METHYLPREDNISOLONE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

STAT Rx USA LLC

INN (Nama Internasional):

METHYLPREDNISOLONE

Komposisi:

METHYLPREDNISOLONE 4 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 orexacerbation) 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 erythema

Ringkasan produk:

Methylprednisolone Tablets are available in the following strengths and package sizes:   4mg (white, oval, quadrisected, imprinted TL 001) Unit of use pack (21 tablets): NDC 16590-149-21 Rx only Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Revised: 03/11

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

METHYLPREDNISOLONE - METHYLPREDNISOLONE TABLET
STAT RX USA LLC
----------
METHYLPREDNISOLONE TABLETS, USP RX ONLY
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 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:
C
H O
Methylprednisolone Tablets, for oral administration, are available as
scored tablets in the following
strengths: 4 mg, 8 mg, 16 mg, and 32 mg. In addition each tablet
contains the following inactive
ingredients: colloidal silicon dioxide, lactose anhydrous (4 mg and 8
mg), lactose monohydrate (16 mg
and 32 mg), magnesium stearate, microcrystalline cellulose,
pregelatinized starch, sodium lauryl sulfate,
and sodium starch glycolate.
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;
22
30
5
synthetic analogs may be used in conjunction with mineralocorticoids
where applicable; in infancy
m