METHYLPREDNISOLONE SODIUM SUCCINATE- methylprednisolone sodium succinate injection, powder, lyophilized, for solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Fresenius Kabi USA, LLC

INN (Algemene Internationale Benaming):

METHYLPREDNISOLONE SODIUM SUCCINATE

Samenstelling:

METHYLPREDNISOLONE 1 g in 16 mL

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 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, 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 supplementation is of particular importance), congenital

Product samenvatting:

Methylprednisolone Sodium Succinate for Injection, USP sterile powder is available as follows: The container closure is not made with natural rubber latex. www.fresenius-kabi.com/us 451282D Revised: February 2023

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

METHYLPREDNISOLONE SODIUM SUCCINATE - METHYLPREDNISOLONE SODIUM
SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
FRESENIUS KABI USA, LLC
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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 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.
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
and 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; and 17.4 mg dibasic sodium
phosphate
mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium
phosphate
dried; and benzyl alcohol.
1 G (MULTI