METHYLPREDNISOLONE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Physicians Total Care, Inc.

INN (nume internaţional):

METHYLPREDNISOLONE

Compoziție:

METHYLPREDNISOLONE 4 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Methylprednisolone Tablets 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 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 rheum

Rezumat produs:

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 Unit of use blister packages of 21        NDC 54868-6624-1 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. Manufactured for: Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45215 USA 70010609 Rev 12/03

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

METHYLPREDNISOLONE - METHYLPREDNISOLONE TABLET
PHYSICIANS TOTAL CARE, INC.
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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
11β,17,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-
dione and the molecular weight is 374.48. The molecular formula is C
H O . The structural formula
is represented below:
Each Methylprednisolone tablet, 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.
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
22
30
5
mineralocorticoid supplementation is of particular importance).
Congenital adrenal hyperplasia
Nonsuppur