METHYLPREDNISOLONE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

NuCare Pharmaceuticals,Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 carditi

Περίληψη προϊόντος:

Methylprednisolone Tablets are available as: 4 mg (white, elliptical, scored, imprinted MEDROL 4) DOSEPAK™ Unit of Use (21 tablets) NDC 68071-2370-1 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Καθεστώς αδειοδότησης:

New Drug Application Authorized Generic

Αρχείο Π.Χ.Π.

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
NUCARE PHARMACEUTICALS,INC.
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METHYLPREDNISOLONE TABLETS, USP
DESCRIPTION
Methylprednisolone tablets are glucocorticoids. 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,
dioxane, and methanol;
slightly soluble in acetone and 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 as follows:
Each tablet contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone.
Inactive ingredients:
4 MG AND 8 MG
16 MG AND 32 MG
Calcium Stearate
Calcium Stearate
Corn Starch
Corn Starch
Lactose
Lactose
Sucrose
Mineral Oil
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
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
episod