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Prednisolone (systemic): Drug information

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

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Millipred [DSC];
  • Orapred ODT;
  • Pediapred
Brand Names: Canada
  • Pediapred [DSC];
  • PMS-Prednisolone
Pharmacologic Category
  • Corticosteroid, Systemic
Dosing: Adult

Dosage guidance:

Safety: To avoid overdosing and subsequent toxicity for select indications with weight-based dosing, consider using ideal body weight in patients with obesity, especially with longer durations of therapy (Ref).

Dosing: Individualize glucocorticoid dosing and use the minimum effective dose/duration. Evidence to support an optimal dose and duration is lacking for most indications; recommendations provided are general guidelines only. Dosing provided is calculated based on prednisone equivalency unless otherwise noted.

Clinical considerations: In patients receiving chronic glucocorticoids (eg, ≥3 to 4 weeks) at supraphysiologic doses (>5 mg/day prednisolone) for indications other than adrenal insufficiency, risk of hypothalamic-pituitary-adrenal axis suppression is increased. If glucocorticoid discontinuation is indicated, reduce dose gradually and monitor for signs of adrenal insufficiency. Higher doses may be needed during acute illness or surgery (Ref).

Usual dosage range:

Oral: 10 to 60 mg/day given in a single daily dose or in 2 to 4 divided doses; Low dose: 2.5 to 10 mg/day; High dose: 1 to 1.5 mg/kg/day (usually not to exceed 80 to 100 mg/day).

The following dosing is an example of a tapered-dosage regimen:

Day 1: 30 mg on day 1 administered as 10 mg at breakfast, 5 mg at lunch, 5 mg at dinner, and 10 mg at bedtime.

Day 2: 25 mg on day 2 administered as 5 mg at breakfast, 5 mg at lunch, 5 mg at dinner, and 10 mg at bedtime.

Day 3: 20 mg on day 3 administered as 5 mg at breakfast, 5 mg at lunch, 5 mg at dinner, and 5 mg at bedtime.

Day 4: 15 mg on day 4 administered as 5 mg at breakfast, 5 mg at lunch, and 5 mg at bedtime.

Day 5: 10 mg on day 5 administered as 5 mg at breakfast and 5 mg at bedtime.

Day 6: 5 mg on day 6 administered as 5 mg at breakfast.

Adrenal insufficiency, chronic

Adrenal insufficiency, chronic (alternative agent):

Note: For use in patients with severe symptoms of cortisol deficiency while using a short-acting glucocorticoid (eg, hydrocortisone) or who have difficulty adhering to multiple daily dosing regimens. Use in combination with fludrocortisone in patients with mineralocorticoid deficiency (eg, primary adrenal insufficiency) (Ref).

Maintenance dosing: Oral: 3 to 5 mg/day in 1 or 2 divided doses (Ref). If given twice daily, administer ~70% to 80% of the daily dose in the morning upon awakening and the remainder at bedtime (Ref). May adjust daily dose if needed based on signs and symptoms of under- or over-replacement; use the lowest effective dose (Ref).

Stress dosing: Note: For use in patients with chronic adrenal insufficiency (AI) and acute physiologic stressors (eg, illness, surgery) to prevent development of adrenal crisis. Patients without known chronic AI with recent or current chronic glucocorticoid use at supraphysiologic doses (eg, >5 mg/day prednisolone) may have hypothalamic-pituitary-adrenal axis suppression and may require stress dosing; individualize treatment decisions in these patients (Ref). If a parenteral glucocorticoid is required (eg, unable to take oral medications, critical illness, labor/delivery, moderate/severe surgical stress), switch to hydrocortisone (Ref). Dosing provided is calculated based on hydrocortisone equivalency.

Acute physiologic stress/illness:

Febrile illness: Double the chronic maintenance dose for fever 38°C (100.4°F) to 39°C (102.2°F) or triple the chronic maintenance oral dose for fever >39°C (>102.2°F) or persistent nausea. Continue higher dose for 3 days, then return to baseline dose if fever has resolved. If fever has not resolved by day 4, further evaluation (with continued use of higher steroid doses if needed) is required (Ref).

Illness requiring hospitalization (eg, community acquired pneumonia): Oral: 12.5 to 20 mg/day in 1 or 2 divided doses. For patients requiring a parenteral glucocorticoid, switch to hydrocortisone. Taper and return to baseline dose within 2 to 3 days following improvement of underlying condition (Ref).

Surgical stress: Minor surgical stress (eg, hernia repair, procedures with local anesthetic): Oral: Give an additional 5 mg supplemental dose on the day of surgery (Ref).

Adrenal insufficiency due to classic congenital adrenal hyperplasia

Adrenal insufficiency due to classic congenital adrenal hyperplasia:

Note: For use as an adjunctive agent in patients in whom adrenal steroid suppression cannot be achieved with short-acting glucocorticoid monotherapy (eg, hydrocortisone), or as alternative monotherapy in patients who have difficulty adhering to multiple daily dosing regimens. In patients with mineralocorticoid deficiency, use in combination with fludrocortisone (Ref).

Monotherapy: Oral: 3 to 5 mg in the morning upon awakening and 1 to 2.5 mg at bedtime (usual dose range: 4 to 6 mg/day) (Ref).

Combination therapy: Oral: 1 to 2 mg at bedtime, in combination with hydrocortisone given during the day (Ref).

Stress dosing: Patients undergoing physiologic stress (eg, febrile illness, surgery, labor/delivery) require increased glucocorticoid doses to prevent adrenal crisis. Individualize treatment decisions; refer to "Dosing: Adrenal Insufficiency, Chronic" for stress dosing instructions (Ref).

Alcoholic hepatitis

Alcoholic hepatitis (severe) (Maddrey Discriminant Function [MDF] score ≥32) (off-label use): Oral: 40 mg daily for 28 days, followed by a 2- to 4-week taper (Ref).

Anaphylaxis-associated residual symptoms

Anaphylaxis-associated residual symptoms (eg, persistent asthma, significant angioedema): Note: Patient should be initially treated with epinephrine for the anaphylaxis event and stabilized. Do not use prednisolone for initial or sole treatment of anaphylaxis because corticosteroids do not result in the prompt relief of upper or lower airway obstruction or shock and do not prevent biphasic anaphylaxis (Ref).

Oral: 1 mg/kg daily for 3 to 5 days; maximum daily dose: 60 mg/day (Ref).

Angioedema and/or new-onset urticaria

Angioedema (acute allergic) and/or new-onset urticaria: Note: For moderate to severe symptoms without signs of anaphylaxis. Use epinephrine if anaphylaxis symptoms (eg, risk of airway or cardiovascular compromise) are present (Ref). In patients with new-onset urticaria, reserve use for those with significant angioedema or with symptoms that are unresponsive to antihistamines (Ref).

Oral: The optimal dosing strategy has not been defined; an example regimen is 20 to 60 mg daily initially, followed by a taper over 5 to 7 days (Ref). The total treatment duration should not exceed 10 days (Ref).

Asthma, acute exacerbation

Asthma, acute exacerbation: Note: For moderate to severe exacerbations or in patients who do not respond promptly and completely to short-acting beta agonists; administer within 1 hour of presentation to emergency department (Ref).

Oral: 40 to 60 mg/day in 1 or 2 divided doses; continue for at least 5 to 7 days or until symptoms are resolved (Ref).

Bell palsy

Bell palsy (off-label use): Oral: 60 mg once daily for 5 days, then taper dose downward by 10 mg daily for 5 days (total treatment duration: 10 days) (Ref) or 50 mg daily (in 1 or 2 divided doses) for 10 days (begin within 72 hours of onset of symptoms) (Ref).

