PREDNISONE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

DIRECT RX

INN (Medzinárodný Name):

PREDNISONE

Zloženie:

PREDNISONE 5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

- 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: 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 3. Collagen Diseases During an exacer

Prehľad produktov:

PredniSONE Tablets are available in the following strengths and package sizes: 1 mg (white, round, flat-faced, beveled edge, scored, debossed “5084” on one side and debossed “V” on the reverse side) 2.5 mg (white, round, flat-faced, beveled edge, scored, debossed “5085” on one side and debossed “V” on the reverse side) 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) 20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side) 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]. REFERENCES 1. Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases. Philadelphia: WBSaunders Company 1992:1050-1. 2. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63. Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182278 R9/11-R3

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

PREDNISONE- PREDNISONE TABLET
DIRECT RX
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PREDNISONE
DESCRIPTION SECTION
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 — lactose monohydrate, magnesium
stearate,
microcrystalline cellulose, pregelatinized starch, sodium starch
glycolate, stearic acid; 2.5
mg — lactose monohydrate, magnesium stearate, microcrystalline
cellulose,
pregelatinized starch, sodium starch glycolate, stearic acid; 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 SECTION
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 & USAGE
1. ENDOCRINE DISORDERS Primary or secondary adrenocortical
insufficiency
(hydrocortisone or cortisone is the first choice; synthetic analogs
may be used in
conjunction with mineralocorticoid