SOLU-MEDROL- methylprednisolone sodium succinate injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHYLPREDNISOLONE SODIUM SUCCINATE (UNII: LEC9GKY20K) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)

Available from:

REMEDYREPACK INC.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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

Authorization status:

New Drug Application

Summary of Product characteristics

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 (