METHYLPREDNISOLONE SODIUM SUCCINATE injection, powder, for solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Hikma Pharmaceuticals USA Inc.

Az alkalmazás módja:

INTRAMUSCULAR

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 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 adrenal hyperplasia,

Termék összefoglaló:

Methylprednisolone Sodium Succinate for Injection, USP is available in the following packages: NDC Strength Unit of Sale 0143-9753-25 40 mg (Single-Dose Vial) Carton of 25 vials 0143-9754-25 125 mg (Single-Dose Vial) Carton of 25 vials Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, nº 8, 8A e 8B – Fervença, 2705 – 906 Terrugem SNT PORTUGAL Distributed by:   Hikma Pharmaceuticals USA Inc.  Berkeley Heights, NJ 07922 PIN520-WES/5 Revised: July 2022 

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

METHYLPREDNISOLONE SODIUM SUCCINATE- METHYLPREDNISOLONE SODIUM
SUCCINATE INJECTION, POWDER, FOR SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP
AFTER MIXING AS DIRECTED WITH BACTERIOSTATIC WATER FOR INJECTION,
CONTAINS
BENZYL ALCOHOL.
NOT FOR USE IN NEONATES.
FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION
DESCRIPTION
Methylprednisolone Sodium Succinate for Injection, USP, Sterile Powder
is an anti-
inflammatory glucocorticoid, which contains Methylprednisolone Sodium
Succinate, USP
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, USP, 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, USP 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, USP, is available in two
strengths and packages
for intravenous or intramuscular administration:
40 MG (SINGLE-DOSE VIAL)—Each mL (when mixed) contains
Methylprednisolone
Sodium Succinate, USP 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 (SINGLE-DOSE VIAL)—Each 2 mL (when mixed) contains
Methylprednisolone
Sodium Succinate, USP equivalent to 125 mg methylprednisolone; also
1.6 mg
monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium
phosphate dried.
IMPORTANT — Use only Water for Injection USP or Bacteriostati