HYDROCORTISONE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Greenstone LLC

INN (Medzinárodný Name):

HYDROCORTISONE

Zloženie:

HYDROCORTISONE 5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Hydrocortisone tablets 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 Non suppurative thyroiditis Hypercalcemia associated with cancer 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 Serum sickness Bronchial asthma Contact dermatitis Atopic dermatitis Drug hypersensitivity reactions 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 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 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

Prehľad produktov:

Hydrocortisone tablets are available in the following strengths and package sizes: 5 mg (white, round, scored, imprinted CORTEF 5) Bottles of 50 NDC 59762-0073-1 10 mg (white, round, scored, imprinted CORTEF 10) Bottles of 100 NDC 59762-0074-1 20 mg (white, round, scored, imprinted CORTEF 20) Bottles of 100 NDC 59762-0075-1 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Stav Autorizácia:

New Drug Application Authorized Generic

Súhrn charakteristických

HYDROCORTISONE- HYDROCORTISONE TABLET
GREENSTONE LLC
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HYDROCORTISONE TABLETS, USP
DESCRIPTION
Hydrocortisone tablets 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 very slightly
soluble in water and in ether; sparingly soluble in acetone and in
alcohol; slightly soluble
in chloroform.
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 are available for oral administration in three
strengths: each
tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone.
Inactive ingredients:
calcium stearate, corn starch, lactose, mineral oil, sorbic acid,
sucrose.
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
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:
Psoriat