section name header

Introduction

ATC Class:H02AB07

VA Class:HS051

AHFS Class:

Generic Name(s):

Prednisone is a synthetic glucocorticoid.

Uses

Prednisone is usually considered the oral glucocorticoid of choice for anti-inflammatory or immunosuppressant effects. Because it has only minimal mineralocorticoid properties, the drug is inadequate alone for the management of adrenocortical insufficiency. If prednisone is used in the treatment of this condition, concomitant therapy with a mineralocorticoid is also required.

Prednisone has been used as adjunctive therapy in the treatment of serious complications from coronavirus disease 2019 (COVID-19).1005,1006,1012 Patients with severe COVID-19 may develop a systemic inflammatory response that can result in lung injury and multisystem organ dysfunction.1005 The potent anti-inflammatory effects of corticosteroids (e.g., prednisone) may prevent or mitigate these deleterious effects.1005 For additional information, see Uses: Coronavirus Disease 2019 (COVID-19), in the Corticosteroids General Statement 68:04.

Dosage and Administration

[Section Outline]

Administration !!navigator!!

Prednisone is administered orally. For patients unable to swallow tablets, prednisone may be administered orally as a commercially available solution, concentrate solution, or an extemporaneously prepared suspension. The oral concentrate may be diluted in juice or other flavored diluent or in semisolid food (e.g., applesauce) prior to administration.

An extemporaneous prednisone suspension containing 10 mg/mL can be prepared in the following manner. First, 5 g of prednisone as tablets is mixed with 200 mL of 0.1% sodium benzoate solution; 100 mL of an aqueous suspension containing 3% tragacanth, 3% acacia, and 0.1% sodium benzoate is then added, and the mixture is stirred until homogeneous. When the prednisone suspension is diluted to 500 mL with a mixture of 67% simple syrup and 33% cherry syrup, it contains prednisone 10 mg/mL and is apparently stable for 2 months at 2-8°C. (4 L of the tragacanth-acacia suspension may be prepared in a container that can be closed for vigorous agitation. Initially, 4 g of sodium benzoate is dissolved in 2 L of purified water. Then 120 g of powdered tragacanth and 120 g of acacia are added in that order and the container shaken vigorously. Additional water is added gradually over 24-48 hours with agitation at regular intervals until a volume of 4 L and a smooth suspension results. To mask the odor, 1 mL of anise oil may be added.)

Dosage !!navigator!!

Dosage of prednisone depends on the condition being treated and the response of the patient. Dosage for infants and children should be based on the severity of the disease and the response of the patient rather than on strict adherence to dosage indicated by age, body weight, or body surface area. After a satisfactory response is obtained, dosage should be decreased in small decrements to the lowest level that maintains an adequate clinical response. The drug should be discontinued as soon as possible. Patients should be continually monitored for signs that indicate dosage adjustment is necessary, such as remissions or exacerbations of the disease and stress (surgery, infection, trauma). When long-term prednisone therapy is necessary, an alternate-day dosage regimen should be considered. Following long-term therapy, prednisone should be withdrawn gradually. (See the Corticosteroids General Statement 68:04.)

The initial adult dosage of prednisone may range from 5-60 mg daily, depending on the disease being treated, and is usually administered in 2-4 divided doses. Some clinicians state that children may be given a dosage of 0.14-2 mg/kg daily or 4-60 mg/m2 daily, administered in 4 divided doses.

Pneumocystis jirovecii Pneumonia

For use as an adjunct to anti-infective therapy in the treatment of moderate to severe pneumonia caused by Pneumocystis jirovecii (formerly Pneumocystis carinii ) in adults and adolescents older than 13 years of age with human immunodeficiency virus (HIV) infection, including those with acquired immunodeficiency syndrome (AIDS), an oral prednisone regimen of 40 mg twice daily for 5 days, followed by 40 mg once daily for 5 days, and then 20 mg once daily for 11 days is recommended.1017 Such adjunctive glucocorticoid therapy should be initiated as soon as possible, preferably within 24-72 hours of initial antipneumocystis therapy.1017 Clinicians should consult published protocols and the most current clinical guidelines.1017 Shorter courses of therapy would be desirable, but rebound deterioration in pulmonary function has occurred in some patients following discontinuance of glucocortical therapy, and some clinicians discourage the use of shorter treatment courses.

