PREDNISONE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Proficient Rx LP

Designació comuna internacional (DCI):

PREDNISONE

Composición:

PREDNISONE 50 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

PredniSONE Tablets USP 50 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 343” debossed on the other side. NDC 63187-243-05 Bottles of 5 tablets NDC 63187-243-07 Bottles of 7 tablets NDC 63187-243-08 Bottles of 8 tablets NDC 63187-243-10 Bottles of 10 tablets NDC 63187-243-15 Bottles of 15 tablets NDC 63187-243-20 Bottles of 20 tablets NDC 63187-243-21 Bottles of 21 tablets NDC 63187-243-30 Bottles of 30 tablets NDC 63187-243-40 Bottles of 40 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. Discard opened bottle after 90 days.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

PREDNISONE- PREDNISONE TABLET
PROFICIENT RX LP
----------
PREDNISONE TABLETS USP, 50 MG
RX ONLY
DESCRIPTION
Each tablet for oral administration contains:
Prednisone.............................................................50
mg
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
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.
CLINICAL PHARMACOLOGY
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-
retaining properties, are used as replacement therapy in
adrenocortical deficiency
21
26
5
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 and solutions 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