Prednisone - Prednisone tablet

Prednisone tablets and solutions are indicated in the following conditions:

The initial dosage of prednisone may vary from 5 mg to 60 mg of prednisone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, prednisone should be discontinued and the patient transferred to other appropriate therapy.

Sodium retention

Fluid retention

Congestive heart failure in susceptible patients

Potassium loss

Hypokalemic alkalosis

Hypertension

Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to partially white, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol.

The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:

•  C₂₁H₂₆O₅                         M.W. 358.44

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

PredniSONE Tablets, USP contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg only).

PredniSONE Oral Solution, USP contains alcohol 5% and the following inactive ingredients: anhydrous citric acid, edetate disodium, fructose, hydrochloric acid, maltol, peppermint oil, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate, vanilla flavor and purified water.

PredniSONE

NDC 0054-8739-25: 10x10 Unit-Dose

NDC 0054-4741-25: Bottle of 100 Tablets

NDC 0054-4741-31: Bottle of 1,000 Tablets

NDC 0054-8740-25: 10x10 Unit-Dose

NDC 0054-4742-25: Bottle of 100 Tablets

NDC 0054-8724-25: 10x10 Unit-Dose

NDC 0054-4728-25: Bottle of 100 Tablets

NDC 0054-4728-31: Bottle of 1,000 Tablets

NDC 0054-0017-20: 10x10 Unit-Dose

NDC 0054-0017-25: Bottle of 100 Tablets

NDC 0054-0017-29: Bottle of 500 Tablets

NDC 0054-0018-20: 10x10 Unit-Dose

NDC 0054-0018-25: Bottle of 100 Tablets

NDC 0054-0018-29: Bottle of 500 Tablets

NDC 0054-0019-20: 10x10 Unit-Dose

NDC 0054-0019-25: Bottle of 100 Tablets

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, child-resistant container as defined in the USP/NF.

PROTECT FROM MOISTURE.

NDC 0054-3722-50: Bottle of 120 mL

NDC 0054-3722-63: Bottle of 500 mL

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF.

NDC 0054-3721-44: Bottle of 30 mL with calibrated oral syringe (graduations of 0.25 mL [1.25 mg] to

1 mL [5 mg] on the syringe)

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense only in the bottle and only with the calibrated oral syringe provided.

Discard opened bottle after 90 days.





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