METHYLPREDNISOLONE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Köp det nu

Ladda ner Produktens egenskaper (SPC)
18-01-2020

Aktiva substanser:

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

Tillgänglig från:

Ingenus Pharmaceuticals, LLC

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

Methylprednisolone tablets, USP are supplied as follows: 4 mg tablets: White to off-white, elliptical shaped, flat faced bevel edged tablets debossed with "ING" above "615" on one side and double scoreline (quadrisect) on the other side, available in bottles of 100 and unit of use blister packages of 21. Bottles of 100 - NDC 50742-189-01 Unit of use blister packages of 21 tablets - NDC 50742-189-21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in USP with child resistant closure.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

                                METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
INGENUS PHARMACEUTICALS, LLC
----------
METHYLPREDNISOLONE TABLETS, USP
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:
Each methylprednisolone tablet, USP for oral administration contains 4
mg of methylprednisolone, USP.
In addition, each tablet contains the following inactive ingredients:
anhydrous lactose, lactose
monohydrate, pregelatinized starch, microcrystalline cellulose and
magnesium stearate.
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 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 
                                
                                Läs hela dokumentet
                                
                            

Sök varningar relaterade till denna produkt