PREDNISONE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT)

Beschikbaar vanaf:

McKesson Corporation dba SKY Packaging

INN (Algemene Internationale Benaming):

PREDNISONE

Samenstelling:

PREDNISONE 5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

PredniSONE Tablets are indicated in the following conditions: - 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 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

Product samenvatting:

Product: 63739-518 NDC: 63739-518-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-519 NDC: 63739-519-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-520 NDC: 63739-520-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

PREDNISONE- PREDNISONE TABLET
MCKESSON CORPORATION DBA SKY PACKAGING
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PREDNISONE TABLETS, USP
1 MG, 2.5 MG, 5 MG, 10 MG AND 20 MG
RX ONLY
DESCRIPTION
PredniSONE Tablets contain prednisone which is a glucocorticoid.
Glucocorticoids are
adrenocortical steroids, both naturally occurring and synthetic, which
are readily
absorbed from the gastrointestinal tract. Prednisone is a white to
practically white,
odorless, crystalline powder. It is very slightly soluble in water;
slightly soluble in alcohol,
chloroform, dioxane, and methanol.
The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione
monohydrate,17,21-dihydroxy-. The structural formula is represented
below:
PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg,
10 mg and 20 mg.
_Inactive ingredients:_ 1 mg — colloidal silicon dioxide, lactose
monohydrate, magnesium
stearate, pregelatinized starch, sodium starch glycolate; 2.5 mg —
colloidal silicon
dioxide, lactose monohydrate, magnesium stearate, pregelatinized
starch, sodium
starch glycolate; 5 mg — colloidal silicon dioxide, lactose
monohydrate, magnesium
stearate, pregelatinized starch, sodium starch glycolate; 10 mg —
colloidal silicon
dioxide, lactose monohydrate, magnesium stearate, pregelatinized
starch, sodium
starch glycolate; 20 mg — FD&C Yellow #6 Lake, lactose monohydrate,
magnesium
stearate, microcrystalline cellulose, sodium starch glycolate.
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
PredniSONE Tablets are indicated in the following conditions:
1. ENDOCRINE DISORDERS
Primary or secondary adrenocortical insufficiency (hydr