Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
METHYLPREDNISOLONE SODIUM SUCCINATE (UNII: LEC9GKY20K) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)
Fresenius Kabi USA, LLC
METHYLPREDNISOLONE SODIUM SUCCINATE
METHYLPREDNISOLONE 1 g in 16 mL
INTRAVENOUS
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 intravenous or intramuscular use of Methylprednisolone Sodium Succinate for Injection sterile powder 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, 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), congenital
Methylprednisolone Sodium Succinate for Injection, USP sterile powder is available as follows: The container closure is not made with natural rubber latex. www.fresenius-kabi.com/us 451282D Revised: February 2023
Abbreviated New Drug Application
METHYLPREDNISOLONE SODIUM SUCCINATE - METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION FRESENIUS KABI USA, LLC ---------- METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP AFTER MIXING AS DIRECTED, CONTAINS BENZYL ALCOHOL. NOT FOR USE IN NEONATES. FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION Rx only DESCRIPTION Methylprednisolone Sodium Succinate for Injection, USP sterile powder is an anti- inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20- dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β). The structural formula is represented below: Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone Sodium Succinate for Injection, USP is available in three strengths for intravenous or intramuscular administration. 40 MG (SINGLE-DOSE VIAL) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried and 25 mg lactose hydrous; and benzyl alcohol. 125 MG (SINGLE-DOSE VIAL) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried; and benzyl alcohol. 1 G (MULTI Прочитайте повний документ