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mechanism of action is Corticosteroid Hormone Receptor Agonists [MoA]

Prednisone

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Prednisone Prescribing Information

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.

IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT

. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of prednisone for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

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 5, 10, or 20 mg of prednisone.

Inactive Ingredients:

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

PredniSONE Tablets, USP

5 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 612” debossed on the other side.

NDC 0054-9828-25: Bottle of 100 Tablets

NDC 0054-9828-31: Bottle of 1,000 Tablets

10 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 899” debossed on the other side.

NDC 0054-9817-25: Bottle of 100 Tablets

NDC 0054-9817-29: Bottle of 500 Tablets

20 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 760” debossed on the other side.

NDC 0054-9818-25: Bottle of 100 Tablets

NDC 0054-9818-29: Bottle of 500 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.

Distributed by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

Manufactured by:

Hikma Pharmaceuticals

PO Box 182400, Amman 11118 – Jordan

2INPRDST-E

Revised January 2025

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