METHYLPREDNISOLONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Avera McKennan Hospital

INN (International Name):

METHYLPREDNISOLONE

Composition:

METHYLPREDNISOLONE 4 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
AVERA MCKENNAN HOSPITAL
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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
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:
Each MethylPREDNISolone Tablet for oral administration contains 4 mg
methylprednisolone.
Inactive ingredients: magnesium stearate, microcrystalline cellulose
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
mineralocorticoid supplementation is of particular importance).
Congenital adrenal hyperplasia
Hypercalcemia associated with cancer
Nonsuppurative thyroiditis
2. RHEUMATIC DISORDERS
As adjunctive therapy for short-term administration (to tide the
patient over an acute episode or
exacerbation