METHYLPREDNISOLONE- methylprednisolone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

METHYLPREDNISOLONE

Composition:

METHYLPREDNISOLONE 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

MethylPREDNISolone Tablets are indicated in the following conditions: Systemic fungal infections and known hypersensitivity to components.

Product summary:

MethylPREDNISolone Tablets are available in the following strengths and package sizes: 4 mg (white, oval, quadrisect tablets debossed “42/16/V” on one side and debossed “4” on the reverse side)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
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.
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.
2.
3.
4.
5.
6.
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
RHEUMATIC DISORDERS
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