PREDNISONE- prednisone tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

REMEDYREPACK INC.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 - 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 arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis - Collagen Diseases During an exacerbation or as maintenance therapy in select

Ürün özeti:

PredniSONE Tablets are available in the following strengths and package sizes: 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) Unit dose packages of 100 (10 x 10) NDC 60687-122-01 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) Unit dose packages of 100 (10 x 10) NDC 60687-134-01 20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side) Unit dose packages of 100 (10 x 10) NDC 60687-145-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

PREDNISONE- PREDNISONE TABLET
REMEDYREPACK INC.
----------
PREDNISONE TABLETS, USP
8416621/0518
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
cortisone is the first choice;
sy