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Verdeso

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Verdeso

Warnings
Precautions

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 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 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 the carcinogenic 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, sustained glucocorticoid-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 albino hairless 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.

Last reviewed on RxList: 4/18/2013
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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