MethylPREDNISolone Acetate Injectable Suspension, USP

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

METHYLPREDNISOLONE ACETATE (UNII: 43502P7F0P) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)

Disponible desde:

Teva Parenteral Medicines, Inc.

Designación común internacional (DCI):

METHYLPREDNISOLONE ACETATE

Composición:

METHYLPREDNISOLONE ACETATE 40 mg in 1 mL

Vía de administración:

INTRA-ARTICULAR

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 intramuscular use of methylprednisolone acetate injectable suspension 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, serum sickness, transfusion reactions. Bullous dermatitis herpetiformis, exfoliative dermatitis, 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, nonsupportive thyroiditis. To tide the p

Resumen del producto:

Methylprednisolone acetate injectable suspension, USP is available as single-dose vials in the following strengths and package sizes: 40 mg per mL NDC 0703-0031 -01 1 mL vials NDC 0703-0031 -04 25 x 1 mL vials 80 mg per mL NDC 0703-0051 -01 1 mL vials NDC 0703-0051 -04 25 x 1 mL vials Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured By: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. F 6/2021

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

METHYLPREDNISOLONE ACETATE- METHYLPREDNISOLONE ACETATE INJECTION,
SUSPENSION
TEVA PARENTERAL MEDICINES, INC.
----------
METHYLPREDNISOLONE
ACETATE INJECTABLE SUSPENSION, USP
SINGLE-DOSE VIAL
NOT FOR INTRAVENOUS USE
DESCRIPTION
Methylprednisolone acetate injectable suspension, USP is an
anti-inflammatory
glucocorticoid for intramuscular, intra-articular, soft tissue or
intralesional injection. It is
available as single-dose vials in two strengths: 40 mg/mL, 80 mg/mL.
Each mL of these preparations contains:
Methylprednisolone acetate, USP ....................................40
MG .............80 MG
Polyethylene glycol 3350
................................................29 mg .............28
mg
Myristyl-gamma-picolinium chloride...............................0.195
mg .........0.189 mg
Sodium Chloride was added to adjust tonicity.
When necessary, pH was adjusted with sodium hydroxide and/or
hydrochloric acid.
The pH of the finished product remains within the USP specified range
(e.g., 3.0 to 7.0).
The chemical name for methylprednisolone acetate, USP is
pregna-1,4-diene-3,20-dione,
21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11β)-. The structural
formula is
represented below:
C
H
O M.W. 416.51
Methylprednisolone acetate injectable suspension, USP contains
methylprednisolone
24
32
6
acetate, USP which is the 6-methyl derivative of prednisolone.
Methylprednisolone
acetate, USP is a white or practically white, odorless, crystalline
powder which melts at
about 215° with some decomposition. It is soluble in dioxane,
sparingly soluble in
acetone, alcohol, chloroform, and methanol, and slightly soluble in
ether. It is practically
insoluble in water.
CLINICAL PHARMACOLOGY
Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids.
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt
retaining properties, are used in replacement therapy in
adrenocortical deficiency states.
Their synthetic analogs are used primarily for their anti-inflammatory
effects in disorders
o