Prednisone
Deltasone®, Orasone®, Prednisone by Schein 

Classification 
Description, Mechanism of Action, Pharmacokinetics
Indications
Dosage
Contraindications/Precautions
Drug Interactions
Adverse Reactions
Patient Education
    Prednisone oral solution or syrup
    Prednisone tablets
Costs and Monitoring

Classification:

• Adrenal Agents
• Antiinflammatory Agents
• Biologic Response Modifiers
• Corticosteroids
• Hormones and Hormone Modifiers
• Immunosuppressives
• Musculoskeletal Agents

Description, Mechanism of Action, Pharmacokinetics

Description: Prednisone is the most commonly-prescribed oral corticosteroid. The drug is metabolized in the liver to its active form, prednisolone. Relative to hydrocortisone, prednisone is roughly 4 times as potent as a glucocorticoid. Prednisone is intermediate between hydrocortisone and dexamethasone in duration of action. Prednisone is used in many conditions, including allograft rejection, asthma, systemic lupus erythematosus, and many other inflammatory states. Prednisone has very little mineralocorticoid activity, so it is not used in the management of adrenal  insufficiency unless a more potent mineralocorticoid is administered concomitantly. Prednisone was first approved by the FDA in 1955.

Mechanism of Action: Glucocorticoids are naturally occurring hormones that prevent or suppress inflammation and immune responses when administered at pharmacological doses. At a molecular level, unbound glucocorticoids readily cross cell membranes and bind with high affinity to specific cytoplasmic receptors. This binding induces a response by modifying transcription and, ultimately protein synthesis to achieve the steroid's  intended action. Such actions may include: inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, and suppression of humoral immune responses. Some of the net effects include reduction in edema or scar tissue, as well as a general suppression in immune response. The degree of clinical effect is normally related to the dose administered. The antiinflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, collectively called lipocortins. Lipocortins, in turn, control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of the precursor molecule arachidonic acid. Likewise, the numerous adverse effectsrelated to corticosteroid use are usually related to the dose administered and the duration of therapy.

Pharmacokinetics: Prednisone is rapidly absorbed across the GI  membrane following oral administration. Peak effects can be observed after 1—2 hours. The circulating drug binds extensively to the plasma proteins albumin and transcortin, with only the unbound portion of a dose active. Systemic prednisone is quickly distributed into the kidneys, intestines, skin, liver and muscle. Corticosteroids distribute into the breastmilk and cross the placenta. Prednisone is metabolized by the liver to the active metabolite prednisolone, which is then further metabolized to inactive compounds. These inactive metabolites, as well as a small portionof unchanged drug, are excreted in the urine. The plasma elimination half-life is 1 hour whereas the biological half-life of prednisone is 18—36 hours.


Indications

• acute lymphocytic leukemia (ALL)
• acute respiratory distress syndrome (ARDS)
• Addison's disease
• adrenal hyperplasia
• adrenocortical insufficiency
• allergic conjunctivitis
• amyloidosis†
• angioedema
• ankylosing spondylitis
• anterior segment inflammation
• asthma
• atopic dermatitis
• autoimmune hepatitis†
• Behcet's syndrome†
• berylliosis
• bone pain†
• bursitis
• carpal tunnel syndrome†
• chorioretinitis
• chronic lymphocytic leukemia (CLL)
• corneal ulcer
• Crohn's disease
• dermatitis
• dermatomyositis†
• endophthalmitis†
• epicondylitis
• erythroblastopenia
• gout
• gouty arthritis
• graft-versus-host disease
• headache
• hemolytic anemia
• Hodgkin's disease
• hypercalcemia
• hypoplastic anemia
• idiopathic thrombocytopenic purpura (ITP)
iritis
• juvenile rheumatoid arthritis (JRA)
• keratitis
• kidney transplant rejection prophylaxis
• Loeffler's syndrome
• lupus nephritis
• mixed connective tissue disease†
• multiple myeloma
• myasthenia gravis
• mycosis fungoides
• nephrotic syndrome
• optic neuritis
• osteoarthritis
• pemphigus
• pericarditis†
• pneumonia†
• pneumonitis
• polyarteritis nodosa†
• polychondritis†
• polymyositis
• psoriasis
• rheumatic carditis
• rheumatoid arthritis
• sarcoidosis
• severe pain
• Stevens-Johnson syndrome
• systemic lupus erythematosus (SLE)
• temporal arteritis†
• tenosynovitis
• thrombocytopenia
• thyroiditis
• tuberculosis
• ulcerative colitis
• urticaria
• uveitis
• Wegener's granulomatosis†

†non-FDA-approved indication

Dosage

Equivalent Glucocorticoid dosages. These are general approximations and may not apply to all diseases or routes of administration.
Equivalent glucocorticoid dosages:
Cortisone--25 mg
Hydrocortisone--20 mg
Prednisolone--5 mg
Prednisone--5 mg
Methylprednisolone--4 mg
Triamcinolone--4 mg
Dexamethasone--0.75 mg
Betamethasone--0.6 mg

For maintenence therapy (i.e., replacement therapy) o= f primary (Addison's disease) or secondary adrenocortical insufficiency:
Oral dosage:
Adults: Prednisone 5 mg PO in the AM, and 2.5 mg PO in the PM. Hydrocortisone and cortisone are the preferred agents for these conditions; prednisone has little to no mineralocorticoid properties. For acute conditions, parenteral therapy is recommended initially.
Children: Prednisone 4—5 mg/m2 PO 1—4 times per day. Hydrocortisone and cortisone are the preferred agents for these conditions; prednisone has little to no mineralocorticoid properties. For acute conditions, parenteral therapy is recommended initially.

For the treatment of congenital adrenal hyperplasia (NOTE: hydrocortisone is the preferred glucocorticoid in infants):
Oral dosage:
Adults: 2.5—5 mg PO once daily at bedtime.
Children: 12—13 mg/m2/day PO administered in 2—3 divided doses.

For kidney transplant rejection prophylaxis:
Oral dosage:
Adults: Dosage is titrated to response. Usual dosage ranges from 5—30 mg PO once daily.
For acute graft-versus-host disease prophylaxis in recipients of a allogeneic bone marrow transplant:
Oral dosage:
Adults: 1—2 mg/kg/day PO administered in divided doses.[531]

For palliative management of lymphocytic leukemia:
for palliative management of acute lymphocytic leukemia (ALL):

Oral dosage:
Adults: 40—50 mg/sq.m. PO once daily indefinitely.
for palliative management of chronic lymphocytic leukemia (CLL) in combination with chlorambucil:
Oral dosage:=
Adults: 80 mg (prednisone) PO once daily on days 1—5. Adm= inister every 2 weeks. OR: 1 mg/kg/day PO on days 1—7, then 0.5 mg/k= g/day PO on days 8—14, then DC. Repeat cycle every 6 weeks.

For the short-term treatment of hypercalcemia secondary to neoplastic disease:
Oral dosage:
Adults: 50—100 mg/day PO for 3—5 days are usually effective in controlling hypercalcemia due to hematologic cancers, lower doses may be effective in some tumor types.[532]

For the treatment of multiple myeloma in combination with an alkylating agent:
Oral dosage:
Adults: 25—60 mg/m2 PO per day for 4 to 7 days; administered in combination with the appropriate dosage regimen of an alkylating agent. This cycle is repeated every 4 to 6 weeks. NOTE: Other multi-drug regimens that include prednisone have been used.

