Brand names: DEPO-Medrol, Medrol, SOLU-Medrol
Drug class: Adrenals
ATC class: H02AB04
VA class: HS051
CAS number: 83-43-2

Medically reviewed by Drugs.com on Feb 28, 2023. Written by ASHP.

Introduction

Synthetic glucocorticoid; minimal mineralocorticoid activity.

Uses for Methylprednisolone

Treatment of a wide variety of diseases and conditions principally for glucocorticoid effects as an anti-inflammatory and immunosuppressant agent and for its effects on blood and lymphatic systems in the palliative treatment of various diseases.

Usually, inadequate alone for adrenocortical insufficiency because of minimal mineralocorticoid activity.

Adrenocortical Insufficiency

Corticosteroids are administered in physiologic dosages to replace deficient endogenous hormones in patients with adrenocortical insufficiency.

Because production of both mineralocorticoids and glucocorticoids is deficient in adrenocortical insufficiency, hydrocortisone or cortisone (in conjunction with liberal salt intake) usually is the corticosteroid of choice for replacement therapy.

If methylprednisolone is used, must also administer a mineralocorticoid (fludrocortisone), particularly in infants.

In suspected or known adrenal insufficiency, parenteral therapy may be used preoperatively or during serious trauma, illness, or shock unresponsive to conventional therapy.

Adrenogenital Syndrome

Lifelong glucocorticoid treatment of congenital adrenogenital syndrome.

In salt-losing forms, cortisone or hydrocortisone is preferred in conjunction with liberal salt intake; a mineralocorticoid may be necessary in conjunction through at least 5–7 years of age.

A glucocorticoid, usually alone, for long-term therapy after early childhood.

In hypertensive forms, a “short-acting” glucocorticoid with minimal mineralocorticoid activity (e.g., methylprednisolone, prednisone) is preferred; avoid long-acting glucocorticoids (e.g., dexamethasone) because of tendency toward overdosage and growth retardation.

Hypercalcemia

Treatment of hypercalcemia associated with malignancy.

Usually ameliorates hypercalcemia associated with bone involvement in multiple myeloma.

Most effective long-term treatment for hypercalcemia associated with breast cancer in postmenopausal women.

Efficacy varies in other malignancies.

Treatment of hypercalcemia associated with sarcoidosis^{† [off-label]}.

Treatment of hypercalcemia associated with vitamin D intoxication^{† [off-label]}.

Not effective for hypercalcemia caused by hyperparathyroidism^{† [off-label]}.

Thyroiditis

Treatment of granulomatous (subacute, nonsuppurative) thyroiditis.

Anti-inflammatory actions relieves fever, acute thyroid pain, and swelling.

May reduce orbital edema in endocrine exophthalmos (thyroid ophthalmopathy).

Usually reserved for palliative therapy in severely ill patients unresponsive to salicylates and thyroid hormones.

Rheumatic Disorders and Collagen Diseases

Short-term adjunctive treatment of acute episodes or exacerbations and systemic complications of rheumatic disorders (e.g., rheumatoid arthritis, juvenile arthritis, psoriatic arthritis, acute gouty arthritis, posttraumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis, ankylosing spondylitis, Reiter syndrome^{† [off-label]}, rheumatic fever^{† [off-label]} [especially with carditis]) and collagen diseases (e.g., acute rheumatic carditis, systemic lupus erythematosus, dermatomyositis^† [polymyositis], polyarteritis nodosa^†, vasculitis^†) refractory to more conservative measures.

Relieves inflammation and suppresses symptoms but not disease progression.

Rarely indicated as maintenance therapy.

May be used as maintenance therapy (e.g., in rheumatoid arthritis, acute gouty arthritis, systemic lupus erythematosus, acute rheumatic carditis) as part of a total treatment program in selected patients when more conservative therapies have proven ineffective.

Glucocorticoid withdrawal is extremely difficult if used for maintenance; relapse and recurrence usually occur with drug discontinuance.

Local injection can provide dramatic relief initially for articular manifestations of rheumatic disorders (e.g., rheumatoid arthritis) that involve only a few persistently inflamed joints or for inflammation of tendons or bursae; inflammation tends to recur and sometimes is more intense after drug cessation.

Local injection used for the management of cystic tumors of an aponeurosis or tendon (ganglia).

Local injection can prevent invalidism by facilitating movement of joints that might otherwise become immobile.

Controls acute manifestations of rheumatic carditis more rapidly than salicylates and may be life-saving; cannot prevent valvular damage and no better than salicylates for long-term treatment.

Adjunctively for severe systemic complications of Wegener’s granulomatosis^†, but cytotoxic therapy is the treatment of choice.

Primary treatment to control symptoms and prevent severe, often life-threatening complications in patients with dermatomyositis^† and polymyositis^†, polyarteritis nodosa^†, relapsing polychondritis^†, polymyalgia rheumatica^† and giant-cell (temporal) arteritis^†, or mixed connective tissue disease syndrome^†. High dosage may be required for acute situations; after a response has been obtained, drug must often be continued for long periods at low dosage.

Polymyositis^† associated with malignancy and childhood dermatomyositis may not respond well.

Rarely indicated in psoriatic arthritis, diffuse scleroderma^† (progressive systemic sclerosis), acute and subacute bursitis, or osteoarthritis^†; risks outweigh benefits.

In osteoarthritis^†, intra-articular injections may be beneficial but should be limited in number as joint damage may occur.

Dermatologic Diseases

Treatment of pemphigus and pemphigoid^†, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, uncontrollable eczema^†, cutaneous sarcoidosis^†, mycosis fungoides, lichen planus, lichen simplex chronicus (neurodermatitis), severe psoriasis, and severe seborrheic dermatitis.

