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: 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, 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

Product summary:

Methylprednisolone Tablets, USP are available in the following strengths and package sizes:   4mg (White, oval shaped tablets, debossed with "TL 001" on one side and quadrisected on the other side.) Unit of use pack (21 tablets): NDC 68788-4593-2 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: 08/2018 Relabeled By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
METHYLPREDNISOLONE TABLETS, USP RX ONLY
DESCRIPTION
Methylprednisolone Tablets, USP 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, USP, 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.
22
30
5
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 whe