PREDNISONE solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
29-05-2015

Aktiv ingrediens:

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

Tilgjengelig fra:

Carilion Materials Management

INN (International Name):

PREDNISONE

Sammensetning:

PREDNISONE 5 mg in 1 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Prednisone tablets and solutions are indicated in the following conditions: 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; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 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. During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acut

Produkt oppsummering:

NDC:68151-0820-8 in a CUP of 1 SOLUTIONS

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

                                PREDNISONE- PREDNISONE SOLUTION
CARILION MATERIALS MANAGEMENT
----------
PREDNISONE TABLETS USP, 1 MG, 2.5 MG, 5 MG, 10 MG, 20 MG, AND 50 MG,
PREDNISONE ORAL SOLUTION USP, 5 MG PER 5 ML AND
PREDNISONE INTENSOL™ ORAL SOLUTION (CONCENTRATE), 5 MG PER ML
RX ONLY
DESCRIPTION
Each tablet for oral administration contains:
Prednisone.............................................................1
mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg
Each 5 mL of oral solution for oral administration contains:
Prednisone...............................................................................................................................
5 mg
Alcohol....................................................................................................................................
5%
Each mL of ™ for oral administration contains: _Intensol_
Prednisone...............................................................................................................................
5 mg
Alcohol....................................................................................................................................
30%
INACTIVE INGREDIENTS
The tablets contain lactose monohydrate, magnesium stearate,
microcrystalline cellulose, pregelatinized
starch and sodium starch glycolate. In addition, the 1 mg, 2.5 mg, and
5 mg tablets also contain stearic
acid.
Prednisone Oral Solution contains alcohol, citric acid, disodium
edetate, fructose, hydrochloric acid,
maltol, peppermint oil, polysorbate 80, propylene glycol, saccharin
sodium, sodium benzoate, vanilla
flavor and water.
Prednisone Intensol contains alcohol, citric acid, poloxamer 188,
propylene glycol and water.
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. The chemical name for prednisone is
pregna-1,4-diene-3,11,20-trione monohydrate,17,21-
dihydroxy-. The structural formula is represented below:
C H O M.W. 35
                                
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