(meth il pred NIS oh lone)
- Medrol Dose Pack
- Methylprednisolone Acetate
- Methylprednisolone Sodium Succinate
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]:
A-Methapred: 40 mg (1 ea [DSC]); 125 mg (1 ea [DSC]) [contains benzyl alcohol]
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 [DSC], 10 mL); 80 mg/mL (1 mL, 5 mL)
Suspension, Injection, as acetate [preservative free]:
Generic: 80 mg/mL (1 mL [DSC])
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)
Brand Names: U.S.
- A-Methapred [DSC]
- P-Care D40
- P-Care D80
- ReadySharp Methylprednisolone
- Corticosteroid, Systemic
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.
Oral: Well absorbed (Czock 2005)
Vd: IV (succinate): 24 ± 6 L (Czock 2005)
Hepatic to metabolites (Czock 2005)
Urine (1.3% [oral], 9.2% [IV succinate] as unchanged drug) (Czock 2005)
Onset of Action
IV (succinate): Within 1 hour; Intra-articular (IV acetate): 1 week
Time to Peak
Oral: 2.1 ± 0.7 hours (Czock 2005)
IV (succinate): 0.8 hours (Czock 2005)
Duration of Action
Intra-articular (IV acetate): 1 to 5 weeks
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)
Special Populations: Elderly
Decreased clearance and increased half-life (Czock 2005)
Special Populations Note
Obesity: Half-life is increased and clearance is decreased (Czock 2005)
Use: Labeled Indications
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).
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).
Off Label Uses
Acute spinal cord injury
Data from two blinded, randomized, controlled trials in patients with acute traumatic spinal cord injury demonstrated no significant to only modest improvement (if treated within 8 hours of injury) with methylprednisolone administration. More complications (eg, wound infections, severe pneumonia, sepsis) occurred with methylprednisolone administration compared to placebo and other treatments [Bracken 1990], [Bracken 1998]. The use of methylprednisolone in this setting remains controversial. According to the American Association of Neurological Surgeons and Congress of Neurological Surgeons Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries, the use of methylprednisolone for the treatment of acute spinal cord injury is not recommended.
Bronchiolitis obliterans syndrome (prevention)
The International Society for Heart and Lung Transplantation, American Thoracic Society, and European Respiratory Society (ISHLT/ATS/ERS) clinical practice guidelines for the diagnosis and management of bronchiolitis obliterans syndrome (BOS) suggest intravenous methylprednisolone to prevent BOS in lung transplant patients who exhibit one of the following: 1) Non-minimal acute cellular rejection (grade ≥ 2) or lymphocytic bronchitis on transbronchial lung biopsy; 2) Clinically significant minimal acute cellular rejection (grade A1) on transbronchial lung biopsy. Long-term, high-dose corticosteroids (equivalent to ≥30 mg/day prednisone) is not recommended in patients who exhibit a decline in FEV1 consistent with the onset of BOS.
Cadaveric organ recovery (hormonal resuscitation)
Data from three retrospective cohort studies of brain-dead donors who successfully donated organs suggests that the use of intravenous methylprednisolone given concomitantly with a continuous infusion of insulin, liothyronine or levothyroxine, and vasopressin may be beneficial for hemodynamically unstable brain-dead donors to increase the quantity and quality of organs available for transplantation [Rosendale 2003a], [Rosendale 2003b], [Salim 2007]. Additional data may be necessary to further define the role of methylprednisolone in this setting.
Based on a consensus document sponsored by the American Society of Transplant Surgeons and the American Society of Transplantation, the use of methylprednisolone (in combination with vasopressin, insulin, and liothyronine) is effective and recommended for hormonal resuscitation in brain-dead donors [Rosengard 2002], [Zaroff 2002].
Cardiac transplant: Acute cellular rejection (ACR) (treatment)
Based on the International Society of Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients, high-dose intravenous corticosteroids (methylprednisolone) are effective and recommended in the treatment of symptomatic ACR (irrespective of ISHLT EMB grade) and asymptomatic severe ACR (ISHLT 3R) of the cardiac allograft. Intravenous methylprednisolone is also an option for asymptomatic moderate ACR (ISHLT 2R). There are currently no large randomized trials evaluating treatments for ACR in cardiac transplantation; recommendations are based on consensus.
Cardiac transplant: Antibody-mediated rejection (AMR) (treatment)
Based on the American Heart Association's Scientific Statement for Antibody-Mediated Rejection in Cardiac Transplantation and the International Society of Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients, intravenous methylprednisolone, typically in combination with other immune therapies, may be a reasonable option for the primary treatment of patients with AMR of the cardiac allograft. ISHLT guidelines state that high-dose corticosteroids (intravenous methylprednisolone) may be used to disrupt the immune-mediated injury of the heart allograft and reduce the risk of recurrent rejection. There are currently no large randomized trials evaluating treatments for AMR in cardiac transplantation; recommendations are based on consensus.
Data from multiple relatively small independent clinical studies enrolling patients with varying degrees of disease severity and evaluating different clinical outcomes and dosing strategies suggest that the use of systemic corticosteroids, including methylprednisolone, in the treatment of COPD exacerbation is beneficial [Albert 1980], [Alía 2011], [Niewoehner 1999], [Sayiner 2001], [Shortall 2002], [Vondracek 2006], [Willaert 2002]. Additional trials may be necessary to further define the role of methylprednisolone as opposed to the recommended use of oral prednisone by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines. The use of IV methylprednisolone in patients with impending or actual acute respiratory failure is considered acceptable.
