METHYLPREDNISOLONE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)

可用日期:

OAKRUM PHARMA, LLC

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Methylprednisolone tablets, USP are indicated in the following conditions: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis)

產品總結:

Methylprednisolone Tablets, USP are available in the following strength and package sizes: 4 mg (white to off-white, oval tablet, quadrisect and debossed S555 one side and quadrisect on the other side) Bottles of 100                                               NDC 72647-331-01 Unit of use blister packages of 21 tablets    NDC 72647-331-04 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, child-resistant containers as defined in the USP/NF.

授权状态:

Abbreviated New Drug Application

产品特点

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
OAKRUM PHARMA, LLC
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METHYLPREDNISOLONE TABLETS, USP 4 MG
DESCRIPTION
Methylprednisolone tablets, USP contain methylprednisolone which is a
glucocorticoid.
Glucocorticoids are adrenocortical steroids, both naturally occurring
and synthetic,
which are readily absorbed from the gastrointestinal tract.
Methylprednisolone occurs as
a white to practically white, odorless, crystalline powder. It is
sparingly soluble in alcohol,
in dioxane, and in methanol, slightly soluble in acetone, and in
chloroform, and very
slightly soluble in ether. It is practically insoluble in water.
The chemical name for methylprednisolone is
pregna-1,4-diene-3,20-dione, 11,17,21­
trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48.
The structural
formula is represented below:
Each Methylprednisolone tablets, USP for oral administration contains
4 mg of
methylprednisolone. Inactive ingredients: Lactose Monohydrate,
Magnesium Stearate,
Microcrystalline Cellulose, Sodium Starch Glycolate.
ACTIONS
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-
retaining properties, are used as replacement therapy in
adrenocortical deficiency
states. Their synthetic analogs are primarily used for their potent
anti-inflammatory
effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify
the body’s immune responses to diverse stimuli.
INDICATIONS AND USAGE
Methylprednisolone tablets, USP are indicated in the following
conditions:
1. ENDOCRINE DISORDERS
Primary or secondary adrenocortical insufficiency (hydrocortisone or
cortisone is the
first choice; synthetic analogs may be used in conjunction with
mineralocorticoids where
applicable; in infancy mineralocorticoid supplementation is of
particular importance).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. RHEUMATIC DISORDERS
As adjunctive therapy for short-term administration (to t