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Methylprednisolone (SOLUMedrol) - Uses, Dose, Side effects, Brands

Methylprednisolone is a synthetic glucocorticoid medication used to treat a variety of conditions such as inflammation, allergic reactions, autoimmune diseases, and certain types of cancers. It works by suppressing the immune system and reducing inflammation in the body.

Methylprednisolone is an intermediate-acting corticosteroid that is 4 - 5 times more potent than hydrocortisone. It is used in the treatment of severe inflammatory, allergic, and autoimmune conditions.

Methylprednisolone Uses:

Oral, IM (acetate or succinate), and IV (succinate only) administration:
- Anti-inflammatory or immunosuppressant agent in the treatment of a variety of diseases, including:
  - Hematologic (eg, warm autoimmune hemolytic anemia immune thrombocytopenia),
  - allergic,
  - gastrointestinal (eg, ulcerative colitis, Crohn disease),
  - Inflammatory,
  - neoplastic,
  - neurologic (eg, multiple sclerosis),
  - rheumatic (eg, antineutrophil cytoplasmic antibody-associated vasculitis, dermatomyositis/ polymyositis, gout, rheumatoid arthritis, mixed cryoglobulinemia syndrome, polyarteritis nodosa, systemic lupus erythematosus), and/or
  - autoimmune origin.
Intra-articular or soft tissue administration (acetate only):
- Gout (acute flare), acute and subacute bursitis, rheumatoid arthritis, acute nonspecific tenosynovitis, epicondylitis, and/or synovitis of osteoarthritis.
Intralesional administration (acetate only):
- Alopecia areata;
- discoid lupus erythematosus;
- keloids;
- lichen planus, lichen simplex chronicus (neurodermatitis),
- localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, and psoriatic plaques; and
- necrobiosis lipoidica diabeticorum.
- It may be useful in the cystic tumor of an aponeurosis or tendon (ganglia).
Off Label Use of Adult
- Used in moderate to severe acute respiratory distress syndrome,
- Used in cardiac transplant: Treatment of acute cellular rejection
- Used in cardiac transplant: Treatment of Antibody-mediated rejection
- Used in the acute exacerbation of chronic obstructive pulmonary disease.
- Used in deceased organ donor management (hormonal resuscitation for the deceased organ donor)
- Used in the treatment of giant cell arteritis,
- Used in acute graft-vs-host disease,
- Used in-hospital cardiac arrest
- Used in severe/refractory nausea and vomiting of pregnancy,
- Used in adjunctive therapy for moderate to severe disease pneumocystis pneumonia,
- Used in metastatic castration-resistant Prostate cancer.

Methylprednisolone Dose in Adults:

Note:

Dosing:

We don't have strong evidence for the best dose and how long to take methylprednisolone for most conditions.
So, the dosing recommendations we give are just general guidelines.
It's important to tailor the dose to each person and to use the smallest effective dose for the shortest time needed.
For some conditions where we use weight-based dosing, like in obese patients, it might be better to use their ideal body weight, especially if treatment lasts a long time.

Hypothalamic-pituitary-adrenal suppression:

Some patients might have their hypothalamic-pituitary-adrenal (HPA) axis suppressed even with lower doses or shorter treatment.
Experts think that HPA-axis suppression is likely in adults who take more than 16 mg a day (during the day) or 4 mg per day (at night) for over three weeks, or if they start to look like they have Cushing's syndrome.
If someone has HPA-axis suppression, it's not safe to suddenly stop treatment.
They might need to slowly reduce the dose instead.

Safety:

Methylprednisolone can be given intravenously (IV), but only the methylprednisolone succinate formulation (Solu-Medrol) is safe for IV use.
The methylprednisolone acetate suspension (Depo-Medrol) is meant for injections into muscles or joints only.
It's not safe to give the acetate preparation through IV because it can cause serious problems.

Methylprednisolone Usual Dosage Range:

Intravenous (IV, succinate formulation): Typically given at a dose of 40 to 125 mg per day, either in one single daily dose or split into smaller doses throughout the day. In rare cases, for certain conditions, the dose might be increased to 1 to 2 mg per kilogram of body weight per day.
Initial high-dose "pulse" therapy: This is used for severe systemic rheumatic disorders. The dosage is 7 to 15 mg per kilogram of body weight per dose (or 500 mg to 1 g per dose), given once daily for 3 to 5 days.
Oral: Usually taken at a dose of 16 to 64 mg per day, either all at once or divided into smaller doses throughout the day.

For example, if you're using a dose-pack containing 21 tablets, the dosing might look like this:

Day 1: 24 mg (6 tablets), divided throughout the day.
Day 2: 20 mg (5 tablets), divided throughout the day.
Day 3: 16 mg (4 tablets), divided throughout the day.
Day 4: 12 mg (3 tablets), divided throughout the day.
Day 5: 8 mg (2 tablets), divided throughout the day.
Day 6: 4 mg (1 tablet) before breakfast.

Intramuscular (IM, acetate or succinate formulations): Typically administered as a single dose of 40 to 60 mg.

Methylprednisolone Dose in the treatment of Intra-articular (acetate suspension):

For intra-articular administration using the acetate suspension of methylprednisolone, the dose can vary based on the size of the joint, the severity of inflammation, the amount of fluid in the joint, and the clinician's judgment. Here are the typical dose ranges:

Larger joint (e.g., knee, shoulder, hip): 20 to 80 mg.
Medium joint (e.g., wrist, ankle, elbow): 10 to 40 mg.
Small joint (e.g., toe, finger): 4 to 10 mg.

Indication-specific dosing:

Methylprednisolone Dose in the treatment of moderate to severe acute respiratory distress syndrome (off-label):

For the off-label treatment of acute respiratory distress syndrome (ARDS), moderate to severe cases, methylprednisolone is administered intravenously (IV) using the succinate formulation.

Loading Dose: 1 mg/kg over 30 minutes.
Days 1 to 14: 1 mg/kg/day, either divided into multiple doses or administered as a continuous infusion.
Days 15 to 21: 0.5 mg/kg/day, divided doses or continuous infusion.
Days 22 to 25: 0.25 mg/kg/day, divided doses or continuous infusion.
Days 26 to 28: 0.125 mg/kg/day, divided doses or continuous infusion.

It's important to calculate the dose based on the patient's ideal body weight. If the patient is extubated between days 1 to 14, the treatment should advance to day 15 and then taper according to the schedule provided. Abrupt discontinuation of methylprednisolone can lead to worsening due to inflammatory response, so tapering is necessary. This regimen should be considered on a case-by-case basis, particularly for patients who haven't responded to other treatments.

Methylprednisolone Dose in the treatment of Allergic conditions:

For the treatment of allergic conditions such as anaphylaxis and acute angioedema or urticaria, methylprednisolone can be administered either intravenously (IV) or orally. Here are the typical dosage recommendations:

Anaphylaxis (adjunct to epinephrine for prevention of late-phase/biphasic reaction):
- IV (succinate): 1 to 2 mg/kg or 50 to 125 mg as a single dose.
Angioedema (acute allergic) and/or urticaria (acute):
- IV (succinate):
  - Initial: 60 to 80 mg; switch to an oral corticosteroid as soon as possible, tapering the dose for a total treatment duration of ≤10 days.
- Oral:
  - Initial: 16 to 32 mg/day in 1 to 2 divided doses for 3 to 4 days; may consider tapering the dose for a total treatment duration of ≤10 days.

It's important to note that methylprednisolone is not recommended for the initial or sole treatment of anaphylaxis. It is used adjunctively, particularly in cases with severe or persistent symptoms that are steroid-responsive. For moderate to severe angioedema or urticaria symptoms without signs of anaphylaxis, methylprednisolone may be used in combination with other treatments such as epinephrine for anaphylaxis or antihistamines. The optimal dosing strategy may vary and should be determined based on clinical judgment and individual patient factors.

Methylprednisolone Dose in the treatment of Acute exacerbation of Asthma:

For the treatment of acute exacerbations of asthma, particularly in cases of moderate to severe exacerbations or when patients do not respond promptly and completely to short-acting beta agonists, methylprednisolone can be administered orally (preferred route) or intravenously (IV, succinate formulation).

Oral (preferred route), IV (succinate): 40 to 60 mg per day, divided into 1 or 2 doses, for a duration of 3 to 10 days. In critically ill patients, doses up to 60 to 80 mg every 6 to 12 hours have been used. If symptoms do not improve and peak expiratory flow does not reach at least 70% of the personal best, longer treatment may be necessary.

It's important to administer methylprednisolone within 1 hour of presentation to the emergency department for acute exacerbations of asthma, as recommended by guidelines. The choice between oral and IV administration depends on the severity of the exacerbation and the patient's clinical condition.

Methylprednisolone Dose in the treatment of acute exacerbation of Chronic obstructive pulmonary disease (off-label):

For the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD), methylprednisolone can be administered orally or intravenously (IV, succinate formulation), depending on the severity of the exacerbation and the patient's ability to tolerate oral therapy.

Oral; IV (succinate): 40 to 60 mg daily for 5 to 14 days. In patients with severe exacerbations but not life-threatening, oral regimens are recommended. The IV route should be reserved for patients who cannot tolerate oral therapy due to conditions like shock or those who are mechanically ventilated. Doses up to 60 mg every 6 hours have been used in critically ill patients, although data on outcomes are limited.

Note: The dose is based on an equivalent dose of prednisone, and the optimal dose has not been definitively established. If the patient shows improvement with therapy, discontinuation without tapering may be possible. However, if the patient does not improve, a longer duration of therapy may be necessary.

Methylprednisolone Dose in the treatment of Deceased organ donor management (hormonal resuscitation for the deceased organ donor) (off-label):

For the management of deceased organ donors, methylprednisolone is sometimes used as part of hormonal resuscitation, although the data supporting its benefit are conflicting.

Intravenous (IV, succinate formulation):
- Regimens may include:
  - 1 gram administered as an IV infusion.
  - 15 mg/kg administered as an IV infusion.
  - 250 mg administered as an IV bolus followed by a continuous infusion at a rate of 100 mg/hour.

As with any medical intervention, the decision to use methylprednisolone in deceased organ donor management should be made based on careful consideration of the patient's clinical condition, potential benefits, and risks, and in accordance with relevant guidelines and protocols.

Methylprednisolone Dose in the treatment of Giant cell arteritis (off-label):

For the treatment of giant cell arteritis (GCA), particularly in patients presenting with threatened or evolving vision loss, methylprednisolone can be administered intravenously (IV) as part of initial pulse therapy.

Initial pulse therapy:
- IV (succinate formulation): 500 mg to 1 gram daily for 3 days.

Following the initial pulse therapy, patients are typically transitioned to an oral glucocorticoid, such as prednisone, for ongoing treatment.

It's crucial to start treatment immediately once GCA is highly suspected, particularly due to the rapidly progressive nature of the disease. In patients without threatened or evolving vision loss, oral glucocorticoids are suggested as initial therapy rather than IV methylprednisolone.

Methylprednisolone Dose in the treatment of acute flare of Gout:

For the treatment of acute flare of gout, methylprednisolone can be administered orally, intra-articularly, intramuscularly, or intravenously depending on the patient's condition and preference.

Oral:
- Initial dose: 24 to 32 mg per day, taken in 1 or 2 divided doses until symptom improvement.
- Tapering: Followed by a 7- to 10-day taper, or a 14- to 21-day taper in patients with multiple prior flares. A tapered (6-day) dose pack may be sufficient in some patients.
Intra-articular (acetate):
- Usual dose:
  - Larger joint (e.g., knee): 40 mg
  - Medium joint (e.g., wrist, ankle, elbow): 30 mg
  - Small joint (e.g., toe, finger): 10 mg
- Range of doses may be used based on patient factors and clinician judgment. The glucocorticoid may be mixed with an equal volume of local anesthetic.
Intramuscular (acetate or succinate):
- Initial dose: 40 to 60 mg as a single dose. It may be repeated once or twice at intervals of at least 48 hours if the benefit fades or there is no resolution of the flare.
Intravenous (succinate, for hospitalized patients):
- Initial dose: 20 mg twice daily until clinical improvement.
- Tapering: Followed by a stepwise reduction in each dose by 50% until 5 mg twice daily. Then, maintain a dose of at least 4 mg (or oral equivalent) twice daily for 5 days.

