País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
Methylprednisolone Sodium Succinate (UNII: LEC9GKY20K) (Methylprednisolone - UNII:X4W7ZR7023)
General Injectables & Vaccines, Inc
Methylprednisolone Sodium Succinate
Methylprednisolone 40 mg in 1 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 SOLU-MEDROL 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, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliiative 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
SOLU-MEDROL Sterile Powder preserved with benzyl alcohol is available in the following packages: 500 mg (Multi-Dose Vial) 8 mL NDC 0009-0758-01 1 gram (Multi-Dose Vial) 16 mL MDC 0009-0698-01 2 gram Vial with Diluent NDC 0009-0795-01 SOLU-MEDROL Sterile Powder preservative-free is available in the following packages: 40 mg Act-O-Vial System (Single-Use Vial) 25x1 mL NDC 0009-0039-28 125 mg Act-O-Vial System (Single-Use Vial) 25x2 mL NDC 0009—0047-22 500 mg Act-O-Vial System (Single-Use Vial) 4 mL NDC 0009-0003-02 1 gram Act-O-Vial System (Single-Use Vial) 8 mL NDC 0009-0018-20 This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com . Pfizer Injectables Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc New York, NY 10017 LAB-0161-17.0 Revised May 2021
New Drug Application
SOLU-MEDROL- METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, FOR SOLUTION GENERAL INJECTABLES & VACCINES, INC ---------- SOLU-MEDROL® (METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP) DESCRIPTION The formulations containing benzyl alcohol should not be used in neonates. For Intravenous or Intramuscular Administration DESCRIPTION SOLU-MEDROL 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, (6ɑ, 11β), and the molecular weight is 496.53. 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 SOLU-MEDROL is available in preservative and preservative-free formulations: When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8. 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 are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they Llegiu el document complet