METHYLPREDNISOLONE- methylprednisolone tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

NuCare Pharmaceuticals,Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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 68071-4262-1 BOTTLES OF 21 Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
NUCARE PHARMACEUTICALS,INC.
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METHYLPREDNISOLONE TABLETS, USP 4 MG
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 tide the