The choice of route and dosage should be determined based on individual patient factors, such as the severity of the flare, the presence of contraindications, and the patient's preference.

Methylprednisolone Dose in the treatment of acute Graft-vs-host disease (off-label):

For the treatment of acute graft-versus-host disease (GVHD) with a grade of 2 or higher, methylprednisolone is commonly used off-label. However, the optimal regimen can vary, and institutional protocols should be consulted as variations exist. Treatment depends on the severity and progression rate of the disease.

Intravenous (IV, succinate formulation):
- Initial dose: 2 mg/kg/day, divided into two doses.
- The dose may vary based on organ involvement and severity.
- Treatment is typically continued for several weeks, followed by a gradual tapering over several months.

It's essential to closely monitor the patient's response to treatment and adjust the dosage and duration accordingly. As with any medical treatment, decisions regarding methylprednisolone use in acute GVHD should be made in consultation.

Methylprednisolone Dose in the treatment of Immune thrombocytopenia (initial therapy):

For the initial therapy of immune thrombocytopenia (ITP), the goal is to achieve a safe platelet count to prevent clinically important bleeding rather than normalization of the platelet count.

Patients with severe bleeding (in combination with other treatments):
- Intravenous (IV, succinate formulation): 1 gram once daily for 3 doses.

It's important to note that due to the short-term response, maintenance therapy with an oral glucocorticoid, such as prednisone, may be required.

Methylprednisolone (SOLUMedrol) Dose in the treatment of Inflammatory bowel disease:

For the treatment of acute inflammatory bowel disease (IBD), such as Crohn's disease and ulcerative colitis, methylprednisolone can be administered intravenously (IV) to manage severe or fulminant cases.

Crohn's disease, acute (severe/fulminant disease and/or unable to take oral):
- IV (succinate formulation): 40 to 60 mg per day.
Ulcerative colitis, acute (severe or fulminant):
- IV (succinate formulation): 60 mg per day, divided into 1 to 3 doses.

It's important to note that methylprednisolone is not intended for long-term use in acute IBD exacerbations. Additionally, for patients who have been receiving chronic corticosteroid treatment, a small increase in their daily dose may be required during an acute exacerbation. However, steroid-sparing agents such as biologic agents and immunomodulators should be introduced with the goal of discontinuing corticosteroid therapy as soon as possible.

Methylprednisolone Dose in the prevention of Iodinated contrast media allergic-like reaction:

For the prevention of allergic-like reactions to iodinated contrast media in patients with a prior reaction or unknown-type reaction, methylprednisolone can be administered either orally or intravenously.

Nonurgent regimen (oral administration):
- Oral: 32 mg administered 12 hours and 2 hours before contrast medium administration, in combination with oral diphenhydramine 50 mg (administered 1 hour prior to contrast).
Urgent (accelerated) regimen (intravenous administration):
- IV (succinate formulation): 40 mg every 4 hours until contrast medium administration, in combination with IV diphenhydramine 50 mg (administered 1 hour prior to contrast).

These regimens aim to prevent allergic-like reactions to iodinated contrast media and should be tailored based on the urgency of the contrast administration and the patient's clinical condition.

Methylprednisolone Dose in the treatment of acute exacerbation of multiple sclerosis:

For the treatment of acute exacerbations of multiple sclerosis (MS) resulting in neurologic symptoms and increased disability or impairments in vision, strength, or cerebellar function, methylprednisolone can be administered intravenously (IV) as initial pulse therapy.

Initial pulse therapy:
- IV (succinate formulation): 500 mg to 1 gram daily for 3 to 7 days, with 5 days being typical.

This initial pulse therapy can be administered alone or followed by an oral taper with prednisone.

Methylprednisolone Dose in the treatment of Myopathies (dermatomyositis and polymyositis):

For the treatment of myopathies such as dermatomyositis or polymyositis, particularly in patients presenting with severe systemic involvement or profound weakness, methylprednisolone can be administered as initial pulse therapy.

Initial pulse therapy:
- IV (succinate formulation): 1 gram daily for 3 to 5 days.

Following the initial pulse therapy, patients are typically transitioned to oral prednisone for ongoing treatment.

Methylprednisolone Dose in the treatment of severe or refractory Nausea and vomiting of pregnancy (off-label):

For the treatment of severe or refractory nausea and vomiting of pregnancy, methylprednisolone can be used off-label as an add-on therapy when all other pharmacologic regimens have failed.

Intravenous (IV, succinate formulation):
- 16 mg every 8 hours for 3 days.

If there is no response within 3 days, treatment should be discontinued. If symptoms improve, the complete 3-day course of treatment should be finished, followed by tapering the dose over 2 weeks.

Methylprednisolone (SOLUMedrol) Dose in the treatment of Pneumocystis pneumonia, adjunctive therapy for moderate to severe disease (off-label):

For the adjunctive therapy of moderate to severe Pneumocystis pneumonia, methylprednisolone can be administered off-label.

Intravenous (IV, succinate formulation):
- 30 mg twice daily on days 1 to 5, beginning as early as possible.
- 30 mg once daily on days 6 to 10.
- 15 mg once daily on days 11 to 21.

These dosages are based on equivalent doses of prednisone.

Methylprednisolone Dose in the treatment of metastatic, castration-resistant prostate cancer (off-label):

For the off-label treatment of metastatic castration-resistant prostate cancer, methylprednisolone can be administered orally.

Oral:
- 4 mg twice daily.

This dosage is typically used in combination with micronized abiraterone acetate as part of the treatment regimen.

Methylprednisolone Dose in the treatment of organ-threatening or life-threatening systemic rheumatic disorders: (eg, antineutrophil cytoplasmic antibody-associated vasculitis, mixed cryoglobulinemia syndrome, polyarteritis nodosa, rheumatoid arthritis, and systemic lupus erythematosus): Note:

For the treatment of systemic rheumatic disorders, particularly in cases where organ-threatening or life-threatening manifestations are present, methylprednisolone can be administered intravenously as initial pulse therapy.

Initial pulse therapy (optional):
- IV (succinate formulation): 7 to 15 mg/kg/day (maximum dose: 500 mg to 1 gram/day) typically for up to 3 days.

Following the initial pulse therapy, patients are typically transitioned to an oral glucocorticoid, such as prednisone. The specific dosage and duration of treatment should be highly individualized, taking into account disease severity, the specific disorder, and disease manifestations.

Methylprednisolone Dose in the treatment of Warm autoimmune hemolytic anemia:

For the treatment of warm autoimmune hemolytic anemia, methylprednisolone can be administered intravenously (IV) initially, followed by an oral glucocorticoid.

IV (succinate formulation):
- 250 mg to 1 gram daily for 1 to 3 days.

Following the initial IV therapy, patients are typically transitioned to an oral glucocorticoid, such as prednisone.

It's important to note that a clinician experienced with the treatment of hemolytic anemia should be involved in therapy decisions.

Methylprednisolone Dose in Childrens:

Note:

The amount of methylprednisolone given depends on what's being treated and how the patient responds.
Doctors start with the smallest effective dose and gradually lower it when possible.
If it's a life-threatening situation, the dose might be higher if given through a vein compared to taking it by mouth.
Only the sodium succinate form can be given through a vein.

Methylprednisolone Dose in the treatment of acute exacerbation of Asthma:

Acute Short-Course "Burst" (NAEPP 2007):

Infants and Children <12 years:
- Oral: 1 to 2 mg/kg/day in divided doses once or twice daily for 3 to 10 days; maximum daily dose: 60 mg/day.
- IM (acetate): 7.5 mg/kg as a one-time dose for children ≤4 years; 240 mg as a one-time dose for children 5 to 11 years.
Children ≥12 years and Adolescents:
- Oral: 40 to 60 mg/day in divided doses once or twice daily for 3 to 10 days.
- IM (acetate): 240 mg as a one-time dose.

Hospital/Emergency Medical Care Doses:

Infants and Children <12 years:
- Oral, IV: 1 to 2 mg/kg/day in 2 divided doses; maximum daily dose: 60 mg/day; continue until peak expiratory flow is 70% of predicted or personal best.
Children ≥12 years and Adolescents:
- Oral, IV: 40 to 80 mg/day in divided doses once or twice daily until peak expiratory flow is 70% of predicted or personal best.

Status Asthmaticus (Previous NAEPP Guidelines):

Children:
- IV: Loading dose: 2 mg/kg/dose, then 0.5 to 1 mg/kg/dose every 6 hours. (Refer to NAEPP 2007 guidelines for asthma exacerbations (emergency medical care or hospital doses) listed above.)

Methylprednisolone Dose in the long-term maintenance treatment of Asthma:

Infants and Children <12 years:
- Oral: 0.25 to 2 mg/kg/day once daily in the morning or every other day as needed for asthma control; maximum daily dose: 60 mg/day.
Children ≥12 years and Adolescents:
- Oral: 7.5 to 60 mg daily once daily in the morning or every other day as needed for asthma control.

Methylprednisolone (SOLUMedrol) General dosing; as anti-inflammatory or immunosuppressive:

Infants, Children, and Adolescents:

Initial Dose:
- Oral, IM (acetate or succinate), IV (succinate): 0.11 to 1.6 mg/kg/day or 3.2 to 48 mg/m²/day; usual range: 0.5 to 1.7 mg/kg/day.
- Administer in divided doses every 6 to 12 hours for oral, IM (succinate), and IV (succinate); for IM (acetate), administer as a single daily dose.
"Pulse" Therapy:
- IV (succinate): 15 to 30 mg/kg/dose once daily for 3 days; maximum dose: 1,000 mg.
Long-acting:
- IM (acetate): 4 to 80 mg every 1 to 2 weeks.

Methylprednisolone Dose in the treatment of Kawasaki disease:

Primary Treatment for Patients at High Risk for Coronary Artery Aneurysms:

Pulse Dosing:
- Infants and Children:
  - IV: 30 mg/kg/dose as a single dose in combination with IVIG and aspirin.
Taper Dosing:
- Infants and Children:
  - IV: 1.6 mg/kg/day in divided doses every 8 hours for 5 days or until afebrile, then transition to oral prednisolone; maximum daily dose: 48 mg/day; give in combination with aspirin and an additional dose of IVIG.
  - Note: Dosing based on the use of IV prednisolone product (2 mg/kg/day), which is not available in the US; dosing converted to equivalent methylprednisolone dosing; however, the clinical necessity of conversion is unknown.

Treatment for Refractory/Resistant Disease:

Pulse Dosing:
- Infants and Children:
  - IV: 30 mg/kg/dose once daily for 1 or 3 days; may be given in combination with an additional IVIG dose.
Taper Dosing:
- Infants and Children:
  - IV: 1.6 mg/kg/day in divided doses every 8 hours for 5 days or until afebrile, then transition to oral prednisolone; maximum daily dose: 48 mg/day; give in combination with aspirin and an additional dose of IVIG.
  - Note: Dosing based on the use of IV prednisolone product (2 mg/kg/day), which is not available in the US; dosing converted to equivalent methylprednisolone dosing; however, the clinical necessity of conversion is unknown.

Methylprednisolone dose in the treatment of Lupus nephritis:

Children and Adolescents:

IV (Succinate):
- High-Dose "Pulse" Therapy: 30 mg/kg/dose or 600 to 1,000 mg/m²/dose once daily for 3 days; maximum dose: 1,000 mg.

Methylprednisolone Dose in the treatment of acute spinal cord injury:

Children and Adolescents:

IV (Succinate):
- Initial Dose: 30 mg/kg over 15 minutes.
- Continuous Infusion: Followed by a continuous infusion of 5.4 mg/kg/hour for 23 hours.