For the treatment of inflammatory bowel disease:
•for short-term treatment of acute  exacerbations of Crohn's disease:
Oral dosage:
Adults: Therapy with corticosteroids in the treatment of Crohn's disease is more effective for small-bowel involvement than for colonic involvement Because of the potential complications of steroid use in this disease, steroids should be used selectively and in the lowest dose possible. Therapy is usually started at 40—60 mg/day PO. Adjust the dose based on response. Although there is no evidence that maintenance therapy prevents recurrences, a substantial percentage of patients will require chronic, low-dose (e.g., 5—15 mg/day) therapy.
for short-term treatment of acute exacerbations of ulcerative colitis:
Oral dosage:
Adults: Therapy is usually started at doses of 40—60 mg/day PO which have been shown to be superior to 20 mg/day PO. Maximum daily dosage is 1 mg/kg/day PO. Improvement is usually noted after 7—10 days. The dose is then tapered over the next 2—3 months and discontinued. Once clinical remission is achieved, corticosteroid therapy should be discontinued since there is no evidence that maintenance therapy prevents recurrences.

For the treatment of serious manifestations of Behcet's syndrome†:
Oral dosage:
Adults: A dosage of 1 mg/kg PO once daily is recommended in internal medicine texts.

For the treatment of rheumatic conditions such as rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), severe psoriasis and psoriatic arthritis, ankylosing spondylitis, acute and subacute bursitis, acute non-specific tenosynovitis, acute gouty arthritis and gout, osteoarthritis, or epicondylitis:
Oral dosage:
Adults:  Dosage is titrated to response. Usual dosage ranges 5—30 mg PO once daily.
Children: 0.05—2 mg/kg/day PO in 1—4 divided doses.

For adjunctive therapy in the treatment of carpal tunnel syndrome†:
NOTE: The definitive treatment for median-nerve entrapment is surgery. Corticosteroids are temporary measures; patients who have intermittent pain and paresthesias without any fixed motor-sensory deficits may respond to conservative therapy.
Oral dosage:
Adults: 20 mg PO daily for 2 weeks, followed by 10 mg PO daily for an additional 2 weeks, has provided relief.

For the treatment of selected cases of collagen disorders and mixed connective tissue disease†:
•for the treatment of systemic lupus erythematosus (SLE)
:
Oral dosage:
Adults: Doses of prednisone for the treatment of various manifestations of SLE vary widely. Doses can range from as low as 5—10 mg/day for maintenance therapy to as high as 1—2 mg/kg/day PO once daily for more acute situations.
• for the treatment of lupus nephritis† in combination with cytotoxic agents (e.g., azathioprine, cyclophosphamide, chlorambucil):
Oral dosage:
Adults: Low to intermediate doses of prednisone (e.g., 0.25 mg/kg/day) are usually adequate for patients with mesangial or mild focal proliferative glomerulonephritis.[997] In patients with diffuse proliferative or severe focal proliferative glomerulonephritis, doses of 1 mg/kg/day for 2 months followed by a gradual tapering have been recommended.[997] In combination with azathioprine or cyclophosphamide,  doses of 60 mg PO once daily have been used. Prednisone should be tapered over a 6 month period to 30—60 mg once every other day.[213] In a comparison of oral prednisone and cytotoxic agents, prednisone was inferior to cytotoxic agents in ability to prevent decline in renal function. In this study, prednisone was dosed at 1 mg/kg/day for the first 4—8 weeks, followed by gradual tapering as tolerated.[670] Some clinicians believe that chronic renal failure is cause to discontinue therapy since serum creatinine concentrations > 3—4 mg/dL suggest limited probability of reversibility.[213]
•for the treatment of systemic dermatomyositis† (polymyositis†) in combination with azathioprine:
Oral dosage:
Adults: Initially, large doses of prednisone are used (e.g., 60 mg PO once daily), once the muscle disease is controlled, prednisone should be tapered to 5—10 mg PO every other day.[213]
for the treatment of nonrheumatic† or rheumaticcarditis, polymyalgia rheumatica†, polyarteritis nodosa†, relapsing polychondritis†, temporal arteritis†, or vasculitis†:
Oral dosage:
Adults: Dosage is titrated to response. Usual dosage ranges 5—30 mg PO once daily (range 5—60 mg PO daily, depending upon disease being treated). Drug can be administered in 1—4 divided doses. Depending on the indication for use, the initial dose may be gradually tapered after 1—2 weeks and discontinued by 4—6 weeks, as guided by the patient's symptoms.
Children: 0.05—2 mg/kg/day PO in 1—4 divided doses.

For the treatment of Wegener's granulomatosis† in combination with cyclophosphamide:
Oral dosage:
Adults: Initially, 15 mg PO four times per day in combination with cyclophosphamide. After 5—7 days, dose should be tapered to single daily dose, then to alternate day therapy; prednisone should be totally discontinued after 4—8 weeks.[213]

For the treatment of autoimmune hepatitis†:
Oral dosage:
Adults: Initially, a dose of 20—30 mg PO once daily has been recommended for autoimmune hepatitis. Some physicians elect to begin therapy with a combination of prednisone and azathioprine. For maintenance therapy, prednisone doses of 5—15 mg PO once daily have been recommended.[1164]

For the treatment of primary amyloidosis† not associated with familial Mediterranean fever:
Oral dosage:
Adults: A 1997 study demonstrated superior results with a combination of melphalan and prednisone than with colchicine alone in the treatment of primary amyloidosis. In this study, prednisone was dosed as 0.8 mg/kg PO once daily for 1 week (e.g., 7 days) every 6 weeks.[1366]

For the treatment of other systemic autoimmune conditions such as acquired hemolytic anemia, congenital hypoplastic anemia, mycosis fungoides, pemphigus, symptomatic sarcoidosis, or nonsuppurative thyroiditis:
Oral dosage:
Adults: Dosage is titrated to response. Usual dosage ranges 5—30 mg PO once daily.

For the treatment of asthma:
for the treatment of a  moderate-severe asthma exacerbation in the emergency department or the hospital:
Oral dosage:
Adults: The National Asthma  Education and Prevention Program Expert Panel recommends 120—180 mg/ day PO in 3—4 divided doses for 48 hours, then 60—80 mg/day PO until the peak expiratory flow (PEF) reaches 70% of predicted or personal best.[1515]
Children: The National Asthma Education and Prevention Program Expert Panel recommends 1 mg/kg PO every 6 hours for 48 hours, then 1—2 mg/kg/day (max: 60 mg/day) PO in 2 divided doses until peak expiratory flow (PEF) reaches 70% of predicted or personal best.[1515]
for the treatment of an acute asthma exacerbation on an outpatient basis in selected patients:
Oral dosage:
Adults: The National Asthma Education and Prevention Program Expert Panel recommends 40—60 mg PO as a single dose or in 2 divided doses for 3—10 days.[1515]
Children: The National Asthma Education and Prevention Program Expert Panel recommends 1—2 mg/kg/day (max:  60 mg/day) PO as a single dose or in 2 divided doses for 3—10 days.[1515]
for long-term prevention of symptoms in severe persistent asthma:
Oral dosage:
Adults and children: The National Asthma Education and Prevention Program Expert Panel recommends 7.5—60 mg PO administered once daily in the morning or every other day (alternate day therapy may produce less adrenal suppression). Taper to the lowest effective dose. If prednisone is administered once daily, one study indicates that it may be more effective to give the dose in the afternoon at 3:00 pm, with no increase in adrenal suppression.[1943]

