Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
METHYLPREDNISOLONE SODIUM SUCCINATE (UNII: LEC9GKY20K) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)
REMEDYREPACK INC.
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: 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. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). 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 adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. To
SOLU-MEDROL Sterile Powder preservative-free is available in the following packages: 125 mg Act-O-Vial System (Single-Dose Vial) NDC: 70518-2023-02 NDC: 70518-2023-03 PACKAGING: 25 in 1 CARTON PACKAGING: 2 mL in 1 VIAL, TYPE 0 Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
New Drug Application
SOLU-MEDROL- METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, FOR SOLUTION REMEDYREPACK INC. ---------- SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP) 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, (6α, 11β), and the molecular weight is 496.53. 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. PRESERVATIVE-FREE FORMULATIONS 40 MG ACT-O-VIAL SYSTEM (SINGLE-DOSE VIAL)—Each mL (when mixed) 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. 125 MG ACT-O-VIAL SYSTEM (SINGLE-DOSE VIAL)—Each 2 mL (when mixed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried. FORMULATIONS PRESERVED WITH BENZYL ALCOHOL 1 GRAM VIAL—Each 16 mL ( Przeczytaj cały dokument