Betamethasone Valerate (Teva-Ectosone)

1. Health Canada Product Monograph — Betamethasone Valerate

• Used for allergic and inflammatory skin conditions that respond to corticosteroid therapy, including psoriasis, atopic eczema (in adults and infants), and nummular eczema.
• Used for anal and vulvar itching, neurodermatitis (lichen simplex chronicus), and intertrigo (skin-fold irritation).
• Used for contact dermatitis, seborrheic dermatitis, exfoliative dermatitis, sun-related (solar) dermatitis, stasis dermatitis, and dyshidrosis (a blistering hand or foot condition).
• The regular (higher) strength may be used for resistant psoriasis, often combined with an occlusive dressing technique.
• The mild (lower) strength is generally used for maintenance therapy once the acute phase is controlled, for milder conditions, or for lesions covering large areas of the body.

• The safety of topical corticosteroids in pregnancy has not been definitively established, although they have not been reported to cause harm to the fetus.
• Potential benefits must be weighed against possible risks, and this product should not be used extensively, in large amounts, or for prolonged periods during pregnancy.

• It is not known whether enough of the drug is absorbed through the skin to appear in breast milk in meaningful amounts.
• A decision should be made to either stop nursing or stop the medication, based on how important the drug is to the mother.

• The product monograph does not identify specific dosing considerations for older adults.
• As with any topical corticosteroid, the smallest effective amount should be used for the shortest necessary time.

• Children may be more susceptible than adults to adrenal (HPA-axis) suppression and Cushing's syndrome from topical corticosteroids, because of a greater skin-surface-area-to-body-weight ratio.
• Effects reported in children include adrenal suppression, a Cushingoid appearance, slowed growth, delayed weight gain, and rarely intracranial hypertension, which can present as a bulging soft spot in infants, headaches, or swelling at the back of the eye.
• Use in children should be limited to the smallest amount consistent with effective treatment, since topical corticosteroid therapy may interfere with normal growth and development.

• Apply a small amount to the affected skin 2 to 3 times daily.
• Resistant or deep-seated lesions, such as thick psoriasis plaques, lichenified hand eczema, or pustular eruptions on the palms and soles, may respond better when the prescriber directs use of an occlusive dressing (hydration) technique.
• With the occlusive technique, a thick layer of cream is applied under a light gauze dressing, then covered with a pliable, impermeable plastic material sealed at the edges, left in place for 1 to 3 days, and repeated as directed.
• If a fine bumpy rash or follicle inflammation develops under an occlusive dressing, the covering should be removed.
• Avoid application in or near the eyes.

• A burning sensation at the application site may occur.
• Itching may occur.
• Skin irritation may occur.
• Dryness of the skin may occur.
• Increased hair growth (hypertrichosis) at the application site may occur.
• Acne-like eruptions may occur.
• Lightening of skin color (hypopigmentation) at the application site may occur.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Suppression of the body's natural adrenal hormone production may occur, especially with prolonged, extensive, or occlusive-dressing use, and can lead to signs of excess corticosteroid exposure such as Cushing's disease.
• Thinning of the skin (atrophy) and stretch marks (striae) can develop, more often with occlusive dressing use.
• Secondary skin infections, including pus-forming infections, occur more often with occlusive dressing use.
• Allergic contact sensitivity to a dressing material or adhesive may occur during occlusive therapy.
• In children, effects can include adrenal suppression, a Cushingoid appearance, slowed growth, delayed weight gain, and rarely intracranial hypertension.
• A fine bumpy (miliary) eruption or folliculitis can develop under an occlusive dressing and requires prompt removal of the covering.

• Use with caution during prolonged, extensive-area, or occlusive-dressing treatment, since absorption into the bloodstream increases; kidney function tests are recommended before and periodically during such treatment.
• Use with caution in infants and children, using the smallest amount consistent with effective treatment.
• If long-term occlusive therapy is required, using small doses, rotating treatment sites, and intermittent rather than continuous use are recommended.
• If a skin infection is present, this product should be stopped and replaced with an appropriate antibacterial treatment until the infection clears.
• Patients should inform any other treating physician of prior corticosteroid use.

• Tuberculosis of the skin.
• Herpes simplex infection of the skin.
• Chickenpox (varicella).
• Vaccinia-related skin lesions.
• Superficial fungal or yeast infections of the skin.
• Application in or near the eyes.
• Known history of sensitivity reactions to any component of the product.

• The product monograph does not identify specific drug-drug interactions for this topical corticosteroid.
• Because systemic absorption is generally low with normal use, clinically significant interactions with oral or other systemic medications are unlikely, though the risk increases with extensive-area, prolonged, or occlusive-dressing use.
• Applying other topical products to the same area of skin should be discussed with a pharmacist.

• Not applicable, as this is a topical cream or lotion that is not taken by mouth.

• Apply 2 to 3 times daily as directed by the prescriber; there is no specific relationship to meals.

• Store the cream at room temperature, between 15 and 30 degrees C.
• Store the lotion between 15 and 30 degrees C and protect it from freezing.

• Teva-Ectosone (betamethasone valerate) is a topical corticosteroid cream or lotion used to relieve redness, itching, and inflammation from conditions such as eczema, psoriasis, and various types of dermatitis.
• Apply a small amount to the affected skin 2 to 3 times a day as directed; the prescriber may recommend a temporary occlusive dressing over resistant areas for better results.
• Common effects at the application site include burning, itching, dryness, and irritation.
• Contact the prescriber's office if the treated skin thins, develops stretch marks, or shows signs of infection, or if a child using this medication seems to grow slowly; seek prompt medical attention for a severe allergic reaction such as widespread rash or swelling.
• Avoid applying near the eyes, and stop use and check with a healthcare provider if a fungal or viral skin infection, such as cold sores, chickenpox, or ringworm, is present.
• Store at room temperature between 15 and 30 degrees C, protect the lotion from freezing, and keep out of reach of children.