Note:

Due to insufficient evidence of clinical efficacy in preserving or improving spinal cord function, the routine use of methylprednisolone in the treatment of acute spinal cord injury is no longer recommended.
If used, methylprednisolone should not be initiated >8 hours after the injury and is not effective in penetrating trauma (eg, gunshot).

Methylprednisolone Dose in the treatment of moderate to severe Pneumocystis pneumonia infection:

Infants and Children:

IV (Succinate):
- Days 1 to 7: 1 mg/kg/dose every 6 hours.
- Days 8 to 9: 1 mg/kg/dose twice daily.
- Days 10 and 11: 0.5 mg/kg/dose twice daily.
- Days 12 to 16: 1 mg/kg/dose once daily.
Note: Initiate therapy within 72 hours of diagnosis, if possible.

Adolescents:

IV (Succinate):
- Days 1 to 5: 30 mg twice daily.
- Days 6 to 10: 30 mg once daily.
- Days 11 to 21: 15 mg once daily.
Note: Initiate therapy within 72 hours of diagnosis, if possible.

Methylprednisolone Dose in the treatment of acute Graft-versus-host disease (GVHD):

Infants, Children, and Adolescents:

IV (Succinate):
- Initial Dose: 1 to 2 mg/kg/dose once daily.
- Adjustment: If using a low dose (1 mg/kg) and no improvement after 3 days, increase dose to 2 mg/kg.
- Duration: Continue therapy for 5 to 7 days.
- Tapering: If improvement observed, may taper by 10% of starting dose every 4 days.
- Considerations: If no improvement, then considered steroid-refractory GVHD, and additional agents should be considered.

Methylprednisolone Pregnancy Risk Category: C

Methylprednisolone, a type of medication, can pass from a pregnant person to their baby through the placenta.
Research suggests that using corticosteroids in the first trimester of pregnancy may be linked to certain birth defects or lower birth weight, but findings are inconsistent and may depend on factors like the dose and reason for use.
Newborns of mothers who used corticosteroids during pregnancy might experience low adrenal function, so monitoring is important.
Generally, it's advised to use the lowest effective dose for the shortest duration during pregnancy, especially avoiding high doses in the first trimester.
For skin conditions, it's best to avoid systemic corticosteroids initially and use them cautiously in the second or third trimester.
Pregnant individuals with poorly controlled asthma may face increased risks, so inhaled corticosteroids are preferred for asthma treatment, reserving systemic corticosteroids for acute exacerbations or severe cases.
Methylprednisolone might be considered for severe nausea and vomiting in pregnancy, but only if other treatments haven't worked, and its use should be carefully monitored due to potential risks to the fetus, especially in the first trimester.
The Transplant Pregnancy Registry International (TPR) monitors pregnancies in individuals who have had transplants or fathered by male transplant recipients, aiming to gather data on outcomes and provide support.

Use of methylprednisolone while breastfeeding

Methylprednisolone can pass into breast milk, with a relative infant dose ranging from 2.8% to 5.6% when compared to a weight-adjusted infant dose.
Generally, breastfeeding is considered acceptable when the relative infant dose is below 10%, but it's typically avoided when it exceeds 25%.
The estimated daily infant dose via breast milk, based on the highest milk concentration observed after maternal administration of methylprednisolone, is 0.8325 mg/kg/day.
However, methylprednisolone levels in breast milk drop below detectable limits within 12 hours after maternal dosing.
While corticosteroids are generally considered acceptable during breastfeeding when used in typical doses, there's a potential risk of adverse effects in the nursing infant, such as growth suppression or interference with natural corticosteroid production.
Therefore, decisions regarding breastfeeding continuation or discontinuation should be made by weighing the importance of treatment to the mother.
Monitoring the nursing infant is recommended, and some guidelines suggest waiting 4 hours after maternal oral corticosteroid dosing before breastfeeding to minimize infant exposure.

Dose in Kidney Disease:

The manufacturer's labeling does not include specific dosage adjustments for renal impairment.
Therefore, caution should be exercised when prescribing methylprednisolone to patients with renal impairment.
Close monitoring for potential adverse effects is advisable, and dosage adjustments may be necessary based on individual patient factors and renal function assessment.

Dose in Liver disease:

The manufacturer's labeling does not include specific dosage adjustments for hepatic impairment.
Therefore, caution should be exercised when prescribing methylprednisolone to patients with hepatic impairment.
Close monitoring for potential adverse effects is advisable, and dosage adjustments may be necessary based on individual patient factors and hepatic function assessment.

Side effects of Methylprednisolone:

Cardiovascular:
- Bradycardia
- Cardiac Arrest
- Cardiac Arrhythmia
- Cardiac Failure
- Cardiomegaly
- Circulatory Shock
- Edema
- Embolism (Fat)
- Hypertension
- Hypertrophic Cardiomyopathy (In Neonates)
- Myocardial Rupture (Post MI)
- Syncope
- Tachycardia
- Thromboembolism
- Thrombophlebitis
- Vasculitis
Central Nervous System:
- Arachnoiditis
- Depression
- Emotional Lability
- Euphoria
- Headache
- Increased Intracranial Pressure
- Insomnia
- Malaise
- Meningitis
- Myasthenia
- Neuritis
- Neuropathy
- Paraplegia
- Paresthesia
- Personality Changes
- Psychic Disorders
- Pseudotumor Cerebri (Usually Following Discontinuation)
- Seizure
- Sensory Disturbance
- Vertigo
Dermatologic:
- Acne Vulgaris
- Allergic Dermatitis
- Alopecia
- Atrophic Striae
- Diaphoresis
- Ecchymoses
- Epidermal Thinning
- Erythema
- Exfoliation Of Skin
- Facial Erythema
- Hyperpigmentation
- Hypertrichosis
- Hypopigmentation
- Skin Atrophy
- Skin Rash
- Suppression Of Skin Test Reaction
- Thinning Hair
- Urticaria
- Xeroderma
Endocrine & Metabolic:
- Adrenal Suppression
- Calcinosis
- Cushingoid State
- Cushing Syndrome
- Decreased Glucose Tolerance
- Diabetes Mellitus
- Fluid Retention
- Glycosuria
- Growth Suppression (Children)
- Hirsutism
- HPA-Axis Suppression
- Hyperglycemia
- Hyperlipidemia
- Hypokalemia
- Hypokalemic Alkalosis
- Insulin Resistance (Increased Requirements For Insulin Or Oral Hypoglycemic Agents In Diabetes)
- Menstrual Disease
- Moon Face
- Negative Nitrogen Balance
- Protein Catabolism
- Sodium Retention
- Weight Gain
Gastrointestinal:
- Abdominal Distention
- Bladder Dysfunction (After Intrathecal Administration
- Including Bowel Dysfunction)
- Carbohydrate Intolerance (Increased)
- Gastrointestinal Hemorrhage
- Gastrointestinal Perforation
- Hiccups
- Increased Appetite
- Intestinal Perforation (Of Both Of The Small And Large Intestines; Especially In Patients With Inflammatory Bowel Disease)
- Nausea
- Pancreatitis
- Peptic Ulcer
- Spermatozoa Disorder (Decreased Motility And Number Of Spermatozoa)
- Ulcerative Esophagitis
Hematologic:
- Leukocytosis (Transient)
- Malignant Neoplasm (Secondary)
- Petechia
Hepatic:
- Hepatomegaly
- Increased Liver Enzymes
- Increased Serum Transaminases
Hypersensitivity:
- Anaphylactoid Reaction
- Anaphylaxis
- Angioedema
- Hypersensitivity Reaction
Infection:
- Increased Susceptibility To Infection
- Infection (Ophthalmic)
- Sterile Abscess
Local:
- Injection Site Infection
Neuromuscular & Skeletal:
- Amyotrophy
- Arthropathy
- Aseptic Necrosis Of Femoral Head
- Aseptic Necrosis Of Humoral Head
- Bone Fracture
- Charcot-Like Arthropathy
- Lipotrophy
- Osteoporosis
- Rupture Of Tendon
- Steroid Myopathy
- Vertebral Compression Fracture
Ophthalmic:
- Blindness
- Exophthalmoses
- Glaucoma
- Increased Intraocular Pressure
- Ophthalmic Inflammation (Ophthalmic)
- Subcapsular Posterior Cataract
- Visual Impairment
Respiratory:
- Pulmonary Edema
- Rhinitis
Miscellaneous:
- Anaphylactoid Reaction
- Anaphylaxis
- Angioedema
- Hypersensitivity Reactions
- Tissue Sloughing (Residue Or Slough At Injection Site)
- Wound Healing Impairment

Contraindications to Methylprednisolone:

Methylprednisolone is contraindicated in individuals with hypersensitivity to methylprednisolone or any component of the formulation, systemic fungal infection (except for intra-articular injection for localized joint conditions), intrathecal administration, and administration of live or attenuated virus vaccines with immunosuppressive doses of corticosteroids.
It is also contraindicated for use in premature infants when formulations contain benzyl alcohol preservative and in cases of immune thrombocytopenia for intramuscular administration only.
Additionally, the 40 mg vial of methylprednisolone sodium succinate is contraindicated in individuals with hypersensitivity to cow's milk or its components or other dairy products.
In Canada, additional contraindications include herpes simplex of the eye, vaccinia, and varicella for methylprednisolone tablets, herpes simplex of the eye, vaccinia, and varicella for methylprednisolone acetate injection, and epidural administration, herpes simplex keratitis, vaccinia, varicella, arrested tuberculosis, acute psychoses, Cushing syndrome, peptic ulcer, and markedly elevated serum creatinine for methylprednisolone sodium succinate.
While documentation of allergenic cross-reactivity for corticosteroids is limited, caution is advised due to similarities in chemical structure and pharmacologic actions, potentially leading to cross-sensitivity.

Warnings and precautions

Suppression of the adrenals:

Methylprednisolone can cause hypercortisolism or suppression of the hypothalamic-pituitary adrenal (HPA) axis, especially in children or patients receiving high doses for a long time.
This suppression can lead to adrenal crisis, so withdrawing or discontinuing the corticosteroid should be done gradually and carefully.
Patients transitioning from systemic corticosteroids to inhaled products need special attention as they may experience adrenal insufficiency or withdrawal symptoms, including an increase in allergic reactions.
Adults taking more than 20 mg per day of prednisone may be particularly at risk, with fatalities reported in asthmatic patients.

Anaphylactoid reactions

Although rare, some patients may experience anaphylactoid reactions while taking corticosteroids.

Dermal changes:

Injection or leakage of methylprednisolone into the skin can lead to skin depression or atrophy, especially if injected into the deltoid muscle.

Hepatic effects

High doses of methylprednisolone, especially intravenously, may cause a rare form of acute hepatitis, which can lead to acute liver failure and even death.
This risk is higher in patients with a history of methylprednisolone-induced toxic hepatitis.

Immunosuppression:

Long-term use of corticosteroids may increase the risk of infections, reactivate latent infections, or mask signs of infection.
Patients should avoid exposure to chickenpox or measles while taking corticosteroids, and caution is needed in those with latent tuberculosis or other infections.

Kaposi Sarcoma:

Prolonged use of corticosteroids has been linked to the development of Kaposi sarcoma, a type of cancer.

Myopathy

High doses of corticosteroids can cause acute myopathy, particularly in patients with neuromuscular disorders, which may involve muscles including those controlling the eyes and breathing.

Psychiatric disorders:

Corticosteroid use may lead to various psychiatric symptoms, from mood swings and insomnia to severe depression or psychosis.

Septic arthritis:

Parenteral corticosteroid therapy may increase the risk of septic arthritis, so appropriate antimicrobial therapy should be initiated if necessary.

Cardiovascular disease

Caution is advised in patients with heart failure or hypertension as corticosteroids can cause fluid retention and electrolyte imbalances, potentially exacerbating these conditions.

Diabetes:

Corticosteroids may affect glucose regulation and lead to hyperglycemia in patients with diabetes mellitus.

Gastrointestinal Disease:

Patients with gastrointestinal diseases such as ulcers or diverticulitis are at increased risk of perforation when taking corticosteroids.

