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

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

NuCare Pharmaceuticals,Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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, perennial or seasonal allergic rhinitis, 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 wi

Resumen del producto:

SOLU-MEDROL Sterile Powder preserved with benzyl alcohol is available in the following packages: NDC 68071-1792-2 GLASS BOTTLE 125mg 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.

Estat d'Autorització:

New Drug Application

Fitxa tècnica

SOLU-MEDROL- METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER,
FOR SOLUTION
NUCARE PHARMACEUTICALS,INC.
REFERENCE LABEL SET ID: C74AD5BA-18CC-4CA5-9845-A4375B5E51C1
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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. 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:
PRESERVATIVE-FREE FORMULATIONS
40 MG ACT-O-VIAL SYSTEM (SINGLE-USE 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 (SINGLEUSE 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.
500 MG ACT-O-VIAL SYSTEM (SINGLEUSE VIAL)—Each 4 mL (when mixed)
contains methylprednisolone
sodium succinate equivale