METHYLPREDNISOLONE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Major Pharmaceuticals

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Methylprednisolone tablets are indicated in the following conditions: 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 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 During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis

Dettagli prodotto:

Methylprednisolone tablets USP, are available in the following strengths and package sizes: Methylprednisolone tablets USP, 4 mg are white to off-white, oval-shaped, flat-faced, beveled-edge tablets, debossed with '916' on one side and quadrisect on other side and are supplied as follows: Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6914-61

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
MAJOR PHARMACEUTICALS
----------
METHYLPREDNISOLONE TABLETS, USP
DESCRIPTION
Methylprednisolone tablets contain methylprednisolone which is a
glucocorticoid.
Glucocorticoids are adrenocortical steroids, both naturally occurring
and synthetic,
which are readily absorbed from the gastrointestinal tract.
Methylprednisolone, USP
occurs as a white to practically white, odorless, crystalline powder.
It melts at about
240°C, with some decomposition. It is practically insoluble in water,
sparingly soluble in
ethanol (96 %), in dioxane, in methanol and slightly soluble in
acetone, in methylene
chloride and in chloroform, very slightly soluble in ether.
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
Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32
mg of
methylprednisolone. In addition each tablet contains the following
inactive ingredients:
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
pregelatinized
starch, and sodium starch glycolate.
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
22
30
5
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