Head injury

High-dose intravenous methylprednisolone should not be used for head injuries as it may increase mortality.

Hepatic impairment

Caution is needed when using corticosteroids in patients with liver impairment, as high doses may worsen fluid retention.

Myasthenia gravis:

Corticosteroids should be used cautiously in patients with myasthenia gravis, as they may exacerbate symptoms.

Ocular disease:

Corticosteroids can increase the risk of glaucoma, cataracts, and corneal perforation, especially in patients with pre-existing eye conditions.

Osteoporosis

Long-term use of corticosteroids can lead to osteoporosis and an increased risk of fractures.

Renal impairment

Patients with renal impairment should use corticosteroids with caution as they may experience fluid retention.

Seizure disorders:

Corticosteroids should be used carefully in patients with a history of seizure disorders, as they may trigger seizures.

Sepsis or septic shock syndrome:

Corticosteroids should not be used to treat sepsis unless the patient is in shock, as they may increase mortality.

Systemic sclerosis (scleroderma).

Higher doses of corticosteroids in patients with systemic sclerosis may increase the risk of scleroderma renal crisis.

Thyroid disease:

Changes in thyroid status may require adjustments in corticosteroid dosage, as metabolism of corticosteroids varies with thyroid function.

Methylprednisolone: Drug Interaction

Risk Factor C (Monitor therapy)
Acetylcholinesterase Inhibitors	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur.
Amphotericin B	Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B.
Androgens	Corticosteroids (Systemic) may enhance the fluid-retaining effect of Androgens.
Antidiabetic Agents	Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents.
Bile Acid Sequestrants	May decrease the absorption of Corticosteroids (Oral).
Bosentan	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Calcitriol (Systemic)	Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic).
Clofazimine	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Coccidioides immitis Skin Test	Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test.
Corticorelin	Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy.
Cosyntropin	Corticosteroids (Systemic) may diminish the diagnostic effect of Cosyntropin.
CycloSPORINE (Systemic)	May increase the serum concentration of MethylPREDNISolone. MethylPREDNISolone may increase the serum concentration of CycloSPORINE (Systemic). MethylPREDNISolone may decrease the serum concentration of CycloSPORINE (Systemic).
CYP3A4 Inducers (Moderate)	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
CYP3A4 Inhibitors (Moderate)	May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors).
Deferasirox	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Deferasirox	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased.
Deferasirox	Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased.
Denosumab	May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased.
DilTIAZem	May increase the serum concentration of Corticosteroids (Systemic).
Duvelisib	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Erdafitinib	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Erdafitinib	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Estrogen Derivatives	May increase the serum concentration of Corticosteroids (Systemic).
Fosnetupitant	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Indacaterol	May enhance the hypokalemic effect of Corticosteroids (Systemic).
Isoniazid	Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid.
Ivosidenib	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Larotrectinib	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Loop Diuretics	Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics.
Netupitant	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Nicorandil	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination.
Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective)	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective).
Nonsteroidal Anti-Inflammatory Agents (Nonselective)	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective).
Ocrelizumab	May enhance the immunosuppressive effect of Immunosuppressants.
Palbociclib	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Pidotimod	Immunosuppressants may diminish the therapeutic effect of Pidotimod.
Quinolones	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased.
Ritodrine	Corticosteroids may enhance the adverse/toxic effect of Ritodrine.
Salicylates	May enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity.
Sargramostim	Corticosteroids (Systemic) may enhance the therapeutic effect of Sargramostim. Specifically, corticosteroids may enhance the myeloproliferative effects of sargramostim.
Sarilumab	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Siltuximab	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Simeprevir	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Siponimod	Immunosuppressants may enhance the immunosuppressive effect of Siponimod.
Somatropin	Corticosteroids (Systemic) may diminish the therapeutic effect of Somatropin.
Tacrolimus (Systemic)	Corticosteroids (Systemic) may decrease the serum concentration of Tacrolimus (Systemic). Conversely, when discontinuing corticosteroid therapy, tacrolimus concentrations may increase.
Tertomotide	Immunosuppressants may diminish the therapeutic effect of Tertomotide.
Thiazide and Thiazide-Like Diuretics	Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics.
Tocilizumab	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Trastuzumab	May enhance the neutropenic effect of Immunosuppressants.
Urea Cycle Disorder Agents	Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range.
Warfarin	Corticosteroids (Systemic) may enhance the anticoagulant effect of Warfarin.
Risk Factor D (Consider therapy modification)
Antacids	May decrease the bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects.
Aprepitant	May increase the serum concentration of Corticosteroids (Systemic). Management: No dose adjustment is needed for single 40 mg aprepitant doses. For other regimens, reduce oral dexamethasone or methylprednisolone doses by 50%, and IV methylprednisolone doses by 25%. Antiemetic regimens containing dexamethasone reflect this adjustment.
Axicabtagene Ciloleucel	Corticosteroids (Systemic) may diminish the therapeutic effect of Axicabtagene Ciloleucel. Management: Avoid use of corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
Baricitinib	Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted.
CYP3A4 Inducers (Strong)	May decrease the serum concentration of MethylPREDNISolone. Management: Consider methylprednisolone dose increases in patients receiving strong CYP3A4 inducers and monitor closely for reduced steroid efficacy.
CYP3A4 Inhibitors (Strong)	May increase the serum concentration of MethylPREDNISolone. Management: Consider methylprednisolone dose reduction in patients receiving strong CYP3A4 inhibitors and monitor for increased steroid related adverse effects.
Dabrafenib	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects).
Desirudin	Corticosteroids (Systemic) may enhance the anticoagulant effect of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation.
Echinacea	May diminish the therapeutic effect of Immunosuppressants.
Enzalutamide	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring.
Fingolimod	Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections).
Fosaprepitant	May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect.
Hyaluronidase	Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required.
Leflunomide	Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly.
Lorlatinib	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences.
Mitotane	May decrease the serum concentration of Corticosteroids (Systemic).
Mitotane	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane.
Neuromuscular-Blocking Agents (Nondepolarizing)	May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur.
Nivolumab	Immunosuppressants may diminish the therapeutic effect of Nivolumab.
Roflumilast	May enhance the immunosuppressive effect of Immunosuppressants.
Sipuleucel-T	Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy.
Stiripentol	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring.
Tisagenlecleucel	Corticosteroids (Systemic) may diminish the therapeutic effect of Tisagenlecleucel. Management: Avoid use of corticosteroids as premedication or at any time during treatment with tisagenlecleucel, except in the case of life-threatening emergency (such as resistant cytokine release syndrome).
Tofacitinib	Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants.
Vaccines (Inactivated)	Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation.
Vaccines (Live)	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided.
Risk Factor X (Avoid combination)
Aldesleukin	Corticosteroids may diminish the antineoplastic effect of Aldesleukin.
BCG (Intravesical)	Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical).
Cladribine	May enhance the immunosuppressive effect of Immunosuppressants.
Conivaptan	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Desmopressin	Corticosteroids (Systemic) may enhance the hyponatremic effect of Desmopressin.
Fexinidazole [INT]	Corticosteroids (Systemic) may enhance the arrhythmogenic effect of Fexinidazole [INT].
Fusidic Acid (Systemic)	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Idelalisib	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Indium 111 Capromab Pendetide	Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide.
Macimorelin	Corticosteroids (Systemic) may diminish the diagnostic effect of Macimorelin.
Mifamurtide	Corticosteroids (Systemic) may diminish the therapeutic effect of Mifamurtide.
MiFEPRIStone	May diminish the therapeutic effect of Corticosteroids (Systemic). MiFEPRIStone may increase the serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (e.g., for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment.
Natalizumab	Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased.
Pimecrolimus	May enhance the adverse/toxic effect of Immunosuppressants.
Tacrolimus (Topical)	May enhance the adverse/toxic effect of Immunosuppressants.
Upadacitinib	Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib.

Monitoring parameters:

Blood Pressure:

Regular monitoring of blood pressure is important, especially in patients receiving long-term corticosteroid therapy, as corticosteroids can cause fluid retention and electrolyte imbalances, which may elevate blood pressure.

Blood Glucose:

Corticosteroids can affect glucose metabolism, leading to hyperglycemia, especially in patients with diabetes mellitus. Monitoring blood glucose levels is essential, particularly in diabetic patients or those at risk of developing diabetes.

Electrolytes:

Corticosteroids may cause electrolyte imbalances, including sodium and potassium disturbances. Monitoring electrolyte levels periodically is necessary, especially in patients receiving prolonged corticosteroid therapy.

Weight:

Regular monitoring of weight is recommended, particularly during long-term corticosteroid treatment, as weight gain is a common side effect of corticosteroid therapy.

Intraocular Pressure:

Patients using corticosteroids for more than six weeks should have their intraocular pressure monitored regularly, as corticosteroids can increase intraocular pressure and potentially lead to glaucoma.

Bone Mineral Density:

Corticosteroids can cause bone loss and increase the risk of osteoporosis and fractures. Monitoring bone mineral density may be necessary, especially in patients receiving long-term corticosteroid therapy.

Growth and Development in Children:

Children receiving corticosteroid therapy should have their growth and development closely monitored, as corticosteroids can affect growth and delay development, particularly when used long-term or at high doses.

HPA Axis Suppression:

Monitoring for signs of hypothalamic-pituitary adrenal (HPA) axis suppression is essential, especially in patients receiving long-term or high-dose corticosteroid therapy. Symptoms of HPA axis suppression may include fatigue, weakness, weight loss, and low blood pressure.

How to administer Methylprednisolone?

Oral Administration:

Take tablets after meals or with food/milk to reduce gastrointestinal upset. If prescribed once daily, take the dose in the morning.

Intramuscular (IM) Administration (Acetate, Succinate):

Avoid injecting into the deltoid muscle due to a high risk of subcutaneous atrophy. Do not inject into areas with evidence of acute local infection.

Intravenous (IV) Administration (Succinate):

The infusion rate depends on the dose and severity of the condition, usually administered intermittently over 15 to 60 minutes.
Larger doses should be infused over at least 30 to 60 minutes; avoid administering large doses as an IV push, as it can lead to severe adverse effects such as hypotension, cardiac arrhythmia, or sudden death.
Bolus doses (30 mg/kg) used in some spinal cord injury trials have been administered over 15 minutes. Do not administer acetate form intravenously.

Intra-articular or Soft Tissue Administration (Acetate):

Follow the manufacturer's instructions for details on intra-articular or soft tissue administration.

Intralesional Administration:

Inject directly into the lesion. For large lesions, administer multiple small injections (20 to 40 mg) into the lesion area. Avoid injecting enough material to cause blanching, as this may lead to a small slough.

Mechanism of action of Methylprednisolone (SOLUMedrol):

Corticosteroids act in specific tissues by binding to intracellular receptors and entering the nucleus, where they regulate gene expression.
They have diverse physiological effects, including controlling carbohydrate, protein, and lipid metabolism, as well as maintaining fluid and electrolyte balance.
Corticosteroids impact cardiovascular, immune, musculoskeletal, endocrine, and nervous system functions.
They reduce inflammation by inhibiting the migration of certain white blood cells and reversing increased capillary permeability.

Onset of action:

IV (succinate): Within 1 hour
Intra-articular (IV acetate): 1 week

Duration:

Intra-articular (IV acetate): 1 to 5 weeks

Absorption:

Oral: Well absorbed (Czock 2005)

Bioavailability:

Oral: 88% ± 23% (Czock 2005)

Distribution:

Volume of distribution (V): IV (succinate): 24 L ± 6 L (Czock 2005)

Metabolism:

Hepatic to metabolites (Czock 2005)

Half-life elimination:

Adolescents: IV: 1.9 ± 0.7 hours (age range: 12 to 20 years; Rouster-Stevens 2008)
Adults:
- Oral: 2.5 ± 1.2 hours (Czock 2005)
- IV (succinate): 0.25 ± 0.1 hour (Czock 2005)

Time to peak, plasma:

Oral: 2.1 ± 0.7 hours (Czock 2005)
IV (succinate): 0.8 hours (Czock 2005)

Excretion:

Urine: 1.3% (oral), 9.2% (IV succinate) as unchanged drug (Czock 2005)

International Brand Names of Methylprednisolone:

DEPO-Medrol
Medrol
P-Care D40
P-Care D80
ReadySharp methylprednisolone
SOLUMedrol
Uni-Med
Adrelan
Advantan
Adventan
Cipridanol
Comedrol
Cryosolona
Depo Medrol
Depo-Medrol
Depo-Medrone
Epizolone-Depot
Flason
Flumethyl
Lexcomet
Lexxema
M-Nisol
M-Prednihexal
Madomed
Meapron
Medason
Medexa
Medisolu
Medixon
Medlon
Mednin
Medrate
Medrol
Medrone
Melone 16
Melsone
Menisone
Meprednisona All Pro
Mepresone
Mesolone
Metcor
Metcort
Methylon
Methylpred
Methylprednisolone David Bull
Methysol
Metrite
Metypred
Neo-Drol
Nisolon-M
Predlitem
Prednivex
Prednol
Prednox
Prena
Pretilon
Prolon
Sanexon
Sol-U-Pred
Sologen
Solomet
Solu Medrol
Solu-Medon
Solu-Medrol
Solu-Medrone
Solu-Moderin
Solu-Pred
Somidex
Sonicor
Thimelon
Thylmedi
Tisolon-4
Tropidrol
Urbason
Urbason Retard
Yalone

Methylprednisolone Brand Names in Pakistan:

Methylprednisolone Injection 1 g in Pakistan
Methypred	Haji Medicine Co.
Solu Medrol	Pfizer Laboratories Ltd.

Methylprednisolone Injection 40 Mg in Pakistan
Ceta-Medrol	Mediceena Pharma (Pvt) Ltd.
Co-Sterol	Cirin Pharmaceuticals (Pvt) Ltd.
Depo Medrol	Pfizer Laboratories Ltd.
Solu Medrol	Pfizer Laboratories Ltd.

Methylprednisolone Injection 125 Mg in Pakistan
Solu Medrol	Pfizer Laboratories Ltd.

Methylprednisolone Injection 500 Mg in Pakistan
Methypred	Haji Medicine Co.
Solu Medrol	Pfizer Laboratories Ltd.

Methylprednisolone Oint 0.1 %W/W in Pakistan
Advantan	Bayer Health Care
Advantan Fatty	Bayer Health Care
Avate	Pearl Pharmaceuticals

Methylprednisolone Cream 0.1 %W/W in Pakistan
Advantan	Bayer Health Care
Avate	Pearl Pharmaceuticals

Methylprednisolone Uses:

Oral, IM (acetate or succinate), and IV (succinate only) administration:
- Anti-inflammatory or immunosuppressant agent in the treatment of a variety of diseases, including:
  - Hematologic (eg, warm autoimmune hemolytic anemia immune thrombocytopenia),
  - allergic,
  - gastrointestinal (eg, ulcerative colitis, Crohn disease),
  - Inflammatory,
  - neoplastic,
  - neurologic (eg, multiple sclerosis),
  - rheumatic (eg, antineutrophil cytoplasmic antibody-associated vasculitis, dermatomyositis/ polymyositis, gout, rheumatoid arthritis, mixed cryoglobulinemia syndrome, polyarteritis nodosa, systemic lupus erythematosus), and/or
  - autoimmune origin.
Intra-articular or soft tissue administration (acetate only):
- Gout (acute flare), acute and subacute bursitis, rheumatoid arthritis, acute nonspecific tenosynovitis, epicondylitis, and/or synovitis of osteoarthritis.
Intralesional administration (acetate only):
- Alopecia areata;
- discoid lupus erythematosus;
- keloids;
- lichen planus, lichen simplex chronicus (neurodermatitis),
- localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, and psoriatic plaques; and
- necrobiosis lipoidica diabeticorum.
- It may be useful in the cystic tumor of an aponeurosis or tendon (ganglia).
Off Label Use of Adult
- Used in moderate to severe acute respiratory distress syndrome,
- Used in cardiac transplant: Treatment of acute cellular rejection
- Used in cardiac transplant: Treatment of Antibody-mediated rejection
- Used in the acute exacerbation of chronic obstructive pulmonary disease.
- Used in deceased organ donor management (hormonal resuscitation for the deceased organ donor)
- Used in the treatment of giant cell arteritis,
- Used in acute graft-vs-host disease,
- Used in-hospital cardiac arrest
- Used in severe/refractory nausea and vomiting of pregnancy,
- Used in adjunctive therapy for moderate to severe disease pneumocystis pneumonia,
- Used in metastatic castration-resistant Prostate cancer.

Methylprednisolone Dose in Adults:

Note:

Dosing:

We don't have strong evidence for the best dose and how long to take methylprednisolone for most conditions.
So, the dosing recommendations we give are just general guidelines.
It's important to tailor the dose to each person and to use the smallest effective dose for the shortest time needed.
For some conditions where we use weight-based dosing, like in obese patients, it might be better to use their ideal body weight, especially if treatment lasts a long time.

Hypothalamic-pituitary-adrenal suppression:

Some patients might have their hypothalamic-pituitary-adrenal (HPA) axis suppressed even with lower doses or shorter treatment.
Experts think that HPA-axis suppression is likely in adults who take more than 16 mg a day (during the day) or 4 mg per day (at night) for over three weeks, or if they start to look like they have Cushing's syndrome.
If someone has HPA-axis suppression, it's not safe to suddenly stop treatment.
They might need to slowly reduce the dose instead.

Safety:

Methylprednisolone can be given intravenously (IV), but only the methylprednisolone succinate formulation (Solu-Medrol) is safe for IV use.
The methylprednisolone acetate suspension (Depo-Medrol) is meant for injections into muscles or joints only.
It's not safe to give the acetate preparation through IV because it can cause serious problems.

Methylprednisolone Usual Dosage Range:

Intravenous (IV, succinate formulation): Typically given at a dose of 40 to 125 mg per day, either in one single daily dose or split into smaller doses throughout the day. In rare cases, for certain conditions, the dose might be increased to 1 to 2 mg per kilogram of body weight per day.
Initial high-dose "pulse" therapy: This is used for severe systemic rheumatic disorders. The dosage is 7 to 15 mg per kilogram of body weight per dose (or 500 mg to 1 g per dose), given once daily for 3 to 5 days.
Oral: Usually taken at a dose of 16 to 64 mg per day, either all at once or divided into smaller doses throughout the day.

For example, if you're using a dose-pack containing 21 tablets, the dosing might look like this:

Day 1: 24 mg (6 tablets), divided throughout the day.
Day 2: 20 mg (5 tablets), divided throughout the day.
Day 3: 16 mg (4 tablets), divided throughout the day.
Day 4: 12 mg (3 tablets), divided throughout the day.
Day 5: 8 mg (2 tablets), divided throughout the day.
Day 6: 4 mg (1 tablet) before breakfast.

Intramuscular (IM, acetate or succinate formulations): Typically administered as a single dose of 40 to 60 mg.

Methylprednisolone Dose in the treatment of Intra-articular (acetate suspension):

Larger joint (e.g., knee, shoulder, hip): 20 to 80 mg.
Medium joint (e.g., wrist, ankle, elbow): 10 to 40 mg.
Small joint (e.g., toe, finger): 4 to 10 mg.

Indication-specific dosing:

Methylprednisolone Dose in the treatment of moderate to severe acute respiratory distress syndrome (off-label):

For the off-label treatment of acute respiratory distress syndrome (ARDS), moderate to severe cases, methylprednisolone is administered intravenously (IV) using the succinate formulation.

Loading Dose: 1 mg/kg over 30 minutes.
Days 1 to 14: 1 mg/kg/day, either divided into multiple doses or administered as a continuous infusion.
Days 15 to 21: 0.5 mg/kg/day, divided doses or continuous infusion.
Days 22 to 25: 0.25 mg/kg/day, divided doses or continuous infusion.
Days 26 to 28: 0.125 mg/kg/day, divided doses or continuous infusion.

Methylprednisolone Dose in the treatment of Allergic conditions:

Anaphylaxis (adjunct to epinephrine for prevention of late-phase/biphasic reaction):
- IV (succinate): 1 to 2 mg/kg or 50 to 125 mg as a single dose.
Angioedema (acute allergic) and/or urticaria (acute):
- IV (succinate):
  - Initial: 60 to 80 mg; switch to an oral corticosteroid as soon as possible, tapering the dose for a total treatment duration of ≤10 days.
- Oral:
  - Initial: 16 to 32 mg/day in 1 to 2 divided doses for 3 to 4 days; may consider tapering the dose for a total treatment duration of ≤10 days.

Methylprednisolone Dose in the treatment of Acute exacerbation of Asthma:

Oral (preferred route), IV (succinate): 40 to 60 mg per day, divided into 1 or 2 doses, for a duration of 3 to 10 days. In critically ill patients, doses up to 60 to 80 mg every 6 to 12 hours have been used. If symptoms do not improve and peak expiratory flow does not reach at least 70% of the personal best, longer treatment may be necessary.

Methylprednisolone Dose in the treatment of acute exacerbation of Chronic obstructive pulmonary disease (off-label):

Oral; IV (succinate): 40 to 60 mg daily for 5 to 14 days. In patients with severe exacerbations but not life-threatening, oral regimens are recommended. The IV route should be reserved for patients who cannot tolerate oral therapy due to conditions like shock or those who are mechanically ventilated. Doses up to 60 mg every 6 hours have been used in critically ill patients, although data on outcomes are limited.

Methylprednisolone Dose in the treatment of Deceased organ donor management (hormonal resuscitation for the deceased organ donor) (off-label):

For the management of deceased organ donors, methylprednisolone is sometimes used as part of hormonal resuscitation, although the data supporting its benefit are conflicting.

Intravenous (IV, succinate formulation):
- Regimens may include:
  - 1 gram administered as an IV infusion.
  - 15 mg/kg administered as an IV infusion.
  - 250 mg administered as an IV bolus followed by a continuous infusion at a rate of 100 mg/hour.

Methylprednisolone Dose in the treatment of Giant cell arteritis (off-label):

Initial pulse therapy:
- IV (succinate formulation): 500 mg to 1 gram daily for 3 days.

Following the initial pulse therapy, patients are typically transitioned to an oral glucocorticoid, such as prednisone, for ongoing treatment.

Methylprednisolone Dose in the treatment of acute flare of Gout:

For the treatment of acute flare of gout, methylprednisolone can be administered orally, intra-articularly, intramuscularly, or intravenously depending on the patient's condition and preference.

Oral:
- Initial dose: 24 to 32 mg per day, taken in 1 or 2 divided doses until symptom improvement.
- Tapering: Followed by a 7- to 10-day taper, or a 14- to 21-day taper in patients with multiple prior flares. A tapered (6-day) dose pack may be sufficient in some patients.
Intra-articular (acetate):
- Usual dose:
  - Larger joint (e.g., knee): 40 mg
  - Medium joint (e.g., wrist, ankle, elbow): 30 mg
  - Small joint (e.g., toe, finger): 10 mg
- Range of doses may be used based on patient factors and clinician judgment. The glucocorticoid may be mixed with an equal volume of local anesthetic.
Intramuscular (acetate or succinate):
- Initial dose: 40 to 60 mg as a single dose. It may be repeated once or twice at intervals of at least 48 hours if the benefit fades or there is no resolution of the flare.
Intravenous (succinate, for hospitalized patients):
- Initial dose: 20 mg twice daily until clinical improvement.
- Tapering: Followed by a stepwise reduction in each dose by 50% until 5 mg twice daily. Then, maintain a dose of at least 4 mg (or oral equivalent) twice daily for 5 days.

The choice of route and dosage should be determined based on individual patient factors, such as the severity of the flare, the presence of contraindications, and the patient's preference.

