SOLU-MEDROL- R METHYLPREDNISOLONE SODIUM SUCCINAT injection, powder, for solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

HF Acquisition Co LLC, DBA HealthFirst

Podání:

INTRAMUSCULAR

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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, 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 adre

Přehled produktů:

SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP is supplied in the following dosage forms. NDC 51662-1483-1 SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP 500mg PER VIAL 4mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms SOLU-MEDROL Sterile Powder preserved with benzyl alcohol is available in the following packages: SOLU-MEDROL Sterile Powder preservative-free is available in the following packages: This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Stav Autorizace:

New Drug Application

Charakteristika produktu

SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT- SOLU-MEDROL(R)
METHYLPREDNISOLONE SODIUM SUCCINAT INJECTION, POWDER, FOR SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION,
USP 500MG PER VIAL 4ML VIAL
SPL UNCLASSIFIED
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. 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 and
the tonicities are, for the 40 mg
per mL solution, 0.50 osmolar; for the 125 mg per 2 mL solution, 0.40
osmolar; for the 1 gram per 8 mL
solution, 0.44 osmolar; for the 2 gram per 30.6 mL solutions, 0.42
osmolar. (Isotonic saline = 0.28
osmolar.)
CLINICAL PHARMACOLOGY
Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids that are readily absorbed
from the gastrointestinal tract.
Naturally occurring glucocorticoids (hydrocorti