Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
PD-Rx Pharmaceuticals, Inc.
HYDROCORTISONE
HYDROCORTISONE 20 mg
ORAL
PRESCRIPTION DRUG
Hydrocortisone Tablets, USP 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 Nonsuppurative 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
Hydrocortisone Tablets USP, 20 mg: White, Round Scored Tablets; Debossed "West-ward 254" on one side and Scored on the other side. Bottles of 30 Tablets NDC 0143-1254-01 Store at 20° to 25 o C (68° to 77 o F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Abbreviated New Drug Application
HYDROCORTISONE- HYDROCORTISONE TABLET PD-RX PHARMACEUTICALS, INC. ---------- HYDROCORTISONE TABLETS Hydrocortisone Tablets, USP Rev. 10/16 R Only DESCRIPTION Hydrocortisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone, USP is a 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 molecular weight is 362.46. It is designated chemically as pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. The molecular formula is C H O and the structural formula is: Each tablet for oral administration contains 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, Magnesium Stearate, Microcrystalline Cellulose, and Sodium Starch Glycolate. 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, USP 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 x 21 30 5 Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. _Rheumatic Disorders_ As adjunctive therapy for short-term administration (to tide the patient over an acute episode Прочитать полный документ