MEDROL- methylprednisole tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Stat Rx USA

INN (nume internaţional):

methylprednisolone

Compoziție:

methylprednisolone 4 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

MEDROL 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 Bullo

Rezumat produs:

MEDROL Tablets are available in the following strengths and package sizes: 2 mg (pink, elliptical, scored, imprinted MEDROL 2)   Bottles of 100                                                   NDC 0009-0049-02 4 mg (white, elliptical, scored, imprinted MEDROL 4)   Bottles of 100                                                   NDC 0009-0056-02   Bottles of 500                                                   NDC 0009-0056-03   Unit dose packages of 100                               NDC 0009-0056-05   DOSEPAK™ Unit of Use (21 tablets)               NDC 0009-0056-04 8 mg (peach, elliptical, scored, imprinted MEDROL 8)   Bottles of 25                                                     NDC 0009-0022-01 16 mg (white, elliptical, scored, imprinted MEDROL 16)   Bottles of 50                                                     NDC 0009-0073-01 32 mg (peach, elliptical, scored, imprinted MEDROL 32)   Bottles of 25                                                     NDC 0009-0176-01 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

MEDROL - METHYLPREDNISOLE TABLET
STAT RX USA
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DESCRIPTION
MEDROL 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:
Each MEDROL Tablet for oral administration contains 2 mg, 4 mg, 8 mg,
16 mg or 32 mg of
methylprednisolone.
Inactive ingredients:
2 MG
4 AND 16 MG
Calcium Stearate
Calcium Stearate
Corn Starch
Corn Starch
Erythrosine Sodium
Lactose
Lactose
Mineral Oil
Mineral Oil
Sorbic Acid
Sorbic Acid
Sucrose
Sucrose
8 AND 32 MG
Calcium Stearate
Corn Starch
F D and C Yellow No.
6
Lactose
Mineral Oil
Sorbic Acid
Sucrose
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
MEDROL 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 asso