Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
METHYLPREDNISOLONE ACETATE (UNII: 43502P7F0P) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)
Aidarex Pharmaceuticals LLC
METHYLPREDNISOLONE ACETATE
METHYLPREDNISOLONE ACETATE 40 mg in 1 mL
INTRALESIONAL
PRESCRIPTION DRUG
When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of Methylprednisolone 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, seasonal or perennial allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenita
Methylprednisolone Acetate Injectable Suspension USP is available in the following strengths and package sizes: 40 mg per mL NDC 52317-0132-01 5 mL multidose vials, packaged individually Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. B 1/2016
Abbreviated New Drug Application
METHYLPREDNISOLONE ACETATE- METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION AIDAREX PHARMACEUTICALS LLC ---------- METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION USP NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL NOT FOR INTRAVENOUS USE RX ONLY DESCRIPTION Methylprednisolone Acetate Injectable Suspension USP is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in two strengths: 40 mg/mL, 80 mg/mL. Each mL of these preparations contains: Methylprednisolone acetate, USP…………………………….. 40 MG 80 MG Polyethylene glycol 3350…………………………………….. 29.1 mg 28.2 mg Polysorbate 80……………………..……………….………... 1.94 mg 1.88 mg Monobasic sodium phosphate……………………………….. 6.8 mg 6.59 mg Dibasic sodium phosphate…………………………………… 1.42 mg 1.37 mg Benzyl alcohol added as a preservative………………………. 9.16 mg 8.88 mg Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range (e.g., 3.0 to 7.0). The chemical name for methylprednisolone acetate, USP is pregna-1,4-diene-3,20-dione, 21- (acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11β). The structural formula is represented below: C H O M.W. 416.51 Methylprednisolone Acetate Injectable Suspension USP contains methylprednisolone acetate, USP which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate, USP is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water. CLINICAL PHARMACOLOGY Glucocorticoids, naturally occurring and synthetic are adrenocortical steroids. Naturally occurring glucocorticoids (hydrocortisone and Pročitajte cijeli dokument