For the treatment of thrombocytopenia:
•in patients = with chronic idiopathic thrombocytopenic purpura (ITP):
Oral dosage:
Adults: 1 mg/kg PO once daily has been recommended as a typical initial dosage[533] however, lower doses of 5—10 mg/day PO are preferable for long-term treatment.[1342]
for the treatment of autoimmune thrombocytopenia associated with SLE:
Oral = dosage:
Adults and children: A comparative study revealed that prednisone in doses of 0.25 mg/kg/day were as effective as higher doses of 1 mg/kg/day.[997]

For the treatment of acute, severe urticaria or angioedema associated with systemic symptoms in patients who fail to respond to epinephrine or histamine blockers including angioedema associated with ACE inhibitor therapy:
Oral dosage:
Adults: Short courses of 30—50 mg/day can be given PO during the late phase of an acute reaction.[570]

For the treatment of myasthenia gravis in patients who are poorly controlled with cholinesterase inhibitor therapy:
Oral dosage:
Adults: Initiate therapy with 15—20 mg/day PO. Increase by 5 mg every 2—3 days as needed up to a maximum of 60 mg/day PO. Then change to every other day therapy.[540]

For the treatment of idiopathic or viral pericarditis†:
Oral dosage:
Adults: 20—80 mg PO once daily. NOTE: Use of corticosteroids are contraindicated in pericarditis after myocardial infarction; corticosteroids retard myocardial scar formation and the incidence of rupture may increase.

For the treatment of nephrotic syndrome:
Oral dosage:
Adults: 40—80 mg/day PO until urine is protein-free, then slowly taper as indicated. Some patients may require long-term dosing.
Children: 2 mg/kg/day or 60 mg/m2/day (maximum 80 mg) PO once daily until urine is protein-free for 3 consecutive days (maximum 28 days). Then 1—1.5 mg/kg or 40 mg/m2 PO every other day for 4 weeks. If needed, the long-term maintenance dose is 0.5—1 mg/kg PO every other day for 3—6 months.[1944]

For the treatment of Stevens-Johnson syndrome:
Oral dosage:
Adults: NOTE: Use of corticosteroids in the treatment of Stevens-Johnson syndrome is controversial.[534] Hydrocortisone equivalents of 240—1000 mg/day have been recommended, however, administration of high-dose corticosteroids have been associated with decreased survival.[535] (Prednisone doses of 60—250 mg/day are equivalent to hydrocortisone doses of 240—1000 mg/day.)

For adjunctive treatment in selected cases of pnuemonia† or pneumonitis:
•for adjunctive treatment of AIDS-associated Pneumocystis carinii pneumonia† (PCP):

Oral dosage:
Adults: For adjunctive treatment in acute AIDS-associated Pneumocystis carinii pneumonia (PCP), give 40 mg PO twice daily for 5 days, then 40 mg PO daily for 5 days, then 20 mg PO daily for 11 days, during anti-infective therapy. In such cases, prednisone should be started within 24—72 hours of the initiation of anti-infective therapy for PCP. Use of corticosteroids in this manner is associated with improved outcomes in patients with PCP.
Children: Safe dosage has not been established.
•for adjunctive treatment of aspiration pneumonitis:
Oral dosage:
Adults: 5—60 mg PO daily. Drug can be administered in 1—4 divided doses. The initial dose may be gradually tapered after 1—2 weeks and discontinued by 4—6 weeks, as guided by the patient's symptoms.
Children: 0.14—2 mg/kg PO daily or 4—60 mg/m2 PO daily, given in 4 divided doses. The initial dose may be gradually tapered after 1—2 weeks and discontinued by 4—6 weeks, as guided by the patient's symptoms.

For the systemic treatment of ophthalmic inflammatory conditions such as endophthalmitis†, optic neuritis, allergic conjunctivitis, keratitis, allergic corneal ulcers, iritis, chorioretinitis, anterior segment inflammation, uveitis, choroiditis, sympathetic ophthalmia (NOTE: Topically applied corticosteroids are as effective as systemic corticosteroids for anterior ocular inflammation):
Oral dosage:
Adults: 5—60 mg PO daily, depending upon disease being treated. Drug can be administered in 1—4 divided doses.
Children:
0.14—2 mg/kg PO daily or 4—60 mg/m2 PO daily, given in 4 divided doses.

For the short-term treatment of acute, severe headache:
Oral dosage:
Adults: 80 mg PO per day for several days.[351] Taper rapidly.

For the adjunctive management of severe pain associated with bone pain†, brain metastases and epidural spinal cord compression:
Oral dosage:
Adults:
10—50 mg/day PO has been used for the management of bone pain. A dosage range of 40—80 mg/day PO has been suggested for the management of spinal cord compression.[1171]

For the treatment of the acute respiratory distress syndrome (ARDS) in patients with sever e disease and no signs of improvement 7—14 days after onset of the condition:
Oral dosage:
Adults: Use of corticosteroids in ARDS is controversial. In patients with severe disease and no signs of improvement, Kollef et al recommend a prednisone-equivalent dose of 2—4 mg (prednisone)/kg/day for 7—14 days.[564] They recommend that corticosteroids not be used in patients at risk of ARDS (i.e., for prophylaxis) or in patients during the first several days of the disease. They also recommend that corticosteroids not be used routinely during the latter phase of the disease unless there is no sign of improvement.

For the treatment of other conditions not listed above including atopic dermatitis, Loeffler's syndrome, berylliosis, erythroblastopenia, or trichinosis:
Oral dosage:
Adults: 5—60 mg PO daily, depending upon disease being treated. Drug can be administered in 1—4 divided doses. Depending on the indication for use, the initial dose may be gradually tapered after 1—2 weeks and discontinued by 4—6 weeks, as guided by the patient's symptoms.
Children:  0.14—2 mg/kg PO daily or 4—60 mg/m2 PO daily, given  in 4 divided doses. Depending on the indication for use, the initial dose may be gradually tapered after 1—2 weeks and discontinued by 4—6 weeks, as guided by the patient's symptoms.

For the treatment of tuberculosis† meningitis or pulmonary tuberculosis† controlled by appropriate antituberculosis chemotherapy:
Oral dosage:
Adults: 5—60 mg PO daily, depending upon disease being treated. Drug can be administered in 1—4 divided doses. For tuberculosis meningitis, many experts recommend the use of corticosteroids in stage 2 (confusion or the presence of focal neurological defects) or stage 3 (stuporous or dense paraplegia or hemiplegia) disease, beginnning with prednisone 60—80 mg PO once daily. Alternatively, initial doses of  0.5—1 mg/kg/day PO have been used in patients with stage 1, 2, or 3  tuberculosis meningitis.[1945] The initial dose may be gradually tapered  after 1—2 weeks and discontinued by 4—6 weeks, as guided by the patient's symptoms.
Children: 0.14—2 mg/kg PO daily or 4—60 mg/m2 PO daily, given in 4 divided doses.

