The number of pages within the document is: 18
The self-declared author(s) is/are:
fda/cder
The subject is as follows:
Original authors did not specify.
The original URL is: LINK
The access date was:
2019-02-07 23:00:03.886886
Please be aware that this may be under copyright restrictions. Please send an email to admin@pharmacoengineering.com for any AI-generated issues.
The content is as follows:
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-inf lammatory 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 dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6, 11), and the molecular weight is 496.53. Th e structural formula is represented below: Methylprednisolone sodium succinate is solu ble in water; it may be administered in a small volume of diluent and is well suited fo r intravenous use in situations where high blood levels of methylpredniso lone are required rapidly. SOLU-MEDROL is available in preservativ e and preservative-free formulations: Preservative-free Formulations 40 mg Act-O-Vial System (Single-Use Vial) ŠEach mL (when mixed) contains methylprednisolone sodium succinate equivale nt 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-Use Vial)ŠEach 2 mL (when mixed) contains methylprednisolone sodium succinate equivale nt to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried. Reference ID: 3032293 1
Please note all content on this page was automatically generated via our AI-based algorithm (TKli1TdayCn3p2DcKziC). Please let us know if you find any errors.