METHYLPREDNISOLONE ACETATE injection, suspension

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Aidarex Pharmaceuticals LLC

Designación común internacional (DCI):

METHYLPREDNISOLONE ACETATE

Composición:

METHYLPREDNISOLONE ACETATE 40 mg in 1 mL

Vía de administración:

INTRALESIONAL

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: 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, seasonal or perennial allergic rhinitis, 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), congenita

Resumen del producto:

Methylprednisolone Acetate Injectable Suspension USP is available in the following strengths and package sizes: 40 mg per mL NDC 52317-0132-01 5 mL multidose vials, packaged individually Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. B 1/2016

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

METHYLPREDNISOLONE ACETATE- METHYLPREDNISOLONE ACETATE INJECTION,
SUSPENSION
AIDAREX PHARMACEUTICALS LLC
----------
METHYLPREDNISOLONE
ACETATE INJECTABLE SUSPENSION USP
NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL
NOT FOR INTRAVENOUS USE
RX ONLY
DESCRIPTION
Methylprednisolone Acetate Injectable Suspension USP is an
anti-inflammatory glucocorticoid for
intramuscular, intra-articular, soft tissue, or intralesional
injection. It is available 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……………………………………..
29.1 mg
28.2 mg
Polysorbate
80……………………..……………….………...
1.94 mg
1.88 mg
Monobasic sodium phosphate………………………………..
6.8 mg
6.59 mg
Dibasic sodium phosphate……………………………………
1.42 mg
1.37 mg
Benzyl alcohol added as a preservative……………………….
9.16 mg
8.88 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 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