Methylprednisolone Dose in the treatment of acute Graft-vs-host disease (off-label):

Intravenous (IV, succinate formulation):
- Initial dose: 2 mg/kg/day, divided into two doses.
- The dose may vary based on organ involvement and severity.
- Treatment is typically continued for several weeks, followed by a gradual tapering over several months.

Methylprednisolone Dose in the treatment of Immune thrombocytopenia (initial therapy):

For the initial therapy of immune thrombocytopenia (ITP), the goal is to achieve a safe platelet count to prevent clinically important bleeding rather than normalization of the platelet count.

Patients with severe bleeding (in combination with other treatments):
- Intravenous (IV, succinate formulation): 1 gram once daily for 3 doses.

It's important to note that due to the short-term response, maintenance therapy with an oral glucocorticoid, such as prednisone, may be required.

Methylprednisolone (SOLUMedrol) Dose in the treatment of Inflammatory bowel disease:

Crohn's disease, acute (severe/fulminant disease and/or unable to take oral):
- IV (succinate formulation): 40 to 60 mg per day.
Ulcerative colitis, acute (severe or fulminant):
- IV (succinate formulation): 60 mg per day, divided into 1 to 3 doses.

Methylprednisolone Dose in the prevention of Iodinated contrast media allergic-like reaction:

Nonurgent regimen (oral administration):
- Oral: 32 mg administered 12 hours and 2 hours before contrast medium administration, in combination with oral diphenhydramine 50 mg (administered 1 hour prior to contrast).
Urgent (accelerated) regimen (intravenous administration):
- IV (succinate formulation): 40 mg every 4 hours until contrast medium administration, in combination with IV diphenhydramine 50 mg (administered 1 hour prior to contrast).

These regimens aim to prevent allergic-like reactions to iodinated contrast media and should be tailored based on the urgency of the contrast administration and the patient's clinical condition.

Methylprednisolone Dose in the treatment of acute exacerbation of multiple sclerosis:

Initial pulse therapy:
- IV (succinate formulation): 500 mg to 1 gram daily for 3 to 7 days, with 5 days being typical.

This initial pulse therapy can be administered alone or followed by an oral taper with prednisone.

Methylprednisolone Dose in the treatment of Myopathies (dermatomyositis and polymyositis):

Initial pulse therapy:
- IV (succinate formulation): 1 gram daily for 3 to 5 days.

Following the initial pulse therapy, patients are typically transitioned to oral prednisone for ongoing treatment.

Methylprednisolone Dose in the treatment of severe or refractory Nausea and vomiting of pregnancy (off-label):

For the treatment of severe or refractory nausea and vomiting of pregnancy, methylprednisolone can be used off-label as an add-on therapy when all other pharmacologic regimens have failed.

Intravenous (IV, succinate formulation):
- 16 mg every 8 hours for 3 days.

If there is no response within 3 days, treatment should be discontinued. If symptoms improve, the complete 3-day course of treatment should be finished, followed by tapering the dose over 2 weeks.

Methylprednisolone (SOLUMedrol) Dose in the treatment of Pneumocystis pneumonia, adjunctive therapy for moderate to severe disease (off-label):

For the adjunctive therapy of moderate to severe Pneumocystis pneumonia, methylprednisolone can be administered off-label.

Intravenous (IV, succinate formulation):
- 30 mg twice daily on days 1 to 5, beginning as early as possible.
- 30 mg once daily on days 6 to 10.
- 15 mg once daily on days 11 to 21.

These dosages are based on equivalent doses of prednisone.

Methylprednisolone Dose in the treatment of metastatic, castration-resistant prostate cancer (off-label):

For the off-label treatment of metastatic castration-resistant prostate cancer, methylprednisolone can be administered orally.

Oral:
- 4 mg twice daily.

This dosage is typically used in combination with micronized abiraterone acetate as part of the treatment regimen.

Initial pulse therapy (optional):
- IV (succinate formulation): 7 to 15 mg/kg/day (maximum dose: 500 mg to 1 gram/day) typically for up to 3 days.

Methylprednisolone Dose in the treatment of Warm autoimmune hemolytic anemia:

For the treatment of warm autoimmune hemolytic anemia, methylprednisolone can be administered intravenously (IV) initially, followed by an oral glucocorticoid.

IV (succinate formulation):
- 250 mg to 1 gram daily for 1 to 3 days.

Following the initial IV therapy, patients are typically transitioned to an oral glucocorticoid, such as prednisone.

It's important to note that a clinician experienced with the treatment of hemolytic anemia should be involved in therapy decisions.

Methylprednisolone Dose in Childrens:

Note:

The amount of methylprednisolone given depends on what's being treated and how the patient responds.
Doctors start with the smallest effective dose and gradually lower it when possible.
If it's a life-threatening situation, the dose might be higher if given through a vein compared to taking it by mouth.
Only the sodium succinate form can be given through a vein.

Methylprednisolone Dose in the treatment of acute exacerbation of Asthma:

Acute Short-Course "Burst" (NAEPP 2007):

Infants and Children <12 years:
- Oral: 1 to 2 mg/kg/day in divided doses once or twice daily for 3 to 10 days; maximum daily dose: 60 mg/day.
- IM (acetate): 7.5 mg/kg as a one-time dose for children ≤4 years; 240 mg as a one-time dose for children 5 to 11 years.
Children ≥12 years and Adolescents:
- Oral: 40 to 60 mg/day in divided doses once or twice daily for 3 to 10 days.
- IM (acetate): 240 mg as a one-time dose.

Hospital/Emergency Medical Care Doses:

Infants and Children <12 years:
- Oral, IV: 1 to 2 mg/kg/day in 2 divided doses; maximum daily dose: 60 mg/day; continue until peak expiratory flow is 70% of predicted or personal best.
Children ≥12 years and Adolescents:
- Oral, IV: 40 to 80 mg/day in divided doses once or twice daily until peak expiratory flow is 70% of predicted or personal best.

Status Asthmaticus (Previous NAEPP Guidelines):

Children:
- IV: Loading dose: 2 mg/kg/dose, then 0.5 to 1 mg/kg/dose every 6 hours. (Refer to NAEPP 2007 guidelines for asthma exacerbations (emergency medical care or hospital doses) listed above.)

Methylprednisolone Dose in the long-term maintenance treatment of Asthma:

Infants and Children <12 years:
- Oral: 0.25 to 2 mg/kg/day once daily in the morning or every other day as needed for asthma control; maximum daily dose: 60 mg/day.
Children ≥12 years and Adolescents:
- Oral: 7.5 to 60 mg daily once daily in the morning or every other day as needed for asthma control.

Methylprednisolone (SOLUMedrol) General dosing; as anti-inflammatory or immunosuppressive:

Infants, Children, and Adolescents:

Initial Dose:
- Oral, IM (acetate or succinate), IV (succinate): 0.11 to 1.6 mg/kg/day or 3.2 to 48 mg/m²/day; usual range: 0.5 to 1.7 mg/kg/day.
- Administer in divided doses every 6 to 12 hours for oral, IM (succinate), and IV (succinate); for IM (acetate), administer as a single daily dose.
"Pulse" Therapy:
- IV (succinate): 15 to 30 mg/kg/dose once daily for 3 days; maximum dose: 1,000 mg.
Long-acting:
- IM (acetate): 4 to 80 mg every 1 to 2 weeks.

Methylprednisolone Dose in the treatment of Kawasaki disease:

Primary Treatment for Patients at High Risk for Coronary Artery Aneurysms:

Pulse Dosing:
- Infants and Children:
  - IV: 30 mg/kg/dose as a single dose in combination with IVIG and aspirin.
Taper Dosing:
- Infants and Children:
  - IV: 1.6 mg/kg/day in divided doses every 8 hours for 5 days or until afebrile, then transition to oral prednisolone; maximum daily dose: 48 mg/day; give in combination with aspirin and an additional dose of IVIG.
  - Note: Dosing based on the use of IV prednisolone product (2 mg/kg/day), which is not available in the US; dosing converted to equivalent methylprednisolone dosing; however, the clinical necessity of conversion is unknown.

Treatment for Refractory/Resistant Disease:

Pulse Dosing:
- Infants and Children:
  - IV: 30 mg/kg/dose once daily for 1 or 3 days; may be given in combination with an additional IVIG dose.
Taper Dosing:
- Infants and Children:
  - IV: 1.6 mg/kg/day in divided doses every 8 hours for 5 days or until afebrile, then transition to oral prednisolone; maximum daily dose: 48 mg/day; give in combination with aspirin and an additional dose of IVIG.
  - Note: Dosing based on the use of IV prednisolone product (2 mg/kg/day), which is not available in the US; dosing converted to equivalent methylprednisolone dosing; however, the clinical necessity of conversion is unknown.

Methylprednisolone dose in the treatment of Lupus nephritis:

Children and Adolescents:

IV (Succinate):
- High-Dose "Pulse" Therapy: 30 mg/kg/dose or 600 to 1,000 mg/m²/dose once daily for 3 days; maximum dose: 1,000 mg.

Methylprednisolone Dose in the treatment of acute spinal cord injury:

Children and Adolescents:

IV (Succinate):
- Initial Dose: 30 mg/kg over 15 minutes.
- Continuous Infusion: Followed by a continuous infusion of 5.4 mg/kg/hour for 23 hours.

Note:

Due to insufficient evidence of clinical efficacy in preserving or improving spinal cord function, the routine use of methylprednisolone in the treatment of acute spinal cord injury is no longer recommended.
If used, methylprednisolone should not be initiated >8 hours after the injury and is not effective in penetrating trauma (eg, gunshot).

Methylprednisolone Dose in the treatment of moderate to severe Pneumocystis pneumonia infection:

Infants and Children:

IV (Succinate):
- Days 1 to 7: 1 mg/kg/dose every 6 hours.
- Days 8 to 9: 1 mg/kg/dose twice daily.
- Days 10 and 11: 0.5 mg/kg/dose twice daily.
- Days 12 to 16: 1 mg/kg/dose once daily.
Note: Initiate therapy within 72 hours of diagnosis, if possible.

Adolescents:

IV (Succinate):
- Days 1 to 5: 30 mg twice daily.
- Days 6 to 10: 30 mg once daily.
- Days 11 to 21: 15 mg once daily.
Note: Initiate therapy within 72 hours of diagnosis, if possible.

Methylprednisolone Dose in the treatment of acute Graft-versus-host disease (GVHD):

Infants, Children, and Adolescents:

IV (Succinate):
- Initial Dose: 1 to 2 mg/kg/dose once daily.
- Adjustment: If using a low dose (1 mg/kg) and no improvement after 3 days, increase dose to 2 mg/kg.
- Duration: Continue therapy for 5 to 7 days.
- Tapering: If improvement observed, may taper by 10% of starting dose every 4 days.
- Considerations: If no improvement, then considered steroid-refractory GVHD, and additional agents should be considered.

Methylprednisolone Pregnancy Risk Category: C

Methylprednisolone, a type of medication, can pass from a pregnant person to their baby through the placenta.
Research suggests that using corticosteroids in the first trimester of pregnancy may be linked to certain birth defects or lower birth weight, but findings are inconsistent and may depend on factors like the dose and reason for use.
Newborns of mothers who used corticosteroids during pregnancy might experience low adrenal function, so monitoring is important.
Generally, it's advised to use the lowest effective dose for the shortest duration during pregnancy, especially avoiding high doses in the first trimester.
For skin conditions, it's best to avoid systemic corticosteroids initially and use them cautiously in the second or third trimester.
Pregnant individuals with poorly controlled asthma may face increased risks, so inhaled corticosteroids are preferred for asthma treatment, reserving systemic corticosteroids for acute exacerbations or severe cases.
Methylprednisolone might be considered for severe nausea and vomiting in pregnancy, but only if other treatments haven't worked, and its use should be carefully monitored due to potential risks to the fetus, especially in the first trimester.
The Transplant Pregnancy Registry International (TPR) monitors pregnancies in individuals who have had transplants or fathered by male transplant recipients, aiming to gather data on outcomes and provide support.

