Methylprednisolone: Drug information
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(For additional information see "Methylprednisolone: Patient drug information" and see "Methylprednisolone: Pediatric drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)
Special Alerts
SOLU-MEDROL ACT-O-VIAL 40 mg Safety Information September 2017

Health Canada is alerting that severe hypersensitivity reactions in patients hypersensitive to milk following the use of Pfizer Canada's SOLU-MEDROL ACT-O-VIAL (methylprednisolone sodium succinate for injection) 40 mg have been internationally reported in the postmarketing setting. SOLU-MEDROL ACT-O-VIAL 40 mg, the only SOLU-MEDROL formulation available in Canada containing bovine-sourced lactose as an excipient, is contraindicated in patients with a known or suspected hypersensitivity to cow's milk. Alternative treatments, including corticosteroid formulations that do not contain bovine-sourced ingredients, should be considered for acute allergy management in patients allergic to cow's milk proteins due to the potential for SOLU-MEDROL ACT-O-VIAL 40 mg to exacerbate the condition.

The Canadian Product Monograph has been updated to reflect this new safety information. Further information may be found at http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2017/64350a-eng.php.

Brand Names: US
  • DEPO-Medrol;
  • Medrol;
  • P-Care D40;
  • P-Care D80;
  • ReadySharp Methylprednisolone;
  • SOLU-medrol
Brand Names: Canada
  • Depo-Medrol;
  • Medrol;
  • Methylprednisolone Acetate;
  • Methylprednisolone Sodium Succinate For Injection;
  • Methylprednisolone Sodium Succinate For Injection USP;
  • Solu-Medrol
Pharmacologic Category
  • Corticosteroid, Systemic
Dosing: Adult

The lowest possible dose should be used to control the condition; when dose reduction is possible, the dose should be reduced gradually. Only sodium succinate salt may be given IV.

Allergic conditions: Oral: Tapered-dosage schedule (eg, dose-pack containing 21 x 4 mg tablets):

Day 1: 24 mg on day 1 administered as 8 mg (2 tablets) before breakfast, 4 mg (1 tablet) after lunch, 4 mg (1 tablet) after supper, and 8 mg (2 tablets) at bedtime OR 24 mg (6 tablets) as a single dose or divided into 2 or 3 doses upon initiation (regardless of time of day)

Day 2: 20 mg on day 2 administered as 4 mg (1 tablet) before breakfast, 4 mg (1 tablet) after lunch, 4 mg (1 tablet) after supper, and 8 mg (2 tablets) at bedtime

Day 3: 16 mg on day 3 administered as 4 mg (1 tablet) before breakfast, 4 mg (1 tablet) after lunch, 4 mg (1 tablet) after supper, and 4 mg (1 tablet) at bedtime

Day 4: 12 mg on day 4 administered as 4 mg (1 tablet) before breakfast, 4 mg (1 tablet) after lunch, and 4 mg (1 tablet) at bedtime

Day 5: 8 mg on day 5 administered as 4 mg (1 tablet) before breakfast and 4 mg (1 tablet) at bedtime

Day 6: 4 mg on day 6 administered as 4 mg (1 tablet) before breakfast

Anti-inflammatory or immunosuppressive: Note: Initial dosage depends upon condition being treated; adjust subsequent doses based on patient response.

Oral: 4 to 48 mg/day in 1 to 4 divided doses initially, followed by gradual reduction in dosage to the lowest possible level consistent with maintaining an adequate clinical response.

IM (succinate): 10 to 40 mg/day initially

IM (acetate): 4 to 120 mg single dose; repeated injections may be necessary for recurrent or chronic conditions.

IV (succinate): 10 to 40 mg over a period of several minutes and repeated IV or IM at intervals depending on clinical response; when high dosages are needed, administer 30 mg/kg over a period ≥30 minutes and may be repeated every 4 to 6 hours for 48 hours.

Intralesional (acetate): 20 to 60 mg; for large lesions, it may be necessary to distribute doses ranging from 20 to 40 mg by repeated local injections; 1 to 4 injections are usually employed with intervals between injections varying with the type of lesion being treated and clinical response.

Soft tissue (acetate): 4 to 30 mg; repeated injections may be necessary for recurrent or chronic conditions.

Arthritis: Intra-articular (acetate): Administer every 1 to 5 weeks.

