Betamethasone valerate

INDICATIONS AND USAGE Betamethasone valerate foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.

DOSAGE AND ADMINISTRATION Note: For proper dispensing of foam, can must be inverted. For application to the scalp invert can and dispense a small amount of betamethasone valerate foam, 0.12% onto a saucer or other cool surface. Do not dispense directly onto hands as foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of foam with fingers and gently massage into affected area until foam disappears. Repeat until entire affected scalp area is treated. Apply twice daily, once in the morning and once at night. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Betamethasone valerate foam, 0.12% should not be used with occlusive dressings unless directed by a physician.

CONTRAINDICATIONS Betamethasone valerate foam, 0.12% is contraindicated in patients who are hypersensitive to betamethasone valerate, to other corticosteroids, or to any ingredient in this preparation.

ADVERSE REACTIONS The most frequent adverse event was burning/itching/ stinging at the application site; the incidence and severity of this event were as follows: Incidence and severity of burning/itching/stinging Product Total incidence Maximum severity Mild Moderate Severe Betamethasone Valerate Foam, 0.12% n=63 34 (54%) 28 (44%) 5 (8%) 1 (2%) Betamethasone Valerate Lotion n=63 33 (52%) 26 (41%) 6 (10%) 1 (2%) Placebo Foam n=32 24 (75%) 13 (41%) 7 (22%) 4 (12%) Placebo Lotion n=30 20 (67%) 12 (40%) 5 (17%) 3 (10%) Other adverse events which were considered to be possibly, probably, or definitely related to Betamethasone Valerate Foam, 0.12% occurred in one patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. 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.

DESCRIPTION Betamethasone valerate foam, 0.12% contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents. Betamethasone valerate is 9-fluoro11ß,17, 21-trihydroxy-16ß-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula C 27 H 37 FO 6 , a molecular weight of 476.58.The following is the chemical structure: Betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether. Betamethasone valerate foam, 0.12% contains 1.2 mg betamethasone valerate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid (anhydrous), ethanol (anhydrous) (60.4%), polysorbate 60, propylene glycol, purified water, stearyl alcohol, and tri-potassium citrate pressurized with a hydrocarbon (propane/butane) propellant. betamethasone valerate chemical structure

OVERDOSAGE Topically applied betamethasone valerate foam, 0.12% can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS ).

HOW SUPPLIED Betamethasone valerate foam, 0.12% contains 1.2 mg of betamethasone valerate, USP per gram. It is white to off white foam available as follows: NDC 62332-708-50 carton containing one 50 g aluminum can NDC 62332-708-31 carton containing one 100 g aluminum can Store at 20 ° to 25 ° C (68 ° to 77 ° F); excursions permitted between 15 ° to 30 ° C (59 ° to 86 ° F) [see USP Controlled Room Temperature]. WARNING FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep this and all medication out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C). Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 PATIENT INFORMATION Betamethasone Valerate (bay'' ta meth' a sone val' er ate) Foam, 0.12% About Betamethasone Valerate Foam, 0.12% Your doctor has prescribed betamethasone valerate foam, 0.12%, for the relief of corticosteroid-responsive skin conditions of the scalp. Betamethasone valerate foam, 0.12% works because its active ingredient is betamethasone valerate, 0.12%. Betamethasone belongs to a group of medicines known as topical corticosteroids. These agents are used to reduce the inflammation, redness, swelling, itching, and tenderness associated with dermatologic conditions. Other ingredients in betamethasone valerate foam, 0.12% include cetyl alcohol, citric acid, ethanol, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol. The foam is dispensed from an aluminum can that is pressurized by a hydrocarbon propellant (propane and butane). If you answer YES to one or more of the following questions, tell your doctor (or pharmacist) before using this medicine, so you can get advice about what to do. Are you allergic to any of the ingredients contained in betamethasone valerate foam, 0.12%? Are you pregnant? Planning on becoming pregnant while using betamethasone valerate foam, 0.12%? Or are you breastfeeding? Do you think you have an infection on your scalp? How to apply betamethasone valerate foam, 0.12% Turn the can upside down and dispense a small amount of betamethasone valerate foam, 0.12% onto a clean saucer or other cool, clean surface. Do not dispense directly onto hands, as foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of foam with fingers and gently massage into affected area until foam disappears. Repeat until entire affected scalp area is treated. Apply twice daily, once in the morning and once at night. Use sparingly—only enough to cover the affected areas. Gently massage the foam in until it is absorbed and allow the areas to dry naturally. When applying to the scalp, move the hair away so that the foam can be applied directly to each affected area. Wash your hands immediately after applying betamethasone valerate foam, 0.12%, and discard any unused dispensed medication. Do not wash or rinse the treated areas immediately after applying betamethasone valerate foam, 0.12%. Do not use this medication for any condition other than the one for which it was prescribed. Betamethasone valerate foam, 0.12% is for external use only. Keep the foam away from your eyes, as it will sting. If the foam gets into your eyes, rinse well with cold water. If the stinging continues, contact your doctor immediately. WHAT YOU SHOULD KNOW ABOUT BETAMETHASONE VALERATE FOAM, 0.12%: What to do if you miss an application If you forget to apply betamethasone valerate foam, 0.12% at the scheduled time, use it as soon as you remember, and then go back to your regular schedule. If you remember at or about the time of your next daily application, apply that dose and continue with your normal application schedule. If you miss several doses, tell your doctor at your next appointment. …