Usually reserved for acute exacerbations unresponsive to conservative therapy.

Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris and pemphigoid^†, and high or massive doses may be required.

For control of severe or incapacitating allergic conditions (e.g., contact dermatitis, atopic dermatitis) intractable to adequate trials of conventional treatment.

Chronic skin disorders seldom an indication for systemic glucocorticoids.

Intralesional or sublesional injections occasionally indicated for localized chronic skin disorders, keloids, psoriatic plaques, alopecia areata, discoid lupus erythematosus, necrobiosis lipoidica diabeticorum, granuloma annulare unresponsive to topical therapy.

Rarely indicated for psoriasis^†; if used, exacerbation may occur when the drug is withdrawn or dosage is decreased.

Rarely indicated systemically for alopecia (areata, totalis, or universalis). May stimulate hair growth, but hair loss returns when the drug is discontinued.

Allergic Conditions

For control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment and control of acute manifestations, including anaphylactic and anaphylactoid reactions^†, angioedema^†, acute noninfectious laryngeal edema, serum sickness, allergic symptoms of trichinosis^†, asthma, urticarial transfusion reactions, drug hypersensitivity reactions, and severe seasonal or perennial rhinitis.

Systemic therapy usually reserved for acute conditions and severe exacerbations.

For acute conditions, usually used in high dosage and with other therapies (e.g., antihistamines, sympathomimetics).

Reserve prolonged treatment of chronic allergic conditions for disabling conditions unresponsive to more conservative therapy and when risks of long-term glucocorticoid therapy are justified.

Ocular Disorders

To suppress a variety of allergic and nonpyogenic ocular inflammations.

To reduce scarring in ocular injuries^†.

For the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and adnexa (e.g., allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, diffuse posterior uveitis and choroiditis, anterior segment inflammation, optic neuritis, sympathetic ophthalmia, temporal arteritis).

Asthma

Corticosteroids are used as adjunctive treatment of acute asthma exacerbations^† and for maintenance treatment of persistent asthma^†.

Systemic glucocorticoids (usually prednisone, prednisolone, and dexamethasone) are used for treatment of moderate to severe acute exacerbations of asthma; speeds resolution of airflow obstruction and reduces rate of relapse.

COPD

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline states that oral glucocorticoids play a role in the acute management of COPD exacerbations, but have no role in the chronic daily treatment of COPD because of the lack of benefit and high rate of systemic complications.

Croup

Adjunctive treatment of croup^† in pediatric patients.

Decreases edema in laryngeal mucosa.

Reduces need for hospitalization, shorter duration of hospitalization, and reduces need for subsequent interventions (e.g., epinephrine).

Sarcoidosis

Management of symptomatic sarcoidosis.

Systemic glucocorticoids are indicated for hypercalcemia; ocular, CNS, glandular, myocardial, or severe pulmonary involvement; or severe skin lesions unresponsive to intralesional injections of glucocorticoids.

Tuberculosis

Treatment of fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous therapy.

Treatment of tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous therapy.

Lipid Pneumonitis

Promotes the breakdown or dissolution of pulmonary lesions and eliminates sputum lipids in lipid pneumonitis^†.

Pneumocystis jirovecii Pneumonia

Corticosteroids are used adjunctively in the treatment of Pneumocystis jiroveci (Pneumocystis carinii) pneumonia.

Coronavirus Disease 2019 (COVID-19)

Adjunctive therapy in the treatment of serious complications from COVID-19^†.

Loeffler’s Syndrome

Symptomatic relief of acute manifestations of symptomatic Loeffler’s syndrome not manageable by other means.

Berylliosis

Symptomatic relief of acute manifestations of berylliosis.

Aspiration Pneumonitis

Symptomatic relief of acute manifestations of aspiration pneumonitis.

Hematologic Disorders

Management of acquired (autoimmune) hemolytic anemia, pure red cell aplasia, idiopathic thrombocytopenic purpura (ITP), secondary thrombocytopenia, erythroblastopenia, or congenital (erythroid) hypoplastic anemia.

High or even massive dosages decrease bleeding tendencies and normalize blood counts; does not affect the course or duration of hematologic disorders.

May not affect or prevent renal complications in Henoch-Schoenlein purpura.

Insufficient evidence of effectiveness in aplastic anemia in children, but widely used.

GI Diseases

Short-term palliative therapy for acute exacerbations and systemic complications of ulcerative colitis, regional enteritis (Crohn’s disease), and celiac disease^†.

Do not use if a probability of impending perforation, abscess, or other pyogenic infection.

Rarely indicated for maintenance therapy in chronic GI diseases (e.g., ulcerative colitis, celiac disease) since does not prevent relapses and may produce severe adverse reactions with long-term administration.

Occasionally, low dosages, in conjunction with other supportive therapy, may be useful for disease unresponsive to the usual therapy indicated for chronic conditions.

Oral corticosteroids may be used for short-term treatment of moderate to severely active Crohn’s disease^†.

Neoplastic Diseases

Alone or as a component of various chemotherapeutic regimens in the palliative treatment of neoplastic diseases of the lymphatic system (e.g., leukemias and lymphomas in adults and acute leukemias in children).

Treatment of breast cancer^†; glucocorticoids alone not as effective as other agents (e.g., cytotoxic agents, hormones, antiestrogens) and should be reserved for unresponsive disease.

Cerebral Edema

To decrease cerebral edema associated with brain tumors and neurosurgery.

Cerebral edema associated with pseudotumor cerebri may also benefit, but efficacy of glucocorticoids is controversial and remains to be established.

Edema resulting from brain abscesses is less responsive than that resulting from brain tumors.

Pharmacologic management of cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy.

Acute Spinal Cord Injury

Has been used in the treatment of acute spinal cord injury^†; some evidence indicates that large IV doses of glucocorticoids (i.e., methylprednisolone) can improve motor and sensory function when treatment is initiated promptly following injury (within 8 hours).

Low Back Pain

Systemic corticosteroids have been used for symptomatic relief of low back pain^†; however, current evidence suggests that corticosteroids do not seem to be effective for improving radicular or nonradicular low back pain.

Multiple Sclerosis

Corticosteroids (e.g., dexamethasone, methylprednisolone) have been used in the treatment of multiple sclerosis^†, but are no longer used as disease-modifying agents because of serious adverse effects associated with chronic administration and the development of more effective disease-modifying drugs. However, corticosteroids may improve symptoms during an acute exacerbation.

Myasthenia Gravis

Corticosteroids have been used in the treatment of myasthenia gravis^†, usually when there is an inadequate response to anticholinesterase therapy.

Organ Transplants

In massive dosage, used concomitantly with other immunosuppressive drugs to prevent rejection of transplanted organs^†.

Incidence of secondary infections is high with immunosuppressive drugs; limit to clinicians experienced in their use.

Trichinosis

Treatment of trichinosis with neurologic or myocardial involvement.

Nephrotic Syndrome and Lupus Nephritis

Treatment of idiopathic nephrotic syndrome without uremia.

Can induce diuresis and remission of proteinuria in nephrotic syndrome secondary to lupus erythematosus or primary renal disease, especially when there is minimal renal histologic change.

Treatment of lupus nephritis.

Carpal Tunnel Syndrome

Local injection of glucocorticoids (e.g., methylprednisolone, betamethasone) into the tissue near the carpal tunnel has been used in a limited number of patients to relieve symptoms (e.g., pain, edema, sensory deficit) of carpal tunnel syndrome^†.

Related/similar drugs

Rinvoq, Cimzia, Otezla, Vumerity, Taltz, Sotyktu, gabapentin

Methylprednisolone Dosage and Administration

General

• Route of administration and dosage depend on the condition being treated and the patient response.

Alternate-day Therapy

• Alternate-day therapy in which a single dose (twice the usual daily dosage) is administered every other morning is the dosage regimen of choice for long-term oral glucocorticoid treatment of most conditions. This regimen provides relief of symptoms while minimizing adrenal suppression, protein catabolism, and other adverse effects.

• If alternate-day therapy is preferred, only use a “short-acting” glucocorticoid that suppresses the HPA axis <1.5 days after a single oral dose (e.g., methylprednisolone, prednisone, prednisolone).

• Some conditions (e.g., rheumatoid arthritis, ulcerative colitis) require daily glucocorticoid therapy because symptoms of the underlying disease cannot be controlled by alternate-day therapy.

Discontinuance of Therapy

• A steroid withdrawal syndrome consisting of lethargy, fever, and myalgia can develop following abrupt discontinuance. Symptoms often occur without evidence of adrenal insufficiency (while plasma glucocorticoid concentrations were still high but were falling rapidly).

• If used for only brief periods (a few days) in emergency situations, may reduce and discontinue dosage quite rapidly.

• Very gradually withdraw systemic glucocorticoids until recovery of HPA-axis function occurs following long-term therapy with pharmacologic dosages. (See Adrenocortical Insufficiency under Warnings.)

• Exercise caution when transferring from systemic glucocorticoid to oral or nasal inhalation corticosteroid therapy.

• Many methods of slow withdrawal or “tapering” have been described.

• In one suggested regimen, decrease by 2–4 mg every 3–7 days of until the physiologic dose (4 mg) is reached.

• Other recommendations state that decrements usually should not exceed 2 mg every 1–2 weeks.

• When a physiologic dosage has been reached, single 20-mg oral morning doses of hydrocortisone can be substituted for whatever glucocorticoid the patient has been receiving. After 2–4 weeks, may decrease hydrocortisone dosage by 2.5 mg every week until a single morning dosage of 10 mg daily is reached.

• For certain acute allergic conditions (e.g., contact dermatitis such as poison ivy) or acute exacerbations of chronic allergic conditions, glucocorticoids may be administered short term (e.g., for 6 days). Administer an initially high dose on the first day of therapy, and then withdraw therapy by tapering the dose over several days.

Administration

Administer orally, by IV injection or infusion, or IM injection. Methylprednisolone sodium succinate for injection (e.g., Solu-Medrol) is administered IV or IM; formulations containing benzyl alcohol should not be used in neonates. Methylprednisolone acetate injectable suspension (e.g., Depo-Medrol) is not for IV use; the multiple-dose vials contain benzyl alcohol and should not be used in neonates.

Methylprednisolone acetate injectable suspension (e.g., Depo-Medrol) may be administered locally by intra-articular, intralesional, intrasynovial, or soft-tissue injection.

Generally reserve IM or IV therapy for patients who are not able to take the drug orally or for use in an emergency situation. After the initial emergency period, a longer-acting injectable corticosteroid preparation or oral administration of a corticosteroid should be considered.

Oral Administration

Methylprednisolone

Administer orally as tablets.

IV Administration

Methylprednisolone Sodium Succinate

Administer by IV injection or infusion.

Reconstitution of Methylprednisolone Sodium Succinate

Reconstitute by pressing on a plastic activator to force the diluent provided from the manufacturer from an upper compartment of a 2-compartment vial to a lower compartment containing sterile powder. Alternately, use bacteriostatic water for injection with benzyl alcohol for reconstitution.

Dilution of Methylprednisolone Sodium Succinate

When administered by IV infusion, the drug can be added to 5% dextrose, or 0.9% sodium chloride, or 5% dextrose in sodium chloride injection.

Rate of Administration of Methylprednisolone Sodium Succinate

Direct IV injection: Administer over a period of several minutes.

IM Administration

Do not administer IM for conditions prone to bleeding (e.g., idiopathic thrombocytopenic purpura [ITP]).

Methylprednisolone Acetate

Administer by IM injection.

Because it is slowly absorbed, IM administration is not indicated when an immediate effect of short duration is required.

Commercially available single-dose vials are for single use only. Although initially sterile, multiple use of a single-dose vial may result in contamination, unless strict aseptic technique is observed.

Methylprednisolone Sodium Succinate

Administer by IM injection.

Absorption from IM injection sites is rapid.

Intra-articular, Intralesional, and Soft Tissue Administration

Methylprednisolone Acetate

Administer by intra-articular, intralesional, intrasynovial, or soft tissue injection.

May infiltrate the tissue surrounding the joint with a local anesthetic (e.g., procaine hydrochloride) before administration of methylprednisolone acetate.

Examine joint fluid to exclude sepsis and avoid injection into an infected site; if joint sepsis is evident, institute appropriate antibacterial therapy. Symptoms of septic arthritis include local swelling, further restriction of joint motion, fever, or malaise. Do not inject glucocorticoids into unstable joints and caution patients not to overuse joints in which the inflammatory process still is active despite symptomatic improvement.

Dosage

Available as methylprednisolone, methylprednisolone acetate, and methylprednisolone sodium succinate. Dosage of methylprednisolone sodium succinate or methylprednisolone acetate is expressed in terms of methylprednisolone or methylprednisolone acetate, respectively.

After a satisfactory response is obtained, decrease dosage in small decrements to the lowest level that maintains an adequate clinical response, and discontinue the drug as soon as possible.

Monitor patients continually for signs that indicate dosage adjustment is necessary, such as remissions or exacerbations of the disease and stress (surgery, infection, trauma).

High dosages may be required for acute situations of certain rheumatic disorders and collagen diseases; after a response has been obtained, drug often must be continued for long periods at low dosage.

High or massive dosages may be required in the treatment of pemphigus, exfoliative dermatitis, bullous dermatitis herpetiformis, severe erythema multiforme, or mycosis fungoides. Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris. Reduce dosage gradually to the lowest effective level, but discontinuance may not be possible.

Massive dosages may be required for treatment of shock.

Increase dosage of rapidly acting corticosteroids in patients subjected to any unusual stress before, during, and after the stressful situation.

Pediatric Patients

Base pediatric dosage on severity of the disease and patient response rather than on strict adherence to dosage indicated by age, body weight, or body surface area.

Usual Dosage

Oral

0.117–1.66 mg/kg daily or 3.3–50 mg/m² daily, administered in 3 or 4 divided doses.

IM

Methylprednisolone sodium succinate: 0.03–0.2 mg/kg or 1–6.25 mg/m² IM 1–2 times daily has been used.

Croup†

IV

Methylprednisolone sodium succinate: Initially, 1–2 mg/kg has been used.

Coronavirus Disease 2019 (COVID-19)†

IV

When a corticosteroid is used, NIH COVID-19 Treatment Guidelines Panel recommends dexamethasone (0.15 mg/kg [maximum 6 mg] given IV or orally once daily for up to 10 days). If dexamethasone not available, may consider equivalent dosages of an alternative corticosteroid (e.g., methylprednisolone). Consult most recent NIH treatment guidelines for additional information on use of corticosteroids in pediatric patients with COVID-19.

Acute Spinal Cord Injury†

IV

Methylprednisolone sodium succinate: 30 mg/kg IV (administered over 15 minutes), followed after 45 minutes by a continuous IV infusion of 5.4 mg/kg per hour for 23 hours has been administered.

Lupus Nephritis†

IV

Methylprednisolone sodium succinate: 30 mg/kg IV every other day for 6 doses.

Adults

Usual Dosage

Oral

Initially, 2–60 mg daily, depending on disease being treated, and is usually divided into 4 doses.

IV or IM

Methylprednisolone sodium succinate: Usually, 10–250 mg; may repeat up to 6 times daily.

IV then IV or IM

Methylprednisolone sodium succinate: For high-dose therapy, administer 30 mg/kg over at least 30 minutes. May repeat every 4–6 hours for 48 hours. Continue high-dose therapy only until the condition stabilizes, usually ≤48–72 hours.

For other conditions, 10–40 mg over several minutes. Administer subsequent doses IV or IM depending on response and clinical condition.

IM

Methylprednisolone acetate: 10–80 mg.

Methylprednisolone acetate for maintenance of patients with rheumatoid arthritis: 40–120 mg weekly.

When methylprednisolone acetate suspension is given as a temporary substitute for oral therapy, dose of the suspension should be equal to the total daily oral dose of methylprednisolone; administer IM once daily. If a prolonged effect is desired, may administer an IM dose of methylprednisolone acetate equal to 7 times the daily oral dose of methylprednisolone once weekly.

Intraarticular, Intrasynovial, Intralesional, or Soft-tissue Injection

Varies depending on location, size, and degree of inflammation. In chronic cases, repeat injections at intervals ranging from 1–5 weeks or more, depending on degree of relief resulting from initial injection.

Large Joints (e.g., knee): 20–80 mg of methylprednisolone acetate.

Smaller Joints: 4–40 mg of methylprednisolone acetate repeated.

Bursae, Ganglia, Tendinitis, Epicondylitis: 4–30 mg of methylprednisolone acetate; repeat if necessary for recurrent or chronic conditions.

Soft Tissue: 4–30 mg of methylprednisolone acetate for soft tissue infiltration; repeat if necessary for recurrent or chronic conditions. .

Dermatologic Diseases

Intralesional Injection

Methylprednisolone acetate: 20–60 mg into the lesion. For large lesions, it may be necessary to administer 20–40 mg doses by repeated local injections spaced across the affected area. Usually, 1–4 injections are employed, with interval between injections varying with the type of lesion treated and the duration of improvement observed with each injection.

IM

Methylprednisolone acetate: In patients with dermatologic lesions, usually, 40–120 mg of methylprednisolone acetate once weekly for 1–4 weeks.

Methylprednisolone acetate: In seborrheic dermatitis, 80 mg weekly may be adequate to control the condition.

Adrenogenital Syndrome

IM

Methylprednisolone acetate: 40 mg every 2 weeks.

Allergic Conditions

Oral

For certain conditions (e.g., contact dermatitis, including poison ivy), 24 mg (6 tablets) for the first day, which is then tapered by 4 mg daily until 21 tablets have been administered. (See Tapered Dosage Schedule table.)

Some clinicians suggest tapering the dosage of the drug over 12 days may be associated with a lower incidence of flare-up of the dermatitis than that associated with 6-day therapy.

IM

Methylprednisolone acetate: In acute severe dermatitis due to poison ivy, 80–120 mg as a single dose. In chronic contact dermatitis, repeated injections at 5- to 10-day intervals may be necessary.

Methylprednisolone acetate: For control of severe or incapacitating allergic conditions (e.g., bronchial asthma, seasonal or perennial allergic rhinitis) intractable to adequate trials of conventional therapy, 80–120 mg.

Following IM administration of 80 to 120 mg to asthmatic patients, relief of symptoms should occur within 6–48 hours and persist for several days to 2 weeks.

Acute Exacerbations of Multiple Sclerosis

IV

For moderate to severe relapses, 1 g daily for 3–5 days, followed by 60 mg of oral prednisone daily, tapering the dosage over 12 days.

Alternatively, 1 g or 15 mg/kg of IV methylprednisolone tapered over 15 days to 1 mg/kg, followed by oral prednisone or prednisolone in gradually decreasing dosages over several weeks to months.

Oral

160 mg daily for 1 week, followed by 64 mg every other day for a month.

Coronavirus Disease 2019 (COVID-19)†

IV

NIH COVID-19 Treatment Guidelines Panel recommends methylprednisolone 32 mg given once daily or in 2 divided doses. Consult most recent NIH treatment guidelines for additional information on use of corticosteroids in patients with COVID-19.

Shock

IV

Life-threatening shock: massive doses of methylprednisolone as the sodium succinate such as 30 mg/kg by direct IV injection (over 3–15 minutes) initially and repeated every 4–6 hours if needed or 100–250 mg by direct IV injection (over 3–15 minutes) initially and repeated at 2- to 6-hour intervals as required.

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.

Continue high-dose therapy only until the patient’s condition has stabilized and usually not beyond 48–72 hours.

Acute Spinal Cord Injury†

IV

Methylprednisolone sodium succinate: Initially, 30 mg/kg of methylprednisolone 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.

Lupus Nephritis†

IV

Methylprednisolone sodium succinate: 1 g IV (over a 1-hour period) daily for 3 consecutive days (“pulse” therapy).

“Pulse” therapy has been followed by long-term oral prednisone or prednisolone therapy (0.5–1 mg/kg per day).

Optic Neuritis†

IV

1 g daily for 3 days followed by oral prednisone 1 mg/kg daily for 11 days has been used.

Cautions for Methylprednisolone

Contraindications

• Known hypersensitivity to methylprednisolone, any ingredient in the respective formulation, or any other corticosteroid.

• IM administration in patients with idiopathic thrombocytopenic purpura.

• Systemic fungal infections, except when administered as an intra-articular injection for localized joint conditions.

• Concurrent administration of live or live, attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids. (See Specific Drugs under Interactions.)

• Intrathecal administration of methylprednisolone acetate.

• Methylprednisolone sodium succinate injection preparations containing benzyl alcohol in premature neonates.

• Methylprednisolone acetate injection preparations (in multiple-dose vials) containing benzyl alcohol in premature infants.

Warnings/Precautions

Warnings

Nervous System Effects

May precipitate mental disturbances ranging from euphoria, insomnia, mood swings, depression and anxiety, and personality changes to frank psychoses. Use may aggravate emotional instability or psychotic tendencies.

Use with caution in patients with myasthenia gravis.

Serious neurologic events, sometimes resulting in death, reported with epidural injection of corticosteroids. Such events have included spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. Safety and efficacy of epidural administration of corticosteroids not established; corticosteroids are not approved for this use.

Results from a multicenter, randomized, placebo controlled study with methylprednisolone hemisuccinate (an IV corticosteroid) showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. Do not use high doses of systemic corticosteroids, including methylprednisolone acetate (Depo-Medrol), for treatment of traumatic brain injury.

Adrenocortical Insufficiency

When given in supraphysiologic doses for prolonged periods, glucocorticoids may cause decreased secretion of endogenous corticosteroids by suppressing pituitary release of corticotropin (secondary adrenocortical insufficiency).

The degree and duration of adrenocortical insufficiency is highly variable among patients and depends on the dose, frequency and time of administration, and duration of glucocorticoid therapy.

Acute adrenal insufficiency (even death) may occur if the drugs are withdrawn abruptly or if patients are transferred from systemic glucocorticoid therapy to local (e.g., inhalation) therapy.

Withdraw methylprednisolone very gradually following long-term therapy with pharmacologic dosages.

Adrenal suppression may persist up to 12 months in patients who receive large dosages for prolonged periods.

Until recovery occurs, signs and symptoms of adrenal insufficiency may develop if subjected to stress (e.g., infection, surgery, trauma) and replacement therapy may be required. Since mineralocorticoid secretion may be impaired, sodium chloride and/or a mineralocorticoid should also be administered.

If the disease flares up during withdrawal, dosage may need to be increased and followed by a more gradual withdrawal.

Immunosuppression

Increased susceptibility to infections secondary to glucocorticoid-induced immunosuppression. Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients. (See Increased Susceptibility to Infection under Warnings.)

Administration of live virus vaccines, including smallpox, is contraindicated in patients receiving immunosuppressive dosages of glucocorticoids. If inactivated viral or bacterial vaccines are administered to such patients, the expected serum antibody response may not be obtained. May undertake indicated immunization procedures in patients receiving glucocorticoids as replacement therapy (e.g., Addison’s disease).

Increased Susceptibility to Infection

Glucocorticoids, especially in large doses, increase susceptibility to and mask symptoms of infection.

Infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections in any organ system, may be associated with glucocorticoids alone or in combination with other immunosuppressive agents; reactivation of latent infections may occur.

Infections may be mild, but they can be severe or fatal, and localized infections may disseminate.

Do not inject methylprednisolone acetate intra-articularly, bursally, or into a tendon for local effect in patients with acute infection.

Do not use, except in life-threatening situations, in patients with viral infections or bacterial infections not controlled by anti-infectives.

Some infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome, particularly in children.

Children and any adult who are not likely to have been exposed to varicella or measles should avoid exposure to these infections while receiving glucocorticoids.

If exposure to varicella or measles occurs in susceptible patients, treat appropriately (e.g., VZIG, IG, acyclovir).

Prolonged use of systemic corticosteroids in patients with COVID-19^† may increase risk of reactivation of latent infections (e.g., HBV, herpesvirus, strongyloidiasis, tuberculosis). Risk of reactivation of latent infections following a 10-day course of dexamethasone (6 mg once daily) or equivalent corticosteroid therapy (e.g., methylprednisolone) not well established. When initiating methylprednisolone in patients with COVID-19, consider appropriate screening and treatment to reduce the risk of Strongyloides hyperinfection in those at high risk (e.g., patients from tropical, subtropical, or warm, temperate regions or those engaged in agricultural activities) and reduce the risk of fulminant reactivation of HBV.

Corticosteroids may exacerbate fungal infections and should not be used in the presence of such infections, unless they are needed to control drug reactions.

Not effective and can have detrimental effects in the management of cerebral malaria. Do not use corticosteroids in cerebral malaria.

Can reactivate tuberculosis. Include chemoprophylaxis in patients with a history of active tuberculosis undergoing prolonged glucocorticoid therapy. Observe closely for evidence of reactivation. Restrict use in active tuberculosis to those with fulminating or disseminated tuberculosis in which glucocorticoids are used in conjunction with appropriate chemoprophylaxis.

Can reactivate latent amebiasis. Exclude possible amebiasis in any patient who has been in the tropics or who has unexplained diarrhea prior to initiating therapy.

Musculoskeletal Effects

Muscle wasting, muscle pain or weakness, delayed wound healing, and atrophy of the protein matrix of the bone resulting in osteoporosis, vertebral compression fractures, aseptic necrosis of femoral or humeral heads, or pathologic fractures of long bones are manifestations of protein catabolism that may occur during prolonged therapy with glucocorticoids. These adverse effects may be especially serious in geriatric or debilitated patients. A high protein diet may help to prevent adverse effects associated with protein catabolism.

An acute, generalized myopathy can occur with the use of high doses of glucocorticoids, particularly in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis) or in patients receiving concomitant therapy with neuromuscular blocking agents (e.g., pancuronium).

Osteoporosis and related fractures are one of the most serious adverse effects of long-term glucocorticoid therapy. The American College of Rheumatology (ACR) has published guidelines on prevention and treatment of glucocorticoid-induced osteoporosis. Recommendations are made according to a patient's risk of fracture.

Fluid and Electrolyte Disturbances

Sodium retention with resultant edema, potassium loss, hypokalemic alkalosis, and elevation of BP may occur with average and large doses of corticosteroids. These effects are less frequent with synthetic glucocorticoids than with hydrocortisone or cortisone, but may occur, especially when synthetic glucocorticoids are given in high dosage for prolonged periods. Edema and CHF (in susceptible patients) may occur.

Dietary salt restriction is advisable and potassium supplementation may be necessary.

Increased calcium excretion and possible hypocalcemia.

Ocular Effects

Prolonged use may result in posterior subcapsular and nuclear cataracts (particularly in children), exophthalmos, and/or increased IOP which may result in glaucoma or may occasionally damage the optic nerve.

May enhance the establishment of secondary bacterial, fungal, and viral infections of the eye.

Use with caution in patients with active ocular herpes simplex infections for fear of corneal perforation.

Endocrine and Metabolic Effects

Administration over a prolonged period may produce various endocrine disorders including hypercorticism (cushingoid state) and amenorrhea or other menstrual difficulties.

Increased or decreased motility and number of sperm in some men.

May decrease glucose tolerance, produce hyperglycemia, and aggravate or precipitate diabetes mellitus, especially in patients predisposed to diabetes mellitus. If glucocorticoid therapy is required in patients with diabetes mellitus, changes in insulin or oral antidiabetic agent dosage or diet may be necessary.

Exaggerated response to the glucocorticoids in hypothyroidism; use with caution. Changes in thyroid status may require dosage adjustment.

Cardiovascular Effects

Use with extreme caution in recent MI since an association between use of glucocorticoids and left ventricular free-wall rupture has been suggested.

Use with caution in patients with CHF and hypertension.

Bradycardia has occurred during or after IV administration of large doses of methylprednisolone sodium succinate; may be unrelated to rate or duration of infusion.

Cardiac arrhythmias, circulatory collapse, and/or cardiac arrest reported following rapid (<10 minutes) administration of large IV doses of methylprednisolone sodium succinate.

Dermatologic Effects

Dermal and/or subdermal changes forming depressions in the skin at the injection site reported with methylprednisolone acetate injectable suspension (Depo-Medrol). Exercise care to minimize the incidence of dermal and subdermal atrophy; do not exceed recommended doses of the injections.

For intralesional use, administer multiple small injections into the area of the lesion, whenever possible.

Avoid injection or leakage into the dermis; avoid injection into the deltoid muscle, because of high incidence of sub-Q atrophy.

Kaposi’s sarcoma has been reported in patients receiving glucocorticoid therapy; discontinuance of such therapy may result in clinical improvement of the disease.

Sensitivity Reactions

Anaphylactic or anaphylactoid reactions with or without circulatory collapse, cardiac arrest, or bronchospasm. Take appropriate precautionary measures prior to administration, especially in patients with a history of allergy to any drug.

Urticaria and other allergic or hypersensitivity reactions reported.

General Precautions

Monitoring

Prior to initiation of long-term glucocorticoid therapy, perform baseline ECGs, blood pressures, chest and spinal radiographs, glucose tolerance tests, and evaluations of HPA-axis function in all patients.

Perform upper GI radiographs in patients predisposed to GI disorders, including those with known or suspected peptic ulcer disease.

During long-term therapy, perform periodic height, weight, chest and spinal radiographs, hematopoietic, electrolyte, glucose tolerance, and ocular and blood pressure evaluations.

Genitourinary Effects

Increased or decreased motility and number of sperm in some men.

GI Effects

Corticosteroids should be used with caution in patients with diverticulitis, nonspecific ulcerative colitis (if there is a probability of impending perforation, abscess, or other pyogenic infection), or those with recent intestinal anastomoses.

Use with caution in patients with active or latent peptic ulcer. Manifestations of peritoneal irritation following GI perforation may be minimal or absent in patients receiving corticosteroids. Suggest concurrent administration of antacids between meals to prevent peptic ulcer formation in patients receiving high dosages of corticosteroids.

Specific Populations

Pregnancy

Corticosteroids have been shown to be teratogenic in many species when administered in clinical doses. No adequate and well-controlled studies in pregnant women. Use during pregnancy only potential benefit justifies potential risk to fetus.

If substantial dosage received during pregnancy, carefully observe infant for signs of hypoadrenalism.

Lactation

Glucocorticoids are distributed into milk and could suppress growth, interfere with endogenous glucocorticoid production, or cause other adverse effects in nursing infants. Discontinue nursing or the drug.

Pediatric Use

The effects of glucocorticoids on the pathophysiology and course of diseases are considered to be similar in adults and children. Evidence of safety and efficacy of corticosteroids in pediatric patients is based on treatment of nephrotic syndrome (in patients >2 years of age) and aggressive leukemias and lymphomas (in patients >1 month of age). Evidence of safety and efficacy in other pediatric indications (e.g., severe asthma and wheezing) is based on controlled trials in adults.

Adverse effects in pediatric patients are similar to those in adults. As in adults, perform periodic evaluations of height, weight, IOP, and BP. Children, like adults, also should undergo clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.

With long-term use, may delay growth and maturation in children and adolescents. Monitor carefully the growth and development of pediatric patients receiving prolonged corticosteroid therapy. Titrate dosage to the lowest effective level. Alternate-day therapy with glucocorticoids that cause shorter HPA-axis suppression than does dexamethasone (e.g., prednisone, prednisolone, methylprednisolone) may minimize growth suppression and should be instituted if growth suppression occurs.

Methylprednisolone sodium succinate (in single-dose vials) and methylprednisolone acetate (in multiple-dose vials) injection preparations containing benzyl alcohol are contraindicated in premature infants. Administration of injections preserved with benzyl alcohol has been associated with toxicity in neonates (gasping syndrome). (See Contraindications under Cautions.)

Safety and efficacy of dexamethasone and other corticosteroids (e.g., methylprednisolone) for COVID-19^† treatment not fully evaluated in pediatric patients. Use caution when extrapolating recommendations for adults with COVID-19 to pediatric patients <18 years of age. The NIH COVID-19 Treatment Guidelines Panel recommends use of dexamethasone (see Pediatric Patients under Dosage, in Dosage and Administration) for hospitalized pediatric patients with COVID-19 who are receiving high-flow oxygen, noninvasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); dexamethasone not routinely recommended for pediatric patients who require only low levels of oxygen support (i.e., nasal cannula only). If dexamethasone not available, the NIH panel states that alternative corticosteroids (e.g., methylprednisolone) at equivalent dosages may be considered. Use of corticosteroids for treatment of severe COVID-19 in pediatric patients who are profoundly immunocompromised not evaluated to date and may be harmful; therefore, the NIH panel states consider such use only on a case-by-case basis. IV corticosteroids have been used as first-line therapy in pediatric patients with multisystem inflammatory syndrome in children (MIS-C); however, the NIH panel recommends consultation with a multidisciplinary team when considering and managing immunomodulating therapy for children with this condition. Optimal choice and combination of immunomodulating therapies for children with MIS-C not definitely established. Consult the most recent NIH COVID-19 treatment guidelines for additional information on use of corticosteroids in pediatric patients with COVID-19.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution. Other clinical experience to date has not identified any differences in responses between geriatric and younger patients.

