METHYLPREDNISOLONE - methylprednisolone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

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: 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 orexacerbation) 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 3.Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus S

Product summary:

Methylprednisolone Tablets are available in the following strengths and package sizes:   4mg (white, oval, quadrisected, imprinted TL 001) Bottles of 100: NDC 59746-001-06 Unit of use pack (21 tablets): NDC 59746-001-03 8mg (white, oval, scored, imprinted TL 002) Bottles of 25:NDC 59746-002-04 Bottles of 100:NDC 59746-002-06 16mg (white, oval-shaped, quadrisected, imprinted TL 003) Bottles of 50:NDC 59746-003-14 32 mg (white, oval-shaped, scored, imprinted TL 015) Bottles of 25:NDC 59746-015-04 Store at 20 to 25° C (68 to 77° F) [see USP Controlled Room Temperature]. Rx only Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Revised: 03/11

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPREDNISOLONE - METHYLPREDNISOLONE TABLET
BRYANT RANCH PREPACK
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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
mine