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

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

REMEDYREPACK INC.

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 with cancer, no

Descriptif du produit:

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:

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

SOLU-MEDROL- METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER,
FOR SOLUTION
REMEDYREPACK INC.
----------
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 equivalent to 500 mg methylprednisolone; also 6.4 mg
monobasic sodium phosphate