Prednisone (Prednisone) - Indications and Dosage

INDICATIONS AND USAGE

Prednisone tablets and solutions are indicated in the following conditions:

1. 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

2. 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 arthritis (selected cases may require low-dose maintenance therapy)

   Ankylosing spondylitis

   Acute and subacute bursitis

   Acute nonspecific tenosynovitis

   Acute gouty arthritis

   Post-traumatic osteoarthritis

   Synovitis of osteoarthritis

   Epicondylitis

3. Collagen diseases:

   During an exacerbation or as maintenance therapy in selected cases of:

   Systemic lupus erythematosus

   Acute rheumatic carditis

4. Dermatologic diseases:

   Pemphigus

   Bullous dermatitis herpetiformis

   Severe erythema multiforme (Stevens-Johnson syndrome)

   Exfoliative dermatitis

   Mycosis fungoides

   Severe psoriasis

   Severe seborrheic dermatitis

5. Allergic states:

   Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:

   Seasonal or perennial allergic rhinitis

   Serum sickness

   Bronchial asthma

   Contact dermatitis

   Atopic dermatitis

   Drug hypersensitivity reactions

6. Ophthalmic diseases:

   Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:

   Allergic conjunctivitis

   Keratitis

   Allergic corneal marginal ulcers

   Herpes zoster ophthalmicus

   Iritis and iridocyclitis

   Chorioretinitis

   Anterior segment inflammation

   Diffuse posterior uveitis and choroiditis

   Optic neuritis

   Sympathetic ophthalmia

7. Respiratory diseases:

   Symptomatic sarcoidosis

   Loeffler’s syndrome not manageable by other means

   Berylliosis

   Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.

   Aspiration pneumonitis

8. Hematologic disorders:

   Idiopathic thrombocytopenic purpura in adults

   Secondary thrombocytopenia in adults

   Acquired (autoimmune) hemolytic anemia

   Erythroblastopenia (RBC anemia)

   Congenital (erythroid) hypoplastic anemia

9. Neoplastic diseases:

   For palliative management of:

   Leukemias and lymphomas in adults

   Acute leukemia of childhood

10. Edematous states:

    To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

11. Gastrointestinal diseases:

    To tide the patient over a critical period of the disease in:

    Ulcerative colitis

    Regional enteritis

12. Miscellaneous:

    Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.

    Trichinosis with neurologic or myocardial involvement.

    In addition to the above indications, prednisone is indicated for systemic dermatomyositis (polymyositis).

DOSAGE AND ADMINISTRATION

Dosage of prednisone should be individualized according to the severity of the disease and the response of the patient. For infants and children, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight.

Hormone therapy is an adjunct to, and not a replacement for, conventional therapy.

Dosage should be decreased or discontinued gradually when the drug has been administered for more than a few days.

The severity, prognosis, expected duration of the disease, and the reaction of the patient to medication are primary factors in determining dosage.

If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued.

Blood pressure, body weight, routine laboratory studies, including two-hour postprandial blood glucose and serum potassium, and a chest X-ray should be obtained at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with known or suspected peptic ulcer disease.

The initial dosage of prednisone may vary from 5 mg to 60 mg 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 increments 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 recommended that it be withdrawn gradually rather than abruptly.

HOW SUPPLIED

PredniSONE Tablets USP

1 mg white, scored tablets (identified 54 092).

NDC 0054-8739-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.

NDC 0054-4741-25: Bottles of 100 tablets.

NDC 0054-4741-31: Bottles of 1000 tablets.

2.5 mg white, scored tablets (Identified 54 339)

NDC 0054-8740-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.

NDC 0054-4742-25: Bottles of 100 tablets.

5 mg white, scored tablets (Identified 54 612).

NDC 0054-8724-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.

NDC 0054-4728-25: Bottles of 100 tablets.

NDC 0054-4728-31: Bottles of 1000 tablets.

10 mg white, scored tablets (Identified 54 899).

NDC 0054-0017-20: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.

NDC 0054-0017-25: Bottles of 100 tablets.

NDC 0054-0017-29: Bottles of 500 tablets.

20 mg white, scored tablets (Identified 54 760).

NDC 0054-0018-20: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.

NDC 0054-0018-25: Bottles of 100 tablets.

NDC 0054-0018-29: Bottles of 500 tablets.

50 mg white, scored tablets (Identified 54 343).

NDC 0054-0019-20: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.

NDC 0054-0019-25: Bottles of 100 tablets.

Storage and Dispense

Store at 25°C (77°F), excursions permitted to 15° to 30°C [see USP Controlled Room Temperature]. Dispense in a tight container, as defined in the USP/NF.

PredniSONE Oral Solution

5 mg per 5 mL Oral Solution.

NDC 0054-8722-16: Unit dose Patient Cup™ filled to deliver 5 mL (5 mg Prednisone), ten 5 mL Patient Cups™ per shelf pack, 4 shelf packs per shipper.

NDC 0054-3722-50: Bottles of 120 mL.

NDC 0054-3722-63: Bottles of 500 mL.

Storage and Dispense

Store at 25°C (77°F), excursions permitted to 15° to 30°C [see USP Controlled Room Temperature]. Dispense in a tight container, as defined in the USP/NF.

PredniSONE Intensol ™

5 mg per mL Intensol™.

NDC 0054-3721-44: Bottles of 30 mL with calibrated dropper (graduations of 0.25 mL to 1.0 mL on the dropper).

Storage and Dispense

Store at 25°C (77°F), excursions permitted to 15° to 30°C [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP/NF. Discard opened bottle after 90 days.

10002424/02 Revised September 2007

© RLI, 2007