Medrol Prescribing Information

The following should be kept in mind when considering alternate day therapy:

methylprednisolone (Rx)

NIH guidelines recommend metabolic-endocrine#corticosteroids (preferably dexamethasone) to reduce mortality in hospitalized patients with COVID-19 disease who are receiving either invasive mechanical ventilation or oxygen alone, but not among those receiving no respiratory support

If dexamethasone is unavailable, use alternant glucocorticoids (eg, prednisone, methylprednisolone, or hydrocortisone)

Methylprednisolone 32 mg IV qDay for up to 10 days or discharge, whichever comes first; use in addition to standard of care

Consider methylprednisolone use as follows

• Supplement oxygen, but not requiring oxygen delivery through high-flow device, noninvasive ventilation, invasive mechanical ventilation, or ECMO
• Requires oxygen delivery through high-glow device or noninvasive ventilation
• Requires invasive mechanical ventilation or ECMO

Pneumocystis (carinii) jiroveci Pneumonia in AIDS Patients (Off-label)

30 mg IV q12hr for 5 days, then 30 mg IV q24hr for 5 days, then 15 mg IV q24hr for 11 days

Acute Spinal Cord Injury (Off-label)

1st hour: 30 mg/kg IV over 15 minutes

Next 23 hours: 5.4 mg/kg/hr IV by continuous infusion

Severe Lupus Nephritis (Off-label)

0.5-1 g IV over 1 hour once daily for 3 days

Dosing Considerations

Methylprednisolone: Usual dosing range, 2-60 mg/day PO divided q6-24hr

Methylprednisolone acetate: Usual dosing range, 10-80 mg IM every 1-2 weeks; as temporary substitute for PO, given in daily IM dose equal to daily PO dose; for prolonged effect, given in weekly IM dose equal to 7 times daily PO dose; unlike methylprednisolone sodium succinate, may not be given IV

Methylprednisolone sodium succinate: Usual dosing range, 10-250 mg IM/IV up to q4hr PRN

Dosage Forms & Strengths

tablet

injectable suspension

• 20mg/mL
• 40mg/mL
• 80mg/mL

powder for injection

Inflammation

0.5-1.7 mg/kg/day IV/PO/IM divided q12hr

Status Asthmaticus

12 years: 40-80 mg/day IM divided q12-24hr until peak expiratory flow is 70% of predicted or personal best; not to exceed 60 mg/day

Pneumocystis (carinii) jiroveci Pneumonia in AIDS Patients (Off-label)

>13 years: 30 mg IV q12hr for 5 days, then 30 mg IV q24hr for 5 days, then 15 mg IV q24hr for 11 days

Severe Lupus Nephritis (Off-label)

30 mg/kg IV every other day for 6 doses

Dosing Considerations

Methylprednisolone: Usual dosing range, 0.117-1.66 mg/kg/day PO divided q6-8hr

Methylprednisolone sodium succinate: Usual dosing range, 0.03-0.2 mg/kg IM q12-24hr

Interactions

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Contraindicated (2)

• mifepristone mifepristone, methylprednisolone. Mechanism: unknown. Contraindicated. Mfr. states that mifepristone is contraindicated in pts. on long term corticosteroid Tx.
• tipranavir tipranavir will increase the level or effect of methylprednisolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

Serious – Use Alternative (84)

• abametapir abametapir will increase the level or effect of methylprednisolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.
• adenovirus types 4 and 7 live, oral methylprednisolone decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Corticosteroids may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of corticosteroid therapy.
• aldesleukin methylprednisolone decreases effects of aldesleukin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid combination because corticosteroids can potentially diminish the antineoplastic effects of aldesleukin.
• anthrax vaccine methylprednisolone decreases effects of anthrax vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
• apalutamide apalutamide will decrease the level or effect of methylprednisolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.
• axicabtagene ciloleucel methylprednisolone, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Consider the use of prophylactic corticosteroid in patients after weighing the potential benefits and risks. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

Monitor Closely (252)

• aceclofenac aceclofenac, methylprednisolone. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.
• acemetacin acemetacin, methylprednisolone. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.
• albiglutide methylprednisolone decreases effects of albiglutide by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully. .
• almotriptan methylprednisolone will decrease the level or effect of almotriptan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
• alprazolam methylprednisolone will decrease the level or effect of alprazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
• amiodarone methylprednisolone will decrease the level or effect of amiodarone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

methylprednisolone will decrease the level or effect of ritonavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

methylprednisolone will decrease the level or effect of verapamil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

