METHYLPREDNISOLONE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Quality Care Products, LLC

INN (International Adı):

METHYLPREDNISOLONE

Kompozisyon:

METHYLPREDNISOLONE 4 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Methylprednisolone Tablets 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) Acute rheumatic carditis

Ürün özeti:

Methylprednisolone Tablets are available in the following strengths and sizes: 4 mg (white, oval, quadrisected, imprinted TL 001) 8 mg (white, oval, scored, imprinted TL 002) 16 mg (white, oval shaped, quadrisected, imprinted TL 003) 32 mg (white, oval shaped, quadrisected, imprinted TL 015) They are supplied by Keltman Pharmaceuticals Inc. as follows: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
QUALITY CARE PRODUCTS, LLC
----------
METHYLPREDNISOLONE
TABLETS, USP
DESCRIPTION
Methylprednisolone Tablets 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:
Methylprednisolone tablets, for oral administration, are available as
scored talets in the
following strengths: 4 mg, 8 mg, 16 mg and 32 mg. In addition each
tablet contains the
following inactive ingredients: colloidal silicon dioxide, lactose
anhydrous (4mg and 8mg),
lactose monohydrate (16mg and 32mg), magnesium stearate,
microcrystalline cellulose,
pregelatinized starch, sodium lauryl sulfate, and 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 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