METHYLPREDNISOLONE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

PD-Rx Pharmaceuticals, Inc.

INN (שם בינלאומי):

METHYLPREDNISOLONE

הרכב:

METHYLPREDNISOLONE 4 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

Methylprednisolone tablets, USP are available in the following strengths and package sizes: 4 mg (white, flat faced, oval shaped with a beveled edge. The upper layer is quadrisected and debossed “42/16/V” with the “42/16” above the lengthwise bisect and the “V” in the lower righthand corner. The lower layer is debossed “4”) Dispense in a tight light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
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 (to tide th