Minor (122)

• acarbose methylprednisolone decreases effects of acarbose by pharmacodynamic antagonism. Minor/Significance Unknown.
• acetazolamide acetazolamide will increase the level or effect of methylprednisolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• alfentanil methylprednisolone will decrease the level or effect of alfentanil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• alfuzosin methylprednisolone will decrease the level or effect of alfuzosin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• alosetron methylprednisolone will decrease the level or effect of alosetron by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• amitriptyline methylprednisolone will decrease the level or effect of amitriptyline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• amphotericin B deoxycholate amphotericin B deoxycholate, methylprednisolone. Mechanism: unspecified interaction mechanism. Minor/Significance Unknown. Potential for hypokalemia.
• anastrozole anastrozole will increase the level or effect of methylprednisolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• armodafinil methylprednisolone will decrease the level or effect of armodafinil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• aspirin methylprednisolone decreases levels of aspirin by increasing renal clearance. Minor/Significance Unknown.
• aspirin rectal methylprednisolone decreases levels of aspirin rectal by increasing renal clearance. Minor/Significance Unknown.
• aspirin/citric acid/sodium bicarbonate methylprednisolone decreases levels of aspirin/citric acid/sodium bicarbonate by increasing renal clearance. Minor/Significance Unknown.
• atazanavir methylprednisolone will decrease the level or effect of atazanavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• balsalazide methylprednisolone decreases levels of balsalazide by increasing renal clearance. Minor/Significance Unknown.
• bendroflumethiazide methylprednisolone, bendroflumethiazide. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.
• bosentan methylprednisolone will decrease the level or effect of bosentan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• bumetanide methylprednisolone, bumetanide. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.
• calcium acetate methylprednisolone decreases levels of calcium acetate by increasing elimination. Minor/Significance Unknown.
• calcium carbonate methylprednisolone decreases levels of calcium carbonate by increasing elimination. Minor/Significance Unknown.
• calcium chloride methylprednisolone decreases levels of calcium chloride by increasing elimination. Minor/Significance Unknown.
• calcium citrate methylprednisolone decreases levels of calcium citrate by increasing elimination. Minor/Significance Unknown.
• calcium gluconate methylprednisolone decreases levels of calcium gluconate by increasing elimination. Minor/Significance Unknown.
• cevimeline methylprednisolone will decrease the level or effect of cevimeline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• chlorothiazide methylprednisolone, chlorothiazide. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.
• chlorpropamide methylprednisolone decreases effects of chlorpropamide by pharmacodynamic antagonism. Minor/Significance Unknown.
• chlorthalidone methylprednisolone, chlorthalidone. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.
• choline magnesium trisalicylate methylprednisolone decreases levels of choline magnesium trisalicylate by increasing renal clearance. Minor/Significance Unknown.
• chromium methylprednisolone decreases levels of chromium by increasing renal clearance. Minor/Significance Unknown.
• clarithromycin methylprednisolone will decrease the level or effect of clarithromycin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

• abametapir Serious – Use Alternative (1) abametapir will increase the level or effect of methylprednisolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.
• acarbose Minor (1) methylprednisolone decreases effects of acarbose by pharmacodynamic antagonism. Minor/Significance Unknown.
• aceclofenac Monitor Closely (1) aceclofenac, methylprednisolone. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.
• acemetacin Monitor Closely (1) acemetacin, methylprednisolone. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.
• acetazolamide Minor (1) acetazolamide will increase the level or effect of methylprednisolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• adenovirus types 4 and 7 live, oral Serious – Use Alternative (1) methylprednisolone decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Corticosteroids may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of corticosteroid therapy.
• albiglutide Monitor Closely (1) methylprednisolone decreases effects of albiglutide by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully. .
• aldesleukin Serious – Use Alternative (1) methylprednisolone decreases effects of aldesleukin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid combination because corticosteroids can potentially diminish the antineoplastic effects of aldesleukin.
• alfentanil Minor (1) methylprednisolone will decrease the level or effect of alfentanil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• alfuzosin Minor (1) methylprednisolone will decrease the level or effect of alfuzosin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• almotriptan Monitor Closely (1) methylprednisolone will decrease the level or effect of almotriptan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
• alosetron Minor (1) methylprednisolone will decrease the level or effect of alosetron by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
• alprazolam Monitor Closely (1) methylprednisolone will decrease the level or effect of alprazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
• amiodarone Monitor Closely (2) methylprednisolone will decrease the level or effect of amiodarone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

methylprednisolone will decrease the level or effect of ritonavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

methylprednisolone will decrease the level or effect of verapamil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