For palliative management of Hodgkin's disease in combination with antineoplastic agents:
•for palliative management of Hodgkin's disease in combination with mechlorethamine, vincristine, vinblastine, and procarbazine (MVVPP chemotherapy regimen)
:
Oral dosage:
Adults: 40 mg/m2 PO on days 1—22, then taper. Chemotherapy cycle is repeated every 57 days.
•for palliative management of Hodgkin's disease in combination with mechlorethamine, vincristine, procarbazine, doxorubicin, bleomycin, and vinblastine (MOPP/APB chemotherapy regimen):
Oral dosage:
Adults: 40 mg/m2 PO on days 1—14. Chemotherapy cycle is repeated every 28 days.

Maximum Dosage Limits:
Dosage must be individualized and is highly variable depending on the nature and severity of the disease, and on patient response. Although there is no absolute maximum dosage, the Boston Collaborative Drug Study found that psychiatric events occurred in fewer than 1% of patients when prednisone was prescribed in doses of 30 mg/day or less, whereas the incidence rose to 18% in patients receiving 80 mg/day.[243]

Patients with hepatic impairment:

Specific guidelines for dosage adjustments in hepatic impairment are not available; prednisone is converted to prednisolone, the active moeity, by the liver. The use of oral prednisolone instead of oral prednisone may be preferred in patients with significant hepatic dysfunction (see Prednisolone monograph); dosages are considered equivalent (i.e., 1 mg prednisone is equivalent to 1 mg of prednisolone).

Patients with renal impairment:
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

†non-FDA-approved indication


Administration Guidelines

NOTE: Dosage must be individualized and is highly variable depending on the nature and severity of the disease, and on patient response. If therapy is continuous for more than several days, withdrawal should generally be gradual.

Oral Administration
All oral dosage forms: Administer with meals to minimize indigestion or GI irritation. If given once daily or every other day, administer in the morning to coincide with the body's normal cortisol secretion.
Oral solution or syrup: Administer using a calibrated measuring device= for accurate measurement of the dose.


Contraindications/Precautions

abrupt discontinuation
• breast-feeding
• cataracts
• children
• coagulopathy
Cushing's syndrome
• diabetes mellitus
• diverticulitis
fungal infection
• GI disease
• glaucoma
• heart failure
• hepatic disease
• herpes infection
• hypertension
• hypothyroidism
• infection
• inflammatory bowel disease
measles
• myasthenia gravis
• myocardial infarction
• osteoporosis
• peptic ulcer disease
• psychosis
• renal disease
• seizure disorder
• surgery
• thromboembolic disease
• tuberculosis
• ulcerative colitis
• vaccination
varicella
• viral infection
• visual disturbance

Absolute contraindications are in italics.

The manufacturers state that prednisone is contraindicated in patients with systemic fungal infection, but many clinicians believe that corticosteroids can be administered to patients with any type of known infection as long as appropriate antifungal therapy is administered simultaneously.

Corticosteroid therapy can mask the symptoms of infection and should not be used in cases of viral infection or bacterial infection which are not adequately controlled by anti-infective agents. Secondary infections are common during corticosteroid therapy. Corticosteroids may reactivate tuberculosis, and should not be used in patients with a history of active tuberculosis except when chemoprophyl axis is instituted concomitantly. Patients receiving immunosuppressive doses of corticosteroids should be advised to avoid exposure to measles or varicella, and if exposed to these diseases, to seek medical advice immediately. In general, corticosteroids should not be used in patients with herpes infection.

Patients should be instructed to notify their physician immediately if signs of infection or injury occur, both during treatment, or up to 12 months following cessation of therapy.  Dosages should be adjusted, or glucocorticoid therapy reintroduced, if required. If surgery is required, patients should advise the attending physician of the corticosteroid they have received within the last 12 months, and the disease for which they were being treated. Identification cards  which include the name of the patient's disease, the currently administer ed type and dose of corticosteroid, and the patient's physician should be carried with the patient at all times.

Corticosteroid therapy has been associated with left ventricular free-wall rupture in patients with recent myocardial infarction, and should therefore be used cautiously in these patients.

Corticosteroids cause edema, which may exacerbate congestive heart failure or hypertension, and should be used with caution in these patients.

Corticosteroids should be used cautiously in  patients with glaucoma or other visual disturbance. Corticosteroids are well known to cause cataracts and can exacerbate glaucoma during long-term administration. Patients receiving topical or systemic corticosteroids chronically should be periodically assessed for cataract formation.

Corticosteroids should be used with caution in patients with GI disease, diverticulitis, intestinal anastomosis (because of the possibility of perforation), or hepatic disease causing hypoalbuminemia such as cirrhosis. While used for the short-term treatment of acute exacerbations of chronic inflammatory bowel disease such as ulcerative colitis and Crohn's disease, corticosteroids should not be used in patients where there is a possibility of impending GI perforation, abscess, or pyogenic infection. Some patients may require long-term corticosteroid therapy to suppress disease activity, but generally this practice is not recommended. Corticosteroids should not be used in patients with peptic ulcer disease except under life-threatening circumstances.

Corticosteroids should be used with extreme caution in patients with psychosis, emotional instability, herpes simplex ocular infections, renal disease, osteoporosis, diabetes mellitus, and seizure disorder, because the drugs may exacerbate these conditions. Patients with hypothyroidism may have an exaggerated response to corticosteroids, thus any steroid should be used with caution in these patients.

Glucocorticoids should be used with caution in patients with myasthenia gravis who are being treated with anticholinesterase agents (see Interactions). Muscle weakness may be transiently increased during the initiation of glucocorticoid therapy in patients with myasthenia gravis,  necessitating respiratory support.

Glucocorticoids may rarely increase blood coagulability and cause intravascular thrombosis, thrombophlebitis, and thromboembolism. Therefore, corticosteroids should be used with caution in patients with coagulopathy or thromboembolic disease.

Increased dosages of rapid-acting corticosteroids may be necessary for patients undergoing physiologic stress, such as major surgery, acute infection, or blood loss. The corticosteroid should be administered before, during, and after the stressful situation.

Complications including cleft palate, still birth, and premature abortion have been reported when corticosteroids were administered during pregnancy. If these drugs must be used during pregnancy, the potential risks should be discussed with the patient. Babies born to women receiving large doses of corticosteroids during pregnancy should be monitored for signs of adrenal insufficiency and appropriate therapy initiated, if necessary. Prednisone is classified as category B but cortisone is classified as pregnancy category D. This probably reflects the fact that cortisone is more commonly used during pregnancy than is prednisone and therefore, more reports of problems have been associated with cortisone than prednisone and not the fact that it is a more potent teratogen. Corticosteroids distribute into breast milk, and the manufacturer states that women receiving pharmacological dosages of corticosteroids should not practice breast-feeding.

Corticosteroid therapy usually does not contraindicate vaccination with live-virus vaccines when such therapy is of short-term (< 2 weeks); low to moderate dose;  long-term alternate day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or via topical administration (skin or eye), by aerosol, or by intra-articular, bursal or tendon injection. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live-virus vaccines. In general, patients with severe immunosuppression due to large doses of corticosteroids should not receive vaccination with live-virus vaccines. When cancer chemotherapy or immunosuppressive therapy is being considered (e.g., for patients with Hodgkin's disease or organ transplantation), vaccination should precede the initiation of chemotherapy or immunotherapy by >2 weeks. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy. In patients who have received high-dose, systemic corticosteroids for >2 weeks, it is recommended to wait at least 3 months after discontinuation of therapy before administering a live-virus vaccine.

Prolonged therapy with corticosteroids should be avoided in children, as the drug may retard bone growth. Children receiving corticosteroids are immunosuppressed, and are therefore more susceptible to infection. Normally innocuous infections can become fatal in these children, and care should be taken to avoid exposure to these diseases.

As glucocorticoids can produce or aggravate Cushing's syndrome, glucocorticoids should be avoided in patients with Cushing's disease.

Pharmacologic doses of corticosteroids administered for prolonged periods may result in hypothalamic-pituitary-adrenal (HPA) suppression. Acute adrenal insufficiency and even death may occur following abrupt discontinuation. Withdrawal from prolonged oral corticosteroid therapy should be gradual; HPA suppression can last for up to 12 months following cessation of therapy, and patients may need supplemental corticosteroid treatment during periods of physiologic stress, such as surgery, acute blood loss, or infection, even after the drug has been discontinued. Also, a non-HPA withdrawal syndrome may occur following abrupt discontinuation of corticosteroid therapy, and is apparently unrelated to adrenocortical insufficiency. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels (see Adverse Reactions).


Drug Interactions

 
 • Amphotericin B
Anticoagulants
Antidiabetic Agents
Antithyroid agents
Barbiturates
Cholinesterase Inhibitors
 • Digoxin
Diuretics
 • Dofetilide
Estrogens
 • Isoproterenol
 • Mifepristone, RU-486
Neuromuscular blockers
 • Nevirapine
Nonsteroidal antiinflammatory drugs (NSAIDs)
 • Phenytoin
 • Porfimer
 • Rifabutin
 • Rifampin
 • Ritonavir
Salicylates
Thyroid hormones
Toxoids
Vaccines

Hepatic microsomal enzyme inducers including barbiturates, phenytoin, rifabutin and rifampin may increase the metabolism of glucocorticoids. Rifabutin and rifampin are particularly potent enzyme inducers. Despite the fact that prednisone is converted in the liver to its active form, prednisolone, prednisolone is also metabolized by the liver and susceptible to accelerated clearance if any of these drugs are added. Dosages of prednisone may require adjustment if these agents, especially rifabutin or rifampin, are initiated or withdrawn during therapy.

Estrogens may increase the concentration of transcortin, thus reducing the amount of unbound cortisone. In addition, estrogens have been shown to decrease the clearance of prednisolone. Since prednisone is metabolized to prednisolone, this interaction should also apply to prednisone. Therefore, the effects of corticosteroids may be altered by the concurrent administration of estrogen, requiring the adjustment of corticosteroid dosages if estrogen is added to or withdrawn during therapy.

The risk of GI ulceration from nonsteroidal anti-inflammatory drugs (NSAIDs) may be increased with corticosteroid therapy. Aspirin, ASA should be used with caution in patients with hypoprothrombinemia who are also receiving corticosteroids. Serum salicylate levels may increase when corticosteroid therapy is discontinued, possibly due to a decrease in corticosteroid-induced metabolism of salicylates. This may rarely precipitate salicylate toxicity. Patients receiving these drugs concomitantly should be observed closely for evidence of adverse effects.

The potassium-wasting effects of corticosteroid therapy may be exacerbated by concomitant administration of other potassium depleting drugs including thiazide diuretics, furosemide, ethacrynic acid and amphotericin B. Serum potassium levels should be monitored in patients receiving these drugs concomitantly.

Glucocorticoids interact with cholinesterase inhibitors, including ambenonium, neostigmine and pyridostigmine, causing severe muscle weakness in patients with myasthenia gravis who receive these drugs concomitantly. Glucocorticoids are used therapeutically, however, in the treatment of some patients with myasthenia gravis.

Killed or inactivated vaccines and toxoids do not represent a danger to immunocompromised persons and generally should be administered as recommended for healthy persons. The immune response of immunocom promised persons to vaccines is not as good as healthy persons; higher doses or more frequent boosters may be required, although the immune response still may be suboptimal. Live-virus vaccines should not be given to immunocompromised individuals due to the potentiation of virus replication and adverse reactions to the virus. Those undergoing high-dose corticosteroid therapy should not be exposed to others who have recently received the oral poliovirus vaccine (OPV). Measles-mumps-rubella (MMR) vaccination is not contraindicated for the close contacts, including health care professionals, of immunocompromised patients. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination. When exposed to a vaccine-preventable disease such as measles, severely immunocompromised children should be considered susceptible regardless of their vaccination history.

Corticosteroid therapy may rarely increase blood coagulability. Patients receiving heparin or warfarin may experience loss of clinical effect. In addition, corticosteroids have been associated with gastrointestinal bleeding. Thus, corticosteroids should be used cautiously in patients receiving  anticoagulants.

The metabolism of corticosteroids is increased in hyperthyroidism and decreased in hypothyroidism. Dosage adjustments may be necessary when initiating, changing or discontinuing thyroid hormones or antithyroid agents.

Systemic corticosteroids increase blood glucose levels; a potential pharmacodynamic interaction exists between corticosteroids and all antidiabetic agents. Diabetic patients who are administered systemic corticosteroid therapy may require an adjustment in the dosing of the antidiabetic agent. Blood lactate concentrations and the lactate to pyruvate ratio increased when metformin was coadministered with corticosteroids (e.g., hydrocortisone). Elevated lactic acid concentrations are associated with an increased risk of lactic acidosis, so patients on metformin concurrently with systemic steroids should be monitored closely.

Patients receiving digoxin and corticosteroids concomitantly are at an increased risk for developing arrhythmias or digitalis toxicity due to corticosteroid-induced hypokalemia. Corticosteroid-induced hypokalemia could also enhance the proarrhythmic effects of dofetilide. Hypokalemia also potentiates neuromuscular blockade associated with nondepolarizing neuromuscular blockers. Corticosteroids should be monitored closely when used with neuromuscular blockers.

Corticosteriods administered prior to or concomitantly with porfimer photodynamic therapy may decrease the efficacy of the treatment.

The risk of cardiac toxicity with isoproterenol in asthma patients appears to be increased with the coadministration of corticosteroids or methylxanthines. Intravenous infusions of isoproterenol in refractory asthmatic children at rates of 0.05-2.7 ug/kg/min have caused clinical deterioration, myocardial infarction (necrosis), congestive heart failure and death.

Mifepristone, RU-486 exhibits antiglucocorticoid activity that may antagonize the corticosteroids. In rats, the activity of dexamethasone was inhibited by oral mifepristone doses of 10—25 mg/kg. A mifepristone dose of 4.5 mg/kg in humans resulted in compensatory increases in ACTH and cortisol. Mifepristone is contraindicated in patients on long-term corticosteroid therapy.

Due to ritonavir inhibition of hepatic enzymes, drug-drug interactions may occur during concurrent administration with prednisone.

In a clinical trial, concomitant use of prednisone (40 mg/day for the first 14 days of nevirapine administration) was associated with an increase in incidence and severity of rash during the first 6 weeks of nevirapine therapy. Therefore, the use of prednisone to prevent nevirapine-associated rash is not recommended.


Adverse Reactions

• abdominal pain
• acne vulgaris
• adrenocortical insufficiency
• amenorrhea
• angioedema
• anorexia
• anxiety
• appetite stimulation
• arthralgia
• avascular necrosis
• bone fractures
• cataracts
• constipation
• Cushing's syndrome
• depression
• diabetes mellitus
• diaphoresis
• diarrhea
• dysmenorrhea
• ecchymosis
• edema
• EEG changes
• emotional lability
• erythema
• esophageal ulceration
• euphoria
• exfoliative dermatitis
• exophthalmos
• fever
• fluid retention
• gastritis
• growth inhibition
• headache
• heart failure
• hirsutism
• hypercholesterolemia
• hyperglycemia
• hypernatremia
• hypertension
• hypocalcemia
• hypokalemia
• hypotension
• hypothalamic-pituitary-adrenal (HPA) suppression
• immunosuppression
• impaired wound healing
• increased intracranial pressure
• infection
• insomnia
• lethargy
• menstrual irregularity
• metabolic alkalosis
• mood lability
• myalgia
• myopathy
• nausea/vomiting
• ocular hypertension
• optic neuritis
• osteoporosis
• palpitations
• pancreatitis
• papilledema
• peptic ulcer
• peripheral neuropathy
• petechiae
• phlebitis
• physiological dependence
• pseudotumor cerebri
• psychosis
• restlessness
• retinopathy
• seizures
• sinus tachycardia
• skin atrophy
• sodium retention
• striae
• thrombocytopenia
• thromboembolism
• thrombosis
• urinary incontinence
• urinary urgency
• urticaria
• vertigo
• visual impairment
• weakness
• weight gain
• weight loss
• withdrawal

NOTE: Prolonged administration of physiologic replacement dosages of glucocorticoids does not usually cause adverse effects. The severity of the adverse effects associated with prolonged administration of pharmacological dosages of corticosteroids increases with duration of therapy. Short term administration of large doses typically does not cause adverse effects, but long term administration can lead to adrenocortical atrophy and generalized protein depletion.

Glucocorticoids are responsible for protein metabolism, and prolonged therapy can result in various musculoskeletal manifestations, including: myopathy (myalgia, muscle wasting, muscle weakness), impaired wound healing, bone matrix atrophy (osteoporosis), bone fractures such as vertebral compression fractures or fractures of long bones, and avascular necrosis of femoral or humoral heads. These effects are more likely to occur in older or debilitated patients. Glucocorticoids interact with calcium metabolism at many sites, including: decreasing the synthesis by osteoblasts of the principle proteins of bone matrix, malabsorption of calcium in both the nephron and the gut, and reduction of sex hormone concentrations. Although all of these actions probably contribute to glucocorticoid-induced osteoporosis, the actions on osteoblasts is most important. Glucocorticoids do not modify vitamin D metabolism.[1441] Postmenopausal women, in particular, should be monitored for signs of osteoporosis during corticosteroid therapy. Because of retardation of bone growth, children receiving prolonged corticosteroid therapy may have growth inhibition. 

Corticosteroid therapy can mask the symptoms of infection and should be avoided during an acute viral or bacterial infection. Immunosuppression is most likely to occur in patients receiving high-dose (e.g., equivalent to 1 mg/kg or more of prednisone daily), systemic corticosteroid therapy for any period of time, particularly in conjunction with corticosteroid sparing drugs (e.g., troleandomycin) and/or concomitant immunosuppressant agents; however, patients receiving moderate dosages of systemic corticosteroids for short periods or low dosages for prolonged periods also may be at risk. Corticosteroids can reactivate tuberculosis and should not be used in patients with a history of active tuberculosis except when chemoprophylaxis is instituted concomitantly. Patients receiving immunosuppressive doses of corticosteroids should be advised to avoid exposure to measles or varicella (chickenpox) and, if exposed to these diseases, to seek medical advice immediately.

Corticosteroids are divided into two classes: mineralocorticoids and glucocorticoids. Mineralocorticoids alter electrolyte and fluid balance by facilitating sodium retention and hydrogen and potassium excretion at the level of the distal renal tubule, resulting in edema and hypertension. Mineralocorticoid properties can cause fluid retention; electrolyte disturbances (hypokalemia, hypokalemic metabolic alkalosis, hypernatremia, hypocalcemia), edema, and hypertension. Prolonged administration of glucocorticoids may also result in edema and hypertension. In a review of 93 studies of corticosteroid use, hypertension was found to develop 4 times as often in steroid recipients compared to control groups.[938] Congestive heart failure may also occur in susceptible patients.

Although corticosteroids are used to treat Graves' ophthalmopathy, ocular effects, such as exophthalmos, posterior subcapsular cataracts, retinopathy, or ocular hypertension, can result from prolonged use of glucocorticoids and could result in glaucoma or ocular nerve damage including optic neuritis. Temporary or permanent visual impairment, including blindness, has been reported with glucocorticoid administration by several routes of administration including intranasal and ophthalmic administration. Secondary fungal and viral infections of the eye can be exacerbated by corticosteroid therapy.

Prolonged corticosteroid therapy may adversely affect the endocrine system, resulting in hypercorticism (Cushing's syndrome), menstrual irregularity including dysmenorrhea or amenorrhea, hyperglycemia, and aggravation of diabetes mellitus in susceptible patients. In a recently-published review of 93 studies of corticosteroid use, the development of diabetes mellitus was determined to occur 4 times more frequently in steroid recipients compared to control groups.[938] In patients with preexisting diabetes mellitus, insulin or oral hypoglycemic dosages may require adjustment during steroid administration. 

Adverse GI effects associated with corticosteroid administration include nausea/vomiting and anorexia with subsequent weight loss. Appetite stimulation with weight gain, diarrhea, constipation, abdominal pain, esophageal ulceration, gastritis, and pancreatitis have also been reported. Although it was once believed that corticosteroids contributed to the development of peptic ulcer disease, in a published review of 93 studies of corticosteroid use, the incidence of peptic ulcer disease was not found to be higher in steroid recipients compared to control groups.[938] While most of these studies did not utilize endoscopy, it is unlikely that corticosteroids contribute to the development of peptic ulcer disease.

Adverse neurologic effects have been reported during prolonged corticosteroid administration and include headache, insomnia, vertigo, restlessness, ischemic peripheral neuropathy, seizures, and EEG changes. Mental disturbances, including mood lability, depression, anxiety, euphoria, personality changes, and psychosis, have also been reported; emotional lability and psychotic problems can be exacerbated by corticosteroid therapy.  

Various adverse dermatologic effects reported during corticosteroid therapy include skin atrophy, acne vulgaris, diaphoresis, impaired wound healing, facial erythema, striae, petechiae, hirsutism, ecchymosis, and easy bruising. Hypersensitivity reactions may manifest as allergic dermatitis, urticaria, and/or angioedema. 

