METHYLPREDNISOLONE ACETATE injection, suspension METHYLPREDNISOLONE ACETATE injection, suspension

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Par Pharmaceutical, Inc.

Tuyến hành chính:

INTRA-ARTERIAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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: A llergic 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. De rmatologic Diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). E ndocrine 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, hypercalc

Tóm tắt sản phẩm:

Methylprednisolone Acetate Injectable Suspension, USP is a white to off-white suspension and is available in the following strengths and package sizes: NDC No. Strength How Supplied 42023-238-01 200 mg per 5 mL (40 mg per mL) 5 mL multiple dose vial (supplied in a single unit) 42023-239-01 400 mg per 10 mL (40 mg per mL) 10 mL multiple dose vial (supplied in a single unit) 42023-240-01 400 mg per 5 mL (80 mg per mL) 5 mL multiple dose vial (supplied in a single unit) Vial stoppers are not manufactured with natural rubber latex.  Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

METHYLPREDNISOLONE ACETATE- METHYLPREDNISOLONE ACETATE INJECTION,
SUSPENSION
METHYLPREDNISOLONE ACETATE- METHYLPREDNISOLONE ACETATE INJECTION,
SUSPENSION
PAR PHARMACEUTICAL, 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 a sterile
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
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 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
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 primar