METHYLPREDNISOLONE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Advanced Rx Pharmacy of Tennessee, LLC

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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, mineralocorticoids 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 erythemat

Dettagli prodotto:

Methylprednisolone tablets, USP 4 mg are white, oval-shaped, uncoated, debossed GG 957 on one side and quadrisect scored on the reverse side are supplied as follows: NDC 80425-0242-02 in Unit of Use pack of 21 tablets Dispense in a tight, light-resistant container as defined in the USP. KEEP OUT OF THE REACH OF CHILDREN. REFERENCES 1Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases. Philadelphia: WBSaunders Company 1992:1050–1. 2 Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954–63. The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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METHYLPREDNISOLONE 4MG TABLET
DESCRIPTION
Methylprednisolone is a glucocorticoid. Glucocorticoids are
adrenocortical steroids, both
naturally occurring and synthetic, which are readily absorbed from the
gastrointestinal
tract. Methylprednisolone is 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 4 mg
methylprednisolone. In addition, each tablet contains the following
inactive ingredients:
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
and pregelatinized
starch (corn).
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, mineralocorticoids supplementation is of
particular importance).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. Rheumatic Disorders
As adjunctive therapy for short-term administration (