METHYLPREDNISOLONE SODIUM SUCCINATE injection, powder, lyophilized, for solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

AuroMedics Pharma LLC

INN (Alþjóðlegt nafn):

METHYLPREDNISOLONE SODIUM SUCCINATE

Samsetning:

METHYLPREDNISOLONE 40 mg

Stjórnsýsluleið:

INTRAMUSCULAR

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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, h

Vörulýsing:

Methylprednisolone sodium succinate for injection, USP is a sterile, white color lyophilized cake, supplied as follows:      40 mg per vial      Single-Dose Vials in a Carton of 25                                               NDC 55150-262-03      125 mg per vial      Single-Dose Vials in a Carton of 25                                               NDC 55150-263-03      500 mg per vial      Multiple-Dose Vials Packaged Individually                                   NDC 55150-264-20     2 grams per vial     Single-Dose Vials Packaged Individually                                        NDC 55150-265-50 STORAGE CONDITIONS Protect from light. Store unreconstituted product at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store solution at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Use solution within 48 hours after mixing. The vial stoppers are not made with natural rubber latex. This product’s label may have been updated. For current full prescribing information, please visit www.auromedics.com . Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad - 500038 India Revised: July 2021

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

METHYLPREDNISOLONE SODIUM SUCCINATE - METHYLPREDNISOLONE SODIUM
SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
AUROMEDICS PHARMA LLC
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METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP
RX ONLY
THE FORMULATIONS CONTAINING BENZYL ALCOHOL SHOULD NOT BE USED IN
NEONATES.
FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION
DESCRIPTION
Methylprednisolone sodium succinate for injection, USP 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.
Methylprednisolone sodium succinate USP is the sodium salt of
methylprednisolone
hemisuccinate USP, which is formed _in situ,_ with the aid of sodium
hydroxide.
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 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 for injection, USP is a sterile,
white color lyophilized
cake, available in preservative and preservative-free formulations:
40 MG (SINGLE-DOSE VIAL):
Each mL (when mixed with 1 mL of Water for Injection USP) contains 53
mg of
methylprednisolone sodium succinate USP equivalent to 40 mg
methylprednisolone; also
1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium
phosphate
dried; 25 mg lactose hydrous. This package does not contain diluent.
Each mL (when mixed with 1 mL of Bacteriostatic Water for Injection
USP) contains 53
mg of