In-hospital cardiac arrest
Data from two randomized controlled trials in patients experiencing in-hospital cardiac arrest (IHCA) suggest that the combination of vasopressin, epinephrine (standard dose), and methylprednisolone administered during cardiac arrest followed by hydrocortisone given after return of spontaneous circulation may be beneficial for the treatment of patients in this setting [Mentzelopoulos 2009], [Mentzelopoulos 2013]. Additional trials are necessary to further define the role of this regimen and of hydrocortisone (post-arrest) for the treatment of patients who experience IHCA.
Based on the 2015 American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, the intra-arrest use of methylprednisolone (in combination with epinephrine and vasopressin) in patients with IHCA followed by hydrocortisone given after return of spontaneous circulation may be considered (based on limited evidence); however, further studies are warranted before routine administration of this combination can be recommended.
Pneumocystis pneumonia (PCP) in HIV-infected patients (children)
Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections Among HIV-Infected Children, methylprednisolone is an effective and recommended alternative corticosteroid in the adjunctive treatment of Pneumocystis pneumonia (PCP) in HIV-infected children.
Pneumocystis pneumonia (PCP) in HIV-infected patients (adolescents and adults)
Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, intravenous methylprednisolone is an effective and recommended alternative to prednisone when parenteral administration is necessary in the adjunctive treatment of Pneumocystis pneumonia (PCP) in adolescent and adult HIV-infected patients.
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.
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
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.
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).
Refer to adult dosing.
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
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: 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.
Methylprednisolone sodium succinate injection: Reconstitute vials only with provided diluent or bacteriostatic water with benzyl alcohol (see manufacturer's labeling for details). For IV infusion, dilute reconstituted dose in D5W, NS, or D5NS. Formulations containing benzyl alcohol should not be used in neonates. Neonates should only receive doses reconstituted with preservative free SWFI.
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.
Take tablets with meals to decrease GI upset; need diet rich in pyridoxine, vitamin C, vitamin D, folate, calcium, phosphorus, and protein.
Methylprednisolone acetate injection and tablets: Store at 20°C to 25°C (68°F to 77°F). Do not autoclave vials.
Methylprednisolone sodium succinate injection: Store intact vials at 20°C to 25°C (68°F to 77°F). Protect from light. Do not autoclave. Store reconstituted solutions at 20°C to 25°C (68°F to 77°F) and use within 48 hours.
Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Monitor therapy
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Amodiaquine: CYP2C8 Inhibitors may increase the serum concentration of Amodiaquine. Avoid combination
Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy
Androgens: Corticosteroids (Systemic) may enhance the fluid-retaining effect of Androgens. 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. Consider therapy modification
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. 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. 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. Consider therapy modification
BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Monitor therapy
Calcitriol (Systemic): Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic). Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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. 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). 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. 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. 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. 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. Monitor therapy
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. 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. Consider therapy modification
Desmopressin: Corticosteroids (Systemic) may enhance the hyponatremic effect of Desmopressin. Avoid combination
DilTIAZem: May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification
Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). 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). Consider therapy modification
Fosaprepitant: May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect. 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. Consider therapy modification
Indacaterol: May enhance the hypokalemic effect of Corticosteroids (Systemic). Monitor therapy
Indium 111 Capromab Pendetide: Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Avoid combination
Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. 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. Consider therapy modification
Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy
Mifamurtide: Corticosteroids (Systemic) may diminish the therapeutic effect of Mifamurtide. 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. Avoid combination
Mitotane: May decrease the serum concentration of Corticosteroids (Systemic). Consider therapy modification
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. 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. Consider therapy modification
Nicorandil: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Monitor therapy
Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. 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). Monitor therapy
Nonsteroidal Anti-Inflammatory Agents (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Monitor therapy
Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy
Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Quinolones: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Monitor therapy
Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. 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. Monitor therapy
Sargramostim: Corticosteroids (Systemic) may enhance the therapeutic effect of Sargramostim. Specifically, corticosteroids may enhance the myeloproliferative effects of sargramostim. Monitor therapy
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy
Tacrolimus (Systemic): Corticosteroids (Systemic) may decrease the serum concentration of Tacrolimus (Systemic). Conversely, when discontinuing corticosteroid therapy, tacrolimus concentrations may increase. Monitor therapy
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. 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. Consider therapy modification
Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy
Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. 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). 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. Consider therapy modification
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. 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. 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. 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. Consider therapy modification
Warfarin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Warfarin. Monitor therapy
Decreased response to skin tests
Frequency not defined:
Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmia, cardiac failure, cardiomegaly, circulatory shock, congestive heart failure, 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)
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.
• 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.
• 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.
• 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.
• 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).
Blood pressure, blood glucose, electrolytes; weight; intraocular pressure (use >6 weeks); bone mineral density; growth and development in children; HPA axis suppression
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 NTPR@giftoflifeinstitute.org.
• Discuss specific use of drug and side effects with patient as it relates to treatment. HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience nausea, vomiting, insomnia, or agitation. Have patient report immediately to prescriber signs of infection, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), signs of Cushings disease (weight gain in upper back or abdomen; moon face; severe headache; or slow healing), signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of skin changes (acne, stretch marks, slow healing, or hair growth), severe loss of strength and energy; irritability; tremors; tachycardia; confusion; dizziness; sweating a lot; shortness of breath; excessive weight gain; swelling of arms or legs; angina; menstrual changes; bone pain; joint pain; vision changes; behavioral changes; depression; seizures; burning or numbness feeling; bruising; bleeding; severe abdominal pain; vomiting blood; or black, tarry, or bloody stools (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
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