Pharmacologic doses of corticosteroids administered for prolonged periods may result in physiological dependence due to hypothalamic-pituitary-adrenal (HPA) suppression. Exogenous corticosteroids exert negative feedback on the pituitary, inhibiting the secretion of adrenocorticotropin (ACTH). This results in a decrease in ACTH-mediated synthesis of endogenous corticosteroids and androgens by the adrenal cortex. The severity of glucocorticoid-induced secondary adrenocortical insufficiency varies among individuals, and is dependent upon the dose, frequency, time of administration, and duration of therapy. Administering the drug on alternate days may help to alleviate this adverse effect. Patients with HPA suppression will require increased doses of corticosteroid therapy during periods of physiologic stress. Acute adrenal insufficiency and even death may occur if sudden withdrawal of the drugs is undertaken. Withdrawal from prolonged oral corticosteroid therapy should be gradual; HPA suppression can last for up to 12 months following cessation of therapy, and patients may need supplemental corticosteroid treatment during periods of physiologic stress, such as surgery, acute blood loss, or infection, even after the drug has been discontinued. Also, a non-HAP withdrawal syndrome may occur following abrupt discontinuance of corticosteroid therapy, and is apparently unrelated to adrenocortical insufficiency. This syndrome includes symptoms such as anorexia, lethargy, nausea/vomiting, headache, fever, arthralgia, myalgia, exfoliative dermatitis, weight loss, and hypotension. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels. Increased intracranial pressure with papilledema (i.e., pseudotumor cerebri) has also been reported with withdrawal of glucocorticoid therapy.

Hypercholesterolemia, atherosclerosis, fat embolism, thrombosis, thromboembolism, and phlebitis, specifically, thrombophlebitis have been associated with corticosteroid therapy. Thrombocytopenia has occurred in several patients receiving prolonged, high-dose corticosteroid therapy. Palpitations, sinus tachycardia, glossitis, stomatitis, urinary incontinence, and urinary urgency have been rarely reported. Corticosteroids may also decrease serum concentrations of vitamin C (ascorbic acid) and vitamin A which may rarely produce symptoms of vitamin A deficiency or vitamin C deficiency.


Patient Education

Prednisone oral solution or syrup

What does prednisone oral solution do?
PREDNISONE (Prednisone Intensol®) is a corticosteroid. It helps to reduce swelling, redness, itching, and allergic reactions and can be used to treat severe allergies, skin problems, asthma, arthritis and other conditions. Generic prednisone oral solution is available.

What should my health care professional know before I take prednisone?
They need to know if you have any of these conditions:
•cataracts or glaucoma
•Cushing's syndrome
•diabetes
•heart problems, or previous heart attack
•high blood pressure or blood clotting disorder
•infection, such as herpes, measles, tuberculosis or chickenpox
•myasthenia gravis
•pschosis
•osteoporosis
•recent surgery
•seizures (convulsions)
•stomach or intestinal disease, including colitis
•under-active thyroid
•an unusual or allergic reaction to prednisone, other corticosteroids, medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding

How should I take this medicine?
Take prednisone oral solution by mouth. Follow the directions on the prescription label. Shake well before using. Use a specially marked spoon or container to measure your medicine. Ask your pharmacist if you do not have one; household spoons are not always accurate. Take with food or milk to avoid stomach upset. If you are only taking prednisone once a day, take it in the morning, which is the time your body normally secretes cortisol. Take your doses at regular intervals. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?
If you miss a dose, take it a soon as you can. If it is almost time for your next dose, consult your prescriber or health care professional. You may need to miss a dose or take a double dose, depending on your condition and treatment. Do not take double or extra doses without advice.

What other medicines can interact with prednisone?
•acetazolamide
•antiinflammatory drugs (NSAIDs, such as ibuprofen)
•barbiturate medicines for inducing sleep or treating seizures
•certain heart medicines
•female hormones, including contraceptives or birth control pills
•live virus vaccines, and other toxoids and vaccines
•medicines for diabetes
•phenytoin
•rifabutin
•rifampin
•water pills
•warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from taking prednisone?
Side effects that you should report to your prescriber or health care professional as soon as possible:
•bloody or black, tarry stools
•confusion, excitement, restlessness, a false sense of well-being
•eye pain, decreased or blurred vision, or bulging eyes
•fever, sore throat, sneezing, cough, or other signs of infection, wounds that will not heal
•frequent passing of urine
•increased thirst
•irregular heartbeat
•menstrual problems
•mental depression, mood swings, mistaken feelings of self-importance or of being mistreated
•muscle cramps or weakness
•nausea, vomiting
•pain in hips, back, ribs, arms, shoulders, or legs
•rounding out of face
•skin problems, acne, thin and shiny skin
•stomach pain
•swelling of feet or lower legs
•unusual bruising, pinpoint red spots on the skin
•unusual tiredness or weakness
•weight gain or weight loss

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
•diarrhea or constipation
•headache
•increased or decreased appetite
•increased sweating
•nervousness, restlessness, or difficulty sleeping
•upset stomach
•unusual increased growth of hair on the face or body

What do I need to watch for while I take prednisone?
Visit your prescriber or health care professional for regular checks on your progress. If you are taking prednisone over a prolonged period, carry an identification card with your name and address, the type and dose of your medicine, and your prescriber's name and address. Do not suddenly stop taking prednisone. You may need to gradually reduce the dose, so that your body can adjust. Follow the advice of your prescriber or health care professional.

If you are taking prednisone regularly, avoid contact with people who have an infection. You will have an increased risk from infection while taking prednisone. Tell your prescriber or health care professional if you are exposed to anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly. 

People who are taking certain dosages of prednisone may need to avoid immunization with certain vaccines or may need to have changes in their vaccination schedules to ensure adequate protection from certain diseases. Make sure to tell your prescriber or health care professional that you are taking prednisone before receiving any vaccine. 

If you are going to have surgery, tell your prescriber or health care professional that you have received prednisone within the last twelve months.

If you receive prednisone every day, you may need to watch your diet. Your body can lose potassium while you are taking this medicine. Ask your prescriber or health care professional about your diet.

Prednisone can affect your blood sugar. If you are diabetic check with your prescriber or health care professional if you need help adjusting the dose of your diabetic medicine.

Alcohol can increase the risk of getting serious side effects while you are taking prednisone. Avoid alcoholic drinks.

Prednisone can interfere with certain lab tests and can cause false skin test results.

Where can I keep my medicine?
Keep out of the reach of children.

Store at room temperature between 15 and 30 degreesC (59 and 86 degreesF); do not freeze. Throw away any unused medicine after the expiration date.

NOTE: This information is not intended to cover all possible uses, precautions, interactions, or adverse effects for this drug. If you have questions about the drug(s) you are taking, check with your health care professional.

Prednisone tablets

What do prednisone tablets do?
PREDNISONE (Deltasone®) is a corticosteroid. It helps to reduce swelling, redness, itching, and allergic reactions and can be used to treat severe allergies, skin problems, asthma, arthritis and other conditions. Generic prednisone tablets are available.

What should my health care professional know before I take prednisone?
They need to know if you have any of these conditions:
•cataracts or glaucoma
•Cushing's syndrome
•diabetes
•heart problems, or previous heart attack
•high blood pressure or blood clotting disorder
•infection, such as herpes, measles, tuberculosis or chickenpox
•myasthenia gravis
•psychosis
•osteoporosis
•recent surgery
•seizures (convulsions)
•stomach or intestinal disease, including colitis
•under-active thyroid
•an unusual or allergic reaction to prednisone, other corticosteroids, medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding

How should I take this medicine?
Take prednisone tablets by mouth. Follow the directions on the prescription label. Swallow the tablets with a drink of water. Take with food or milk to avoid stomach upset. If you are only taking prednisone once a day, take it in the morning, which is the time your body normally secretes cortisol. Take your doses at regular intervals. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?
If you miss a dose, take it a soon as you can. If it is almost time for your next dose, consult your prescriber or health care professional. You may need to miss a dose or take a double dose, depending on your condition and treatment. Do not take double or extra doses without advice.