Use of methylprednisolone while breastfeeding

Methylprednisolone can pass into breast milk, with a relative infant dose ranging from 2.8% to 5.6% when compared to a weight-adjusted infant dose.
Generally, breastfeeding is considered acceptable when the relative infant dose is below 10%, but it's typically avoided when it exceeds 25%.
The estimated daily infant dose via breast milk, based on the highest milk concentration observed after maternal administration of methylprednisolone, is 0.8325 mg/kg/day.
However, methylprednisolone levels in breast milk drop below detectable limits within 12 hours after maternal dosing.
While corticosteroids are generally considered acceptable during breastfeeding when used in typical doses, there's a potential risk of adverse effects in the nursing infant, such as growth suppression or interference with natural corticosteroid production.
Therefore, decisions regarding breastfeeding continuation or discontinuation should be made by weighing the importance of treatment to the mother.
Monitoring the nursing infant is recommended, and some guidelines suggest waiting 4 hours after maternal oral corticosteroid dosing before breastfeeding to minimize infant exposure.

Dose in Kidney Disease:

The manufacturer's labeling does not include specific dosage adjustments for renal impairment.
Therefore, caution should be exercised when prescribing methylprednisolone to patients with renal impairment.
Close monitoring for potential adverse effects is advisable, and dosage adjustments may be necessary based on individual patient factors and renal function assessment.

Dose in Liver disease:

The manufacturer's labeling does not include specific dosage adjustments for hepatic impairment.
Therefore, caution should be exercised when prescribing methylprednisolone to patients with hepatic impairment.
Close monitoring for potential adverse effects is advisable, and dosage adjustments may be necessary based on individual patient factors and hepatic function assessment.

Side effects of Methylprednisolone:

Cardiovascular:
- Bradycardia
- Cardiac Arrest
- Cardiac Arrhythmia
- Cardiac Failure
- Cardiomegaly
- Circulatory Shock
- Edema
- Embolism (Fat)
- Hypertension
- Hypertrophic Cardiomyopathy (In Neonates)
- Myocardial Rupture (Post MI)
- Syncope
- Tachycardia
- Thromboembolism
- Thrombophlebitis
- Vasculitis
Central Nervous System:
- Arachnoiditis
- Depression
- Emotional Lability
- Euphoria
- Headache
- Increased Intracranial Pressure
- Insomnia
- Malaise
- Meningitis
- Myasthenia
- Neuritis
- Neuropathy
- Paraplegia
- Paresthesia
- Personality Changes
- Psychic Disorders
- Pseudotumor Cerebri (Usually Following Discontinuation)
- Seizure
- Sensory Disturbance
- Vertigo
Dermatologic:
- Acne Vulgaris
- Allergic Dermatitis
- Alopecia
- Atrophic Striae
- Diaphoresis
- Ecchymoses
- Epidermal Thinning
- Erythema
- Exfoliation Of Skin
- Facial Erythema
- Hyperpigmentation
- Hypertrichosis
- Hypopigmentation
- Skin Atrophy
- Skin Rash
- Suppression Of Skin Test Reaction
- Thinning Hair
- Urticaria
- Xeroderma
Endocrine & Metabolic:
- Adrenal Suppression
- Calcinosis
- Cushingoid State
- Cushing Syndrome
- Decreased Glucose Tolerance
- Diabetes Mellitus
- Fluid Retention
- Glycosuria
- Growth Suppression (Children)
- Hirsutism
- HPA-Axis Suppression
- Hyperglycemia
- Hyperlipidemia
- Hypokalemia
- Hypokalemic Alkalosis
- Insulin Resistance (Increased Requirements For Insulin Or Oral Hypoglycemic Agents In Diabetes)
- Menstrual Disease
- Moon Face
- Negative Nitrogen Balance
- Protein Catabolism
- Sodium Retention
- Weight Gain
Gastrointestinal:
- Abdominal Distention
- Bladder Dysfunction (After Intrathecal Administration
- Including Bowel Dysfunction)
- Carbohydrate Intolerance (Increased)
- Gastrointestinal Hemorrhage
- Gastrointestinal Perforation
- Hiccups
- Increased Appetite
- Intestinal Perforation (Of Both Of The Small And Large Intestines; Especially In Patients With Inflammatory Bowel Disease)
- Nausea
- Pancreatitis
- Peptic Ulcer
- Spermatozoa Disorder (Decreased Motility And Number Of Spermatozoa)
- Ulcerative Esophagitis
Hematologic:
- Leukocytosis (Transient)
- Malignant Neoplasm (Secondary)
- Petechia
Hepatic:
- Hepatomegaly
- Increased Liver Enzymes
- Increased Serum Transaminases
Hypersensitivity:
- Anaphylactoid Reaction
- Anaphylaxis
- Angioedema
- Hypersensitivity Reaction
Infection:
- Increased Susceptibility To Infection
- Infection (Ophthalmic)
- Sterile Abscess
Local:
- Injection Site Infection
Neuromuscular & Skeletal:
- Amyotrophy
- Arthropathy
- Aseptic Necrosis Of Femoral Head
- Aseptic Necrosis Of Humoral Head
- Bone Fracture
- Charcot-Like Arthropathy
- Lipotrophy
- Osteoporosis
- Rupture Of Tendon
- Steroid Myopathy
- Vertebral Compression Fracture
Ophthalmic:
- Blindness
- Exophthalmoses
- Glaucoma
- Increased Intraocular Pressure
- Ophthalmic Inflammation (Ophthalmic)
- Subcapsular Posterior Cataract
- Visual Impairment
Respiratory:
- Pulmonary Edema
- Rhinitis
Miscellaneous:
- Anaphylactoid Reaction
- Anaphylaxis
- Angioedema
- Hypersensitivity Reactions
- Tissue Sloughing (Residue Or Slough At Injection Site)
- Wound Healing Impairment

Contraindications to Methylprednisolone:

Methylprednisolone is contraindicated in individuals with hypersensitivity to methylprednisolone or any component of the formulation, systemic fungal infection (except for intra-articular injection for localized joint conditions), intrathecal administration, and administration of live or attenuated virus vaccines with immunosuppressive doses of corticosteroids.
It is also contraindicated for use in premature infants when formulations contain benzyl alcohol preservative and in cases of immune thrombocytopenia for intramuscular administration only.
Additionally, the 40 mg vial of methylprednisolone sodium succinate is contraindicated in individuals with hypersensitivity to cow's milk or its components or other dairy products.
In Canada, additional contraindications include herpes simplex of the eye, vaccinia, and varicella for methylprednisolone tablets, herpes simplex of the eye, vaccinia, and varicella for methylprednisolone acetate injection, and epidural administration, herpes simplex keratitis, vaccinia, varicella, arrested tuberculosis, acute psychoses, Cushing syndrome, peptic ulcer, and markedly elevated serum creatinine for methylprednisolone sodium succinate.
While documentation of allergenic cross-reactivity for corticosteroids is limited, caution is advised due to similarities in chemical structure and pharmacologic actions, potentially leading to cross-sensitivity.

Warnings and precautions

Suppression of the adrenals:

Methylprednisolone can cause hypercortisolism or suppression of the hypothalamic-pituitary adrenal (HPA) axis, especially in children or patients receiving high doses for a long time.
This suppression can lead to adrenal crisis, so withdrawing or discontinuing the corticosteroid should be done gradually and carefully.
Patients transitioning from systemic corticosteroids to inhaled products need special attention as they may experience adrenal insufficiency or withdrawal symptoms, including an increase in allergic reactions.
Adults taking more than 20 mg per day of prednisone may be particularly at risk, with fatalities reported in asthmatic patients.

Anaphylactoid reactions

Although rare, some patients may experience anaphylactoid reactions while taking corticosteroids.

Dermal changes:

Injection or leakage of methylprednisolone into the skin can lead to skin depression or atrophy, especially if injected into the deltoid muscle.

Hepatic effects

High doses of methylprednisolone, especially intravenously, may cause a rare form of acute hepatitis, which can lead to acute liver failure and even death.
This risk is higher in patients with a history of methylprednisolone-induced toxic hepatitis.

Immunosuppression:

Long-term use of corticosteroids may increase the risk of infections, reactivate latent infections, or mask signs of infection.
Patients should avoid exposure to chickenpox or measles while taking corticosteroids, and caution is needed in those with latent tuberculosis or other infections.

Kaposi Sarcoma:

Prolonged use of corticosteroids has been linked to the development of Kaposi sarcoma, a type of cancer.

Myopathy

High doses of corticosteroids can cause acute myopathy, particularly in patients with neuromuscular disorders, which may involve muscles including those controlling the eyes and breathing.

Psychiatric disorders:

Corticosteroid use may lead to various psychiatric symptoms, from mood swings and insomnia to severe depression or psychosis.

Septic arthritis:

Parenteral corticosteroid therapy may increase the risk of septic arthritis, so appropriate antimicrobial therapy should be initiated if necessary.

Cardiovascular disease

Caution is advised in patients with heart failure or hypertension as corticosteroids can cause fluid retention and electrolyte imbalances, potentially exacerbating these conditions.

Diabetes:

Corticosteroids may affect glucose regulation and lead to hyperglycemia in patients with diabetes mellitus.

Gastrointestinal Disease:

Patients with gastrointestinal diseases such as ulcers or diverticulitis are at increased risk of perforation when taking corticosteroids.

Head injury

High-dose intravenous methylprednisolone should not be used for head injuries as it may increase mortality.

Hepatic impairment

Caution is needed when using corticosteroids in patients with liver impairment, as high doses may worsen fluid retention.

Myasthenia gravis:

Corticosteroids should be used cautiously in patients with myasthenia gravis, as they may exacerbate symptoms.

Ocular disease:

Corticosteroids can increase the risk of glaucoma, cataracts, and corneal perforation, especially in patients with pre-existing eye conditions.

Osteoporosis

Long-term use of corticosteroids can lead to osteoporosis and an increased risk of fractures.

Renal impairment

Patients with renal impairment should use corticosteroids with caution as they may experience fluid retention.

Seizure disorders:

Corticosteroids should be used carefully in patients with a history of seizure disorders, as they may trigger seizures.

Sepsis or septic shock syndrome:

Corticosteroids should not be used to treat sepsis unless the patient is in shock, as they may increase mortality.

Systemic sclerosis (scleroderma).

Higher doses of corticosteroids in patients with systemic sclerosis may increase the risk of scleroderma renal crisis.

Thyroid disease:

Changes in thyroid status may require adjustments in corticosteroid dosage, as metabolism of corticosteroids varies with thyroid function.

