Prednisone

— THERAPEUTIC CATEGORIES —
  • Corticosteroid-responsive disorders

Prednisone Generic Name & Formulations

General Description

Prednisone 1mg, 2.5mg, 5mg, 10mg, 20mg, 50mg; scored tabs.

Pharmacological Class

Glucocorticoid.

How Supplied

Contact supplier.

Mechanism of Action

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

Prednisone Indications

Indications

Corticosteroid-responsive disorders.

Indications

Prednisone Tablets are indicated for the following conditions:

  • 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

    • Hypercalcemia associated with cancer

    • Nonsuppurative thyroiditis

  • 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

  • Collagen Diseases

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

    • Systemic lupus erythematosus

    • Systemic dermatomyositis (polymyositis)

    • Acute rheumatic carditis

  • Dermatologic Diseases

    • Pemphigus

    • Bullous dermatitis herpetiformis

    • Severe erythema multiforme (Stevens-Johnson syndrome)

    • Exfoliative dermatitis

    • Mycosis fungoides

    • Severe psoriasis

    • Severe seborrheic dermatitis

  • Allergic States – Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:

    • Seasonal or perennial allergic rhinitis

    • Bronchial asthma

    • Contact dermatitis

    • Atopic dermatitis

    • Serum sickness

    • Drug hypersensitivity reactions

  • Ophthalmic Diseases – Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:

    • Allergic corneal marginal ulcers

    • Herpes zoster ophthalmicus

    • Anterior segment inflammation

    • Diffuse posterior uveitis and choroiditis

    • Sympathetic ophthalmia

    • Allergic conjunctivitis

    • Keratitis

    • Chorioretinitis

    • Optic neuritis

    • Iritis and iridocyclitis

  • 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

  • Hematologic Disorders

    • Idiopathic thrombocytopenic purpura in adults

    • Secondary thrombocytopenia in adults

    • Acquired (autoimmune) hemolytic anemia

    • Erythroblastopenia (RBC anemia)

    • Congenital (erythroid) hypoplastic anemia

  • Neoplastic Diseases – For palliative management of:

    • Leukemias and lymphomas in adults

    • Acute leukemia of childhood

  • 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.

  • Gastrointestinal Diseases – To tide the patient over a critical period of the disease in:

    • Ulcerative colitis

    • Regional enteritis

  • Nervous System

    • Acute exacerbations of multiple sclerosis

  • Miscellaneous

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

    • Trichinosis with neurologic or myocardial involvement

Prednisone Dosage and Administration

Adults and Children

See full labeling. Initially 5–60mg daily.

Adults and Children

General

  • Dose requirements are variable and must be individualized according to the disease and patient’s response.

  • Initially 5–60mg daily depending on the specific disease entity being treated.

  • For situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required.

  • Maintain or adjust initial dosage until a satisfactory response is noted.

  • If there is a lack of clinical response after a reasonable period of time, discontinue prednisone and transfer the patient to other appropriate therapy. 

  • Once the patient achieves a favorable response, determine the appropriate maintenance dose by decreasing the initial drug dose in small decrements.

  • Based on changes in clinical status, dosage adjustments may be needed. Patients who are exposed to stressful situations, may need to increase dose of rapidly acting corticosteroids before, during, and after a stressful situation.

  • Gradually withdraw if discontinuing treatment after long-term therapy.

Multiple Sclerosis

  • Treatment of acute exacerbations of multiple sclerosis: Prednisolone 200mg daily for a week followed by 80mg every other day for 1 month have been shown to be effective. (Same dosage range for prednisone and prednisolone.)

Alternate Day Therapy

  • Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.

  • The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.

  • Keep the following in mind when considering alternate day therapy:

    • Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids.

    • Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated.

    • In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable.

    • Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum.

    • As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone).

    • The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).

    • In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed.

    • In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted.

    • Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.

Prednisone Contraindications

Contraindications

Systemic fungal infections. Live vaccines.

