methylprednisolone (Rx)

Brand and Other Names:Medrol, Medrol Dosepak, more...DepoMedrol, SoluMedrol
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 2mg
  • 4mg
  • 8mg
  • 16mg
  • 32mg

injectable suspension

  • 20mg/mL
  • 40mg/mL
  • 80mg/mL

powder for injection

  • 40mg
  • 125mg
  • 500mg
  • 1g
  • 2g
more...

Allergic Conditions

Day 1: 8 mg PO before breakfast, 4 mg after lunch and after dinner, and 8 mg at bedtime

Day 2: 4 mg PO before breakfast, after lunch, and after dinner and 8 mg at bedtime

Day 3: 4 mg PO before breakfast, after lunch, after dinner, and at bedtime

Day 4: 4 mg PO before breakfast, after lunch, and at bedtime

Day 5: 4 mg PO before breakfast and at bedtime

Day 6: 4 mg PO before breakfast

May be tapered over 12 days (to decrease chance of dermatitis flareup)

Acute Exacerbations of Multiple Sclerosis

160 mg IV once daily for 1 week, then 64 mg IV every other day for 1 month

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

  • 2mg
  • 4mg
  • 8mg
  • 16mg
  • 32mg

injectable suspension

  • 20mg/mL
  • 40mg/mL
  • 80mg/mL

powder for injection

  • 40mg
  • 125mg
  • 500mg
  • 1g
  • 2g
more...

Inflammation

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

Status Asthmaticus

<12 years: 1-2 mg/kg IV/IM in 2 divided doses until peak expiratory flow is 70% of predicted or personal best; not to exceed 60 mg/day  

>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

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Interactions

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            Adverse Effects

            Frequency Not Defined

            Acne

            Adrenal suppression

            Amenorrhea

            Delayed wound healing

            Delirium

            Diabetes mellitus

            Edema

            Emotional instability

            Erythema

            Fluid retention

            GI perforation

            Glucose intolerance

            Growth suppression (children)

            Hallucinations

            Headache

            Hepatomegaly

            Hepatitis

            Hypokalemic alkalosis

            Increased transaminases

            Insomnia

            Leukocytosis

            Menstrual irregularity

            Myopathy

            Neuritis

            Osteoporosis

            Peptic ulcer

            Perianal pruritus

            Pituitary adrenal axis suppression

            Protein catabolism

            Pseudotumor cerebri (on withdrawal)

            Psychosis

            Sodium and water retention

            Seizure

            Tachycardia

            Ulcerative esophagitis

            Urticaria

            Vasculitis

            Vertigo

            Weight gain

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            Warnings

            Contraindications

            Untreated serious infections

            Documented hypersensitivity

            Intrathecal administration

            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 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 corticosteroids may increase in hyperthyroid patients and decrease in hypothyroid ones; dose adjustments may be necessary

            Patients receiving 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 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 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 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 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 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 corticosteroids, the rate of occurrence of infectious complications increases; corticosteroids may also mask some signs of current infection; 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 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 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 corticosteroids

            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 corticosteroids have not been established, and 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)
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            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.

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            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: 1-2 hr (PO); 4-8 days (IM); 1 week (intra-articular)

            Duration: 30-36 hr (PO); 1-4 weeks (IM)

            Peak plasma time: 31 min (IV)

            Distribution

            Vd: 0.7-1.5 L/kg

            Metabolism

            Extensively metabolized in liver

            Elimination

            Half-life: 3-3.5 hr

            Dialyzable: Hemodialysis, slightly

            Total body clearance: 16-21 L/hr

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

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            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

            Syringe: Doxapram

            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

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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