Methylprednisolone: Drug Interaction

Risk Factor C (Monitor therapy)
Acetylcholinesterase Inhibitors	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur.
Amphotericin B	Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B.
Androgens	Corticosteroids (Systemic) may enhance the fluid-retaining effect of Androgens.
Antidiabetic Agents	Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents.
Bile Acid Sequestrants	May decrease the absorption of Corticosteroids (Oral).
Bosentan	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Calcitriol (Systemic)	Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic).
Clofazimine	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Coccidioides immitis Skin Test	Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test.
Corticorelin	Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy.
Cosyntropin	Corticosteroids (Systemic) may diminish the diagnostic effect of Cosyntropin.
CycloSPORINE (Systemic)	May increase the serum concentration of MethylPREDNISolone. MethylPREDNISolone may increase the serum concentration of CycloSPORINE (Systemic). MethylPREDNISolone may decrease the serum concentration of CycloSPORINE (Systemic).
CYP3A4 Inducers (Moderate)	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
CYP3A4 Inhibitors (Moderate)	May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors).
Deferasirox	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Deferasirox	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased.
Deferasirox	Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased.
Denosumab	May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased.
DilTIAZem	May increase the serum concentration of Corticosteroids (Systemic).
Duvelisib	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Erdafitinib	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Erdafitinib	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Estrogen Derivatives	May increase the serum concentration of Corticosteroids (Systemic).
Fosnetupitant	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Indacaterol	May enhance the hypokalemic effect of Corticosteroids (Systemic).
Isoniazid	Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid.
Ivosidenib	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Larotrectinib	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Loop Diuretics	Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics.
Netupitant	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Nicorandil	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination.
Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective)	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective).
Nonsteroidal Anti-Inflammatory Agents (Nonselective)	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective).
Ocrelizumab	May enhance the immunosuppressive effect of Immunosuppressants.
Palbociclib	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Pidotimod	Immunosuppressants may diminish the therapeutic effect of Pidotimod.
Quinolones	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased.
Ritodrine	Corticosteroids may enhance the adverse/toxic effect of Ritodrine.
Salicylates	May enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity.
Sargramostim	Corticosteroids (Systemic) may enhance the therapeutic effect of Sargramostim. Specifically, corticosteroids may enhance the myeloproliferative effects of sargramostim.
Sarilumab	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Siltuximab	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Simeprevir	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Siponimod	Immunosuppressants may enhance the immunosuppressive effect of Siponimod.
Somatropin	Corticosteroids (Systemic) may diminish the therapeutic effect of Somatropin.
Tacrolimus (Systemic)	Corticosteroids (Systemic) may decrease the serum concentration of Tacrolimus (Systemic). Conversely, when discontinuing corticosteroid therapy, tacrolimus concentrations may increase.
Tertomotide	Immunosuppressants may diminish the therapeutic effect of Tertomotide.
Thiazide and Thiazide-Like Diuretics	Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics.
Tocilizumab	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers).
Trastuzumab	May enhance the neutropenic effect of Immunosuppressants.
Urea Cycle Disorder Agents	Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range.
Warfarin	Corticosteroids (Systemic) may enhance the anticoagulant effect of Warfarin.
Risk Factor D (Consider therapy modification)
Antacids	May decrease the bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects.
Aprepitant	May increase the serum concentration of Corticosteroids (Systemic). Management: No dose adjustment is needed for single 40 mg aprepitant doses. For other regimens, reduce oral dexamethasone or methylprednisolone doses by 50%, and IV methylprednisolone doses by 25%. Antiemetic regimens containing dexamethasone reflect this adjustment.
Axicabtagene Ciloleucel	Corticosteroids (Systemic) may diminish the therapeutic effect of Axicabtagene Ciloleucel. Management: Avoid use of corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
Baricitinib	Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted.
CYP3A4 Inducers (Strong)	May decrease the serum concentration of MethylPREDNISolone. Management: Consider methylprednisolone dose increases in patients receiving strong CYP3A4 inducers and monitor closely for reduced steroid efficacy.
CYP3A4 Inhibitors (Strong)	May increase the serum concentration of MethylPREDNISolone. Management: Consider methylprednisolone dose reduction in patients receiving strong CYP3A4 inhibitors and monitor for increased steroid related adverse effects.
Dabrafenib	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects).
Desirudin	Corticosteroids (Systemic) may enhance the anticoagulant effect of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation.
Echinacea	May diminish the therapeutic effect of Immunosuppressants.
Enzalutamide	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring.
Fingolimod	Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections).
Fosaprepitant	May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect.
Hyaluronidase	Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required.
Leflunomide	Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly.
Lorlatinib	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences.
Mitotane	May decrease the serum concentration of Corticosteroids (Systemic).
Mitotane	May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane.
Neuromuscular-Blocking Agents (Nondepolarizing)	May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur.
Nivolumab	Immunosuppressants may diminish the therapeutic effect of Nivolumab.
Roflumilast	May enhance the immunosuppressive effect of Immunosuppressants.
Sipuleucel-T	Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy.
Stiripentol	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring.
Tisagenlecleucel	Corticosteroids (Systemic) may diminish the therapeutic effect of Tisagenlecleucel. Management: Avoid use of corticosteroids as premedication or at any time during treatment with tisagenlecleucel, except in the case of life-threatening emergency (such as resistant cytokine release syndrome).
Tofacitinib	Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants.
Vaccines (Inactivated)	Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation.
Vaccines (Live)	Corticosteroids (Systemic) may enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided.
Risk Factor X (Avoid combination)
Aldesleukin	Corticosteroids may diminish the antineoplastic effect of Aldesleukin.
BCG (Intravesical)	Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical).
Cladribine	May enhance the immunosuppressive effect of Immunosuppressants.
Conivaptan	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Desmopressin	Corticosteroids (Systemic) may enhance the hyponatremic effect of Desmopressin.
Fexinidazole [INT]	Corticosteroids (Systemic) may enhance the arrhythmogenic effect of Fexinidazole [INT].
Fusidic Acid (Systemic)	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Idelalisib	May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors).
Indium 111 Capromab Pendetide	Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide.
Macimorelin	Corticosteroids (Systemic) may diminish the diagnostic effect of Macimorelin.
Mifamurtide	Corticosteroids (Systemic) may diminish the therapeutic effect of Mifamurtide.
MiFEPRIStone	May diminish the therapeutic effect of Corticosteroids (Systemic). MiFEPRIStone may increase the serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (e.g., for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment.
Natalizumab	Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased.
Pimecrolimus	May enhance the adverse/toxic effect of Immunosuppressants.
Tacrolimus (Topical)	May enhance the adverse/toxic effect of Immunosuppressants.
Upadacitinib	Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib.

Monitoring parameters:

Blood Pressure:

Regular monitoring of blood pressure is important, especially in patients receiving long-term corticosteroid therapy, as corticosteroids can cause fluid retention and electrolyte imbalances, which may elevate blood pressure.

Blood Glucose:

Corticosteroids can affect glucose metabolism, leading to hyperglycemia, especially in patients with diabetes mellitus. Monitoring blood glucose levels is essential, particularly in diabetic patients or those at risk of developing diabetes.

Electrolytes:

Corticosteroids may cause electrolyte imbalances, including sodium and potassium disturbances. Monitoring electrolyte levels periodically is necessary, especially in patients receiving prolonged corticosteroid therapy.

Weight:

Regular monitoring of weight is recommended, particularly during long-term corticosteroid treatment, as weight gain is a common side effect of corticosteroid therapy.

Intraocular Pressure:

Patients using corticosteroids for more than six weeks should have their intraocular pressure monitored regularly, as corticosteroids can increase intraocular pressure and potentially lead to glaucoma.

Bone Mineral Density:

Corticosteroids can cause bone loss and increase the risk of osteoporosis and fractures. Monitoring bone mineral density may be necessary, especially in patients receiving long-term corticosteroid therapy.

Growth and Development in Children:

Children receiving corticosteroid therapy should have their growth and development closely monitored, as corticosteroids can affect growth and delay development, particularly when used long-term or at high doses.

HPA Axis Suppression:

Monitoring for signs of hypothalamic-pituitary adrenal (HPA) axis suppression is essential, especially in patients receiving long-term or high-dose corticosteroid therapy. Symptoms of HPA axis suppression may include fatigue, weakness, weight loss, and low blood pressure.

How to administer Methylprednisolone?

Oral Administration:

Take tablets after meals or with food/milk to reduce gastrointestinal upset. If prescribed once daily, take the dose in the morning.

Intramuscular (IM) Administration (Acetate, Succinate):

Avoid injecting into the deltoid muscle due to a high risk of subcutaneous atrophy. Do not inject into areas with evidence of acute local infection.

Intravenous (IV) Administration (Succinate):

The infusion rate depends on the dose and severity of the condition, usually administered intermittently over 15 to 60 minutes.
Larger doses should be infused over at least 30 to 60 minutes; avoid administering large doses as an IV push, as it can lead to severe adverse effects such as hypotension, cardiac arrhythmia, or sudden death.
Bolus doses (30 mg/kg) used in some spinal cord injury trials have been administered over 15 minutes. Do not administer acetate form intravenously.

Intra-articular or Soft Tissue Administration (Acetate):

Follow the manufacturer's instructions for details on intra-articular or soft tissue administration.

Intralesional Administration:

Inject directly into the lesion. For large lesions, administer multiple small injections (20 to 40 mg) into the lesion area. Avoid injecting enough material to cause blanching, as this may lead to a small slough.

Mechanism of action of Methylprednisolone (SOLUMedrol):

Corticosteroids act in specific tissues by binding to intracellular receptors and entering the nucleus, where they regulate gene expression.
They have diverse physiological effects, including controlling carbohydrate, protein, and lipid metabolism, as well as maintaining fluid and electrolyte balance.
Corticosteroids impact cardiovascular, immune, musculoskeletal, endocrine, and nervous system functions.
They reduce inflammation by inhibiting the migration of certain white blood cells and reversing increased capillary permeability.

Onset of action:

IV (succinate): Within 1 hour
Intra-articular (IV acetate): 1 week

Duration:

Intra-articular (IV acetate): 1 to 5 weeks

Absorption:

Oral: Well absorbed (Czock 2005)

Bioavailability:

Oral: 88% ± 23% (Czock 2005)

Distribution:

Volume of distribution (V): IV (succinate): 24 L ± 6 L (Czock 2005)

Metabolism:

Hepatic to metabolites (Czock 2005)

Half-life elimination:

Adolescents: IV: 1.9 ± 0.7 hours (age range: 12 to 20 years; Rouster-Stevens 2008)
Adults:
- Oral: 2.5 ± 1.2 hours (Czock 2005)
- IV (succinate): 0.25 ± 0.1 hour (Czock 2005)

Time to peak, plasma:

Oral: 2.1 ± 0.7 hours (Czock 2005)
IV (succinate): 0.8 hours (Czock 2005)

Excretion:

Urine: 1.3% (oral), 9.2% (IV succinate) as unchanged drug (Czock 2005)

International Brand Names of Methylprednisolone:

DEPO-Medrol
Medrol
P-Care D40
P-Care D80
ReadySharp methylprednisolone
SOLUMedrol
Uni-Med
Adrelan
Advantan
Adventan
Cipridanol
Comedrol
Cryosolona
Depo Medrol
Depo-Medrol
Depo-Medrone
Epizolone-Depot
Flason
Flumethyl
Lexcomet
Lexxema
M-Nisol
M-Prednihexal
Madomed
Meapron
Medason
Medexa
Medisolu
Medixon
Medlon
Mednin
Medrate
Medrol
Medrone
Melone 16
Melsone
Menisone
Meprednisona All Pro
Mepresone
Mesolone
Metcor
Metcort
Methylon
Methylpred
Methylprednisolone David Bull
Methysol
Metrite
Metypred
Neo-Drol
Nisolon-M
Predlitem
Prednivex
Prednol
Prednox
Prena
Pretilon
Prolon
Sanexon
Sol-U-Pred
Sologen
Solomet
Solu Medrol
Solu-Medon
Solu-Medrol
Solu-Medrone
Solu-Moderin
Solu-Pred
Somidex
Sonicor
Thimelon
Thylmedi
Tisolon-4
Tropidrol
Urbason
Urbason Retard
Yalone

Methylprednisolone Brand Names in Pakistan:

Methylprednisolone Injection 1 g in Pakistan
Methypred	Haji Medicine Co.
Solu Medrol	Pfizer Laboratories Ltd.

Methylprednisolone Injection 40 Mg in Pakistan
Ceta-Medrol	Mediceena Pharma (Pvt) Ltd.
Co-Sterol	Cirin Pharmaceuticals (Pvt) Ltd.
Depo Medrol	Pfizer Laboratories Ltd.
Solu Medrol	Pfizer Laboratories Ltd.

Methylprednisolone Injection 125 Mg in Pakistan
Solu Medrol	Pfizer Laboratories Ltd.

Methylprednisolone Injection 500 Mg in Pakistan
Methypred	Haji Medicine Co.
Solu Medrol	Pfizer Laboratories Ltd.

Methylprednisolone Oint 0.1 %W/W in Pakistan
Advantan	Bayer Health Care
Advantan Fatty	Bayer Health Care
Avate	Pearl Pharmaceuticals

Methylprednisolone Cream 0.1 %W/W in Pakistan
Advantan	Bayer Health Care
Avate	Pearl Pharmaceuticals

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