Prednisone Boxed Warnings

Not Applicable

Prednisone Warnings/Precautions

Warnings/Precautions

Tuberculosis. Latent amebiasis. Strongyloides infestation. Hypothyroidism. Ocular herpes simplex. Cirrhosis. Renal insufficiency. If exposed to chickenpox or measles, consider prophylactic passive immune therapy. Ulcerative colitis if perforation pending. Peptic ulcer. Diverticulitis. Intestinal anastomoses. Myasthenia gravis. Hypertension. Osteoporosis. Diabetes. Kaposi's sarcoma. Supplement with additional steroids in physiologic stress. Avoid abrupt cessation. May increase risk and mask signs of infection. May cause electrolyte imbalances, adrenocortical insufficiency, psychotic derangements. Alternate, intermittent, or single-daily doses at 8AM minimize adrenal suppression. Use lowest effective dose. Monitor weight, growth, fluid and electrolyte balance. Pregnancy. Nursing mothers.

Warnings/Precautions

  • Increase dose of rapidly acting corticosteroids before, during, and after a stressful situation.

  • May increase the risk of and may cause some signs of infection.

  • Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

  • May cause elevated blood pressure, salt, and water retention, and increased excretion of potassium. May need to restrict dietary salt and administer potassium supplements. All corticosteroids increase calcium excretion.

  • Do not vaccinate against smallpox during corticosteroid therapy. Do not administer other immunization procedures during corticosteroid therapy (esp on high dose) due to the potential risk of neurological complications and a lack of antibody response.

  • Restrict the use of prednisone tablets in active tuberculosis to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate anti-tuberculous regimen.

  • Monitor closely for reactivation of tuberculosis if corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity. Patients should receive chemoprophylaxis during prolonged corticosteroid therapy.

  • Increased risk for infections in children who are taking immunosuppressant drugs. For example, chickenpox and measles can be more serious or even fatal in children on immunosuppressant corticosteroids. Avoid exposure. If exposed, consider therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobin (IVIG), as appropriate. If chickenpox develops, consider treating with antiviral agents.

General Precautions

  • May minimize drug-induced secondary adrenocortical insufficiency by gradual dose reduction. Reinstitutue hormone therapy in any situation of stress occurring during that period. Administer salt and/or mineralocorticoid concomitantly because mineralocorticoid secretion may be impaired.

  • Patients with hypothyroidism or cirrhosis may have an enhanced effect from corticosteroids.

  • Use caution in patients with ocular herpes simplex due to risk for corneal perforation.

  • Use the lowest dose needed to control the condition, and reduce dose when possible, and gradually reduce.

  • Psychic derangements may occur during treatment. Symptoms range from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. 

  • Use caution when using aspirin with corticosteroids in hypoprothrombinemia.

  • Use caution in nonspecific ulcerative colitis if there is a risk for impending perforation, abscess or other pyogenic infection: diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis: and myasthenia gravis.

  • Monitor carefully the growth and development of infants and children on prolonged corticosteroid therapy.

  • For each individual, a risk/benefit decision must be made as to dose and duration of treatment and whether daily or intermittent therapy should be used.

  • Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine.

Pregnancy Considerations

Usage in Pregnancy

  • The use of corticosteroids in pregnancy requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.

  • Carefully observe infants born of mothers who received substantial doses of corticosteroids during pregnancy. Monitor for signs of hypoadrenalism.

Nursing Mother Considerations

  • The use of corticosteroids in nursing mothers require that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.

Other Considerations for Specific Populations

Women of Child-Bearing Potential

  • The use of corticosteroids in women of child-bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.

Prednisone Pharmacokinetics

Metabolism

Hepatic.

Elimination

Renal. Half-life: 2–3 hours.

Prednisone Interactions

Interactions

Barbiturates, hydantoins, rifampin, other hepatic enyzme inducers may decrease effects. Potentiated by ketoconazole, troleandomycin. Excretion of high-dose aspirin increased. Caution with diuretics, digoxin, aspirin in hypoprothrombinemia. Potentiated by oral contraceptives. Monitor oral anticoagulants.

Prednisone Adverse Reactions

Adverse Reactions

HPA axis suppression, increased susceptibility to infection, glaucoma, cataracts, secondary infections, hypokalemia, hypocalcemia, hypernatremia, hypertension, CHF, psychic disorders, myopathy, osteoporosis, peptic ulcer, dermal atrophy, increased intracranial pressure, carbohydrate intolerance.

Prednisone Clinical Trials

See Literature

Prednisone Note

Notes

Formerly known under the brand names Deltasone, Meticorten, Orasone, Paracort.

Prednisone Patient Counseling

Patient Counseling

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice.