METHYLPREDNISOLONE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Medsource Pharmaceuticals

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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, mineralocorticoids 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 cardit

Каталог на резюме:

Methylprednisolone tablets, USP 4 mg are white, oval-shaped, uncoated, debossed GG 957 on one side and quadrisect scored on the reverse side are supplied as follows: NDC 0781-5022-07 in Unit of Use pack of 21 tablets NDC 0781-5022-01 in bottles of 100 tablets NDC 0781-5022-10 in bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container as defined in the USP. KEEP OUT OF THE REACH OF CHILDREN. The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
MEDSOURCE PHARMACEUTICALS
----------
METHYLPREDNISOLONE TABLETS, USP 4 MG
RX ONLY
DESCRIPTION
Methylprednisolone is a glucocorticoid. Glucocorticoids are
adrenocortical steroids, both naturally
occurring and synthetic, which are readily absorbed from the
gastrointestinal tract. Methylprednisolone
is 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 tablet for oral administration, contains 4 mg
methylprednisolone. In addition,
each tablet contains the following inactive ingredients: lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, and pregelatinized starch.
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,
mineralocorticoids 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 tid