País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT)
State of Florida DOH Central Pharmacy
PREDNISONE
PREDNISONE 5 mg
ORAL
PRESCRIPTION DRUG
PredniSONE Tablets 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 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 arthriti
PredniSONE Tablets are available in the following strengths and package sizes: 1 mg (white, round, flat-faced, beveled edge, scored, debossed "5084" on one side and debossed "V" on the reverse side) 2.5 mg (white, round, flat-faced, beveled edge, scored, debossed "5085" on one side and debossed "V" on the reverse side) 5 mg (white, round, scored, debossed "5094" on one side and debossed "V" on the reverse side) 10 mg (white, round, scored, debossed "5093" on one side and debossed "V" on the reverse side) 20 mg (peach, round, scored, debossed "5092" on one side and debossed "V" on the reverse side) They are supplied by State of Florida DOH Central Pharmacy as follows:
Abbreviated New Drug Application
PREDNISONE - PREDNISONE TABLET STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- PREDNISONE TABLETS, USP 1 MG, 2.5 MG, 5 MG, 10 MG AND 20 MG RX ONLY DESCRIPTION PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy- and its molecular weight is 358.43. The structural formula is represented below: PREDNISONE TABLETS ARE AVAILABLE IN 5 STRENGTHS: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg. _INACTIVE INGREDIENTS:_ 1 mg – lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg – lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg – colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg – colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg – FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. 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 are indicated in the following conditions: 1. ENDOCRINE DIS Leer el documento completo