section name header

Introduction

AHFS Class:

Generic Name(s):

Methylprednisolone is a synthetic glucocorticoid.

Uses

Methylprednisolone and its derivatives are used principally as anti-inflammatory or immunosuppressant agents. Because methylprednisolone has only minimal mineralocorticoid properties, the drug is inadequate alone for the management of adrenocortical insufficiency. If methylprednisolone is used in the treatment of this condition, concomitant therapy with a mineralocorticoid also is required.

Methylprednisolone has been used as adjunctive therapy in the treatment of serious complications from coronavirus disease 2019 (COVID-19).1005,1006,1010,1011,1012,1013,1014 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., methylprednisolone) 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!!

The route of administration and dosage of methylprednisolone and its derivatives depend on the condition being treated and the response of the patient. IM or IV therapy is generally reserved for patients who are unable to take the drug orally or for use in emergency situations. After the initial emergency period, a longer-acting injectable corticosteroid preparation or oral administration of a corticosteroid should be considered.

Dosage !!navigator!!

General

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. 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 oral methylprednisolone therapy is necessary, an alternate-day dosage regimen should be considered. Following long-term therapy, methylprednisolone should be withdrawn gradually. (See the Corticosteroids General Statement 68:04.)

Methylprednisolone

Methylprednisolone is administered orally. The initial adult dosage may range from 2-60 mg daily, depending on the disease being treated, and is usually administered in 4 divided doses. Some clinicians state that children may be given a dosage of 0.117-1.66 mg/kg daily or 3.3-50 mg/m2 daily, administered in 3 or 4 divided doses.

For certain allergic conditions (e.g., contact dermatitis including poison ivy), methylprednisolone may be administered for short-term use (e.g., 6 days) using 4-mg tablets; the recommended initial dosage is 24 mg (6 tablets) for the first day, which is then tapered by 4 mg daily until 21 tablets have been administered. On the first day, 8 mg (2 tablets) is administered twice daily (before breakfast and at bedtime) and 4 mg (1 tablet) is administered twice daily (after lunch and dinner). On the second day, 4 mg (1 tablet) is administered 3 times daily (before breakfast, after lunch, and after dinner) and 8 mg (2 tablets) is administered at bedtime. On the third day, 4 mg (1 tablet) is administered 4 times daily (before breakfast, after lunch, after dinner, and at bedtime). On the fourth day, 4 mg (1 tablet) is administered 3 times daily (before breakfast, after lunch, and at bedtime). On the fifth day, 4 mg (1 tablet) is administered twice daily (before breakfast and at bedtime). On the sixth day, 4 mg (1 tablet) is administered before breakfast. Some clinicians state that tapering the dosage of the drug over a longer period (e.g., 12 days instead of 6 days) may be associated with a lower incidence of flare-up of the dermatitis than that associated with 6-day therapy.

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), methylprednisolone 1-2 mg/kg daily (maximum 60 mg daily) may be added to existing asthma therapy. (See Asthma under Uses: Respiratory Diseases, in the Corticosteroids General Statement 68:04.) In adults and adolescents with very poorly controlled, moderate-to-severe asthma (i.e., at least 2 exacerbations per year requiring oral corticosteroids), methylprednisolone 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 (usually 3-10 days) of oral corticosteroid therapy should be continued until the patient achieves a peak expiratory flow (PEF) of 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.

Methylprednisolone 7.5-60 mg daily in the morning or every other day is suggested in adults and adolescents with severe asthma who are inadequately controlled with a high-dose inhaled corticosteroid, intermittent oral corticosteroid therapy, and a long-acting inhaled β2-agonist bronchodilator, based on consensus and clinical experience. A short course (2 weeks) of oral corticosteroids may be considered to confirm clinical response prior to implementing long-term therapy with these agents. Once long-term oral corticosteroid therapy is initiated, the lowest possible effective dosage (i.e., alternate-day or once-daily administration) should be used and the patient should be monitored carefully for adverse effects. Once asthma is well controlled, repeated attempts should be made to reduce the oral corticosteroid dosage.

