METHYLPREDNISOLONE ACETATE injection, suspension

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

REMEDYREPACK INC.

Via di somministrazione:

INTRASYNOVIAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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, 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, hypercalcemia asso

Dettagli prodotto:

Methylprednisolone acetate injectable suspension, USP is available in the following strengths and package sizes: 40 mg per mL 5 mL multidose vials, packaged individually NDC: 70518-2459-00 PACKAGING: 1 in 1 CARTON, 5 mL in 1 VIAL MULTI DOSE TYPE 0 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

METHYLPREDNISOLONE ACETATE- METHYLPREDNISOLONE ACETATE INJECTION,
SUSPENSION
REMEDYREPACK INC.
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METHYLPREDNISOLONE
ACETATE INJECTABLE SUSPENSION, USP
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
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 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 cortisone),
wh