Large joints (eg, knee, ankle, shoulder): 20 to 80 mg

Medium joints (eg, elbow, wrist): 10 to 40 mg

Small joints (eg, metacarpophalangeal, interphalangeal, sternoclavicular, acromioclavicular): 4 to 10 mg

Asthma, exacerbations:

Acute, short-course “burst” (NAEPP 2007):

Oral: 40 to 60 mg/day in divided doses once or twice daily for 3 to 10 days; Note: Burst should be continued until symptoms resolve and peak expiratory flow is at least 80% of personal best; usually requires 3 to 10 days of treatment; longer treatment may be required.

IM (acetate): 240 mg as a one-time dose; Note: This may be given in place of short-course “burst” of oral steroids in patients who are vomiting or if compliance is a problem.

Hospital/emergency medical care doses: 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.

Asthma, long-term (maintenance) (NAEPP 2007): Oral: 7.5 to 60 mg once daily in the morning or every other day as needed for asthma control

Multiple sclerosis, acute exacerbation:

Note: Treatment guidelines recommend high-dose IV methylprednisolone succinate or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011]); NICE 2014).

Manufacturer’s labeling: Oral, IV (succinate only), IM (acetate or succinate): 160 mg daily for 1 week, followed by 64 mg every other day for 1 month.

Off-label dosing:

Oral: 500 mg daily for 5 days (NICE 2014).

IV (succinate only): 1,000 mg daily for 3 to 7 days (AAN [Scott 2011]; NICE 2014).

Bronchiolitis obliterans syndrome, prevention (off-label use): IV (sodium succinate): 1000 mg daily for 3 days. Note: Many centers use 10 to 15 mg/kg/day for smaller patients (Meyer 2014).

Cadaveric organ recovery (hormonal resuscitation) (off-label use): IV (sodium succinate): 15 mg/kg or 2,000 mg bolus administered to the brain-dead donor who is hemodynamically unstable requiring significant vasopressor support; give concomitantly with vasopressin, levothyroxine or liothyronine (preferred), dextrose (if bolus dose insulin used), and regular insulin (bolus dose or continuous infusion). If continuous infusion insulin is employed, maintain blood glucose 120 to 180 mg/dL (Rosendale 2003a; Rosendale 2003b; Rosengard 2002; Salim 2007; Zaroff 2002).

Cardiac transplant: Acute cellular rejection (treatment) or antibody-mediated rejection (treatment) (off-label use): IV (sodium succinate): 250 to 1,000 mg daily for 3 days (AHA [Colvin 2015]; ISHLT [Costanzo 2010]).

COPD exacerbation (off-label use): Note: Dose, frequency, and duration of therapy not established. GOLD guidelines recommend the use of oral prednisone; however, methylprednisolone may be used as an alternative (GOLD [Decramer 2014]). No comparative studies exist to examine safety and efficacy between low-, medium-, or high-dose regimens. While several clinical trials have examined the use of methylprednisolone in this setting, these trials included low numbers of patients, employed vastly different regimens, and/or examined different clinical outcomes (Albert 1980; Alía 2011; Niewoehner 1999; Sayiner 2001; Shortall 2002; Vrondracek 2006; Willaert 2002). Current dosing strategies are empiric and have not been established by clinical trials. Based on expert opinion, commonly used regimens ranging from 60 to 125 mg IV administered 1 to 4 times daily followed by oral therapy (eg, prednisone 40 mg once daily) for a total of 5 to 14 days of therapy may be employed; the shorter duration (ie, 5 days) may be preferred (Leuppi 2013); however, comparative prospective data does not exist. IV administration with a higher dose (eg, ≥60 mg) may be preferred for those patients with impending or actual acute respiratory failure; outcome trials not available for this approach.

Dermatomyositis/polymyositis (off-label dosing): IV (succinate): 1,000 mg daily for 3 to 5 days for severe muscle weakness, followed by conversion to oral prednisone (Drake 1996)

Gout, acute (off-label dosing): IV (succinate), IM: Initial: 0.5 to 2 mg/kg; may be repeated as clinically indicated (ACR guidelines [Khanna 2012])

Lupus nephritis (off-label dosing): High-dose “pulse” therapy: IV (succinate): 0.5 to 1 g/day for 3 days (Ponticelli 2010)

Pneumocystis pneumonia in AIDS patients (off-label use): IV (succinate): 30 mg twice daily on days 1 to 5, then 30 mg once daily on days 6 to 10, then 15 mg once daily on days 11 to 21 (CDC 2009a).

Spinal cord injury, acute (off-label use): IV (succinate): 30 mg/kg over 15 minutes followed in 45 minutes by a continuous infusion of 5.4 mg/kg/hour for 23 hours; Note: Due to insufficient evidence of clinical efficacy (ie, 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 in this setting, methylprednisolone should not be initiated >8 hours after the injury; not effective in penetrating trauma (eg, gunshot) (Consortium for Spinal Cord Medicine 2008).