Bullous pemphigoid

Bullous pemphigoid (off-label use): Oral: Initial: 0.5 mg/kg/day. May begin gradual taper over 4 to 6 months when disease is controlled (eg, no new lesions or pruritic symptoms for ≥2 weeks and most established lesions have healed). May discontinue therapy if complete remission maintained for at least 3 to 6 months on doses ≤0.1 mg/kg/day (usual total duration: 9 to 12 months) (Ref).

Inadequate initial control: In patients who do not achieve disease control within 1 to 3 weeks of initial therapy, may increase to 0.75 mg/kg/day; may also consider addition of other agents (eg, topical corticosteroids, immunosuppressants) (Ref).

Disease recurrence: Return to the preceding lowest effective treatment dose; if not effective, return to initial effective dose (Ref).

Chronic obstructive pulmonary disease, acute exacerbation

Chronic obstructive pulmonary disease, acute exacerbation (off-label use):

Note: In patients with severe but not life-threatening exacerbations, oral regimens are recommended. In patients who cannot tolerate oral therapy (eg, shock, mechanically ventilated), use IV methylprednisolone (Ref).

Oral: 40 mg once daily for 5 days (Ref). Note: Higher dosing, extended durations, and/or longer tapers may be used based on exacerbation severity and individual patient response to prior courses (Ref).

Duchenne muscular dystrophy

Duchenne muscular dystrophy (off-label use): Oral: 0.75 mg/kg/day (Ref). Some experts use a maximum dose of 40 mg/day due to potential for greater adverse effects and decreased benefit at higher doses (Ref).

Note: In patients who experience intolerable adverse effects, may decrease the dose by 25% to 33% (Ref). If adverse effects persist, continue to gradually taper to as low as 0.3 mg/kg/day, which may provide benefit (Ref). Doses as high as 1.5 mg/kg/day have been studied, but there is no evidence that doses >0.75 mg/kg/day provide greater efficacy (Ref).

Giant cell arteritis, treatment

Giant cell arteritis, treatment (off-label use): Note: To reduce the risk of visual loss, start treatment immediately once diagnosis is highly suspected (Ref). In patients presenting with threatened vision loss, pulse IV methylprednisolone is suggested as initial therapy prior to an oral glucocorticoid (eg, prednisolone) (Ref).

Oral: 40 to 60 mg once daily for 2 to 4 weeks; if reversible symptoms persist or worsen, may increase dose up to a maximum dose of 80 mg once daily until symptomatic control is achieved (Ref). Alternatively, may initiate at 1 mg/kg once daily (maximum: 80 mg/day), particularly in patients with signs of ischemic organ damage (eg, vision loss) (Ref). Once signs/symptoms have declined and laboratory values have returned to normal or near normal, begin to taper until discontinuation over the next 6 to 12 months (Ref).

Gout, treatment, acute flares

Gout, treatment, acute flares:

Note: Avoid use in patients with known or suspected septic arthritis (Ref).

Oral: 30 to 40 mg/day given once daily or in 2 divided doses until symptom improvement (usually 2 to 5 days), then taper gradually as tolerated (typically over 7 to 10 days); a slower taper (eg, over 14 to 21 days) may be required, particularly in patients with multiple recent flares (Ref).

Hepatitis, autoimmune

Hepatitis, autoimmune (off-label use):

Note: Approach to treatment should be patient-specific and guided by response to treatment. Monotherapy induction regimen included below; other induction regimens (eg, combination therapy with a glucocorticoid-sparing agent) may be used in select patients (Ref).

Induction: Initial: Oral: 40 to 60 mg once daily for 1 week or until biochemical remission achieved, followed by a taper (eg, reduce daily dose by 5 to 10 mg at weekly intervals) based on symptoms and laboratory values to 20 mg once daily or a dose sufficient for maintenance of remission (Ref). Some experts initiate therapy at 20 to 30 mg once daily depending on severity of disease and tolerance to glucocorticoids (Ref).

Maintenance: Further taper dose to one that maintains remission (eg, taper the dose by 2.5 to 5 mg every 2 to 4 weeks to reach 5 to 10 mg/day). Specific maintenance approach will depend on patient response to initial treatment and tapering (Ref).

IgA nephropathy, primary, nonvariant

IgA nephropathy, primary, nonvariant (adjunctive agent) (off-label use): Note: May consider for use in selected patients at high risk of chronic kidney disease progression (eg, proteinuria ≥0.75 to 1 g/day) despite 3 to 6 months of optimized doses of nonimmunosuppressive therapies (eg, renin-angiotensin system inhibitors) (Ref). The optimal dose of prednisolone has not been established and may vary based on institutional protocols and patient-specific factors; an example regimen (based on an equivalent dose of methylprednisolone) is provided below.

Oral: 0.5 mg/kg once daily for 2 months (maximum dose: 40 mg/day). Taper daily dose every month over an additional 4 to 7 months. Note: Antimicrobial prophylaxis for Pneumocystis pneumonia was also prescribed for the first 12 weeks of therapy (Ref).

Immune thrombocytopenia

Immune thrombocytopenia: Note: Goal of therapy is to provide a safe platelet count to prevent clinically important bleeding rather than normalization of the platelet count. For patients with severe bleeding, a pulse of dexamethasone or methylprednisolone is recommended; due to the short-term response associated with methylprednisolone, a prednisolone taper may be required following pulse doses of methylprednisolone. For minor bleeding, prednisolone is an appropriate initial therapy (Ref).

Initial therapy: Oral: 1 mg/kg/day (range: 0.5 to 2 mg/kg/day; maximum: 80 mg/day) for 1 to 2 weeks, followed by a gradual taper (Ref). Total duration of therapy should not exceed 6 weeks; if there is no response within 2 weeks, taper over 1 week and discontinue (Ref).

Pregnancy associated: Oral: Initial: 10 to 20 mg once daily (Ref). Adjust to the minimum effective dose to achieve response; generally, continue for at least 21 days, then taper to the minimum effective dose required to maintain platelet count to prevent major bleeding (Ref) or 1 mg/kg/day for 2 weeks, followed by a gradual taper (Ref).

Fetal alloimmune thrombocytopenia (maternal administration): Oral: 0.5 to 1 mg/kg/day. Dose is dependent upon gestational age and risk of fetal/neonatal intracranial hemorrhage and is administered in addition to immune globulin IV (Ref).

Inflammatory bowel disease

Inflammatory bowel disease:

Crohn disease (moderate to severe or select patients with mild disease), induction: Note: Not for long-term use (Ref).

Oral: 40 to 60 mg once daily for 7 to 14 days, followed by a taper of up to 3 months (eg, reduce dose by 5 mg/day at weekly intervals until 20 mg/day is reached, then further reduce by 2.5 to 5 mg/day at weekly intervals) (Ref). Tapering regimens vary; some experts recommend a more rapid taper with a goal of discontinuing therapy within 1 to 2 months; if symptoms return, may resume therapy and taper more slowly (Ref). Steroid-sparing agents (eg, biologic agents, immunomodulators) should be introduced with a goal of discontinuing corticosteroid therapy as soon as possible (Ref).

Ulcerative colitis (moderate to severe), induction: Note: Not for long-term use (Ref).

Oral: 40 to 60 mg/day in 1 to 2 divided doses. Clinical improvement is expected within 7 days; pace of tapering (usually over 1 to 3 months) should be guided by symptoms, cumulative steroid exposure, and onset of action of additional therapies (Ref).

