VERDESO Foam is not for oral, ophthalmic, or intravaginal use.

A thin layer of VERDESO Foam should be applied to the affected area(s) twice daily. Shake the can before use. VERDESO Foam should be dispensed by inverting the can (upright actuation will cause loss of the propellant which may affect product delivery). Dispense the smallest amount of foam necessary to adequately cover the affected area(s) with a thin layer.

The medication should not be dispensed directly on the face. Dispense in hands and gently massage into affected areas of the face until the medication disappears. For areas other than the face, the medication may be dispensed directly onto the affected area. Take care to avoid contact with the eyes or other mucous membranes.

Patients should dispense the smallest amount of foam necessary to adequately cover the affected area with a thin layer. Therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. The safety and efficacy of VERDESO Foam has not been established beyond 4 weeks of use. Treatment should not exceed 4 consecutive weeks.

Unless directed by a physician, VERDESO Foam should not be used with occlusive dressings.

How Supplied

Dosage Forms And Strengths

Foam, 0.05%. Each gram of VERDESO Foam contains 0.5 mg of desonide in a white to off-white petrolatum-based emulsion aerosol foam.

VERDESO Foam is a white to off-white aerosol foam supplied in 100-g (NDC63032- 111-00) and 50-g (NDC 63032-111-50) aluminum cans.

Storage and Handling

Store at USP controlled room temperature 68°F to 77°F (20°C to 25°C) with excursions permitted between 15°C (59°F) and 30°C (86°F).

WARNING: FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION.

Contents under pressure. Do not puncture or incinerate. Do not expose containers to heat, and/or store at temperatures above 120oF (49oC).

Avoid contact with eyes or other mucous membranes.

Keep out of reach of children.

Manufactured for: Stiefel Laboratories, Inc., Research Triangle Park, NC 27709. Revised: 04/2013

Side Effects

Clinical Trial Experience

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 clinical practice.

In a controlled clinical trial of 581 subjects aged 3 months to 17 years, adverse reactions occurred at the application site in 6% of subjects treated with VERDESO Foam and 14% of subjects treated with vehicle foam. Other commonly reported adverse reactions for VERDESO Foam and vehicle foam are noted in Table 1.

Table 1: Adverse Reactions in the Clinical Trial

ADVERSE REACTION VERDESO FOAM 
(N = 387)
VEHICLE FOAM 
(N = 194)
Upper respiratory tract infection 37 (10%) 12 (6%)
Cough 14 (4%) 3 (2%)
Application site burning 11 (3%) 15 (8%)
Viral infection 6 (2%) 0 (0%)
Elevated blood pressure 6 (2%) 1 (1%)
Headache 7 (2%) 1 (1%)
Asthma 3 (1%) 0 (0%)
Irritability 2 (1%) 0 (0%)
Pharyngitis 2 (1%) 0 (0%)
Application site atrophy 5 (1%) 0 (0%)
Application site reactions (including atrophy, striae, telangiectasia, and pigmentation changes) 3 (1%) 6 (3%)

 

Other local adverse events occurred at rates less than 1.0%. The majority of adverse reactions were transient and mild to moderate in severity, and they were not affected by age, race, or gender.

The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been identified during post-approval use of VERDESO Foam: application site irritation, application site erythema, application site reactions, skin reactions, and swelling face.

Interactions

No information provided.

Warnings

Included as part of the PRECAUTIONS section.

 

Precautions

Hypothalamic-Pituitary-Adrenal Axis Suppression

VERDESO Foam has been shown to reversibly suppress the HPA axis.

Topical application of VERDESO Foam may result in systemic absorption and effects including HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, facial swelling, glycosuria, withdrawal, and growth retardation in children. Use of VERDESO Foam for longer than 4 weeks may suppress the immune system [see Nonclinical Toxicology].

Conditions that augment systemic absorption include the application of topical corticosteroids over large body surface areas, prolonged use, or the addition of occlusive dressings. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.

An adrenocorticotropic hormone (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.

