METHYLPREDNISOLONE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Osta se nyt

Valmisteyhteenveto Valmisteyhteenveto (SPC)
12-09-2019

Aktiivinen ainesosa:

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

Saatavilla:

McKesson Corporation dba SKY Packaging

INN (Kansainvälinen yleisnimi):

METHYLPREDNISOLONE

Koostumus:

METHYLPREDNISOLONE 4 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

Product: 63739-133 NDC: 63739-133-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

                                METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
MCKESSON CORPORATION DBA SKY PACKAGING
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METHYLPREDNISOLONE TABLETS USP
RX ONLY
DESCRIPTION
Methylprednisolone tablets, USP contain methylprednisolone, USP which
is a glucocorticoid.
Glucocorticoids are adrenocortical steroids, both naturally occurring
and synthetic, which are readily
absorbed from the gastrointestinal tract. Methylprednisolone, USP
occurs as a white to practically
white, 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, USP 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, USP for oral administration contains 4
mg of methylprednisolone, USP.
Inactive ingredients: magnesium stearate, microcrystalline cellulose
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 supplementation is of particular importance).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. RHEUMATIC DISORDERS
As adjunctive therapy for short-term administration 
                                
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