Iodinated contrast media allergic-like reaction, prevention

Iodinated contrast media allergic-like reaction, prevention: Note: Generally reserved for patients with a prior allergic-like or unknown-type iodinated contrast reaction who will be receiving another iodinated contrast agent. Nonurgent premedication with an oral corticosteroid is generally preferred when contrast administration is scheduled to begin in ≥12 hours; however, consider an urgent (accelerated) regimen with an IV corticosteroid (eg, methylprednisolone) for those requiring contrast in <12 hours (Ref).

Nonurgent regimen: Oral: 50 mg administered 13 hours, 7 hours, and 1 hour before contrast medium administration in combination with oral diphenhydramine 50 mg (administered 1 hour prior to contrast) (Ref).

Minimal change disease, treatment

Minimal change disease, treatment (off-label use): Initial therapy: Oral: 1 mg/kg/day (maximum: 80 mg/day) once daily or 2 mg/kg every other day (maximum: 120 mg every other day) for 4 to 16 weeks (if no response by 16 weeks, patient is most likely glucocorticoid resistant); ~2 weeks after achieving complete remission, gradually taper (eg, decrease by 5 to 10 mg/week for a total period of glucocorticoid exposure of up to 6 months); the duration of initial pulse therapy and tapering schedule can vary (Ref).

Multiple sclerosis, acute exacerbation

Multiple sclerosis, acute exacerbation: Note: For patients with an acute exacerbation resulting in neurologic symptoms and increased disability or impairments in vision, strength, or cerebellar function (Ref).

Initial pulse therapy using an oral glucocorticoid (alternative agent to IV methylprednisolone pulse therapy): Oral: 625 mg to 1.25 g daily for 3 to 7 days (5 days typically), either alone or followed by a taper (Ref).

Taper following IV methylprednisolone or prednisone pulse therapy: Oral: 1 mg/kg/day (maximum: 80 mg/day), followed by a taper; total duration of oral therapy is usually 11 to 14 days (Ref). Tapering schedules vary and some experts prefer to omit taper following initial pulse glucocorticoid therapy (Ref).

Myasthenia gravis, crisis

Myasthenia gravis, crisis (adjunctive therapy) (off-label use): Note: Used in conjunction with immune globulin IV or plasma exchange (Ref).

Oral: 1 mg/kg/day (usual dose range: 60 to 80 mg daily), followed by a taper (Ref).

Myopathies, treatment

Myopathies (dermatomyositis/polymyositis), treatment:

Initial therapy (or following initial therapy with pulse IV methylprednisolone in select patients): Oral: 0.5 to 1 mg/kg/day (maximum: 80 mg/day) as a single daily dose until improvement (usually for 4 to 6 weeks); then gradually tapered (total duration usually 9 to 12 months) (Ref). Note: Continuing high dose (1 mg/kg/day) for more than 6 weeks may increase risk of developing glucocorticoid-associated myopathy (Ref).

Pericarditis, acute or recurrent

Pericarditis, acute or recurrent (alternative agent) (off-label use): Note: May be used for patients with contraindications or incomplete response to nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine. Glucocorticoid therapy early in the course of pericarditis is more likely to be associated with recurrent episodes (Ref). Glucocorticoid therapy should be avoided in patients with pericarditis secondary to acute myocardial infarction given lack of benefit and potential harm (Ref).

Oral: 0.2 to 0.5 mg/kg/day until resolution of symptoms for at least 24 hours and normalization of inflammatory biomarkers (eg, C-reactive protein) if monitored; the initial dose is typically continued for 2 to 4 weeks then gradually tapered over 2 to 3 months if patient remains asymptomatic and inflammatory biomarkers remain normal (if monitored). Use in combination with colchicine (Ref).

Pneumocystis pneumonia, adjunctive therapy for moderate to severe disease

Pneumocystis pneumonia, adjunctive therapy for moderate to severe disease (off-label use): Note: Recommended for patients with PaO2 <70 mm Hg on room air or PAO2-PaO2 ≥35 mm Hg (Ref); some experts additionally recommend for patients with oxygen saturation <92% on room air (Ref).

Oral: 40 mg twice daily on days 1 to 5 beginning as early as possible, followed by 40 mg once daily on days 6 to 10, then 20 mg once daily on days 11 to 21 (Ref).

Polymyalgia rheumatica

Polymyalgia rheumatica: Note: Goal of therapy is to alleviate symptoms; therapy has not been shown to improve prognosis or prevent progression to giant cell arteritis (Ref).

Oral: Initial: Usual dose: 15 mg/day in a single daily dose or in divided doses; some experts consider lower initial doses of 7.5 to 10 mg/day for smaller patients with mild symptoms or at high risk for side effects (eg, labile diabetes) and higher initial doses of 20 mg/day (or 25 mg/daily [rarely]) for patients with more severe symptoms. Divided doses may help with pain and stiffness in evenings and following morning. Once symptoms are controlled, maintain dose for 2 to 4 weeks and gradually taper (generally over a 1- to 2-year period); some patients may require longer treatment (Ref).

Prostate cancer, advanced or metastatic

Prostate cancer, advanced or metastatic: Oral: 5 mg once daily (in combination with abiraterone); treatment duration depends on disease stage and radiotherapy intent (Ref) or 10 mg once daily (in combination with docetaxel and androgen-deprivation therapy) for six 21-day cycles (Ref) or 5 mg twice daily (in combination with abiraterone and olaparib) until disease progression or unacceptable toxicity (Ref) or 5 mg twice daily (in combination with mitoxantrone) for up to ten 21-day cycles (Ref).

Systemic rheumatic disorders

Systemic rheumatic disorders (eg, antineutrophil cytoplasmic antibody-associated vasculitis, mixed cryoglobulinemia syndrome, polyarteritis nodosa, rheumatoid arthritis, systemic lupus erythematosus):

Note: The following dosage ranges are for guidance only; dosing should be highly individualized, taking into account disease severity, the specific disorder, and disease manifestations:

Mild to moderate disease: Oral: Initial: 5 to 30 mg/day in a single daily dose or in divided doses, then taper to the minimum effective dose, depending on response (Ref).

Severe disease: Initial therapy (or following initial therapy with pulse IV methylprednisolone in select patients):

Oral: 1 mg/kg/day (maximum: 60 to 80 mg/day) in a single daily dose or in divided doses; typically given for several weeks, then tapered gradually; may be given as part of an appropriate combination regimen; for severe systemic lupus erythematosus, up to 2 mg/kg/day may be given initially (Ref).

Takayasu arteritis

Takayasu arteritis (off-label use): Oral: Initial: 40 to 60 mg daily in combination with appropriate steroid-sparing agent; gradually taper to lowest effective dose (Ref); some experts initiate treatment with 1 mg/kg/day (maximum: 60 to 80 mg/day) (Ref). Note: Long-term therapy may be required to prevent progression (Ref).

Thyroid eye disease, moderate to severe

Thyroid eye disease, moderate to severe (off-label use):

Note: For use as an alternative to IV glucocorticoids (eg, methylprednisolone); in patients with sight-threatening disease (eg, compressive optic neuropathy), urgent administration of IV glucocorticoids is required (Ref).

Oral: 60 to 100 mg once daily for 7 days, then gradually taper dose by 5 to 10 mg/week over 4 to 6 months based on clinical response and then discontinue (Ref).

Thyroiditis, subacute

Thyroiditis, subacute (off-label use): Note: For use in patients whose pain does not respond to full dose of NSAIDs over several days or patients who present initially with moderate to severe pain (Ref).