Dosing: Pediatric

(For additional information see "Methylprednisolone: Pediatric drug information")

The lowest possible dose should be used to control the condition; when dose reduction is possible, the dose should be reduced gradually. Only sodium succinate salt may be given IV.

Anti-inflammatory or immunosuppressive: Note: Initial dosage depends upon condition being treated; adjust subsequent doses based on patient response.

Infants, Children, and Adolescents: Oral, IM (acetate or succinate), IV (succinate): Initial: 0.11 to 1.6 mg/kg/day or 3.2 to 48 mg/m2/day in 3 to 4 divided doses; usual range: 0.5 to 1.7 mg/kg/day (Kliegman 2015); for oral, IM (succinate), and IV (succinate) may also administer in divided doses every 6 to 12 hours (Kliegman 2015); for IM (acetate) administer as a single daily dose

“Pulse” therapy: IV (succinate): 30 mg/kg/dose once daily for 1 to 5 days; maximum: 1,000 mg/day (Kliegman 2015)

Long-acting: IM (acetate): 4 to 80 mg every 1 to 2 weeks

Asthma, exacerbations:

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; Note: Burst should be continued until symptoms resolve or patient achieves peak expiratory flow 80% of personal best; usually requires 3 to 10 days of treatment (~5 days on average); longer treatment may be required

IM (acetate): Note: This may be given in place of short-course “burst” of oral steroids in patients who are vomiting or if compliance is a problem.

Children ≤4 years: 7.5 mg/kg as a one-time dose; maximum dose: 240 mg

Children 5 to 11 years: 240 mg as a one-time dose

Children ≥12 years and Adolescents: Oral, IM (acetate): Refer to adult dosing.

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: Refer to adult dosing

Status asthmaticus (previous NAEPP guidelines; still used by some clinicians): Children: IV: Loading dose: 2 mg/kg/dose, then 0.5 to 1 mg/kg/dose every 6 hours; Note: See NAEPP 2007 guidelines for asthma exacerbations (emergency medical care or hospital doses) listed above

Asthma, long-term treatment (maintenance) (NAEPP, 2007):

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: Refer to adult dosing

Lupus nephritis (off-label dosing): 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/day (Adams 2006; Marks 2010)

Pneumocystis pneumonia; moderate or severe infection (off-label use): Note: Initiate therapy within 72 hours of diagnosis, if possible.

Infants and Children: IV (succinate): 1 mg/kg/dose every 6 hours on days 1 to 7, then 1 mg/kg/dose twice daily on days 8 and 9, then 0.5 mg/kg/dose twice daily on days 10 and 11, and then 1 mg/kg/dose once daily on days 12 to 16 (CDC 2009)

Adolescents: IV (succinate): Refer to adult dosing

Spinal cord injury, acute (off-label use): IV (succinate): 30 mg/kg over 15 minutes, followed in 45 minutes by a continuous infusion of 5.4 mg/kg/hour for 23 hours. Note: Due to insufficient evidence of clinical efficacy (ie, 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 in this setting, methylprednisolone should not be initiated >8 hours after the injury; not effective in penetrating trauma (eg, gunshot) (Consortium for Spinal Cord Medicine 2008).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Kit, Injection, as acetate:

P-Care D40: 40 mg/mL [contains polyethylene glycol]

P-Care D80: 40 mg/mL [contains polyethylene glycol]

ReadySharp Methylprednisolone: 80 mg/mL [contains polyethylene glycol]

Solution Reconstituted, Injection, as sodium succinate [strength expressed as base]:

SOLU-medrol: 500 mg (1 ea); 1000 mg (1 ea)

SOLU-medrol: 2 g (1 ea) [contains benzyl alcohol]

Generic: 40 mg (1 ea); 125 mg (1 ea); 1000 mg (1 ea)

Solution Reconstituted, Injection, as sodium succinate [strength expressed as base, preservative free]:

SOLU-medrol: 40 mg (1 ea) [contains lactose]

SOLU-medrol: 125 mg (1 ea); 500 mg (1 ea); 1000 mg (1 ea)

Suspension, Injection, as acetate:

DEPO-Medrol: 20 mg/mL (5 mL); 40 mg/mL (5 mL, 10 mL) [contains benzyl alcohol, polyethylene glycol, polysorbate 80]

DEPO-Medrol: 40 mg/mL (1 mL) [contains polyethylene glycol]

DEPO-Medrol: 80 mg/mL (1 mL)

