METHYLPREDNISOLONE ACETATE injection, suspension

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

methylprednisolone acetate (UNII: 43502P7F0P) (methylprednisolone - UNII:X4W7ZR7023)

Beszerezhető a:

Sagent Pharmaceuticals

Az alkalmazás módja:

INTRA-ARTICULAR

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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, sterile aqueous 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 adre

Termék összefoglaló:

Methylprednisolone Acetate Injectable Suspension, USP, sterile aqueous suspension, is supplied as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2021 Sagent Pharmaceuticals, Inc. June 2021 SAGENT Pharmaceuticals®

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

METHYLPREDNISOLONE ACETATE- METHYLPREDNISOLONE ACETATE INJECTION,
SUSPENSION
SAGENT PHARMACEUTICALS
----------
METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION, USP
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
(NOT FOR INTRAVENOUS USE)
SAGENT
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 per mL, 80 mg per mL.
Each mL of these preparations contains:
Methylprednisolone acetate……………………………………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, USP……………………………..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., 3.5 to 7.0).
The chemical name for methylprednisolone acetate is
pregna-1,4-diene-3,20-dione, 21-
(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11ß)- and the molecular
weight is 416.51.
The structural formula is represented below:
®
Methylprednisolone Acetate Injectable Suspension, USP, sterile aqueous
suspension,
contains methylprednisolone acetate which is the 6-methyl derivative
of prednisolone.
Methylprednisolone acetate 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
practica