Oral: Initial: 40 mg/day for 1 to 2 weeks; gradually taper (eg, by 5 to 10 mg/day every 5 to 7 days) based on clinical response. If pain recurs, increase to the lowest dose that controlled the pain; maintain that dose for ~2 weeks and attempt to taper again (Ref).

Urticaria, chronic spontaneous, acute exacerbation

Urticaria, chronic spontaneous, acute exacerbation (off-label use): Note: For the temporary control of severe exacerbations (Ref).

Oral: 35 to 40 mg once daily until symptoms are controlled (usually occurs after 2 to 3 days of therapy), then taper by 5 to 10 mg/day over a period of 1 to 3 weeks followed by discontinuation (Ref).

Warm autoimmune hemolytic anemia

Warm autoimmune hemolytic anemia: Oral: 1 to 2 mg/kg/day until a hemoglobin response has occurred (typically within 1 to 3 weeks). After hemoglobin stabilization, begin tapering to the lowest dose to maintain remission followed by gradual tapering with an eventual goal of discontinuation (total duration of therapy: 3 to 12 months); a clinician experienced with the treatment of hemolytic anemia should be involved with therapy (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: The pharmacokinetics and pharmacodynamics of prednisolone in kidney impairment are not well understood (Ref). Prednisolone clearance is reduced ~40% in patients with uremia (Ref) and is slightly dialyzable (≤17.5%) (Ref); however, the clinical implications of these findings are unclear.

Altered kidney function: No dosage adjustment necessary for any degree of kidney impairment (Ref).

Hemodialysis, intermittent (thrice weekly): No supplemental dose or dosage adjustment necessary (Ref).

Peritoneal dialysis: No dosage adjustment necessary (Ref).

CRRT: No dosage adjustment necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing; use lowest effective dose.

Dosing: Pediatric

(For additional information see "Prednisolone (systemic): Pediatric drug information")

Dosage guidance:

Dosing: Adjust dose depending upon condition being treated and response of patient. The lowest possible dose should be used to control the condition; when dose reduction is possible, the dose should be reduced gradually. Consider alternate day therapy for long-term therapy.

General dosing, anti-inflammatory or immunosuppressive: Infants, Children, and Adolescents: Oral: 0.1 to 2 mg/kg/day in divided doses 1 to 4 times daily.

Asthma

Asthma:

National Asthma Education and Prevention Program guidelines (Ref):

Asthma exacerbations/Short-course "burst":

Infants and Children <12 years: Oral: 1 to 2 mg/kg/day in divided doses 1 to 2 times daily; maximum daily dose: 60 mg/day. Usual duration: 3 to 10 days.

Children ≥12 years and Adolescents: Oral: 40 to 60 mg in divided doses 1 to 2 times daily. Usual duration: 3 to 10 days.

Long-term treatment for severe, persistent asthma (non-acute):

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

Children ≥12 years and Adolescents: Oral: 7.5 to 60 mg daily given as a single dose in the morning or every other day as needed for asthma control.

Global Initiative for Asthma guidelines (Ref): Management in primary care or acute care facility.

Infants and Children <12 years: Oral: 1 to 2 mg/kg/day for 3 to 5 days.

Maximum daily dose age-dependent:

Infants and Children ≤2 years: 20 mg/day.

Children 3 to 5 years: 30 mg/day.

Children 6 to 11 years: 40 mg/day.

Children ≥12 years and Adolescents: Oral: 1 mg/kg/day for 5 to 7 days; maximum daily dose: 50 mg/day.

Bell palsy

Bell palsy: Limited data available:

Infants, Children, and Adolescents <16 years: Optimal regimen not defined: Oral: 1 to 2 mg/kg/day for 5 to 7 days, followed by a 7- to 10-day taper. Begin treatment within 72 hours of onset of symptoms; usual maximum daily dose: 50 to 60 mg/day (Ref). Pediatric patients with Bell palsy may experience spontaneous recovery, even without treatment; potential benefit of treatment is unclear (Ref).

Adolescents ≥16 years: Oral: 50 mg daily given in 1 or 2 divided doses for 10 days; treatment should begin within 72 hours of onset of symptoms (Ref) or 1 mg/kg/day for 7 days; maximum daily dose 60 mg/day; followed by a gradual taper over 7 days (Ref).

Congenital adrenal hyperplasia

Congenital adrenal hyperplasia: Note: Individualize dose by monitoring growth, hormone levels, and bone age; mineralocorticoid (eg, fludrocortisone) and sodium supplement may be required in salt losers (Ref):

Adolescents (fully grown): Oral: 4 to 6 mg daily in divided doses 2 times daily; use of a liquid dosage form may be preferable to allow for better dose titration (Ref). Note: For younger patients who are still growing, hydrocortisone or fludrocortisone are preferred.

Crohn disease

Crohn disease: Note: Use for induction in patients with active luminal disease if exclusive enteral nutrition is poorly tolerated or ineffective (Ref). Limited data available:

Weight-directed dosing: Children and Adolescents: Oral: 1 to 2 mg/kg/day; maximum daily dose: 60 mg/day; continue for 2 to 4 weeks until remission, then gradually taper over 4 to 8 weeks (Ref).

Fixed dose (Ref): Children and Adolescents: Oral:

10 to 20 kg: 20 mg once daily until clinical remission or a maximum of 4 weeks (whichever occurs first) followed by tapering in 2.5 to 5 mg increments every 5 to 7 days. Goal to discontinue by ≤10 weeks.

>20 to 30 kg: 30 mg once daily until clinical remission or a maximum of 4 weeks (whichever occurs first) followed by tapering in 5 mg increments every 5 to 7 days. Goal to discontinue by ≤10 weeks.

>30 kg: 40 mg once daily until clinical remission or a maximum of 4 weeks (whichever occurs first) followed by tapering in 5 mg increments every 5 to 7 days. Goal is to discontinue by ≤10 weeks.

Croup, mild

Croup, mild: Limited data available:

Infants and Children: Oral: 1 mg/kg once (Ref); maximum dose: 60 mg/dose (based on other pulmonary indications).

Dermatomyositis, juvenile

Dermatomyositis, juvenile: Limited data available: Children and Adolescents: Oral: 1 to 2 mg/kg/day; usual recommended maximum daily dose: 60 mg/day; higher doses of 80 mg/day have also been reported; continue for 4 weeks then if adequate patient response, begin taper; taper dose by 0.5 mg/kg increments every 2 weeks based on response until dose is 0.5 mg/kg/day, then taper every 4 weeks as tolerated; optimal duration is unknown; use in combination with other immunosuppressants (eg, methotrexate) (Ref).

Duchenne muscular dystrophy

Duchenne muscular dystrophy (DMD): Children ≥4 years and Adolescents: Oral: Usual recommended dose: 0.75 mg/kg/day; maximum dose: 40 mg/dose (Ref). If adverse effects persist, continue to gradually taper to as low as 0.3 mg/kg/day, which may provide benefit (Ref). Doses as high as 1.5 mg/kg/day have been studied, but there is no evidence that doses >0.75 mg/kg/day provide greater efficacy and it is associated with more adverse effects (Ref).

Infantile hemangioma, second-line treatment

Infantile hemangioma, second-line treatment: Note: Use if oral propranolol is contraindicated, poorly tolerated, or produces inadequate response (Ref).