Adverse Effects

Frequency Not Defined

Delayed wound healing

Growth suppression (children)

Pituitary adrenal axis suppression

Pseudotumor cerebri (on withdrawal)

Sodium and water retention

Warnings

Contraindications

Untreated serious infections

Documented hypersensitivity to drug or components (eg, lactose monohydrate from cow milk)

Systemic fungal infection (except intra-articular injection in localized joint conditions)

IM route is contraindicated in idiopathic thrombocytopenic purpura

Premature infants (formulations containing benzyl alcohol only)

Traumatic brain injury (high doses)

Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of metabolic-endocrine#corticosteroids

Cautions

Use with caution in cirrhosis, ocular herpes simplex, hypertension, diverticulitis, hypothyroidism, myasthenia gravis, peptic ulcer disease, osteoporosis, ulcerative colitis, psychotic tendencies, renal insufficiency, pregnancy, diabetes mellitus, history of seizure disorders, multiple sclerosis, thromboembolic disorders, myocardial infarction

Long-term treatment: Risk of osteoporosis, myopathy, delayed wound healing

Minimal mineralocorticoid activity

Use in septic shock or sepsis syndrome not proven effective and may increase mortality in some patients including patients with elevated serum creatinine and patients who develop secondary infections

Clearance of metabolic-endocrine#corticosteroids may increase in hyperthyroid patients and decrease in hypothyroid ones; dose adjustments may be necessary

Patients receiving metabolic-endocrine#corticosteroids should avoid chickenpox or measles-infected persons if unvaccinated

Latent tuberculosis may be reactivated (patients with positive tuberculin test should be monitored)

Some suggestion (not fully substantiated) of slightly increased cleft palate risk if metabolic-endocrine#corticosteroids are used in pregnancy

May cause hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing syndrome, or hyperglycemia

Prolonged corticosteroid use may result in elevated IOP, glaucoma, or cataracts

Killed or inactivated vaccines may be administered; however, the response to such vaccines cannot be predicted

Immunization procedures may be undertaken in patients who are receiving metabolic-endocrine#corticosteroids as replacement therapy in physiologic doses (eg, for Addison’s disease)

Injection may result in dermal and/or subdermal changes forming depressions in the skin at injection site; to minimize incidence of dermal and subdermal atrophy, care must be exercised not to exceed recommended doses in injections; avoid injection into deltoid muscle due to high incidence of subcutaneous atrophy

Increased dosage of rapidly acting metabolic-endocrine#corticosteroids indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation

Not for use in the treatment of traumatic brain injury

Average and large doses of metabolic-endocrine#corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium; dietary salt restriction and potassium supplementation may be necessary; all metabolic-endocrine#corticosteroids increase calcium excretion

Drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage; relative insufficiency may persist for months after discontinuation of therapy; therefore, in situation of stress occurring during that period, hormone therapy should be reinstituted

Rarely, high doses of cyclically pulsed intravenous methylprednisolone (usually for the treatment of exacerbations of multiple sclerosis at doses of 1 g/day) can induce a toxic form of acute hepatitis; discontinue therapy if it occurs; since recurrence has occurred after re-challenge, avoid use in patients with a history of toxic hepatitis caused by methylprednisolone

With increasing doses of metabolic-endocrine#corticosteroids, the rate of occurrence of infectious complications increases; metabolic-endocrine#corticosteroids may also mask some signs of current infection; metabolic-endocrine#corticosteroids may exacerbate systemic fungal infections and should not be used in presence of such infections unless needed to control drug reactions; latent amebiasis or active amebiasis should be ruled out before initiating corticosteroid therapy patients who have spent time in tropics or patients with unexplained diarrhea

Lowest possible dose should be used to control condition under treatment; when reduction in dosage possible, reduction should be gradual

Risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used

Kaposi’s sarcoma reported in patients receiving corticosteroid therapy, most often for chronic conditions; discontinuation of therapy may result in clinical improvement

Although controlled clinical trials have shown metabolic-endocrine#corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not affect the ultimate outcome or natural history of the disease

Psychic derangements may appear when metabolic-endocrine#corticosteroids used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations; also, existing emotional instability or psychotic tendencies may be aggravated by metabolic-endocrine#corticosteroids

Give consideration to potential for hypersensitivity reactions to cow’s milk ingredients in Solumedrol; if appropriate, stop administration of injection solution Solumedrol and treat patient’s condition accordingly; alternative treatments, including use of corticosteroid formulations that do not contain ingredients produced from cow’s milk, should be considered for acute allergy management

Increased incidence of scleroderma reported in patients with systemic sclerosis; use caution

Pediatric patients

• As in adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis
• Pediatric patients treated with metabolic-endocrine#corticosteroids by any route, including systemically administered metabolic-endocrine#corticosteroids, may experience a decrease in growth velocity; this negative impact of metabolic-endocrine#corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression (ie, cosyntropin stimulation and basal cortisol plasma levels)
• Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function
• The linear growth of pediatric patients treated with metabolic-endocrine#corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives; in order to minimize the potential growth effects of metabolic-endocrine#corticosteroids, pediatric patients should be titrated to the lowest effective dose
• Hypertrophic cardiomyopathy was reported after administration of hydrocortisone to prematurely born infants, therefore appropriate diagnostic evaluation and monitoring of cardiac function and structure should be performed

Epidural injection

• Serious neurologic events, some resulting in death, have been reported with epidural injection
• Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke
• These serious neurologic events have been reported with and without use of fluoroscopy
• Safety and effectiveness of epidural administration of metabolic-endocrine#corticosteroids have not been established, and metabolic-endocrine#corticosteroids are not approved for this use

Methylprednisolone preserved with benzyl alcohol

• Methylprednisolone preserved with benzyl alcohol should not be administered to neonates, infants, pregnant women, or breastfeeding women
• Benzyl alcohol is associated with serious adverse events and death, particularly in pediatric patients (gasping syndrome, characterized by CNS depression, metabolic acidosis, and gasping respirations)

Pregnancy & Lactation

Pregnancy category: C

Lactation: Drug enters milk; use with caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Pharmacology

Mechanism of Action

Potent glucocorticoid with minimal to no mineralocorticoid activity

Modulates carbohydrate, protein, and lipid metabolism and maintenance of fluid and electrolyte homeostasis

Controls or prevents inflammation by controlling rate of protein synthesis, suppressing migration of polymorphonuclear leukocytes (PMNs) and fibroblasts, reversing capillary permeability, and stabilizing lysosomes at cellular level

Absorption

Onset: PO: 1-2 hr; IV (Succinate): within 1 hr; Intra-articular (acetate): 1 week; IM (succinate): Rapid absorption

Duration (intra-articular): Slow absorption from intra-articular site; may continue 1 week

Peak plasma time: PO: 2.1 ± 0.7 hr; IV (succinate): 0.8 hr

Distribution

Vd: IV (succinate): 24 L ± 6 L

Metabolism

Extensively metabolized in liver

Elimination

Half-life (adults): Oral: 2.5 ± 1.2 hr; IV (succinate): 0.25 ± 0.1 hr

Dialyzable: Hemodialysis, slightly

Excretion: Urine (mainly, as metabolites), feces (minimally)

Administration

IV Compatibilities

Solution: D5/0.5 NS, D5/NS, D5W, LR, NS

Additive: Chloramphenicol sodium succinate, cimetidine, clindamycin, dopamine, granisetron, heparin, norepinephrine, penicillin G potassium, ranitidine, theophylline, verapamil

Syringe: Diatrizoate meglumine, diatrizoate meglumin/diatrizoate sodium, granisetron, iohexol, iopamidol, iothalamate meglumine, ioxalate meglumine/ioxalate sodium, metoclopramide

Y-site (partial list): Acyclovir, amifostine, amiodarone, cisplatin, dopamine, enalaprilat, famotidine, heparin, inamrinone, linezolid, meperidine, metronidazole, midazolam, morphine, sodium bicarbonate

IV Incompatibilities

Additive: Aminophylline(?), calcium gluconate, cytarabine(?), glycopyrrolate, metaraminol, nafcillin, penicillin G sodium

Y-site: Allopurinol, amsacrine, ciprofloxacin, cisatracurium(?), diltiazem(?), etoposide phosphate, fenoldopam, filgrastim, gemcitabine, heparin/hydrocortisone(?), ondansetron, paclitaxel, potassium chloride(?), propofol, sargramostim, vinorelbine, vitamins B and C(?)