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, methylprednisolone 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, methylprednisolone 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, .

Methylprednisolone Acetate

Methylprednisolone acetate may be administered by IM, intra-articular, intralesional, intrasynovial, or soft tissue injection. The manufacturer of Depo-Medrol® states that this formulation of methylprednisolone acetate should not be administered intrathecally because of reports of severe adverse events with such use. (See Cautions: Other Adverse Effects, in the Corticosteroids General Statement 68:04.) Because it is slowly absorbed, IM administration of methylprednisolone acetate suspension is not indicated when an immediate effect of short duration is required. The usual adult IM dose of methylprednisolone acetate is 10-80 mg. When methylprednisolone acetate suspension is given as a temporary substitute for oral therapy, the dose of the suspension should be equal to the total daily oral dose of methylprednisolone and should be administered IM once daily. If a prolonged effect is desired, a dose of methylprednisolone acetate equal to 7 times the daily oral dose of methylprednisolone may be administered IM once weekly. For maintenance therapy in patients with rheumatoid arthritis, 40-120 mg may be administered IM weekly. In patients with congenital adrenogenital syndrome, 40 mg of methylprednisolone acetate administered IM every 2 weeks may be adequate.

For intra-articular, intralesional, or soft tissue injection, the dosage of methylprednisolone acetate varies with the degree of inflammation and the size and location of the affected area. A local anesthetic such as 1% procaine hydrochloride may be infiltrated into the tissue surrounding the joint before administration of methylprednisolone acetate. For large joints such as the knee, 20-80 mg of methylprednisolone acetate may be used. For smaller joints, 4-40 mg may be adequate. The dose for bursae, ganglia, and soft tissue infiltration is 4-30 mg. Methylprednisolone acetate in a dosage of 20-60 mg may be administered intralesionally. Absorption of methylprednisolone acetate from intra-articular injection sites is usually very slow and continues for about 7 days. Intra-articular, intralesional, intrasynovial, and soft tissue injections may be repeated every 1-5 weeks depending on the response of the patient.

For control of severe or incapacitating allergic conditions (e.g., bronchial asthma, seasonal or perennial allergic rhinitis) intractable to adequate trials of conventional therapy, the usual IM dose of methylprednisolone acetate is 80-120 mg in adults. For pediatric patients with such conditions, the American Academy of Pediatrics (AAP) recommends an initial IM methylprednisolone acetate dose of 1-2 mg/kg. A single methylprednisolone acetate IM injection of 7.5 mg/kg or 240 mg is recommended by the National Asthma Education and Prevention Program (NAEPP) in infants and children 4 years of age or younger or adults and children 5 years of age or older, respectively, with very poorly-controlled, moderate-to-severe asthma as an alternative to a short course of an oral corticosteroid to gain prompt control of asthma in those who are vomiting or noncompliant with oral corticosteroid therapy. Relief of asthma symptoms should occur within 6-48 hours and persist for several days to 2 weeks. Relief of coryzal symptoms of allergic rhinitis should occur within 6 hours and persist for several days to 3 weeks.

Methylprednisolone Sodium Succinate

Methylprednisolone sodium succinate may be administered by IM or IV injection or by IV infusion; absorption from IM injection sites is rapid. Methylprednisolone sodium succinate is reconstituted for IM or IV injection with bacteriostatic water for injection containing 0.9% benzyl alcohol according to the manufacturer's instructions. When the drug is administered by direct IV injection it should be administered over a period of at least 1 minute. For IV infusion, the reconstituted methylprednisolone sodium succinate should be further diluted with 5% dextrose, 0.9% sodium chloride, 5% dextrose in 0.9% sodium chloride injection, or other compatible IV solution.

Dosage of methylprednisolone sodium succinate is expressed in terms of methylprednisolone. IM or IV dosage of methylprednisolone as the sodium succinate may range from 10 mg to 1.5 g daily; however, much higher IV dosages have been used in the management of life-threatening shock. The usual adult dosage is 10-250 mg IM or IV and may be repeated up to 6 times daily. Some clinicians state that children may be given 0.03-0.2 mg/kg or 1-6.25 mg/m2 IM 1-2 times daily.