The effect of VERDESO Foam on HPA axis function was investigated in pediatric subjects in one trial. In this trial, subjects with atopic dermatitiscovering at least 25% of their body applied VERDESO Foam twice daily for 4 weeks. Three out of 75 subjects (4%) displayed adrenal suppression after 4 weeks of use based on the cosyntropin stimulation test. The laboratory suppression was transient; all subjects had returned to normal when tested 4 weeks posttreatment.

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

Concomitant therapy with topical corticosteroids should be used with caution because a cumulative effect may occur.

Skin Irritation

VERDESO Foam may cause local skin adverse reactions [see ADVERSE REACTIONS]. If irritation develops, VERDESO Foam should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.

Concomitant Skin Infections

If concomitant skin infections are present or develop, the use of an appropriate antifungal, antibacterial, or antiviral agent should be instituted. If a favorable response does not occur promptly, use of VERDESO Foam should be discontinued until the infection has been adequately controlled.

Flammable Contents

The contents of VERDESO Foam include alcohol and propane/butane, which are flammable. Avoid fire, flame, and/or smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).

Laboratory Tests

The cosyntropin (ACTH1-24) stimulation test may be helpful in evaluating patients for HPA axis suppression.

Patient Counseling Information

See FDA-Approved Patient Labeling (PATIENT INFORMATION)

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 or other mucous membranes. The medication should not be dispensed directly onto the face. Dispense in hands and gently massage into affected areas of the face until the medication disappears. For areas other than the face, the medication may be dispensed directly on the affected area. Wash hands after use.
  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, otherwise covered, or wrapped so as to be occlusive unless directed by the physician.
  4. Patients should report any signs of local or systemic adverse reactions to the physician.
  5. Patients should inform their physicians that they are using VERDESO Foam if surgery is contemplated.
  6. Therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.
  7. Do not use other corticosteroid-containing products while using VERDESO Foam without first consulting your physician.
  8. The propellant in VERDESO Foam is flammable. Avoid fire, flame, or smoking during and immediately following application.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate thecarcinogenic potential of VERDESO Foam or desonide. The effects of desonide on fertility have not been evaluated. In a 90-day repeat-dose toxicity study in rats, topical administration of VERDESO Foam at dose concentrations from 0.025% to 0.125% or from 0.075 to 0.375 mg/kg/day of desonide resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organs systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustainedglucocorticoid-related immune suppression may increase the risk of infection and possibly the risk for carcinogenesis.

Topical doses of 0% (foam vehicle), 0.025%, 0.05%, and 0.125% desonide foam were evaluated in a 52-week dermal photocarcinogenicity study (40 weeks of treatment followed by 12 weeks of observation) conducted in albinohairless mice with concurrent exposure to low level ultraviolet radiation. Topical treatment with increasing concentrations of desonide foam did not have an adverse effect in this study. The results of this study suggest that topical treatment with VERDESO Foam did not enhance photocarcinogenicity.

Desonide revealed no evidence of mutagenic potential based on the results of two in vitro genotoxicity tests (Ames assay, mouse lymphoma cell assay) and an in vivo genotoxicity test (mouse micronucleus assay).

Use In Specific Populations

Pregnancy

Teratogenic Effects - Pregnancy Category C

There are no adequate and well-controlled studies of VERDESO Foam in pregnant women. Therefore, VERDESO Foam 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 long-term reproductive studies in animals have been performed with VERDESO Foam. 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 to 15) and pregnant rabbits (gestational days 6 to 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 at a topical dose of 0.6 g cream/kg/day in rabbits. These doses (0.2 g cream/kg/day in rats and 0.6 g cream/kg/day in rabbits) 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 VERDESO Foam is administered to a nursing woman.

If used during lactation, VERDESO Foam should not be applied on the chest to avoid accidental ingestion by the infant.

Pediatric Use

Safety and efficacy in pediatric patients younger than 3 months have not been established; therefore, the use of VERDESO Foam 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 and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of 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 an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

The effect of VERDESO Foam on HPA axis function was investigated in pediatric subjects aged 6 months to 17 years in one trial. In this trial, subjects with atopic dermatitis covering at least 25% of their body applied VERDESO Foam twice daily for 4 weeks. Three out of 75 subjects (4%) displayed adrenal suppression after 4 weeks of use based on the ACTH stimulation test. The suppression was transient; all subjects' cortisol levels had returned to normal when tested 4 weeks posttreatment.