DEPO-Medrol: 80 mg/mL (5 mL) [contains benzyl alcohol, polyethylene glycol, polysorbate 80]

DEPO-Medrol: 80 mg/mL (1 mL) [contains polyethylene glycol]

Generic: 40 mg/mL (1 mL, 5 mL, 10 mL); 80 mg/mL (1 mL, 5 mL)

Suspension, Injection, as acetate [preservative free]:

Generic: 80 mg/mL (2 mL [DSC])

Tablet, Oral:

Medrol: 2 mg, 8 mg, 16 mg, 32 mg, 4 mg [scored]

Generic: 8 mg, 16 mg, 32 mg, 4 mg

Tablet Therapy Pack, Oral:

Medrol: 4 mg (21 ea) [scored]

Generic: 4 mg (21 ea)

Generic Equivalent Available (US)

Yes

Administration

Oral: Administer tablets after meals or with food or milk to decrease GI upset. If prescribed once daily, administer in the morning.

IM (acetate, succinate): Avoid injection into the deltoid muscle due to a high incidence of subcutaneous atrophy. Avoid injection or leakage into the dermis. Do not inject into areas that have evidence of acute local infection.

IV (succinate): Rate dependent upon dose; typically, intermittent infusion is administered over 15 to 60 minutes. Do not administer moderate- or high-dose IV push; severe adverse effects, including hypotension, cardiac arrhythmia, and sudden death, have been reported in patients receiving high-dose methylprednisolone IV push over <20 minutes (Barron 1982, Ditzian-Kadanoff 1987, Garin 1986, Liebling 1981, Lucas 1993). Do not give acetate form IV.

Low dose (eg, ≤1.8 mg/kg or ≤125 mg/dose): IV push over 3 to 15 minutes; maximum concentration: 125 mg/mL

Moderate dose (eg, ≥2 mg/kg or 250 mg/dose): Administer over 15 to 30 minutes

High dose (eg, ≥15 mg/kg or ≥500 mg/dose): Administer over 30 to 60 minutes; doses ≥1,000 mg: Administer over 60 minutes. Note: In some of the adult spinal cord injury trials, bolus doses (30 mg/kg) have been administered over 15 minutes.

Intra-articular or soft tissue (acetate): See manufacturer’s labeling for details.

Intralesional: Inject directly into the lesion. For large lesions, administer multiple small injections (20 to 40 mg) into the area of the lesion. Avoid injection of sufficient material to cause blanching because this may be followed by a small slough.

Use

Oral, IM, and IV administration:

Allergic: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in atopic dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, serum sickness, and/or transfusion reactions.

Dermatologic: Bullous dermatitis herpetiformis; contact dermatitis; exfoliative dermatitis; exfoliative erythroderma; mycosis fungoides; pemphigus; erythema multiforme (Stevens-Johnson syndrome); severe psoriasis; severe seborrheic dermatitis.

Endocrine: Congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis; primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable).

GI: To tide the patient over a critical period of the disease in Crohn disease or ulcerative colitis.

Hematologic: Acquired (autoimmune) hemolytic anemia; congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia); erythroblastopenia (RBC anemia; oral only); immune thrombocytopenia (formerly known as idiopathic thrombocytopenic purpura) (adults; oral and IV only); pure red cell aplasia (excluding oral); secondary thrombocytopenia.

Neoplastic: Palliative management of leukemias and lymphomas.

Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury (excluding oral).

Ophthalmic:

Oral: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis; allergic corneal marginal ulcers; anterior segment inflammation; chorioretinitis; diffuse posterior uveitis and choroiditis; herpes zoster ophthalmicus; iritis and iridocyclitis; keratitis; optic neuritis; sympathetic ophthalmia; uveitis.

Injection: Sympathetic ophthalmia; temporal arteritis, uveitis and other ocular inflammatory conditions unresponsive to topical corticosteroids.

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

Respiratory: Aspiration pneumonitis (oral only); asthma; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; idiopathic eosinophilic pneumonias; symptomatic sarcoidosis.

Rheumatic: As adjunctive therapy for short-term administration in acute rheumatic carditis, acute gouty arthritis, ankylosing spondylitis, dermatomyositis, polymyositis, psoriatic arthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis), systemic lupus erythematosus; as adjunctive therapy for short-term administration in acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, posttraumatic osteoarthritis, relapsing polychondritis, synovitis of osteoarthritis (oral only).

Miscellaneous: Trichinosis with neurologic or myocardial involvement; tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.

Intra-articular or soft tissue administration (methylprednisolone acetate only): As adjunctive therapy for short-term administration in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, and/or synovitis of osteoarthritis.

Intralesional administration (methylprednisolone acetate only): Alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic; infiltrated, inflammatory lesions of granuloma annulare; lichen planus; lichen simplex chronicus (neurodermatitis); psoriatic plaques; necrobiosis lipoidica diabeticorum. May be useful in cystic tumor of an aponeurosis or tendon (ganglia).

Use: Off-Label

Acute spinal cord injury; Bronchiolitis obliterans syndrome (prevention); Cadaveric organ recovery (hormonal resuscitation); Cardiac transplant: Acute cellular rejection (ACR) (treatment); Cardiac transplant: Antibody-mediated rejection (AMR) (treatment); COPD exacerbation; In-hospital cardiac arrest; Pneumocystis pneumonia (PCP) in HIV-infected patients (children); Pneumocystis pneumonia (PCP) in HIV-infected patients (adolescents and adults)

Medication Safety Issues
Sound-alike/look-alike issues:

MethylPREDNISolone may be confused with medroxyPROGESTERone, methotrexate, methylTESTOSTERone, predniSONE

DEPO-Medrol may be confused with Depo-Provera, SOLU-Medrol

Medrol may be confused with Mebaral

SOLU-Medrol may be confused with salmeterol, Solu-CORTEF

International issues:

Medrol [U.S., Canada, and multiple international markets] may be confused with Medral brand name for omeprazole [Mexico]

Adverse Reactions

Frequency not defined:

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, emotionallability, 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

<1%, postmarketing, and/or case reports: Venous thrombosis (Johannesdottir 2013)

Contraindications

Hypersensitivity to methylprednisolone or any component of the formulation; systemic fungal infection (except intra-articular injection for localized joint conditions); intrathecal administration; live or attenuated virus vaccines (with immunosuppressive doses of corticosteroids); use in premature infants (formulations containing benzyl alcohol preservative only); immune thrombocytopenia (formerly known as idiopathic thrombocytopenic purpura) (IM administration only)

Additional contraindication: Methylprednisolone sodium succinate 40 mg vial only: Hypersensitivity to cow's milk or its components or other dairy products which may contain trace amounts of milk ingredients (known or suspected).

Canadian labeling: Additional contraindications (not in US labeling):

Methylprednisolone tablets: Herpes simplex of the eye, vaccinia and varicella (except for short-term or emergency therapy)

Methylprednisolone acetate injection: Epidural or intravascular administration; intra-articular injections in unstable joints; herpes simplex of the eye, vaccinia and varicella (except for short-term or emergency therapy)

Methylprednisolone sodium succinate: Epidural administration; herpes simplex keratitis, vaccinia and varicella, arrested tuberculosis, acute psychoses, Cushing syndrome, peptic ulcer, markedly elevated serum creatinine (except for short-term or emergency therapy)

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.

• Anaphylactoid reactions: Rare cases of anaphylactoid reactions have been observed in patients receiving corticosteroids.

• Dermal changes: Avoid injection or leakage into the dermis; dermal and/or subdermal skin depression may occur at the site of injection. Avoid deltoid muscle injection; subcutaneous atrophy may occur.

• Hepatic effects: High doses of methylprednisolone IV (usually doses of 1 g/day) may induce a toxic form of acute hepatitis (rare); serious hepatic injury may occur, resulting in acute liver failure and death. Time to onset can be several weeks or longer; resolution has been observed after discontinuation of therapy. Discontinue methylprednisolone if toxic hepatitis occurs. Avoid use of high doses in patients with a history of methylprednisone-induced toxic hepatitis.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, cause activation of latent infections, mask acute infection (including fungal infections), prolong or exacerbate viral or parasitic infections, or limit response to killed or inactivated vaccines. Exposure to chickenpox or measles should be avoided; corticosteroids should not be used to treat ocular herpes simplex. Corticosteroids should not be used for cerebral malaria, fungal infections, or viral hepatitis. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only fulminating or disseminated TB in conjunction with antituberculosis treatment). Amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiation of corticosteroids. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination and fatalities have occurred.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); discontinuation may result in clinical improvement (Goedert 2002).

• Myopathy: Acute myopathy has been reported with high dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles; monitor creatine kinase; recovery may be delayed.

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including euphoria, insomnia, mood swings, personality changes, severe depression, or psychotic manifestations. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

• Septic arthritis: May occur as a complication to parenteral therapy; institute appropriate antimicrobial therapy as required.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with heart failure (HF) and/or hypertension; use has been associated with fluid retention, electrolyte disturbances, and hypertension. Use with caution following acute myocardial infarction (MI); corticosteroids have been associated with myocardial rupture.

• Diabetes: Use corticosteroids with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, ulcerative colitis, abscess or other pyogenic infection) due to perforation risk.

• Head injury: Increased mortality was observed in patients receiving high-dose IV methylprednisolone; high-dose corticosteroids should not be used for the management of head injury.

• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred especially during initial treatment with corticosteroids.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Not recommended for the treatment of optic neuritis; may increase frequency of new episodes. Use with caution in patients with a history of ocular herpes simplex; corneal perforation has occurred; do not use in active ocular herpes simplex. Consider routine eye exams in chronic users.

• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.

• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.

• Systemic sclerosis: Use with caution in patients with systemic sclerosis; an increase in scleroderma renal crisis incidence has been observed with corticosteroid use.

• Seizure disorders: Use corticosteroids with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.

• Septic shock or sepsis syndrome: A study has failed to demonstrate efficacy in septic shock or sepsis syndrome treatment; use may increase mortality in some populations (eg, patients with elevated serum creatinine, patients who develop secondary infections after use).

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.

Concurrent drug therapy issues

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use with caution in the elderly with the smallest possible effective dose for the shortest duration.

• Pediatric: May affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Methylprednisolone acetate IM injection (multiple-dose vial) and the diluent for methylprednisolone sodium succinate injection may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Discontinuation of therapy: Withdraw therapy with gradual tapering of dose.

• Epidural injection: Corticosteroids are not approved for epidural injection. Serious neurologic events (eg, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke), some resulting in death, have been reported with epidural injection of corticosteroids, with and without use of fluoroscopy.

• Stress: Patients may require higher doses when subject to stress (ie, trauma, surgery, severe infection).

Metabolism/Transport Effects

Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

(For additional information: Launch drug interactions program)

Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor therapy

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination

Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Risk C: Monitor therapy

Androgens: Corticosteroids (Systemic) may enhance the fluid-retaining effect of Androgens. Risk C: Monitor therapy

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. Risk D: Consider therapy modification

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

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. Risk D: Consider therapy modification

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. Risk D: Consider therapy modification

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Risk C: Monitor therapy

Calcitriol (Systemic): Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic). Risk C: Monitor therapy

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Risk C: Monitor therapy

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. Risk C: Monitor therapy

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). Risk C: Monitor therapy

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. Risk D: Consider therapy modification

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. Risk D: Consider therapy modification

Deferasirox: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Risk C: Monitor therapy

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. Risk D: Consider therapy modification

Desmopressin: Corticosteroids (Systemic) may enhance the hyponatremic effect of Desmopressin. Risk X: Avoid combination

DilTIAZem: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Risk D: Consider therapy modification

Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy

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). Risk D: Consider therapy modification

Fosaprepitant: May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect. Risk D: Consider therapy modification

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. Risk D: Consider therapy modification

Indacaterol: May enhance the hypokalemic effect of Corticosteroids (Systemic). Risk C: Monitor therapy

Indium 111 Capromab Pendetide: Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Risk X: Avoid combination

Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Risk C: Monitor therapy

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. Risk D: Consider therapy modification

Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy

Macimorelin: Corticosteroids (Systemic) may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination

Mifamurtide: Corticosteroids (Systemic) may diminish the therapeutic effect of Mifamurtide. Risk X: Avoid combination

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. Risk X: Avoid combination

Mitotane: May decrease the serum concentration of Corticosteroids (Systemic). Risk D: Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Risk X: Avoid combination

Neuromuscular-Blocking Agents (Nondepolarizing): May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Risk D: Consider therapy modification

Nicorandil: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Risk C: Monitor therapy

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Risk D: Consider therapy modification

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor therapy

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Risk C: Monitor therapy

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Risk X: Avoid combination

Quinolones: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Risk C: Monitor therapy

Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Risk C: Monitor therapy

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Risk D: Consider therapy modification

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. Risk C: Monitor therapy

Sargramostim: Corticosteroids (Systemic) may enhance the therapeutic effect of Sargramostim. Specifically, corticosteroids may enhance the myeloproliferative effects of sargramostim. Risk C: Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Risk C: Monitor therapy

Tacrolimus (Systemic): Corticosteroids (Systemic) may decrease the serum concentration of Tacrolimus (Systemic). Conversely, when discontinuing corticosteroid therapy, tacrolimus concentrations may increase. Risk C: Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Risk X: Avoid combination

