Dexamethasone (Dexamethasone) - Description and Clinical Pharmacology

Rx only

DESCRIPTION

Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol ™ Oral Solution (Concentrate), 1 mg per mL are for oral administration.

Each tablet contains:

Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg

Each 5 mL of Oral Solution contains:

Dexamethasone....................................................... 0.5 mg

Each mL of Intensol ™ Oral Solution (Concentrate) contains:

Dexamethasone....................................................... 1 mg

Alcohol 30%

Inactive Ingredients

The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg).

The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water.

The Intensol ™ oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water.

Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C₂₂H₂₉FO₅. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is:

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CLINICAL PHARMACOLOGY

Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Glucocorticoids cause varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have sodium-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs including dexamethasone are primarily used for their anti-inflammatory effects in disorders of many organ systems.

At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.