METHYLPREDNISOLONE SODIUM SUCCINATE- methylprednisolone sodium succinate injection, powder, lyophilized, 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:

Cardinal Health

INN (International Name):

METHYLPREDNISOLONE SODIUM SUCCINATE

Composition:

METHYLPREDNISOLONE 125 mg in 2 mL

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 Methylprednisolone Sodium Succinate for Injection, USP 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, exfoliative 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 supplemen

Product summary:

Methylprednisolone Sodium Succinate for Injection, USP sterile powder is available as follows:  NDC No. 55154-9383-5    Methylprednisolone Sodium Succinate for Injection USP, 40 mg per vial, 3 mL single dose vial, overbagged with 5 vials per bag 55154-9557-5 Methylprednisolone Sodium Succinate for Injection USP, 125 mg per vial, 3 mL single dose vial, overbagged with 5 vials per bag This container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPREDNISOLONE SODIUM SUCCINATE- METHYLPREDNISOLONE SODIUM
SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
CARDINAL HEALTH
----------
METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION USP
AFTER MIXING AS DIRECTED, CONTAINS BENZYL ALCOHOL.
NOT FOR USE IN NEONATES.
FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION
Rx only
DESCRIPTION
Methylprednisolone Sodium Succinate for Injection, USP 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).
The structural formula is:
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.
Methylprednisolone Sodium Succinate for Injection, USP is available in
three strengths for intravenous
or intramuscular administration.
40 MG (SINGLE DOSE VIAL) Each mL (when mixed as directed) contains
methylprednisolone sodium
succinate equivalent to 40 mg methylprednisolone; also, 1.6 mg
monobasic sodium phosphate
anhydrous; 17.46 mg dibasic sodium phosphate dried; 25 mg lactose
hydrous; and benzyl alcohol.
125 MG (SINGLE DOSE VIAL) Each 2 mL (when mixed as directed) contains
methylprednisolone sodium
succinate equivalent to 125 mg methylprednisolone; also, 1.6 mg
monobasic sodium phosphate
anhydrous; 17.4 mg dibasic sodium phosphate dried; and benzyl alcohol.
1 G (MULTIPLE DOSE VIAL_)_ Each 16 mL (when mixed as directed)
contains methylprednisolone sodium
succinate equivalent to