METHYLPREDNISOLONE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Doc Rx

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 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 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematos

Περίληψη προϊόντος:

Methylprednisolone Tablets, oval and scored, are available in the following strength and package size: 4 mg are white oval tablets with “MP” debossed on one side and quadrisect scored on the other side. NDC 69306-400-21           Blister Pack of 21 tablets (relabeled from NDC 42806-400-21)    Store at controlled room temperature 20° to 25°C (68° to 77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature] Protect from light.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
DOC RX
----------
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:
Each Methylprednisolone tablet for oral administration contains 4mg of
methylprednisolone.
Inactive ingredients: Colloidal Silicon Dioxide, Lactose
Monohydrate-Cellulose
Microcrystalline, Magnesium Stearate, Croscarmellose Sodium.
The USP dissolution test is pending.
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; 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 a