METHYLPREDNISOLONE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Preferred Pharmaceuticals, Inc.

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 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

Каталог на резюме:

Methylprednisolone tablets USP, are available in the following strengths and package sizes: Methylprednisolone tablets USP, 4 mg are white to off-white, oval-shaped, flat-faced, beveled-edge tablets, debossed with '916' on one side and quadrisect on other side and are supplied as follows: NDC 68788-7655-02 in unit-of-use cartons of 21 tablets Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
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, USP occurs as a white to
practically white, odorless,
crystalline powder. It melts at about 240°C, with some decomposition.
It is practically insoluble in
water, sparingly soluble in ethanol (96 %), in dioxane, in methanol
and slightly soluble in acetone, in
methylene chloride and in chloroform, very slightly soluble in ether.
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:
C
H O
Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32
mg of methylprednisolone. In
addition each tablet contains the following inactive ingredients:
lactose monohydrate, magnesium
stearate, microcrystalline cellulose, pregelatinized starch, 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 is of particular importance).
Congenital adrenal hyperplasi