METHYLPREDNISOLONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

METHYLPREDNISOLONE

Composition:

METHYLPREDNISOLONE 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methylprednisolone tablets, USP are indicated in the following conditions: - 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 - 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

Product summary:

Methylprednisolone tablets, USP are supplied as follows 4 mg tablets: White to off-white, oval tablets debossed WATSON and 790 on one side and quadrisected on the other side, available in bottles of 100 and unit of use blister packages of 21. NDC 66267-961-21 Store at controlled room temperature 15° to 30°C (59° to 86°F). [See USP.] Dispense in a tight, light-resistant container as defined in USP/NF.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
NUCARE 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 C
H
O
. The
structural formula is represented below:
Each methylprednisolone tablet, USP for oral administration contains 4
mg of methylprednisolone. In
addition, each tablet contains the following inactive ingredients:
anhydrous lactose, croscarmellose
sodium, lactose monohydrate, magnesium stearate, microcrystalline
cellulose, polacrilin potassium,
sodium starch glycolate, and stearic acid.
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.
22
30
5
INDICATIONS AND USAGE
Methylprednisolone tablets, USP 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 import