PREDNISONE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

A-S Medication Solutions

INN (mednarodno ime):

PREDNISONE

Sestava:

PREDNISONE 10 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 cancer - Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthriti

Povzetek izdelek:

Product: 50090-1002 Product: 50090-1990 NDC: 50090-1990-5 14 TABLET in a BOTTLE NDC: 50090-1990-7 15 TABLET in a BOTTLE Product: 50090-2136 NDC: 50090-2136-0 30 TABLET in a BOTTLE Product: 50090-2402

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

PREDNISONE- PREDNISONE TABLET
A-S MEDICATION SOLUTIONS
----------
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 (hydrocortisone or