What other medicines can interact with prednisone?
•acetazolamide
•antiinflammatory drugs (NSAIDs, such as ibuprofen)
•barbiturate medicines for inducing sleep or treating seizures
•certain heart medicines
•female hormones, including contraceptives or birth control pills
•live virus vaccines, and other toxoids and vaccines
•medicines for diabetes
•phenytoin
•rifabutin
•rifampin
•water pills
•warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from taking prednisone?
Side effects that you should report to your prescriber or health care professional as soon as possible:
•bloody or black, tarry stools
•confusion, excitement, restlessness, a false sense of well-being
•eye pain, decreased or blurred vision, or bulging eyes
•fever, sore throat, sneezing, cough, or other signs of infection, wounds that will not heal
•frequent passing of urine
•increased thirst
•irregular heartbeat
•menstrual problems
•mental depression, mood swings, mistaken feelings of self-importance or of being mistreated
•muscle cramps or weakness
•nausea, vomiting
•pain in hips, back, ribs, arms, shoulders, or legs
•rounding out of face
•skin problems, acne, thin and shiny skin
•stomach pain
•swelling of feet or lower legs
•unusual bruising, pinpoint red spots on the skin
•unusual tiredness or weakness
•weight gain or weight loss

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they
continue or are bothersome):
•diarrhea or constipation
•headache
•increased or decreased appetite
•increased sweating
•nervousness, restlessness, or difficulty sleeping
•upset stomach
•unusual increased growth of hair on the face or body

What do I need to watch for while I take prednisone?
Visit your prescriber or health care professional for regular checks on your progress. If you are taking prednisone over a prolonged period, carry an identification card with your name and address, the type and dose of your medicine, and your prescriber's name and address. Do not suddenly stop taking prednisone. You may need to gradually reduce the dose, so that your body can adjust. Follow the advice of your prescriber or health care professional.

If you are taking prednisone regularly, avoid contact with people who have an infection. You will have an increased risk from infection while taking prednisone. Tell your prescriber or health care professional if you are exposed to anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly.

People who are taking certain dosages of prednisone may need to avoid immunization with certain vaccines or may need to have changes in their vaccination schedules to ensure adequate protection from certain diseases. Make sure to tell your prescriber or health care professional that you are taking prednisone before receiving any vaccine.

If you are going to have surgery, tell your prescriber or health care professional that you have received prednisone within the last twelve months.

If you receive prednisone every day, you may need to watch your diet. Your body can lose potassium while you are taking this medicine. Ask your prescriber or health care professional about your diet.

Prednisone can affect your blood sugar. If you are diabetic check with your prescriber or health care professional if you need help adjusting the dose of your diabetic medicine.

Alcohol can increase the risk of getting serious side effects while you are taking prednisone. Avoid alcoholic drinks.

Prednisone can interfere with certain lab tests and can cause false skin test results.

Where can I keep my medicine?
Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degreesF). Throw away any unused medicine after the expiration date.

NOTE: This information is not intended to cover all possible uses, precautions, interactions, or adverse effects for this drug. If you have questions about the drug(s) you are taking, check with your health care professional.

Costs and Monitoring

Relative Drug Costs
• generic available
• available from many manufacturers
• Corticosteroid (Oral) Cost Index: 1
• Antiinflammatory Agent Cost Index: 1
• Hormonal (Oral) Agent Cost Index: 1

Monitoring Parameters
• blood glucose
• serum potassium

Total Cost of Therapy
• 5 mg PO qd: <$5.00/mo.
• 20 mg PO qd: <$5.00/mo.
• 50 mg PO qd: <$5.00/mo.


References

213. Clements PJ, Davis J. Cytotoxic drugs: their clinical application to the rheumatic diseases. Sem Arth Rheum 1986;15:231—54.

243. Boston Collaborative Drug Surveillance Group Acute adverse reactions to prednisone in relation to dosage. Clin Pharmacol Ther 1973;13;694—8.

351. Schulman EA, Silberstein SD. Symptomatic and prophylactic treatment of migraine and tension-type headache. Neurology 1992;42(suppl 2):16—21.

531. Yee GC, McGuire TR. Allogeneic bone marrow transplantation in the treatment of hematologic diseases. Clin Pharm 1985;4:149—60.

532. Singer FR, Fernandez M. Therapy of hypercalcemia of malignancy. Am J Med 1987;82(suppl 2A):34—41. 

533. George JN, El-Harake MA, Raskob GE. Chronic idiopathic thrombocytopenic purpura. N Engl J Med 1994;331:1207—11.

534. Crosby SS, Murray KM, Marvin JA et al. Management of Stevens-Johnson syndrome. Clin Pharm 1986;5:682—9.

535. Halebian PH, Madden MR, Finklestein JL et al. Improved burn center survival of patients with toxic epidermal necrolysis managed without corticosteroids. Ann Surg 1986;204:503—12.

540. Drachman DB. Myasthenia gravis. N Engl J Med 1994;330:1797—1810.

564. Kollef MH, Schuster DP. The acute respiratory distress syndrome. N Engl J Med 1995;332:27—37.

570. Israili ZH, Hall WD. Cough and angioneurotic edema associated with angiotensin-converting enzyme inhibitor therapy. Ann Intern Med 1992;117:234—42.

670. Austin, HA III, Klippel JH, Balow JE et al. Therapy of lupus nephritis. Controlled trial of prednisone and cytotoxic drugs. N Engl J Med 1986;314:614—9.

938. Conn HO, Poynard T. Corticosteroids and peptic ulcer: meta-analysis of adverse events during steroid therapy. J Intern Med 1994;236:619—32.

997. Boumpas DT, Austin HA, Fessler BJ et al. Systemic lupus erythematosus: emerging concepts. Ann Intern Med 1995;122:940—50.

1164. Krawitt EL. Autoimmune hepatitis. N Engl J Med 1996;334:897—903.

1171. Jacox A, Carr DB, Payne R. New clinical-practice guidelines for the management of pain in patients with cancer. N Engl J Med 1994;330:651—5.

1342. McMillan R. Therapy for adults with refractory chronic immune thrombocytopenic purpura. Ann Intern Med 1997;126:307—14. 

1366. Kyle RA, Gertz MA, Greipp PR et al. A trial of three regimens for primary amyloidosis: colchicine alone, melphalan and prednisone, and melphalan, prednisone, and colchicine. N Engl J Med 1997;336:1202—7.

1441. Reid IR. Preventing glucocorticoid-induced osteoporosis. N Engl J Med 1997;337:420—1.

1515. National Asthma Education and Prevention Program Expert Panel 2. Expert panel report 2: guidelines for the diagnosis and management of asthma. Bethesda (MD): National Institutes of Health. National Heart, Lung, and Blood Institute; 1997 July. NIH Publication No. 97—4051.

1943. Beam WR, Weiner DE, Martin RJ. Timing of prednisone and alterations of airways inflammation in nocturnal asthma. Am Rev Respir Dis 1992;146:1524—30.

1944. Report of a workshop by the British Association for Paediatric Nephrology and Research Unit, Royal College of Physicians. Consensus statement on management and audit potential for steroid responsive nephrotic syndrome. Arch Dis Child 1994;70:151—7.

1945. Kent SJ, Crowe SM, Yung A, et al. Tuberculosis meningitis: a 30-year review. Clin Infect Dis 1993;17:987—94.