Prednisone

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

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 non-specific tenosynovitis

Acute gouty arthritis

Post-traumatic osteoarthritis

Synovitis of osteoarthritis

Epicondylitis

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

Systemic lupus erythematosus

Acute rheumatic carditis

Pemphigus

Bullous dermatitis herpetiformis

Severe erythema multiforme (Stevens-Johnson syndrome)

Exfoliative dermatitis

Mycosis fungoides

Severe psoriasis

Severe seborrheic dermatitis

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

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.

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

Idiopathic thrombocytopenic purpura in adults

Secondary thrombocytopenia in adults

Acquired (autoimmune) hemolytic anemia

Erythroblastopenia (RBC anemia)

Congenital (erythroid) hypoplastic anemia

For palliative management of:

Leukemias and lymphomas in adults

Acute leukemia of childhood

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

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

Ulcerative colitis

Regional enteritis

Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculous chemotherapy

Trichinosis with neurologic or myocardial involvement

Dosage of prednisone tablets 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.

Sodium retention

Fluid retention

Congestive heart failure in susceptible patients

Potassium loss

Hypokalemic alkalosis

Hypertension

Muscle weakness

Steroid myopathy

Loss of muscle mass

Osteoporosis

Tendon rupture, particularly of the Achilles tendon

Vertebral compression fractures

Aseptic necrosis of femoral and humeral heads

Pathologic fracture of long bones

Peptic ulcer with possible perforation and hemorrhage

Pancreatitis

Abdominal distention

Ulcerative esophagitis

Impaired wound healing

Thin fragile skin

Petechiae and ecchymoses

Facial erythema

Increased sweating

May suppress reactions to skin tests

Convulsions

Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment

Vertigo

Headache

Menstrual irregularities

Development of Cushingoid state

Suppression of growth in children;

Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness

Decreased carbohydrate tolerance

Manifestations of latent diabetes mellitus

Increased requirements for insulin or oral hypoglycemic agents in diabetics

Posterior subcapsular cataracts

Increased intraocular pressure

Glaucoma

Exophthalmos

Negative nitrogen balance due to protein catabolism.

Urticaria and other allergic, anaphylactic or hypersensitivity reactions

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

Prednisone, USP is a white or practically white, crystalline powder and has a molecular weight of 358.4 g/mol. It melts at about 234°C. Prednisone, USP is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Prednisone tablets, USP contain 1 mg or 5 mg of prednisone, USP.

The inactive ingredients for prednisone tablets, USP include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate type A and stearic acid.

Meets USP Dissolution Test 2.

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 response to diverse stimuli.