PREDNISONE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Blenheim Pharmacal, Inc.

DCI (Dénomination commune internationale):

PREDNISONE

Composition:

PREDNISONE 20 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

PredniSONE Tablets USP 1 mg, round, white, scored tablets (Identified 54 092) NDC 0054-8739-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4741-25: Bottles of 100 tablets. NDC 0054-4741-31: Bottles of 1000 tablets. 2.5 mg, round, white, scored tablets (Identified 54 339) NDC 0054-8740-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4742-25: Bottles of 100 tablets. 5 mg, round, white, scored tablets (Identified 54 612) NDC 0054-8724-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4728-25: Bottles of 100 tablets. NDC 0054-4728-31: Bottles of 1000 tablets. 10 mg, round, white, scored tablets (Identified 54 899) NDC 0054-0017-20: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-0017-25: Bottles of 100 tablets. NDC 0054-0017-29: Bottles of 500 tablets. 20 mg, round, white, scored tablets (Identified 54 760) NDC 0054-0018-20: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-0018-25: Bottles of 100 tablets. NDC 0054-0018-29: Bottles of 500 tablets. 50 mg, round, white, scored tablets (Identified 54 343) NDC 0054-0019-20: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-0019-25: Bottles of 100 tablets. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight container, as defined in the USP/NF. PROTECT FROM MOISTURE. PredniSONE Oral Solution USP, 5 mg per 5 mL Clear, colorless solution NDC 0054-8722-16: Unit dose Patient Cup™ filled to deliver 5 mL (5 mg Prednisone), ten 5 mL Patient Cups™ per shelf pack, 4 shelf packs per shipper. NDC 0054-3722-50: Bottles of 120 mL. NDC 0054-3722-63: Bottles of 500 mL. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight container, as defined in the USP/NF. PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL Clear, colorless, slightly viscous solution NDC 0054-3721-44: Bottles of 30 mL with calibrated dropper (graduations of 0.25 mL [1.25 mg] to 1.0 mL [5 mg] on the dropper). Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

PREDNISONE- PREDNISONE TABLET
BLENHEIM PHARMACAL, INC.
----------
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 _Intensol_™ for oral administration contains:
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. 358.43
Pre