Coronavirus Disease 2019 (COVID-19)

When used for adjunctive therapy in adults with coronavirus disease 2019 (COVID-19), the National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel recommends prednisone 40 mg given orally once daily or in 2 divided doses when dexamethasone is not available.1005

When a corticosteroid is used for adjunctive therapy in pediatric patients with COVID-19, the NIH panel recommends dexamethasone (0.15 mg/kg [maximum dosage 6 mg] given IV or orally for up to 10 days).1005 If dexamethasone is not available, equivalent dosages of an alternative corticosteroid (e.g., prednisone) may be considered.1005

For additional information, see Dosage: Coronavirus Disease 2019 (COVID-19), in the Corticosteroids General Statement 68:04. Clinicians also should consult the most recent NIH COVID-19 treatment guidelines for additional information on use of corticosteroids in patients with COVID-19.1005

Allergic Conditions

For certain allergic conditions (e.g., contact dermatitis including poison ivy), prednisone may be administered for short-term use (e.g., 6 days) using 5-mg tablets; the recommended initial dosage is 30 mg (6 tablets) for the first day, which is then tapered by 5 mg daily until 21 tablets have been administered. On the first day, 10 mg (2 tablets) is administered twice daily (before breakfast and at bedtime) and 5 mg (1 tablet) is administered twice daily (after lunch and dinner). On the second day, 5 mg (1 tablet) is administered 3 times daily (before breakfast, after lunch, and after dinner) and 10 mg (2 tablets) is administered at bedtime. On the third day, 5 mg (1 tablet) is administered 4 times daily (before breakfast, after lunch, after dinner, and at bedtime). On the fourth day, 5 mg (1 tablet) is administered 3 times daily (before breakfast, after lunch, and at bedtime). On the fifth day, 5 mg (1 tablet) is administered twice daily (before breakfast and at bedtime). On the sixth day, 5 mg (1 tablet) is administered before breakfast.

Asthma

To gain prompt control of asthma in infants and children 4 years of age or younger with very poorly controlled, moderate-to-severe asthma (i.e., more than 3 exacerbations per year requiring oral corticosteroids) and in children 5-11 years of age with asthma of comparable control and severity (i.e., at least 2 exacerbations per year requiring oral corticosteroids), prednisone 1-2 mg/kg daily (maximum 60 mg daily) may be added to existing asthma therapy. In adults and adolescents with very poorly controlled, moderate-to-severe asthma (i.e., at least 2 exacerbations per year requiring oral corticosteroids), prednisone 40-60 mg daily as a single dose or in 2 divided doses may be added to low-to-high maintenance dosages of the inhaled corticosteroid and a long-acting inhaled β2-agonist bronchodilator. A short course of oral corticosteroid therapy (usually 3-10 days) should be continued until the patient achieves a peak expiratory flow (PEF) of at least 80% of his or her personal best and until symptoms resolve. However, a longer duration of treatment may be needed in some patients. There is no evidence that tapering the dosage after improvement will prevent a relapse.

For the treatment of moderate-to-severe exacerbations of asthma associated with a viral respiratory infection in infants and children 4 years of age or younger with intermittent asthma, prednisone 1 mg/kg daily for 3-10 days or equivalent daily dosage should be considered. For those with a history of viral-associated severe asthma exacerbations, initiation of oral corticosteroids should be considered at the first sign of infection.

For the treatment of acute asthma exacerbations in the community setting, 0.5-1 mg/kg of prednisone or equivalent during a 24-hour period is recommended to quickly resolve all but the mildest exacerbations of asthma, especially in patients whose response to a short-acting inhaled β2-agonist is not prompt or sustained. For emergency department treatment of moderate-to-severe acute asthma exacerbations not controlled with an inhaled β2-adrenergic agonist in children 11 years of age or younger, prednisone 1-2 mg/kg daily in 2 divided doses (maximum 60 mg daily) can be added. For treatment of such exacerbations in adults and adolescents, prednisone 40-80 mg daily as a single dose or in 2 divided doses can be added to an inhaled β2-adrenergic agonist. Treatment should be continued until the patient achieves a PEF of 70% of predicted or personal best. For additional information on the stepped-care approach to drug therapy in asthma, see Asthma under Uses: Respiratory Diseases, in the Corticosteroids General Statement 68:04.

Advanced Pulmonary or Extrapulmonary Tuberculosis

For enhancing resolution of severe systemic and respiratory complications of advanced pulmonary tuberculosis, corticosteroid dosages equivalent to 40-60 mg daily of prednisone, tapered over 4-8 weeks, have been used.101,102 (See Advanced Pulmonary and Extrapulmonary Tuberculosis under Uses: Respiratory Diseases, in the Corticosteroids General Statement 68:04.) A prednisone dosage of 1 mg/kg daily for 30 days, followed by gradual tapering of the dosage over a period of weeks, has been suggested in patients with tuberculous meningitis.102 Tuberculous pericarditis has been treated with prednisone (or prednisolone) dosages of 60 mg daily tapered over 6-12 weeks. For the treatment of pain, dyspnea, and fever associated with tuberculous pleurisy, corticosteroid dosages equivalent to 20-40 mg daily of prednisone tapered over 4-8 weeks have been suggested. Prednisone 2-5 mg/kg per day (or equivalent), with dosage reduction to 1 mg/kg per day over the first week and tapered over the next 5 weeks, has been used to hasten resolution of mediastinal lymphadenopathy associated with primary intrathoracic tuberculosis.

Other Information

[Section Outline]

Chemistry and Stability

Chemistry !!navigator!!

Prednisone is a synthetic glucocorticoid. Prednisone occurs as a white to practically white, odorless, crystalline powder and is very slightly soluble in water and slightly soluble in alcohol. Prednisone oral solution has a pH of 2.6-3.6 and contains 4-6% alcohol, and the oral concentrate solution has a pH of 3-4 and contains about 30% alcohol.

Stability !!navigator!!

Prednisone tablets should be stored in well-closed containers at a temperature less than 40°C, preferably between 15-30°C. Prednisone oral solution and oral concentrate solution should be stored in tight containers at 15-30°C.

Additional Information

For further information on chemistry, pharmacology, uses, pharmacokinetics, cautions, drug interactions, laboratory test interferences, and dosage and administration of prednisone, see the Corticosteroids General Statement 68:04.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

predniSONE

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder

Oral

Solution

5 mg/5 mL

predniSONE Oral Solution

Roxane

Solution, concentrate

5 mg/mL

predniSONE Intensol®

Roxane

Tablets

1 mg*

predniSONE Tablets

2.5 mg*

predniSONE Tablets

5 mg*

Sterapred® 5 mg Unipak®

Merz

Sterapred® 5 mg 12 Day Unipak®

Merz

10 mg*

Sterapred® DS Unipak®

Merz

Sterapred® DS 12 Day Unipak®

Merz

20 mg*

predniSONE Tablets

50 mg*

predniSONE Tablets

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Copyright

AHFS® Drug Information. © Copyright, 1959-2024, Selected Revisions August 30, 2021. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

101. Dooley DP, Carpenter JL, Rademacher S. Adjunctive corticosteroid therapy for tuberculosis: a critical reappraisal of the literature. Clin Infect Dis . 1997; 25:872-87. [PubMed 9356803]

102. Alzeer AH, FitzGerald JM. Corticosteroids and tuberculosis: risks and use as adjunct therapy Tuber Lung Dis . 1993; 74:6-11.

1005. National Institutes of Health. COVID-19 treatment guidelines. Updated 2021 Aug 4. From NIH website. Accessed 2021 Aug 12. Updates may be available at NIH website. [Web]

1006. World Health Organization. Therapeutics and COVID-19: living guideline. 2021 Jul 6. From WHO website. Accessed 2021 Jul 7. [Web]

1012. Li Q, Li W, Jin Y et al. Efficacy Evaluation of Early, Low-Dose, Short-Term Corticosteroids in Adults Hospitalized with Non-Severe COVID-19 Pneumonia: A Retrospective Cohort Study. Infect Dis Ther . 2020; 9:823-36. [PubMedCentral][PubMed 32880102]

1015. Stauffer WM, Alpern JD, Walker PF. COVID-19 and Dexamethasone: A Potential Strategy to Avoid Steroid-Related Strongyloides Hyperinfection. JAMA . 2020; 324:623-4. [PubMed 32761166]

1016. Liu J, Wang T, Cai Q et al. Longitudinal changes of liver function and hepatitis B reactivation in COVID-19 patients with pre-existing chronic hepatitis B virus infection. Hepatol Res . 2020; 50:1211-21. [PubMedCentral][PubMed 32761993]

1017. Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. Accessed 2021 Aug 9. Updates may be available at the NIH hivinfo website. [Web]