Infants: Oral: 2 to 3 mg/kg/day up to 5 mg/kg/day; may be administered once daily or in divided doses up to 4 times daily; duration depends on response rate, patient age, and phase of hemangioma growth, but usually ranges for 4 to 12 weeks followed by a gradual taper and completion of therapy by 9 to 12 months of age (Ref).

Immune thrombocytopenia, newly diagnosed

Immune thrombocytopenia (ITP), newly diagnosed (non-life threatening bleeding): Variable regimens reported: Infants, Children, and Adolescents: Oral: Initial: 2 to 4 mg/kg/day in 3 to 4 divided doses for 5 to 7 days; maximum daily dose: 120 mg/day; higher maximum doses of 200 mg/day have also been reported (Ref); alternatively, 1 to 2 mg/kg/day up to 80 mg/day for 1 to 2 weeks followed by a taper with goal of discontinuing therapy by 3 weeks (Ref).

Juvenile idiopathic arthritis

Juvenile idiopathic arthritis (JIA): Note: Therapy should be individualized based on type of JIA as well as disease severity and activity (Ref).

Polyarticular JIA: Note: In patients with polyarticular JIA with high or moderate disease activity, bridging therapy with a limited course (<3 months) of oral glucocorticoids during initiation or escalation of therapy is recommended; chronic low dose glucocorticoids is not recommended (Ref).

Children and Adolescents (Ref): Variable regimens reported:

Low dose: Oral: 0.25 mg/kg/day; maximum daily dose: 20 mg/day; after 1 week begin tapering dose by decreasing dose to 0.125 mg/kg/day, then in 3 to 4 days, decrease to 0.05 mg/kg/day and discontinue after a total of 2 weeks.

Medium dose: Oral: 0.5 mg/kg/day; maximum daily dose: 30 mg/day; after 1 week begin taper by decreasing dose to 0.4 mg/kg/day for 7 days, then decrease to 0.25 mg/kg/day for 7 days and then 0.1 mg/kg/day for 7 days; discontinue after a total of 4 weeks.

High dose: Oral: 1 mg/kg/day; maximum daily dose: 60 mg/day; begin tapering dose after 1 to 2 weeks; decrease dose in 0.25 mg/kg/day increments every 1 to 4 weeks; tapering duration varies with some tapering doses over 4 weeks and others use a slower taper and taper off over 3 months.

Systemic JIA: Infants ≥6 months, Children, and Adolescents: Oral: Initial: 1 mg/kg/day administered once daily (initial maximum daily dose: 60 mg/day); may be used in combination with methylprednisolone pulse therapy; evaluate initial response at 1 to 2 weeks and then at 1 month of therapy; if patient improves then taper prednisolone, if unchanged then continue current prednisolone therapy and if worsened then increase dose to 2 mg/kg/day (maximum daily dose: 100 mg/day). After 1 month, if improvement, begin taper; if condition worsens or unchanged then increase or continue prednisolone dose at 2 mg/kg/day (maximum daily dose: 100 mg/day) and/or may add or repeat methylprednisolone pulse therapy. After 3 months of glucocorticoid therapy, if improvement (prednisolone dose <50% starting dose), continue taper and reassess monthly; if patient remains unchanged (prednisolone dose >50% of starting dose) or worsened, additional therapy should be considered (Ref).

Kawasaki disease, primary adjunctive treatment for patients at high risk for IVIG resistance or coronary artery aneurysms

Kawasaki disease (KD), primary adjunctive treatment for patients at high risk for IVIG resistance or coronary artery aneurysms: Limited data available: Note: Use to transition patients receiving IV corticosteroids for treatment of KD (in combination with IVIG and aspirin):

Infants and Children: Oral: 2 mg/kg/day in divided doses every 8 hours until c-reactive protein (CRP) normalizes; maximum daily dose: 60 mg/day (Ref). Some centers use less frequent dosing (eg, every 12 hours) to minimize adverse reactions (eg, effect on sleep) and for convenience (eg, ease of dosing at home). Once CRP normalized, taper over 15 days according to institutional practice (tapers may vary); a longer course, tapering over 2 to 3 weeks, may be considered (Ref).

Lupus nephritis

Lupus nephritis: Children and Adolescents: Oral: Initial therapy: 0.35 to 1 mg/kg/day beginning after initial methylprednisolone pulse; maximum daily dose: 80 mg/day; use as part of an appropriate combination regimen. Taper over ~6 months to a dose ≤5 mg/day based on clinical response. Use lowest dose necessary after initial flare and consider discontinuation once patient has had complete clinical renal response for ≥12 months (Ref).

Nephrotic syndrome

Nephrotic syndrome:

Initial episode: Children and Adolescents: Oral: 2 mg/kg/dose or 60 mg/m2/dose once daily (maximum dose: 60 mg/dose) for 4 to 6 weeks; then decrease to 1.5 mg/kg/dose or 40 mg/m2/dose every other day (maximum dose: 50 mg/dose) for 4 to 6 weeks (Ref).

Relapse: Children and Adolescents: Oral: 2 mg/kg/dose or 60 mg/m2/dose once daily (maximum dose: 60 mg/dose) until complete remission for at least 3 days; then decrease to 1.5 mg/kg/dose or 40 mg/m2/dose every other day (maximum dose: 50 mg/dose) for at least 4 weeks, then taper. Duration of alternate-day dosing is variable; some patients require maintenance dosing to prevent relapse, use lowest effective dose (preferably ≤0.5 mg/kg/dose every other day) (Ref).

Ulcerative colitis, moderate to severe

Ulcerative colitis, moderate to severe: Note: Not for long-term maintenance; use for induction only.

Children and Adolescents: Oral: 1 to 2 mg/kg/day administered in the morning for 2 to 3 weeks; maximum daily dose: 60 mg/day; if no response after 7 to 14 days optimal dosing and compliance should be assessed; after the initial 2 to 3 weeks, the dose is gradually decreased over 8 to 10 weeks (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Use with caution.

Hemodialysis: Slightly dialyzable (7% to 17.5%) (Ref).

Intermittent hemodialysis: Supplemental dose necessary (Ref).

Peritoneal dialysis: Supplemental dose is not necessary (Ref).

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Use with caution.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined.

Cardiovascular: Bradycardia, cardiomegaly, cholesterol embolus syndrome, circulatory shock, edema, heart failure, hypertrophic cardiomyopathy (premature infants), myocardial rupture (after recent myocardial infarction), syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis

Dermatologic: Acne vulgaris, allergic dermatitis, atrophic striae, diaphoresis, dry scalp, ecchymoses, facial erythema, hyperpigmentation, hypopigmentation, inadvertent suppression of skin test reaction, skin atrophy, skin rash, thinning hair (scalp), urticaria

Endocrine & metabolic: Decreased serum potassium, fluid retention, growth retardation (children), hirsutism, HPA-axis suppression, hypokalemic alkalosis, impaired glucose tolerance, menstrual disease, negative nitrogen balance (due to protein catabolism), sodium retention, weight gain

Gastrointestinal: Hiccups, impaired intestinal carbohydrate absorption, increased appetite, nausea, pancreatitis

Genitourinary: Asthenospermia, oligospermia

Hematologic & oncologic: Petechia

Hepatic: Hepatomegaly, increased liver enzymes

Hypersensitivity: Nonimmune anaphylaxis

Infection: Sterile abscess

Nervous system: Abnormal sensory symptoms, amyotrophy, arachnoiditis, headache, increased intracranial pressure (with papilledema), insomnia, malaise, meningitis, myasthenia, neuritis, neuropathy, paraplegia, paresis (paraparesis), paresthesia, seizure, vertigo