For control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment, such as bronchial asthma in pediatric patients, the AAP recommends an initial IV methylprednisolone dose of 1-2 mg/kg.

For use as an adjunct to anti-infective therapy in the treatment of moderate to severe pneumonia caused by Pneumocystis jirovecii (formerly known as 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 IV methylprednisolone regimen of 30 mg twice daily for 5 days, followed by 30 mg once daily for 5 days, and then 15 mg once daily for 11 days is recommended when a parenteral glucocorticoid is necessary.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 glucocorticoid therapy would be desirable, but rebound deterioration in pulmonary function has occurred in some patients following discontinuance of glucocorticoid therapy, and some clinicians discourage the use of shorter treatment courses.

In life-threatening shock, massive IV doses of methylprednisolone as the sodium succinate (such as 30 mg/kg initially and repeated every 4-6 hours if needed or 100-250 mg initially and repeated at 2- to 6-hour intervals as required) have been recommended. In such cases, the drug is administered by direct IV injection over a period of 3-15 minutes. Alternatively, following the initial dose by direct IV injection, additional doses of 30 mg/kg may be administered by slow continuous IV infusion every 12 hours for 24-48 hours. High-dose therapy should be continued only until the patient's condition has stabilized and usually should not be continued beyond 48-72 hours.

When used to treat motor and/or sensory deficits and potentially minimize disability in patients with acute spinal cord injury, an initial dose of 30 mg/kg of methylprednisolone given by rapid IV injection over 15 minutes, followed in 45 minutes by IV infusion of 5.4 mg/kg per hour for 23 hours (total dose administered over 24 hours), has been recommended. Other glucocorticoids and other methylprednisolone dosage regimens have not been shown to be effective in humans to date, and glucocorticoid therapy should be initiated as early as possible after spinal cord injury since appreciable benefit has been observed only when methylprednisolone therapy was initiated within 8 hours of injury.

In the successful management of severe lupus nephritis, methylprednisolone as the sodium succinate has been administered by so-called “pulse” therapy. In adults, a daily dose of 1 g has been given IV over a 1-hour period for 3 consecutive days; children have been given 30 mg/kg IV every other day for 6 doses. “Pulse” therapy with methylprednisolone sodium succinate has been followed by long-term oral prednisone or prednisolone therapy (0.5-1 mg/kg daily).

For the management of croup in pediatric patients, AAP recommends an initial IV methylprednisolone dose of 1-2 mg/kg.

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 methylprednisolone 32 mg given IV 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., methylprednisolone) 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

Other Information

[Section Outline]

Chemistry and Stability

Chemistry !!navigator!!

Methylprednisolone is a synthetic glucocorticoid. The free alcohol and the acetate ester of methylprednisolone occur as white or practically white, odorless, crystalline powders and are practically insoluble in water and sparingly soluble in alcohol. The sodium succinate ester of methylprednisolone occurs as a white or nearly white, odorless, hygroscopic, amorphous solid and is very soluble in water and in alcohol.

Hydrochloric acid and/or sodium hydroxide may be added during manufacture of methylprednisolone acetate sterile suspensions to adjust pH to 3.5-7. Following reconstitution with the diluent supplied by the manufacturers, methylprednisolone sodium succinate injection has a pH of 7-8.

Stability !!navigator!!

Commercially available preparations of methylprednisolone should be stored at a temperature less than 40°C, preferably between 15-30°C; freezing of methylprednisolone acetate sterile suspension should be avoided. Unreconstituted methylprednisolone sodium succinate sterile powder and reconstituted solutions of the drug, and methylprednisolone sodium acetate solution for injection should be stored at a controlled room temperature of 20-25°C. Reconstituted solutions of methylprednisolone sodium succinate should not be used unless they are clear, and unused solutions should be discarded after 48 hours.

Injections of methylprednisolone acetate and methylprednisolone sodium succinate have been reported to be incompatible with various drugs, but the compatibility depends on several factors (e.g., concentrations of the drugs, resulting pH, temperatures). Specialized references should be consulted for specific compatibility information. Methylprednisolone acetate sterile suspension should not be diluted or mixed with any other solution.

Additional Information

For further information on chemistry, pharmacology, pharmacokinetics, uses, cautions, drug interactions, laboratory test interferences, and dosage and administration of methylprednisolone, see the Corticosteroids General Statement 68:04. For EENT and topical uses, see 84:06.08. The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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.

methylPREDNISolone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

2 mg

Medrol® (scored)

Pfizer

4 mg*

Medrol® (scored)

Pfizer

Medrol® Dosepak® (scored; available as 6-day mnemonic pack of 21 tablets)

Pfizer

Methylprednisolone Tablets

8 mg*

Medrol® (scored)

Pfizer

Methylprednisolone Tablets

16 mg*

Medrol® (scored)

Pfizer

Methylprednisolone Tablets

32 mg*

Medrol® (scored)

Pfizer

Methylprednisolone Tablets

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

methylPREDNISolone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injectable suspension

20 mg/mL

DEPO-Medrol®

Pfizer

40 mg/mL*

DEPO-Medrol®

Pfizer

Methylprednisolone Acetate Injectable Suspension

80 mg/mL*

DEPO-Medrol®

Pfizer

Methylprednisolone Acetate Injectable Suspension

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

methylPREDNISolone Sodium Succinate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection

40 mg (of methylprednisolone)*

A-methaPred®

Hospira

Methylprednisolone Sodium Succinate Injection

SOLU-Medrol®

Pfizer

125 mg (of methylprednisolone)*

A-methaPred®

Hospira

Methylprednisolone Sodium Succinate Injection

SOLU-Medrol®

Pfizer

500 mg (of methylprednisolone)

SOLU-Medrol®

Pfizer

1 g (of methylprednisolone)*

Methylprednisolone Sodium Succinate Injection

SOLU-Medrol®

Pfizer

2 g (of methylprednisolone)

SOLU-Medrol®

Pfizer

* 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.

1000. Food and Drug Administration. Epidural corticosteroid injection: Drug safety communication - risk of rare but serious neurologic problems. 2014 Apr 23. From FDA website. Accessed 2014 May 19. [Web]

1001. Food and Drug Administration. FDA drug safety communication: FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain. 2014 Apr 23. From FDA website. Accessed 2014 May 19. [Web]

1002. Rathmell JP. Toward improving the safety of transforaminal injection. Anesth Analg . 2009; 109:8-10. [PubMed 19535690]

1003. Cohen SP, Bicket MC, Jamison D et al. Epidural steroids: a comprehensive, evidence-based review. Reg Anesth Pain Med . 2013 May-Jun; 38:175-200.

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]

1010. Jeronimo CMP, Farias MEL, Val FFA et al. Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With Coronavirus Disease 2019 (COVID-19; Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial. Clin Infect Dis . 2021; 72:e373-e381. [PubMed 32785710][PubMedCentral]

1011. Salton F, Confalonieri P, Meduri GU et al. Prolonged Low-Dose Methylprednisolone in Patients With Severe COVID-19 Pneumonia. Open Forum Infect Dis . 2020; 7:ofaa421. [PubMed 33072814][PubMedCentral]

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. [PubMed 32880102][PubMedCentral]

1013. WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group., Sterne JAC, Murthy S et al. Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis. JAMA . 2020; 324:1330-41. [PubMed 32876694][PubMedCentral]

1014. Fadel R, Morrison AR, Vahia A et al. Early short-course corticosteroids in hospitalized patients with COVID-19. Clin Infect Dis. 2020; 71:2114-20. PMID: 32427279. DOI: 10.1093/cid/ciaa601.

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. [PubMed 32761993][PubMedCentral]

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]