With prolonged therapy, muscle wasting, muscle pain or weakness, delayed wound healing, and atrophy of the protein matrix of the bone resulting in osteoporosis, vertebral compression fractures, aseptic necrosis of femoral or humeral heads, or pathologic fractures of long bones may occur. May be especially serious in geriatric or debilitated patients.

Select dosage with caution, usually initiating therapy at the low end of the dosing range, because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.

Before initiating glucocorticoid therapy in postmenopausal women, consider that such women are especially prone to osteoporosis.

Use with caution in patients with osteoporosis.

Hepatic Impairment

Patients with cirrhosis show an exaggerated response to glucocorticoids.

Renal Impairment

Use with caution.

Common Adverse Effects

Associated with long-term therapy: Bone loss, cataracts, indigestion, muscle weakness, back pain, bruising, oral candidiasis.

Drug Interactions

Metabolized by CYP3A4.

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A4 (e.g., ketoconazole, macrolide antibiotics): Potential pharmacokinetic interaction (increased plasma concentrations and decreased corticosteroid clearance); may require decrease of corticosteroid dosage to avoid potential adverse effects).

Inducers of CYP3A4 (e.g., barbiturates, carbamazepine, ephedrine, phenytoin, rifampin): Potential pharmacokinetic interaction (increased metabolism of corticosteroids); may require increase of corticosteroid dosage).

Specific Drugs and Skin Tests

Methylprednisolone Pharmacokinetics

Absorption

Bioavailability

Absorption from IM injection of methylprednisolone sodium succinate is rapid.

Systemic absorption of methylprednisolone acetate occurs slowly following intra-articular, intrabursal, intrasynovial, intradermal, or soft tissue injection; Absorption from intra-articular injection sites is usually very slow and continues for about 7 days.

Onset

Following IM administration (80–120 mg) in patients with severe poison ivy, relief onset within 8–12 hours.

Duration

The duration of anti-inflammatory activity of methylprednisolone approximately equals the duration of HPA-axis suppression, about 1.25–1.5 days for a single 40-mg oral dose.

Distribution

Extent

Most glucocorticoids are removed rapidly from the blood and distributed to muscles, liver, skin, intestines, and kidneys.

Glucocorticoids appear in breast milk and the placenta.

Elimination

Metabolism

Metabolized in most tissues, but mainly in the liver, to inactive compounds.

Half-life

Approximately 2.5–3.5 hours following oral administration of methylprednisolone or IV or IM administration of methylprednisolone sodium succinate.

Special Populations

The metabolic clearance of corticosteroids may be decreased in patients with hypothyroidism and increased in those with hyperthyroidism.

Stability

Storage

Oral

Tablets

20–25°C.

Parenteral

Powder for Injection

Store unreconstituted at 20–25°C. Store reconstituted solution at 20–25°C; use reconstituted solution within 48 hours

Suspension for Injection

20–25°C.

Single-dose vials of methylprednisolone acetate injectable suspension (Depo-Medrol) are not intended for multiple-dose withdrawal; discard any remaining suspension.

Avoid contamination of multiple-dose vials of methylprednisolone acetate injectable suspension by using strict aseptic technique. Use povidone-iodine solution or similar product to cleanse the vial top prior to aspiration of contents. Although initially sterile, such vials may become contaminated; use of disposable sterile syringes and needles is necessary.

Similar to other corticosteroids, methylprednisolone acetate suspension is heat labile; do not autoclave when it is desirable to sterilize the outside of the vial.

Actions

• Principally an anti-inflammatory or immunosuppressant agent.

• Exhibits potent anti-inflammatory activity and minimal mineralocorticoid properties.

• Decreases inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; or reducing leukocyte adhesion to capillary endothelium.

• Inhibits macrophage accumulation in inflamed areas.

• Reduces capillary wall permeability and edema formation.

• Antagonizes histamine activity and release of kinin from substrates.

• Reduces fibroblast proliferation, collagen deposition, and subsequent scar tissue formation.

• Stimulates erythroid cells of bone marrow, prolongs survival time of erythrocytes and platelets, and produces neutrophilia and eosinopenia.

• Promotes gluconeogenesis, redistribution of fat from peripheral to central areas of the body, and protein catabolism, which results in negative nitrogen balance.

• Reduces intestinal absorption and increase renal excretion of calcium.

• Suppresses the immune response by reducing activity and volume of the lymphatic system, producing lymphocytopenia.

• Decreases immunoglobulin and complement concentrations and passage of immune complexes through basement membranes.

• Depresses reactivity of tissue to antigen-antibody interactions.

Advice to Patients

• In patients receiving long-term therapy, importance of not discontinuing the drug abruptly or without supervision of a clinician.

• Importance of notifying a clinician of any infections, signs of infections (e.g., fever, sore throat, pain during urination, muscle aches), or injuries that develop during therapy or within 12 months after therapy is discontinued.

• Importance of carrying identification cards listing the diseases being treated, the glucocorticoid regimen, and the name and telephone number of the clinician.

• When surgery is required, importance of informing the attending physician, dentist, or anesthesiologist of recent (within 12 months) glucocorticoid therapy.

• In immunosuppressed patients, importance of avoiding exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

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.

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

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

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

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