Neuromuscular & skeletal: Aseptic necrosis of femoral head, aseptic necrosis of humeral head, Charcot arthropathy, rupture of tendon

Ophthalmic: Exophthalmos

Respiratory: Pulmonary edema

Miscellaneous: Wound healing impairment

Postmarketing:

Cardiovascular: Cardiac arrhythmia (including atrial fibrillation) (van der Hooft 2006), hypertension (Mebrahtu 2020), venous thrombosis (Johannesdottir 2013)

Endocrine & metabolic: Cushing syndrome (Hopkins 2005), diabetes mellitus (Tamez-Perez 2015), exacerbation of diabetes mellitus (Tamez-Perez 2015), hyperglycemia (Tamez-Perez 2015), moon face (Hopkins 2005), prediabetes (Tamez-Perez 2015), redistribution of body fat (Hopkins 2005)

Gastrointestinal: Abdominal distention (Liu 2013), peptic ulcer (with possible perforation and hemorrhage) (Liu 2013), ulcerative esophagitis (Liu 2013)

Hypersensitivity: Anaphylaxis (Erdman 2005), angioedema (Gaspar de Sousa 2010)

Infection: Infection (Youssef 2016)

Nervous system: Psychological disorder (including depression, emotional lability, euphoria, personality changes) (Ciriaco 2013)

Neuromuscular & skeletal: Bone fracture (Buckley 2018), osteoporosis (Buckley 2018), steroid myopathy (Haran 2018), vertebral compression fracture (Buckley 2018)

Ophthalmic: Glaucoma (Razeghinejed 2012), increased intraocular pressure (Phulke 2017), subcapsular posterior cataract (Urban 1986)

Contraindications

Hypersensitivity to prednisolone or any component of the formulation; administration of live or live attenuated virus vaccines (with immunosuppressive doses of corticosteroids); systemic fungal infections.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Canadian labeling: Additional contraindications (not in US labeling): Hepatitis; herpes; shingles; varicella; measles; uncontrolled active infections; uncontrolled psychotic states.

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. Adult 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.

• Immunosuppression: Corticosteroids suppress the immune system and increase risk of infection with any pathogen, including bacterial, fungal, helminthic, protozoan, or viral; severe and sometimes fatal corticosteroid-associated infections have occurred. Corticosteroids may reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections, increase the risk of reactivation or exacerbation of latent infections, or mask some signs of infection. Avoid exposure to varicella or measles; if exposure occurs, prophylaxis with an appropriate immunoglobulin may be indicated; antiviral treatment may be considered if varicella infection occurs. Tuberculosis (TB) reactivation may occur when treating patients with latent TB or tuberculin reactivity; administer chemoprophylaxis in patients with latent TB or tuberculin reactivity during prolonged use of prednisolone. Avoid use in patients with active ocular herpes simplex. Hepatitis B reactivation can occur (infrequently) in patients who are hepatitis B carriers. For patients who show evidence of hepatitis B infection, consult an infectious disease specialist regarding monitoring and treatment options before initiating prednisolone. May exacerbate systemic fungal infections. Amebiasis reactivation may occur. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination, and fatalities have occurred. Avoid use in patients with cerebral malaria.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma; clinical improvement may occur with prednisolone discontinuation.

• 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 severe depression, euphoria, insomnia, mood swings, personality changes, and frank psychotic manifestations. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with HF and/or hypertension; use has been associated with fluid retention, electrolyte disturbances, and hypertension. Use with caution following acute 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. Avoid ethanol may enhance gastric mucosal irritation.

• 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.

• Kidney impairment: Use with caution in patients with kidney impairment; fluid retention may occur.

• Myasthenia gravis: Use may cause transient worsening of myasthenia gravis (MG) (eg, within first 2 weeks of treatment); monitor for worsening MG (AAN [Narayanaswami 2021]).

• 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. Use with caution in patients with a history of ocular herpes simplex; corneal perforation has occurred; do not use in active ocular herpes simplex. Not recommended for the treatment of optic neuritis; may increase frequency of new episodes. 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.

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

• Systemic sclerosis: Use with caution in patients with systemic sclerosis; an increase in scleroderma renal crisis incidence has been observed with corticosteroid use. Monitor BP and kidney function in patients with systemic sclerosis treated with corticosteroids (EULAR [Kowal-Bielecka 2017]).

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in patients with hyperthyroidism and decreases in patients with hypothyroidism.

Special populations:

• Older adults: Use cautiously in older adults 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: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of 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 derivative with caution in neonates. See manufacturer’s labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).

Other warnings/precautions:

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

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

Warnings: Additional Pediatric Considerations

May cause osteoporosis (at any age) or inhibition of bone growth in pediatric patients. Use with caution in patients with osteoporosis. In a population-based study of children, risk of fracture was shown to be increased with >4 courses of corticosteroids; underlying clinical condition may also impact bone health and osteoporotic effect of corticosteroids (Leonard 2007). Increased intraocular pressure (IOP) may occur, especially with prolonged use; in children, increased IOP has been shown to be dose dependent and produce a greater IOP in children <6 years than older children treated with ophthalmic dexamethasone (Lam 2005). Corticosteroids have been associated with myocardial rupture; hypertrophic cardiomyopathy has been reported in premature neonates.

Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms Considerations

Orapred oral solution contains fructose.

Orapred ODT dispersible tablets contain sucrose.

Dosage Forms: US

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

Solution, Oral:

Generic: 15 mg/5 mL (5 mL, 240 mL, 480 mL)

Solution, Oral, as sodium phosphate [strength expressed as base]:

Pediapred: 5 mg/5 mL (120 mL) [alcohol free, dye free, sugar free; contains edetate (edta) disodium, methylparaben; raspberry flavor]

Generic: 10 mg/5 mL (237 mL); 15 mg/5 mL (5 mL, 237 mL); 20 mg/5 mL (237 mL); 25 mg/5 mL (30 mL [DSC], 237 mL); 5 mg/5 mL (5 mL, 120 mL)

Tablet, Oral, as base:

Millipred: 5 mg [DSC] [contains fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10), sodium benzoate]

Millipred: 5 mg [DSC] [scored; contains fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10), sodium benzoate]

Generic: 5 mg

Tablet Disintegrating, Oral, as sodium phosphate [strength expressed as base]:

Orapred ODT: 10 mg [DSC]

Orapred ODT: 10 mg [grape flavor]

Orapred ODT: 15 mg [DSC]

Orapred ODT: 15 mg [grape flavor]

Orapred ODT: 30 mg [DSC]

Orapred ODT: 30 mg [grape flavor]

Generic: 10 mg, 15 mg, 30 mg

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Pediapred Oral)

5 mg/5 mL (per mL): $1.66

Solution (prednisoLONE Oral)

15 mg/5 mL (per mL): $1.44

Solution (prednisoLONE Sodium Phosphate Oral)

5 mg/5 mL (per mL): $22.90

10 mg/5 mL (per mL): $2.99 - $3.84

15 mg/5 mL (per mL): $0.31

20 mg/5 mL (per mL): $4.24 - $5.46

25 mg/5 mL (per mL): $1.48 - $1.55

Tablet, orally-disintegrating (Orapred ODT Oral)

10 mg (per each): $28.60

15 mg (per each): $37.20

30 mg (per each): $47.20

Tablet, orally-disintegrating (prednisoLONE Sodium Phosphate Oral)

10 mg (per each): $14.38

15 mg (per each): $23.97

30 mg (per each): $30.82

Tablets (prednisoLONE Oral)

5 mg (per each): $14.06 - $16.68

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.

Dosage Forms: Canada

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

Solution, Oral, as sodium phosphate [strength expressed as base]:

Pediapred: 5 mg/5 mL ([DSC]) [contains edetate (edta) disodium, methylparaben]

Generic: 5 mg/5 mL (120 mL)

Administration: Adult

Oral: Administer after meals or with food or milk to decrease GI upset.

Orapred ODT: Do not break, cut, split or use partial tablet. Remove tablet from blister pack just prior to use. May swallow whole or allow to dissolve on tongue.

Administration: Pediatric

Oral: Administer after meals or with food or milk to decrease GI upset.

Orapred ODT: Do not cut, split, or break tablets; do not use partial tablets. Remove tablet from blister pack immediately prior to use. May swallow tablet whole or allow to dissolve on tongue.

Use: Labeled Indications

Anti-inflammatory or immunosuppressant agent in the treatment of a variety of diseases, including allergic (eg, angioedema, new-onset urticaria), hematologic (eg, immune thrombocytopenia, warm autoimmune hemolytic anemia), dermatologic, GI, inflammatory, ophthalmic, neoplastic, rheumatic (eg, acute gout flare, vasculitis, dermatomyositis, mixed cryoglobulinemia syndrome, polyarteritis nodosa, polymyositis, polymyalgia rheumatica, rheumatoid arthritis, systemic lupus erythematosus), autoimmune, nervous system (eg, acute exacerbations of multiple sclerosis), renal, respiratory (eg, asthma), and endocrine (eg, primary or secondary adrenocorticoid deficiency, congenital adrenal hyperplasia); solid organ rejection (acute/chronic).

Use: Off-Label: Adult

Alcoholic hepatitis (severe); Bell palsy; Bullous pemphigoid; Chronic obstructive pulmonary disease, acute exacerbation; Duchenne muscular dystrophy; Giant cell arteritis, treatment; Hepatitis, autoimmune; IgA nephropathy, primary, nonvariant; Minimal change disease, treatment; Myasthenia gravis, crisis; Pericarditis, acute or recurrent; Pneumocystis pneumonia, adjunctive therapy for moderate to severe disease; Takayasu arteritis; Thyroid eye disease, moderate to severe; Thyroiditis, subacute; Urticaria, chronic spontaneous, acute exacerbation

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

PrednisoLONE may be confused with predniSONE

Pediapred may be confused with Pediazole

Prelone may be confused with PROzac

Metabolism/Transport Effects

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

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Abrocitinib. Management: The use of abrocitinib in combination with other immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider Therapy Modification

Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may increase adverse/toxic effects of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor

Aldesleukin: Corticosteroids (Systemic) may decrease therapeutic effects of Aldesleukin. Risk X: Avoid

Amphotericin B: Corticosteroids (Systemic) may increase hypokalemic effects of Amphotericin B. Risk C: Monitor

Androgens: Corticosteroids (Systemic) may increase fluid-retaining effects of Androgens. Risk C: Monitor

Antacids: May decrease 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 decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor

Antithymocyte Globulin (Equine): Corticosteroids (Systemic) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of systemic corticosteroid is reduced. Corticosteroids (Systemic) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Baricitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Baricitinib. Management: The use of baricitinib in combination with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider Therapy Modification

BCG Products: Corticosteroids (Systemic) may decrease therapeutic effects of BCG Products. Corticosteroids (Systemic) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

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

Brincidofovir: Corticosteroids (Systemic) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Corticosteroids (Systemic). Risk X: Avoid

Calcitriol (Systemic): Corticosteroids (Systemic) may decrease therapeutic effects of Calcitriol (Systemic). Risk C: Monitor

CAR-T Cell Immunotherapy: Corticosteroids (Systemic) may decrease therapeutic effects of CAR-T Cell Immunotherapy. Corticosteroids (Systemic) may increase adverse/toxic effects of CAR-T Cell Immunotherapy. Specifically, the severity and duration of neurologic toxicities may be increased. Management: Avoid use of corticosteroids as premedication before treatment with CAR-T cell immunotherapy agents. Corticosteroids are indicated and may be required for treatment of toxicities such as cytokine release syndrome or neurologic toxicity. Risk D: Consider Therapy Modification

Carbimazole: May decrease serum concentration of PrednisoLONE (Systemic). Risk C: Monitor

Cardiac Glycosides: Corticosteroids (Systemic) may increase adverse/toxic effects of Cardiac Glycosides. Risk C: Monitor

Chikungunya Vaccine (Live): Corticosteroids (Systemic) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Cladribine: Corticosteroids (Systemic) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

Coccidioides immitis Skin Test: Coadministration of Corticosteroids (Systemic) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing systemic corticosteroids (dosed at 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks) several weeks prior to coccidioides immitis skin antigen testing. Risk D: Consider Therapy Modification

Corticorelin: Corticosteroids (Systemic) may decrease therapeutic effects of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor

Cosyntropin: Coadministration of Corticosteroids (Systemic) and Cosyntropin may alter diagnostic results. Risk C: Monitor

COVID-19 Vaccine (Inactivated Virus): Corticosteroids (Systemic) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Corticosteroids (Systemic) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Corticosteroids (Systemic) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

CycloSPORINE (Systemic): May increase neuroexcitatory and/or seizure-potentiating effects of PrednisoLONE (Systemic). PrednisoLONE (Systemic) may decrease serum concentration of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase serum concentration of PrednisoLONE (Systemic). Risk C: Monitor

CYP3A4 Inducers (Moderate): May decrease serum concentration of PrednisoLONE (Systemic). Risk C: Monitor

CYP3A4 Inducers (Strong): May decrease serum concentration of PrednisoLONE (Systemic). Risk C: Monitor

CYP3A4 Inhibitors (Strong): May increase serum concentration of PrednisoLONE (Systemic). Risk C: Monitor

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

Dengue Tetravalent Vaccine (Live): Corticosteroids (Systemic) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Corticosteroids (Systemic) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Corticosteroids (Systemic). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and systemic corticosteroids. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Desirudin: Corticosteroids (Systemic) may increase anticoagulant effects 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 increase hyponatremic effects of Desmopressin. Risk X: Avoid

Deucravacitinib: May increase immunosuppressive effects of Corticosteroids (Systemic). Management: The use of deucravacitinib in combination with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider Therapy Modification

Dinutuximab Beta: Corticosteroids (Systemic) may increase immunosuppressive effects of Dinutuximab Beta. Management: Corticosteroids are not recommended for 2 weeks prior to dinutuximab beta, during therapy and for 1 week after treatment. Doses equivalent to over 2 mg/kg or 20 mg/day of prednisone (persons over 10 kg) for 2 or more weeks are considered immunosuppressive Risk D: Consider Therapy Modification

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

Etrasimod: Corticosteroids (Systemic) may increase immunosuppressive effects of Etrasimod. Risk C: Monitor

Filgotinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Filgotinib. Management: Coadministration of filgotinib with systemic corticosteroids at doses equivalent to greater than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks is not recommended. Risk D: Consider Therapy Modification

Gallium Ga 68 Dotatate: Coadministration of Corticosteroids (Systemic) and Gallium Ga 68 Dotatate may alter diagnostic results. Risk C: Monitor

Growth Hormone Analogs: Corticosteroids (Systemic) may decrease therapeutic effects of Growth Hormone Analogs. Growth Hormone Analogs may decrease active metabolite exposure of Corticosteroids (Systemic). Risk C: Monitor

