PREDNISONE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

QPharma Inc

DCI (Dénomination commune internationale):

PREDNISONE

Composition:

PREDNISONE 10 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) Acute rheumatic carditis Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Acute exacerbations of multiple sclerosis Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement Systemic fungal infections and known hypersensitivity to components.

Descriptif du produit:

PredniSONE Tablets, USP 10 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 899” debossed on the other side. NDC 42708-045-21: Bottle of 21 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, child-resistant container as defined in the USP/NF. Distr. by: Hikma Pharmaceuticals USA Inc. Eatontown, NJ 07724 C50000278/03 Revised December 2020

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

PREDNISONE- PREDNISONE TABLET
QPHARMA INC
----------
PREDNISONE TABLETS, USP
RX ONLY
DESCRIPTION
Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical
steroids, both
naturally occurring and synthetic, which are readily absorbed from the
gastrointestinal
tract. Prednisone, USP is a white to partially white, crystalline
powder. It is very slightly
soluble in water; slightly soluble in alcohol, chloroform, dioxane,
and methanol.
The chemical name for prednisone is
17,21-dihydroxypregna-1,4-dienne-3,11,20-trione.
The structural formula is represented below:
1. C
H
O
M.W. 358.44
Each tablet, for oral administration, contains 1, 2.5, 5, 10, 20, or
50 mg of prednisone.
PredniSONE Oral Solution contains 5 mg prednisone per 5 mL, and
PredniSONE _Intensol_
Oral Solution [Concentrate] contains 5 mg prednisone per mL.
_Inactive Ingredients:_
PredniSONE Tablets, USP contain the following inactive ingredients:
lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
pregelatinized starch,
21
26
5
_TM_
sodium starch glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg
only).
PredniSONE Oral Solution, USP contains alcohol 5% and the following
inactive
ingredients: anhydrous citric acid, edetate disodium, fructose,
hydrochloric acid, maltol,
peppermint oil, polysorbate 80, propylene glycol, saccharin sodium,
sodium benzoate,
vanilla flavor and purified water.
PredniSONE _Intensol™_ Oral Solution (Concentrate) contains alcohol
30% and the
following inactive ingredients: anhydrous citric acid, poloxamer 188,
propylene glycol
and purified water.
ACTIONS
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
Prednisone tab