מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
BETAMETHASONE ACETATE (UNII: TI05AO53L7) (BETAMETHASONE - UNII:9842X06Q6M), BETAMETHASONE SODIUM PHOSPHATE (UNII: 7BK02SCL3W) (BETAMETHASONE - UNII:9842X06Q6M)
Terrain Pharmaceuticals
BETAMETHASONE ACETATE
BETAMETHASONE ACETATE 3 mg in 1 mL
INTRALESIONAL
PRESCRIPTION DRUG
When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular
Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, 5 mL multiple dose vial; box of one: NDC 0517-0720-01 SHAKE WELL BEFORE USING. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Rx only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Revised September 2015
Abbreviated New Drug Application
READYSHARP BETAMETHASONE- BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE INJECTION, SUSPENSION TERRAIN PHARMACEUTICALS ---------- READYSHARP BETAMETHASONE 30 MG/5 ML (6 MG PER ML) DESCRIPTION Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP is a sterile aqueous suspension containing betamethasone 3 mg per milliliter as betamethasone sodium phosphate, and betamethasone acetate 3 mg per milliliter. Inactive ingredients per mL: dibasic sodium phosphate 7.1 mg; monobasic sodium phosphate 3.4 mg; edetate disodium 0.1 mg; and benzalkonium chloride 0.2 mg as a preservative. The pH is adjusted to between 6.8 and 7.2. The formula for betamethasone sodium phosphate is C H FNa O P and it has a molecular weight of 516.40. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β- methylpregna-1,4-diene-3,20-dione 21-(disodium phosphate). The formula for betamethasone acetate is C H FO and it has a molecular weight of 434.50. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene- 3,20-dione 21-acetate. The chemical structures for betamethasone sodium phosphate and betamethasone acetate are as follows: 22 28 2 8 24 31 6 Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic. It is freely soluble in water and in methanol, but is practically insoluble in acetone and in chloroform. Betamethasone acetate is a white to creamy white, odorless powder that sinters and resolidifies at about 165ºC, and remelts at about 200ºC to 220ºC with decomposition. It is practically insoluble in water, but freely soluble in acetone, and is soluble in alcohol and in chloroform. CLINICAL PHARMACOLOGY Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt- retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs ar קרא את המסמך השלם