HYDROCORTISONE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Disponible desde:

Aurobindo Pharma Limited

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Hydrocortisone tablets are indicated in the following conditions. 1. 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 Non suppurative thyroiditis Hypercalcemia associated with cancer 2. 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 Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5. 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 6. 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 7. 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 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. 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. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Miscellaneous 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

Resumen del producto:

Hydrocortisone Tablets USP are available in the following strengths and package sizes: Hydrocortisone Tablets USP, 5 mg are white to off-white, round shaped tablets, with score line on one side and debossed with ‘HC5’ on other side.  Bottles of 50                     NDC 59651-413-50 Hydrocortisone Tablets USP, 10 mg are white to off-white, round shaped tablets, with score line on one side and debossed with ‘HC10’ on other side.   Bottles of 100                  NDC 59651-414-01 Hydrocortisone Tablets USP, 20 mg are white to off-white, round shaped tablets, with score line on one side and debossed with ‘HC20’ on other side.  Bottles of 100                 NDC 59651-415-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

HYDROCORTISONE - HYDROCORTISONE TABLET
AUROBINDO PHARMA LIMITED
----------
HYDROCORTISONE TABLETS, USP
RX ONLY
DESCRIPTION
Hydrocortisone Tablets USP contain hydrocortisone which is a
glucocorticoid.
Glucocorticoids are adrenocortical steroids, both naturally occurring
and synthetic,
which are readily absorbed from the gastrointestinal tract.
Hydrocortisone USP is white
to practically white, odorless, crystalline powder with a melting
point of about 215°C. It is
sparingly soluble in acetone and in alcohol; slightly soluble in
chloroform; practically
insoluble in water and in ether.
The chemical name for hydrocortisone is
pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,
(11β)-. Its molecular weight is 362.46 and the structural formula is
as outlined below.
Hydrocortisone tablets USP are available for oral administration in
three strengths: each
tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone USP.
Inactive
ingredients: colloidal silicon dioxide, copovidone, lactose
monohydrate, magnesium
stearate, microcrystalline cellulose, pregelatinized starch (maize)
and sodium starch
glycolate.
FDA approved identification test differs from the USP test.
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 AND USAGE
Hydrocortisone tablets are indicated in the following conditions.
1. 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
Non suppurative thyroiditis