METHYLPREDNISOLONE SODIUM SUCCINATE injection

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Dr. Reddy's Laboratories Inc

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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, USP 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 hyp

Produkto santrauka:

Methylprednisolone sodium succinate for injection, USP is a sterile, white or off-white lyophilized lumps or powder, available in the following packages: Manufactured By Tianjin Kingyork Pharmaceuticals (Tianjin. China) Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540 USA January 2022

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

METHYLPREDNISOLONE SODIUM SUCCINATE- METHYLPREDNISOLONE SODIUM
SUCCINATE INJECTION
DR. REDDY'S LABORATORIES INC
----------
AFTER MIXING AS DIRECTED, CONTAINS BENZYL ALCOHOL. NOT FOR USE 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.
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.
Methylprednisolone sodium succinate for injection, USP is available in
following strengths
for intravenous or intramuscular administration:
40 MG (SINGLE- DOSE VIAL) Each mL (when mixed as directed) 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 25mg lactose hydrous. This package does not contain
diluent. The
recommended diluents are Water for Injection USP or Bacteriostatic
water for Injection
USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as
a preservative.
125 MG (SINGLE- DOSE VIAL) Each 2 mL (when mixed as directed) contains
methylprednisolone sodium succinate equivalent to 125 mg
methylprednisolone; also 1.6
mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodi