Betamethasone valerate (topical)

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Betamethasone valerate (topical) is an adrenal glucocorticoidand endocrine-metabolic agent that is FDA approved for the treatment of the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Common adverse reactions include hypertension, skin atrophy, erythema, striae, folliculitis, vesicles in skin, pruritus of skin, stinging of skin, depression, and euphoria.

• Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

• Apply a thin film of Betamethasone Valerate Cream or Ointment to the affected skin areas one to three times a day. Dosage once or twice a day is often effective.

• Apply a few drops of Betamethasone Valerate Lotion to the affected area and massage lightly until it disappears. Apply twice daily, in the morning and at night. Dosage may be increased in stubborn cases. Following improvement, apply once daily. For the most effective and economical use, apply nozzle very close to affected area and gently squeeze bottle.

There is limited information regarding Off-Label Guideline-Supported Use of Betamethasone valerate in adult patients.

There is limited information regarding Off-Label Non–Guideline-Supported Use of Betamethasone valerate in adult patients.

There is limited information regarding FDA-Labeled Use of Betamethasone valerate in pediatric patients.

There is limited information regarding Off-Label Guideline-Supported Use of Betamethasone valerate in pediatric patients.

There is limited information regarding Off-Label Non–Guideline-Supported Use of Betamethasone valerate in pediatric patients.

• Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

• General:

• Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

• Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

• Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or substitute to a less potent steroid.

• Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

• Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.

• If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

• In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

• The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

(There is limited information regarding Postmarketing Experience of Betamethasone valerate in the drug label.)

There is limited information regarding Drug Interactions of Betamethasone valerate in the drug label.

Pregnancy Category (FDA): C

• Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Betamethasone valerate in women who are pregnant.

There is no FDA guidance on use of Betamethasone valerate during labor and delivery.

• It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

• Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

• Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

• Administration of topical corticosteroids to pediatric patients 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.

There is no FDA guidance on the use of Betamethasone valerate with respect to geriatric patients.

There is no FDA guidance on the use of Betamethasone valerate with respect to specific gender populations.

There is no FDA guidance on the use of Betamethasone valerate with respect to specific racial populations.

There is no FDA guidance on the use of Betamethasone valerate in patients with renal impairment.

There is no FDA guidance on the use of Betamethasone valerate in patients with hepatic impairment.

There is no FDA guidance on the use of Betamethasone valerate in women of reproductive potentials and males.

There is no FDA guidance one the use of Betamethasone valerate in patients who are immunocompromised.

• Topical

There is limited information regarding Monitoring of Betamethasone valerate in the drug label.

There is limited information regarding IV Compatibility of Betamethasone valerate in the drug label.

• Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.

• topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

• The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

• Betamethasone Valerate Cream, Ointment and Lotion contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

• Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is:

• The following tests may be helpful in evaluating the HPA axis suppression:

• Urinary free cortisol test
• ACTH stimulation test

• The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

• Topical corticosteroidscan be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption oftopical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.

• Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

There is limited information regarding Nonclinical Toxicology of Betamethasone valerate in the drug label.

• Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

• Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, NY 11747

• Store at room temperature 15° – 30°C (59° – 86°F).

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• 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.

• Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.

• The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.

• Patients should report any signs of local adverse reactions especially under occlusive dressing.

• Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Alcohol-Betamethasone valerate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

• Celestone®

There is limited information regarding Betamethasone valerate (topical) Look-Alike Drug Names in the drug label.

Drug Shortage

The contents of this FDA label are provided by the National Library of Medicine.