Telaprevir: Corticosteroids (Systemic) may decrease the serum concentration of Telaprevir. Telaprevir may increase the serum concentration of Corticosteroids (Systemic). Management: Concurrent use of telaprevir and systemic corticosteroids is not recommended. When possible, consider alternatives. If used together, employ extra caution and monitor closely for excessive corticosteroid effects and diminished telaprevir effects. Risk D: Consider therapy modification

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

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). Risk D: Consider therapy modification

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. Risk D: Consider therapy modification

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy

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. Risk C: Monitor therapy

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. Risk D: Consider therapy modification

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 D: Consider therapy modification

Warfarin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Warfarin. Risk C: Monitor therapy

Pregnancy Implications

Adverse events have been observed with corticosteroids in animal reproduction studies. Methylprednisolone crosses the placenta (Anderson 1981). Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts or decreased birth weight; however, information is conflicting and may be influenced by maternal dose/indication for use (Lunghi 2010; Park-Wyllie 2000; Pradat 2003). Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor.

When systemic corticosteroids are needed in pregnancy for rheumatic disorders, it is generally recommended to use the lowest effective dose for the shortest duration of time, avoiding high doses during the first trimester (Götestam Skorpen 2016; Makol 2011; Østensen 2009).

For dermatologic disorders in pregnant women, systemic corticosteroids are generally not preferred for initial therapy; should be avoided during the first trimester; and used during the second or third trimester at the lowest effective dose (Bae 2012; Leachman 2006).

Pregnant women with poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used medications. Uncontrolled asthma is associated with an increased risk of perinatal mortality, preeclampsia, preterm birth, and low birth weight infants. Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy; however, systemic corticosteroids should be used to control acute exacerbations or treat severe persistent asthma (ACOG 2008; GINA 2016; Namazy 2016).

The National Transplantation Pregnancy Registry (NTPR) is a registry which follows pregnancies which occur in maternal transplant recipients or those fathered by male transplant recipients. The NTPR encourages reporting of pregnancies following solid organ transplant by contacting them at 877-955-6877 or [email protected]

Breast-Feeding Considerations

Methylprednisolone is present in breast milk (Cooper 2015; Strijbos 2015).

The relative infant dose (RID) of methylprednisolone is 2.8% to 5.6% when calculated using the highest breast milk concentration located and compared to a weight-adjusted infant dose of 15 to 30 mg/kg/day. In general, breastfeeding is considered acceptable when the RID is <10%; when an RID is >25% breastfeeding should generally be avoided (Anderson 2016; Ito 2000). Using the highest milk concentration (5.55 mcg/mL), the estimated daily infant dose via breast milk is 0.8325 mg/kg/day. This milk concentration was obtained following maternal administration of methylprednisolone 1,000 mg IV infused over 2 hours. The maximum milk concentration occurred 1 hour after the maternal dose and methylprednisolone was below the limits of quantification 12 hours after the dose (Cooper 2015).

The manufacturer notes that when used systemically, maternal use of corticosteroids have the potential to cause adverse events in a breastfeeding infant (eg, growth suppression, interfere with endogenous corticosteroid production) and therefore recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of treatment to the mother.

Corticosteroids are generally considered acceptable in breastfeeding women when used in usual doses (Götestam Skorpen 2016; WHO 2002); however, monitoring of the nursing infant is recommended (WHO 2002). If there is concern about exposure to the infant, some guidelines recommend waiting 4 hours after the maternal dose of an oral systemic corticosteroid before breastfeeding in order to decrease potential exposure to the breastfeeding infant (based on a study using prednisolone) (Bae 2012; Butler 2014; Götestam Skorpen 2016; Leachman 2006; Makol 2011; Ost 1985).

Dietary Considerations

Take tablets with meals to decrease GI upset; need diet rich in pyridoxine, vitamin C, vitamin D, folate, calcium, phosphorus, and protein.

Monitoring Parameters

Blood pressure, blood glucose, electrolytes; weight; intraocular pressure (use >6 weeks); bone mineral density; growth and development in children; HPA axis suppression

Mechanism of Action

In a tissue-specific manner, corticosteroids regulate gene expression subsequent to binding specific intracellular receptors and translocation into the nucleus. Corticosteroids exert a wide array of physiologic effects including modulation of carbohydrate, protein, and lipid metabolism and maintenance of fluid and electrolyte homeostasis. Moreover cardiovascular, immunologic, musculoskeletal, endocrine, and neurologic physiology are influenced by corticosteroids. Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability.