IV/IM Preparation

Reconstitute for IM/IV injection with BWI containing 0.9% benzyl alcohol

IV Administration

Inject directly into vein or into tubing of running IV

Injection: Administer over at least 1 minute

Infusion: Further dilute reconstituted mixture with D5W, NS, D5/NS, or other compatible solution

Push: Administer over 10-20 minutes

Images

BRAND	FORM.	UNIT PRICE	PILL IMAGE
Methylpred DP oral

Copyright © 2010 First DataBank, Inc.

Patient Handout

Patient Education
methylprednisolone oral

COMMON BRAND NAME(S): Medrol

USES: Methylprednisolone is used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/kidney/intestinal/lung diseases, and immune system disorders. It decreases your immune system’s response to various diseases to reduce symptoms such as swelling, pain, and allergic-type reactions. This medication is a corticosteroid hormone.Methylprednisolone may also be used with other medications in hormone disorders.

HOW TO USE: Take this medication by mouth as directed by your doctor, usually with food or milk. Follow your dosing instructions carefully. The dosage and length of treatment are based on your medical condition and response to treatment. Different dosing schedules exist for this medication. If you are not taking the same dose each day or if you take this medication every other day, it may help to mark your calendar with a reminder. Consult your doctor or pharmacist if you have any questions.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.If you suddenly stop using this medication, you may have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used methylprednisolone for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal. See also Precautions section.Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Nausea, vomiting, heartburn, headache, dizziness, trouble sleeping, appetite changes, increased sweating, or acne may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn’t go away, fever, chills, cough, white patches in the mouth).Tell your doctor right away if you have any serious side effects, including: unusual weight gain, menstrual period changes, bone/joint pain, easy bruising/bleeding, mental/mood changes (such as mood swings, depression, agitation), muscle weakness/pain, puffy face, slow wound healing, swelling of the ankles/feet/hands, thinning skin, unusual hair/skin growth, vision problems, fast/slow/irregular heartbeat, symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds).Get medical help right away if you have any very serious side effects, including: seizures.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking methylprednisolone, tell your doctor or pharmacist if you are allergic to it; or to prednisone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, blood clots, brittle bones (osteoporosis), diabetes, eye diseases (such as cataracts, glaucoma, herpes infection of the eye), heart problems (such as recent heart attack, congestive heart failure), high blood pressure, current/past infections (such as those caused by tuberculosis, threadworm, herpes, fungus), kidney disease, liver disease, mental/mood conditions (such as psychosis, depression, anxiety), stomach/intestinal problems (such as diverticulitis, ulcer, ulcerative colitis), seizures.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis).This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Consult your doctor or pharmacist for more information.Methylprednisolone can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using methylprednisolone before having any immunizations, vaccinations, or skin tests. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication. See also Medical Alert section.Older adults may be more sensitive to the side effects of this drug, especially bone loss/pain, stomach/intestinal bleeding, and mental/mood changes (such as confusion).This medication may slow down a child’s growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child’s height and growth can be checked.During pregnancy, this medication should be used only when clearly needed. It may rarely harm an unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for a long time may have hormone problems. Tell your doctor right away if you notice symptoms such as nausea/vomiting that doesn’t stop, severe diarrhea, or weakness in your newborn.This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.Some products that may interact with this drug include: aldesleukin, mifepristone, other drugs that can also cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, “blood thinners” such as warfarin/dabigatran, NSAIDs such as ibuprofen, celecoxib, aspirin, salicylates).If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.Other medications can affect the removal of methylprednisolone from your body, which may affect how methylprednisolone works. Examples include azole antifungals (such as ketoconazole), cyclosporine, estrogens, HIV protease inhibitors (such as darunavir), macrolide antibiotics (such as erythromycin), ritonavir, St. John’s wort, some drugs used to treat seizures (such as phenytoin, phenobarbital), among others.This medication may interfere with certain laboratory tests (such as skin tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.If this medication is used for a long time, lab and/or medical tests (such as blood sugar/mineral levels, blood pressure, eye exams, bone density tests, height/weight measurements) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.Taking this medication for a long time may cause brittle bones (osteoporosis). Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, getting enough calcium and vitamin D, and limiting alcohol. Consult your doctor for specific advice.

MISSED DOSE: If you are taking this medication once daily and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.If you do not take the same dose each day or if you take this medication every other day, ask your doctor or pharmacist what you should do if you miss a dose.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised March 2023. Copyright(c) 2023 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Medrol Prescribing Information

Medically reviewed by Drugs.com. Last updated on Nov 1, 2022.

