METHYLPREDNISOLONE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Keltman Pharmaceuticals Inc.

SNN (starptautisko nepatentēto nosaukumu):

METHYLPREDNISOLONE

Kompozīcija:

METHYLPREDNISOLONE 4 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

Methylprednisolone Tablets are available in the following strengths and sizes: 4 mg (white, oval, quadrisected, imprinted TL 001) 8 mg (white, oval, scored, imprinted TL 002) 16 mg (white, oval shaped, quadrisected, imprinted TL 003) 32 mg (white, oval shaped, quadrisected, imprinted TL 015) They are supplied by Keltman Pharmaceuticals Inc. as follows: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Autorizācija statuss:

New Drug Application

Produkta apraksts

METHYLPREDNISOLONE - METHYLPREDNISOLONE TABLET
KELTMAN PHARMACEUTICALS INC.
----------
METHYLPREDNIS OLONE
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 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:
Methylprednisolone tablets, for oral administration, are available as
scored talets 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 (4mg and
8mg), lactose monohydrate (16mg
and 32mg), magnesium stearate, microcrystalline cellulose,
pregelatinized starch, sodium lauryl sulfate,
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
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 supplementat