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Prednisone (Prednisone) - Description and Clinical Pharmacology

 
 



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DESCRIPTION

Each tablet contains:

Prednisone. .. .. .. .. . 1, 2.5, 5, 10, 20, or 50 mg

Each 5 mL oral solution contains:

Prednisone. .. .. .. .. . 5 mg

Alcohol. .. .. .. .. . 5%

Each mL Intensol ™ contains:

Prednisone. .. .. .. .. . 5 mg

Alcohol. .. .. .. .. . 30%

Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The molecular formula for prednisone is C21H26O5. Chemically, it is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione and has the following structural formula:

Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.44. It melts at about 230°C with some decomposition. Prednisone is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 1, 2.5, 5, 10, 20, or 50 mg of prednisone. Prednisone Oral Solution contains 5 mg prednisone per 5 mL, and Prednisone Intensol contains 5 mg prednisone per mL.

Inactive Ingredients:

The tablets contain lactose, pregelatinized starch (corn), microcrystalline cellulose, sodium starch glycolate and magnesium stearate. The 1, 2.5 and 5 mg strengths also contain stearic acid.

The oral solution contains alcohol, citric acid, disodium edetate, fructose, hydrochloric acid, maltol, peppermint oil, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate, vanilla flavor and water. The Intensol™ contains alcohol, citric acid, poloxamer 188, propylene glycol and water.

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, such as prednisone, are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Glucocorticoids, such as prednisone, cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.

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