On This Page

• Description
• Indications and Usage
• Contraindications
• Warnings
• Precautions
• Drug Interactions
• Patient Counseling Information
• Adverse Reactions/Side Effects
• Dosage and Administration
• How Supplied/Storage and Handling
• References

Medrol Description

Medrol Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water.

The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. The structural formula is represented below:

Each Medrol Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone.

16 mg and 32 mg

ACTIONS

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.

Related/similar drugs

Indications and Usage for Medrol

Medrol Tablets are indicated in the following conditions:

1. Endocrine Disorders

Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).

Congenital adrenal hyperplasia

Hypercalcemia associated with cancer

2. Rheumatic Disorders

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)

Acute and subacute bursitis

Synovitis of osteoarthritis

Acute nonspecific tenosynovitis

Acute gouty arthritis

3. Collagen Diseases

During an exacerbation or as maintenance therapy in selected cases of:

Systemic lupus erythematosus

Systemic dermatomyositis (polymyositis)

Acute rheumatic carditis

4. Dermatologic Diseases

Bullous dermatitis herpetiformis

Severe erythema multiforme

Severe seborrheic dermatitis

5. Allergic States

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:

Seasonal or perennial allergic rhinitis

Drug hypersensitivity reactions

6. Ophthalmic Diseases

Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:

Allergic corneal marginal ulcers

Herpes zoster ophthalmicus

Anterior segment inflammation

Diffuse posterior uveitis and choroiditis

Iritis and iridocyclitis

7. Respiratory Diseases

Loeffler’s syndrome not manageable by other means

Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy

8. Hematologic Disorders

Idiopathic thrombocytopenic purpura in adults

Secondary thrombocytopenia in adults

Acquired (autoimmune) hemolytic anemia

Erythroblastopenia (RBC anemia)

Congenital (erythroid) hypoplastic anemia

9. Neoplastic Diseases

For palliative management of:

Leukemias and lymphomas in adults

Acute leukemia of childhood

10. Edematous States

To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

11. Gastrointestinal Diseases

To tide the patient over a critical period of the disease in:

12. Nervous System

Acute exacerbations of multiple sclerosis

13. Miscellaneous

Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.

Trichinosis with neurologic or myocardial involvement.

Contraindications

Systemic fungal infections and known hypersensitivity to components.

Warnings

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.

Corticosteroids may mask some signs of infection, and new infections may appear during their use. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1

These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 There may be decreased resistance and inability to localize infection when corticosteroids are used.

Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Usage in pregnancy

Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of child-bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism.

Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids.

The use of Medrol Tablets in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed, to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents may be considered. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Precautions

General Precautions

Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.

The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Caution is required in patients with systemic sclerosis because an increased incidence of scleroderma renal crisis has been observed with corticosteroids, including methylprednisolone.

Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.

Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION.)

Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

DRUG INTERACTIONS

The pharmacokinetic interactions listed below are potentially clinically important. Mutual inhibition of metabolism occurs with concurrent use of cyclosporin and methylprednisolone; therefore, it is possible that adverse events associated with the individual use of either drug may be more apt to occur. Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of methylprednisolone and may require increases in methylprednisolone dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of methylprednisolone and thus decrease its clearance. Therefore, the dose of methylprednisolone should be titrated to avoid steroid toxicity.

Methylprednisolone may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when methylprednisolone is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia.

The effect of methylprednisolone on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulant when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

Information for the Patient

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Adverse Reactions

Fluid and Electrolyte Disturbances

• Sodium retention • Congestive heart failure in susceptible patients • Hypertension • Fluid retention • Potassium loss • Hypokalemic alkalosis

• Muscle weakness • Loss of muscle mass • Steroid myopathy • Osteoporosis • Tendon rupture, particularly of the Achilles tendon • Vertebral compression fractures • Aseptic necrosis of femoral and humeral heads • Pathologic fracture of long bones

• Peptic ulcer with possible perforation and hemorrhage • Pancreatitis • Abdominal distention • Ulcerative esophagitis

Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

• Impaired wound healing • Petechiae and ecchymoses • May suppress reactions to skin tests • Thin fragile skin • Facial erythema • Increased sweating

• Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment • Convulsions • Vertigo • Headache

• Development of Cushingoid state • Suppression of growth in children • Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness • Menstrual irregularities • Decreased carbohydrate tolerance • Manifestations of latent diabetes mellitus • Increased requirements of insulin or oral hypoglycemic agents in diabetics

• Posterior subcapsular cataracts • Increased intraocular pressure • Glaucoma • Exophthalmos

• Negative nitrogen balance due to protein catabolism

The following additional reactions have been reported following oral as well as parenteral therapy: Urticaria and other allergic, anaphylactic or hypersensitivity reactions.

