METHYLPREDNISOLONE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

REMEDYREPACK INC.

INN (Mezinárodní Name):

METHYLPREDNISOLONE

Složení:

METHYLPREDNISOLONE 4 mg

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
REMEDYREPACK INC.
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METHYLPREDNISOLONE TABLETS, USP RX ONLY
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:
C
H
O
Methylprednisolone Tablets, for oral administration, are available as
scored tablets 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 (4 mg and 8
mg), lactose monohydrate (16 mg
and 32 mg), magnesium stearate, microcrystalline cellulose,
pregelatinized starch, sodium lauryl sulfate,
and sodium starch glycolate.
CLINICAL PHARMACOLOGY
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
mineralo