METHYLPREDNISOLONE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Proficient Rx LP

INN (International Name):

METHYLPREDNISOLONE

Sammensetning:

METHYLPREDNISOLONE 4 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Methylprednisolone tablets, USP are indicated in the following conditions: Systemic fungal infections and known hypersensitivity to components.

Produkt oppsummering:

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. 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
PROFICIENT RX LP
----------
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.
INDICATIONS AND USAGE
Methylprednisolone tablets, USP are indicated in the following
conditions:
22
30
5
1.
2.
3.
4.
5.
6.
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
im