Medrol Dosage and Administration

The initial dosage of Medrol Tablets may vary from 4 mg to 48 mg of methylprednisolone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Medrol should be discontinued and the patient transferred to other appropriate therapy.

IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT . After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Medrol for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Multiple Sclerosis

In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).

ADT® (Alternate Day Therapy)

Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.

The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for reestablishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.

A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenal cortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenal cortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.

The diurnal rhythm of the HPA axis is lost in Cushing’s disease, a syndrome of adrenal cortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.

During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every six hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenal cortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenal cortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.

The following should be kept in mind when considering alternate day therapy:

• Basic principles and indications for corticosteroid therapy should apply. The benefits of ADT should not encourage the indiscriminate use of steroids. • ADT is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. • In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with ADT. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended.
Once control has been established, two courses are available: (a) change to ADT and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. • Because of the advantages of ADT, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (eg, patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on ADT may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. • As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (eg, dexamethasone and betamethasone). • The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). • In using ADT it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of ADT will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the offsteroid day. Other symptomatic therapy may be added or increased at this time if needed. • In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be reinstituted. • Although many of the undesirable features of corticosteroid therapy can be minimized by ADT, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.

How is Medrol Supplied

Medrol Tablets are available in the following strengths and package sizes:

2 mg (white, elliptical, scored, imprinted Medrol 2)

Bottles of 100 NDC 0009-0020-01

4 mg (white, elliptical, scored, imprinted Medrol 4)

Bottles of 100 NDC 0009-0056-02

DOSEPAK ™ Unit of Use (21 tablets) NDC 0009-0056-04

8 mg (white, elliptical, scored, imprinted Medrol 8)

Bottles of 25 NDC 0009-0022-01

16 mg (white, elliptical, scored, imprinted Medrol 16)

Bottles of 50 NDC 0009-0073-01

32 mg (white, elliptical, scored, imprinted Medrol 32)

Bottles of 25 NDC 0009-0176-01

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

REFERENCES

1 Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases . Philadelphia: WBSaunders Company 1992:1050–1.

2 Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954–63.

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com.

LAB-0157-8.0
Revised January 2019

PRINCIPAL DISPLAY PANEL – 4 mg Tablet Bottle Label

Medrol ®
methylprednisolone
tablets, USP

100 Tablets
Rx only

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Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL – 4 mg Tablet Dose Pack

DAY 1
Before Breakfast
Before Breakfast
After Lunch
After Dinner
At Bedtime
At Bedtime

DAY 2
Before Breakfast
After Lunch
After Dinner
At Bedtime
At Bedtime

DAY 3
Before Breakfast
After Lunch
After Dinner
At Bedtime

DAY 4
Before Breakfast
After Lunch
At Bedtime

DAY 5
Before Breakfast
At Bedtime

DAY 6
Before Breakfast

Medrol ® Dosepak™
(methylprednisolone) tablets, USP
4 mg

Distributed by Pharmacia & Upjohn Co.
Division of Pfizer Inc, NY, NY 10017

Unless otherwise directed by your physician, all six (6)
tablets in the row labeled DAY 1 should be taken the day
you receive your prescription, even though you may not
receive it until late in the day.

All six (6) tablets may be taken immediately as a single
dose, or may be divided into two or three doses and taken
at intervals between the time you receive the medicine and
your regular bedtime.

Package Not Child-Resistant.
Keep Out of Reach of Children.

LOT: XXXXXXX
EXP: YYYY MMM

PRINCIPAL DISPLAY PANEL – 4 mg Tablet Dose Pack Carton

Medrol ® Dosepak™ 4 mg
(methylprednisolone) tablets, USP

One blister containing 21 tablets

PRINCIPAL DISPLAY PANEL – 8 mg Tablet Bottle Label

Medrol ®
methylprednisolone
tablets, USP

25 Tablets
Rx only

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Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL – 16 mg Tablet Bottle Label

Medrol ®
methylprednisolone
tablets, USP

50 Tablets
Rx only

Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL – 32 mg Tablet Bottle Label

Medrol ®
methylprednisolone
tablets, USP

25 Tablets
Rx only

Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL – 2 mg Tablet Bottle Label