Pharmacodynamics/Kinetics

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: Vd: 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)

Pricing: US

Kit (ReadySharp Methylprednisolone Injection)

80 mg/mL (1): $349.83

Solution (reconstituted) (MethylPREDNISolone Sodium Succ Injection)

40 mg (1): $6.00

125 mg (1): $9.60

1000 mg (1): $36.00

Solution (reconstituted) (SOLU-medrol Injection)

2 g (1): $99.73

40 mg (1): $7.22

125 mg (1): $11.63

500 mg (1): $27.74

1000 mg (1): $50.27

Suspension (DEPO-Medrol Injection)

20 mg/mL (5 mL): $39.67

40 mg/mL (1 mL): $12.68

80 mg/mL (1 mL): $22.01

Suspension (MethylPREDNISolone Acetate Injection)

40 mg/mL (1 mL): $10.44

80 mg/mL (1 mL): $17.16

Suspension (MethylPREDNISolone Acetate PF Injection)

80 mg/mL (1 mL): $100.00

Tablet Therapy Pack (Medrol Oral)

4 mg (21): $77.08

Tablet Therapy Pack (MethylPREDNISolone Oral)

4 mg (21): $30.01

Tablets (Medrol Oral)

2 mg (100): $194.04

4 mg (100): $367.06

8 mg (25): $128.92

16 mg (50): $398.18

32 mg (25): $296.45

Tablets (MethylPREDNISolone Oral)

4 mg (100): $142.93

8 mg (25): $50.26

16 mg (50): $155.29

32 mg (25): $115.62

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Adrelan (PH);
  • Advantan (MX);
  • Adventan (ES);
  • Cipridanol (PY);
  • Cryosolona (MX);
  • Depo Medrol (AE, BH, JO, KW, LB, QA, SA);
  • Depo-Medrol (BB, CR, DO, EG, ET, GT, HN, IS, LU, LV, MX, NI, NO, PA, SI, SK, SV, UA, VN, ZW);
  • Depo-Medrone (IE, MT);
  • Epizolone-Depot (ET);
  • Flason (ID);
  • Flumethyl (ID);
  • Lexcomet (ID);
  • Lexxema (ES);
  • M-Nisol (LK);
  • M-Prednihexal (DE);
  • Madomed (TH);
  • Meapron (KR);
  • Medason (HK);
  • Medisolu (KR);
  • Medixon (ID, MY, PH);
  • Mednin (TW);
  • Medrate (DE);
  • Medrol (AE, BB, BE, BH, BM, BS, BZ, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GR, GT, GY, HN, HR, ID, IE, IL, IN, IQ, IR, IT, JM, JO, KR, KW, LB, LT, LU, LV, LY, MT, NI, NL, NO, NZ, OM, PA, PE, PH, PL, PT, QA, RO, RU, SA, SE, SI, SK, SR, SV, SY, TR, TT, VE, VN, YE, ZA);
  • Medrone (GB);
  • Melone 16 (TW);
  • Melsone (IN);
  • Menisone (TW);
  • Meprednisona All Pro (AR);
  • Mepresone (PH);
  • Mesolone (KR);
  • Metcor (ID);
  • Metcort (PH);
  • Methylon (KR);
  • Methylpred (AU);
  • Methylprednisolone David Bull (LU);
  • Methysol (KR);
  • Metrite (LK);
  • Metypred (UA);
  • Neo-Drol (LK);
  • Nisolon-M (KR);
  • Predlitem (MX);
  • Prednivex (LK, PH);
  • Prednol (TR);
  • Prednox (PH);
  • Prena (KR);
  • Pretilon (ID);
  • Prolon (ID);
  • Sanexon (ID, LK);
  • Sol-U-Pred (LK);
  • Sologen (KR);
  • Solomet (FI);
  • Solu Medrol (BF, BJ, CI, ET, GH, GM, GN, KE, LK, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW);
  • Solu-Medon (VN);
  • Solu-Medrol (AE, AU, BB, BG, BH, CL, CN, CR, CY, DO, EG, GT, HK, HN, HR, IS, JO, JP, KW, LB, LT, LU, LV, MX, MY, NI, PA, PK, QA, RO, SA, SI, SK, SV, TH, TR, UY, VN);
  • Solu-Medrone (IE, MT);
  • Solu-Moderin (ES);
  • Solu-Pred (MY);
  • Somidex (TH);
  • Sonicor (ID);
  • Thimelon (ID);
  • Thylmedi (VN);
  • Tisolon-4 (ID);
  • Tropidrol (ID);
  • Urbason (AT, CZ, DE, ES, HR, NL);
  • Urbason Retard (BE, IT);
  • Yalone (ID)
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