METHYLPREDNISOLONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Altura 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: 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

Product summary:

Methylprednisolone Tablets are available as: 4 mg (white, elliptical, imprinted G 3327 on one side and the number 4 on the other) They are supplied by Altura Pharmaceuticals, Inc. as follows: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Authorization status:

New Drug Application

Summary of Product characteristics

METHYLPREDNISOLONE - METHYLPREDNISOLONE TABLET
ALTURA PHARMACEUTICALS, INC.
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METHYLPREDNISOLONE TABLETS, USP
DESCRIPTION
Methylprednisolone tablets are 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 tablet contains 4 mg of methylprednisolone and the following
inactive ingredients: Calcium
Stearate, Corn Starch, Lactose, Mineral Oil, Sorbic Acid, and Sucrose.
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 hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. RHEUMATIC DISORDERS
As adjunctive therapy for short-term administration (to tide the
patient over an acute episode or
exacerbation) in:
Rheumatoid arthritis, includ