Medrol ®
methylprednisolone
tablets, USP

100 Tablets
Rx only

Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:0009-0049
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYLPREDNISOLONE (METHYLPREDNISOLONE)	METHYLPREDNISOLONE	2 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM STEARATE
STARCH, CORN
LACTOSE, UNSPECIFIED FORM
MINERAL OIL
SORBIC ACID
SUCROSE
FD&C RED NO. 3

Product Characteristics
Color	PINK	Score	4 pieces
Shape	OVAL	Size	8mm
Flavor	Imprint Code	Medrol;2
Contains

Packaging
#	Item Code	Package Description
1	NDC:0009-0049-02	100 TABLET in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA011153	10/24/1957	05/24/2015

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:0009-0056
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYLPREDNISOLONE (METHYLPREDNISOLONE)	METHYLPREDNISOLONE	4 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM STEARATE
STARCH, CORN
LACTOSE, UNSPECIFIED FORM
SUCROSE

Product Characteristics
Color	WHITE	Score	4 pieces
Shape	OVAL	Size	8mm
Flavor	Imprint Code	Medrol;4
Contains

Packaging
#	Item Code	Package Description
1	NDC:0009-0056-02	100 TABLET in 1 BOTTLE
2	NDC:0009-0056-04	1 DOSE PACK in 1 CARTON
2	21 TABLET in 1 DOSE PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA011153	10/24/1957

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:0009-0022
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYLPREDNISOLONE (METHYLPREDNISOLONE)	METHYLPREDNISOLONE	8 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM STEARATE
STARCH, CORN
LACTOSE, UNSPECIFIED FORM
SUCROSE

Product Characteristics
Color	WHITE	Score	4 pieces
Shape	OVAL	Size	9mm
Flavor	Imprint Code	Medrol;8
Contains

Packaging
#	Item Code	Package Description
1	NDC:0009-0022-01	25 TABLET in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA011153	10/24/1957

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:0009-0073
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYLPREDNISOLONE (METHYLPREDNISOLONE)	METHYLPREDNISOLONE	16 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM STEARATE
STARCH, CORN
LACTOSE, UNSPECIFIED FORM
MINERAL OIL
SUCROSE

Product Characteristics
Color	WHITE	Score	4 pieces
Shape	OVAL	Size	10mm
Flavor	Imprint Code	Medrol;16
Contains

Packaging
#	Item Code	Package Description
1	NDC:0009-0073-01	50 TABLET in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA011153	10/24/1957

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:0009-0176
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYLPREDNISOLONE (METHYLPREDNISOLONE)	METHYLPREDNISOLONE	32 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM STEARATE
STARCH, CORN
LACTOSE, UNSPECIFIED FORM
MINERAL OIL
SUCROSE

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL	Size	12mm
Flavor	Imprint Code	Medrol;32
Contains

Packaging
#	Item Code	Package Description
1	NDC:0009-0176-01	25 TABLET in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA011153	10/24/1957

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:0009-0020
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYLPREDNISOLONE (METHYLPREDNISOLONE)	METHYLPREDNISOLONE	2 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM STEARATE
STARCH, CORN
LACTOSE, UNSPECIFIED FORM
MINERAL OIL
SORBIC ACID
SUCROSE

Product Characteristics
Color	WHITE	Score	4 pieces
Shape	OVAL	Size	8mm
Flavor	Imprint Code	Medrol;2
Contains

Packaging
#	Item Code	Package Description
1	NDC:0009-0020-01	100 TABLET in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA011153	09/20/2013

Labeler – Pharmacia & Upjohn Company LLC (618054084)

Establishment
Name	Address	ID/FEI	Operations
Pharmacia & Upjohn Company LLC	618054084	API MANUFACTURE(0009-0049, 0009-0056, 0009-0022, 0009-0073, 0009-0176, 0009-0020), ANALYSIS(0009-0049, 0009-0056, 0009-0022, 0009-0073, 0009-0176, 0009-0020)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Italia S.r.l.	458521908	ANALYSIS(0009-0049, 0009-0056, 0009-0022, 0009-0073, 0009-0176, 0009-0020), MANUFACTURE(0009-0049, 0009-0056, 0009-0022, 0009-0073, 0009-0176, 0009-0020), PACK(0009-0049, 0009-0056, 0009-0022, 0009-0073, 0009-0176, 0009-0020), LABEL(0009-0049, 0009-0056, 0009-0022, 0009-0073, 0009-0176, 0009-0020)

Pharmacia & Upjohn Company LLC

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