Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)
Strides Pharma Inc.
Hydrocortisone
Hydrocortisone 5 mg
ORAL
PRESCRIPTION DRUG
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) - Acut
Hydrocortisone tablets, USP are available in the following strengths and package sizes: 5 mg White to off-white oval tablets debossed on one side with a bisect and other side with "P5". NDC 42543-140-50: Bottles of 50 tablets 10 mg White to off-white oval tablets debossed on one side with a bisect and other side with "P10". NDC 42543-141-01: Bottles of 100 tablets 20 mg White to off-white oval tablets debossed on one side with a bisect and other side with "P20". NDC 42543-142-01: Bottles of 100 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
HYDROCORTISONE- HYDROCORTISONE TABLET STRIDES PHARMA INC. ---------- HYDROCORTISONE TABLETS, USP 5 MG, 10 MG AND 20 MG 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 215º 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, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. 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 th Leggi il documento completo