Hyaluronidase: Corticosteroids (Systemic) may decrease therapeutic effects 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

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Corticosteroids (Systemic) may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Management: Carefully consider the need for corticosteroids, at doses of a prednisone-equivalent of 10 mg or more per day, during the initiation of immune checkpoint inhibitor therapy. Use of corticosteroids to treat immune related adverse events is still recommended Risk D: Consider Therapy Modification

Indium 111 Capromab Pendetide: Coadministration of Corticosteroids (Systemic) and Indium 111 Capromab Pendetide may alter diagnostic results. Risk X: Avoid

Inebilizumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Corticosteroids (Systemic) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiation of systemic corticosteroids at immunosuppressive doses. Influenza vaccines administered less than 14 days prior to or during such therapy should be repeated 3 months after therapy. Risk D: Consider Therapy Modification

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

Leflunomide: Corticosteroids (Systemic) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as systemic corticosteroids. Risk D: Consider Therapy Modification

Licorice: May increase serum concentration of Corticosteroids (Systemic). Risk C: Monitor

Loop Diuretics: Corticosteroids (Systemic) may increase hypokalemic effects of Loop Diuretics. Risk C: Monitor

Lutetium Lu 177 Dotatate: Corticosteroids (Systemic) may decrease therapeutic effects of Lutetium Lu 177 Dotatate. Management: Avoid repeated use of high-doses of corticosteroids during treatment with lutetium Lu 177 dotatate. Use of corticosteroids is still permitted for the treatment of neuroendocrine hormonal crisis. The effects of lower corticosteroid doses is unknown. Risk D: Consider Therapy Modification

Macimorelin: Coadministration of Corticosteroids (Systemic) and Macimorelin may alter diagnostic results. Risk X: Avoid

MethIMAzole: May decrease serum concentration of PrednisoLONE (Systemic). Risk C: Monitor

MetyraPONE: Coadministration of Corticosteroids (Systemic) and MetyraPONE may alter diagnostic results. Management: Consider alternatives to the use of the metyrapone test in patients taking systemic corticosteroids. Risk D: Consider Therapy Modification

Mifamurtide: Corticosteroids (Systemic) may decrease therapeutic effects of Mifamurtide. Risk X: Avoid

MiFEPRIStone: May decrease therapeutic effects of Corticosteroids (Systemic). MiFEPRIStone may increase serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (eg, for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment. Risk X: Avoid

Mumps- Rubella- or Varicella-Containing Live Vaccines: Corticosteroids (Systemic) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Corticosteroids (Systemic) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Corticosteroids (Systemic) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Neuromuscular-Blocking Agents (Nondepolarizing): May increase adverse neuromuscular effects of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Management: If concomitant therapy is required, use the lowest dose for the shortest duration to limit the risk of myopathy or neuropathy. Monitor for new onset or worsening muscle weakness, reduction or loss of deep tendon reflexes, and peripheral sensory decriments Risk D: Consider Therapy Modification

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

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Corticosteroids (Systemic) may increase adverse/toxic effects of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk C: Monitor

Nonsteroidal Anti-Inflammatory Agents (Nonselective): Corticosteroids (Systemic) may increase adverse/toxic effects of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor

Nonsteroidal Anti-Inflammatory Agents (Topical): May increase adverse/toxic effects of Corticosteroids (Systemic). Specifically, the risk of gastrointestinal bleeding, ulceration, and perforation may be increased. Risk C: Monitor

Ocrelizumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Ozanimod: Corticosteroids (Systemic) may increase immunosuppressive effects of Ozanimod. Risk C: Monitor

Pidotimod: Corticosteroids (Systemic) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Corticosteroids (Systemic). Risk X: Avoid

Pneumococcal Vaccines: Corticosteroids (Systemic) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Corticosteroids (Systemic) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Corticosteroids (Systemic) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Corticosteroids (Systemic) may increase adverse/toxic effects of Polymethylmethacrylate. Specifically, the risk for hypersensitivity or implant clearance may be increased. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

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

Rabies Vaccine: Corticosteroids (Systemic) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ritodrine: Corticosteroids (Systemic) may increase adverse/toxic effects of Ritodrine. Risk C: Monitor

Ruxolitinib (Topical): Corticosteroids (Systemic) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Salicylates: May increase adverse/toxic effects of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Risk C: Monitor

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

Sipuleucel-T: Corticosteroids (Systemic) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing immunosuppressants, such as systemic corticosteroids, prior to initiating sipuleucel-T therapy. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone given for 2 or more weeks are immunosuppressive. Risk D: Consider Therapy Modification

Sitafloxacin: Corticosteroids (Systemic) may increase adverse/toxic effects of Sitafloxacin. Specifically, the risk of tendonitis and tendon rupture may be increased. Management: Consider alternatives to coadministration of corticosteroids and sitafloxacin unless the benefits of coadministration outweigh the risk of tendon disorders. Risk D: Consider Therapy Modification

Sodium Benzoate: Corticosteroids (Systemic) may decrease therapeutic effects of Sodium Benzoate. Risk C: Monitor

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Corticosteroids (Systemic). Risk C: Monitor

Succinylcholine: Corticosteroids (Systemic) may increase neuromuscular-blocking effects of Succinylcholine. Risk C: Monitor

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

Tacrolimus (Topical): Corticosteroids (Systemic) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Corticosteroids (Systemic) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Corticosteroids (Systemic) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Tofacitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider Therapy Modification

Typhoid Vaccine: Corticosteroids (Systemic) may decrease therapeutic effects of Typhoid Vaccine. Corticosteroids (Systemic) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Corticosteroids (Systemic) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Upadacitinib. Management: Coadministration of upadacitinib with systemic corticosteroids at doses equivalent to greater than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks is not recommended. Risk D: Consider Therapy Modification

Urea Cycle Disorder Agents: Corticosteroids (Systemic) may decrease therapeutic effects 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

Vaccines (Live): Corticosteroids (Systemic) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone > 2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines 4 weeks prior to therapy if possible. Risk D: Consider Therapy Modification

Vaccines (Non-Live/Inactivated/Non-Replicating): Corticosteroids (Systemic) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider Therapy Modification

Vitamin K Antagonists: Corticosteroids (Systemic) may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor

Yellow Fever Vaccine: Corticosteroids (Systemic) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Yellow Fever Vaccine. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Corticosteroids (Systemic) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Pregnancy Considerations

Prednisolone crosses the placenta; prior to reaching the fetus, prednisolone is converted by placental enzymes to prednisone. As a result, the amount of prednisolone reaching the fetus is ~8 to 10 times lower than the maternal serum concentration (healthy individuals at term; similar results observed with preterm pregnancies complicated by HELLP syndrome) (Beitins 1972; van Runnard Heimel 2005). 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.

Prednisolone is a preferred oral corticosteroid for the treatment of maternal conditions during pregnancy because placental enzymes limit passage to the embryo (ACOG 2019).

When systemic corticosteroids are needed in pregnancy for rheumatic disorders, nonfluorinated corticosteroids such as prednisolone are preferred. Chronic high doses should be avoided (ACR [Sammaritano 2020]).

Prednisolone may be used (alternative agent) to treat primary adrenal insufficiency (PAI) in pregnancy. Pregnant patients with PAI should be monitored at least once each trimester (ES [Bornstein 2016]). Prednisolone may be used to treat patients during pregnancy who require therapy for congenital adrenal hyperplasia (ES [Speiser 2018]).

For dermatologic disorders in pregnant patients, 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). