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:

Henry Schein, 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: 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

Product summary:

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 00090047-22 500 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

Authorization status:

New Drug Application

Summary of Product characteristics

SOLU-MEDROL- METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER,
FOR
SOLUTION
HENRY SCHEIN, 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 modify
the body