PREDNISONE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Strides Pharma Science Limited

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Prednisone tablets USP 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 in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer. 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; posttraumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis. Collagen Diseases : during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, acute rheumatic carditis. Dermatologic Diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis. Allergic States: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions. Ophthalmic Diseases : severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia. Respiratory Diseases : 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. Hematologic Disorders: idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. Neoplastic Diseases : for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement. In addition to the above indications, prednisone tablets are indicated for systemic dermatomyositis (polymyositis). Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components.

Rezumat produs:

PredniSONE Tablets USP 1 mg - white to off white color, circular, biconvex tablets debossed with "P1" on one side and break line on other side. Store at 20° to 25 °C (68° to 77 °F); excursions permitted to 15° to 30 °C (59° to 86 °F) [see USP Controlled Room Temperature]. Dispense in a tight, child-resistant container as defined in the USP/NF.                                                        PROTECT FROM MOISTURE. Manufactured by: Strides Pharma Science Limited Bengaluru - 562106, India. Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 02/2024

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

PREDNISONE - PREDNISONE TABLET
STRIDES PHARMA SCIENCE LIMITED
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PREDNISONE TABLETS USP
RX ONLY
DESCRIPTION
Prednisone Tablets USP are available for oral administration
containing 1 mg of
prednisone USP. Each tablet contains the following inactive
ingredients: lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
pregelatinized starch
(maize starch), sodium starch glycolate.
Prednisone tablets USP 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 17, 21-
dihydroxypregna-1,4-diene-3,11,20-trione. The structural formula is
represented below:
Prednisone is a white to partially white, crystalline powder. It is
very slightly soluble in
water; slightly soluble in alcohol, chloroform, dioxane, and methanol.
FDA approved dissolution test specifications differ from USP.
CLINICAL PHARMACOLOGY
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 AND USAGE
Prednisone tablets USP 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 in
conjunction with
mineralocorticoids where applicable; in infancy mineralocorticoid
supplementation is of
particular importance), congenital adrenal hyperplasia, nonsuppurative
thyroiditis,
hypercalcemia associated with cancer.
_Rheumatic disorders_: as adjunctive therapy for short-term
administration (to tide the
patient over an acute episode or exacerbation) in: psoriat