Geriatric Use

Clinical trials of VERDESO Foam did not include any subjects aged 65 or over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

OverDose

Topically applied VERDESO Foam can be absorbed in sufficient amounts to produce systemic effects.

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 and Cushing's syndrome when they are treated with topical corticosteroids.

ContrainDications

None.

Clinical Pharamacology

Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in the treatment of atopic dermatitis is unknown.

The contribution to efficacy by individual components of the vehicle has not been established.

Pharmacodynamics

In an HPA axis suppression trial, three of 75 (4%) pediatric subjects with mild to moderate atopic dermatitis covering at least 25% body surface area, who applied VERDESO Foam twice daily, experienced reversible suppression of the adrenal glands (as indicated by a 30- minute post-stimulation cortisollevel ≤ 18 mcg/dL) following 4 weeks of therapy. [See WARNINGS ANDPRECAUTIONS and Pediatric Use].

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation, the integrity of the epidermal barrier, and age. 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 are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

Clinical Studies

In a double-blind, randomized trial of 581 subjects aged 3 months to 17 years, with mild to moderate atopic dermatitis, VERDESO Foam was applied twice daily for 4 weeks. Success was defined as the proportion of subjects who had all of the following: an Investigator's Static Global Assessment (ISGA) score of clear or almost clear, a minimum improvement in the 5- point ISGA score of 2 grades from Baseline to Week 4, and a score of absent or minimal for both erythema and induration/papulation at Week 4. The results of this trial are presented in the following table.

Table 2: Results of Clinical Trial in Subjects Aged 3 Months to 17 Years With Mild to Moderate Atopic Dermatitis

  VERDESO FOAM VEHICLE FOAM
Number of Subjects 387 194
Subjects Achieving Success 152 (39%) 18 (9%)

Patient Information

VERDESO® 
(ver-DES-o)
(desonide) Foam 0.05%

Read the Patient Information that comes with VERDESO Foam before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What is VERDESO Foam?

VERDESO Foam is a prescription medicine used on the skin (topical) to treat mild or moderate atopic dermatitis in people 3 months of age and older.

It is not known if VERDESO Foam is safe and effective when used for longer than 4 weeks in a row. You should not use VERDESO Foam for more than 4 weeks in a row without talking with your doctor.

It is not known if VERDESO Foam is safe and effective in children younger than 3 months of age.

What should I tell my doctor before using VERDESO Foam?

Before using VERDESO Foam, tell your doctor if you:

  • have a skin infection that is not healing.
  • have had irritation or other skin reaction to a steroid medicine in the past.
  • plan to have surgery.
  • are pregnant or plan to become pregnant. It is not known if VERDESO Foam will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if VERDESO Foam passes into your breast milk. If you use VERDESO Foam while breastfeeding, do not apply it to your chest area. This will help prevent your baby from swallowing VERDESO Foam.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you use another medicine on your skin for your atopic dermatitis.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use VERDESO Foam?

  • Use VERDESO Foam exactly as prescribed. Do not use more VERDESO Foam than is needed to cover the affected areas.
  • Do not get VERDESO Foam in your eyes, mouth, or vagina.
  • VERDESO Foam is usually applied to the affected skin areas 2 times each day.
  • Talk to your doctor if your skin does not improve after using VERDESO Foam for 4 weeks.
  • You should not use VERDESO Foam for more than 4 weeks in a row without talking with your doctor.
  • VERDESO Foam contains alcohol. Alcohol-based products are flammable. Avoid fire, flames, or smoking while applying VERDESO Foam to your skin and right after you apply it.

Applying VERDESO Foam.

  1. Before applying VERDESO Foam for the first time, break the tiny plastic seal at the base of the nozzle by gently pushing it back away from the seal. Shake the can before use. Remove the cap.
  2. Turn the can upside down. Depress the button to dispense a small amount of VERDESO Foam into the palm of your hand or directly onto the affected skin area. Do not apply VERDESO Foam directly to your face. Use the smallest amount of VERDESO Foam needed to cover the affected areas with a thin layer.
  3. Gently massage the VERDESO Foam into the affected areas until it disappears. Avoid getting the medicine in your eyes.
  4. Do not apply directly on the face. Place in hands and gently massage affected areas of face. Take care to avoid eyes and lips. Remember to wash hands after use.
  5. Do not apply a bandage over VERDESO Foam unless your doctor tells you to.

What are the possible side effects of VERDESO Foam?

Common side effects of VERDESO Foam include:

  • upper respiratory tract infection
  • burning where you apply VERDESO Foam
  • cough
  • headache
  • increased blood pressure

Tell your doctor if you have any side effects that bother you or that do not go away.

These are not all the possible side effects of VERDESO Foam. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or to Stiefel at 1-888-784-3335 (STIEFEL).

How should I store VERDESO Foam?

  • Store the can of VERDESO Foam at room temperature, 68° to 77°F (20°C to 25°C).
  • Do not place the can of VERDESO Foam in the refrigerator or freezer.
  • Do not expose containers to heat, and/or store at temperatures above 120°F (49°C).
  • Do not break through (puncture) the can of VERDESO Foam.
  • VERDESO Foam is flammable. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION.
  • Keep VERDESO Foam and all medicines out of the reach of children.

General information about VERDESO Foam

Do not use VERDESO Foam for a condition for which it was not prescribed. Do not give VERDESO Foam to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet summarizes the most important information about VERDESO Foam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about VERDESO Foam that is written for health professionals.

What are the ingredients in VERDESO Foam?

Active ingredient: desonide

Inactive Ingredients: anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, potassium citrate (monohydrate), propylene glycol, purified water, sorbitan monolaurate, and phenoxyethanol as a preservative. The can is pressurized with a hydrocarbon (propane/butane) propellant.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

DESONIDE FOAM - TOPICAL

 

(DES-oh-nide)

 

COMMON BRAND NAME(S): Verdeso

 

USES: This medication is used to treat a certain skin condition (atopic dermatitis). Desonide reduces the swelling, itching, and redness that can occur in this type of condition. Desonide is a mild corticosteroid.

 

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using desonide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication only on the skin.

Shake the can well before using. Wash your hands. Clean and dry the affected area. Hold the can upside down to spray the foam onto the affected skin, usually 2 times daily or as directed by your doctor. If you hold the bottle upright while spraying, you may not get enough medication in the foam. If treating the face, do not spray directly onto the face. Instead, spray the foam onto the hand and then apply to the face. After applying the foam, gently rub in until the medication disappears. Do not bandage, wrap, or cover the area unless you are instructed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants.

After applying the medication, wash and dry your hands, unless you are using this medication to treat the hands. Avoid getting this medication in the eyes, nose, or mouth. If you get the medication in these areas, rinse with plenty of water.

Use this medication only for the condition for which it was prescribed. Do not use it for longer than prescribed.

Tell your doctor if your condition persists or worsens after 4 weeks.

Consumer Overview Side Effect

SIDE EFFECTS: Stinging, burning, irritation, dryness, or redness at the application site may occur. Acne, new/unwanted hair growth, "hair bumps" (folliculitis), skin thinning/discoloration, or stretch marks may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Skin infections can become worse while you are using this medication. Tell your doctor promptly if redness, swelling, or irritation does not improve.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

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

Learn More »
 

PRECAUTIONS: Before using desonide, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Do not use if there is an infection or sore in the area to be treated.

Children may be more sensitive to the effects of too much corticosteroid medication. Consult your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription or nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.

Tell all your doctors that you use or have used this medication.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from moisture. Avoid freezing. Do not puncture the can or expose to high heat or open flame. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

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 (Verdeso)?
  • 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 (Verdeso)?

 

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 Verdeso (desonide foam) 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.

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.

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.

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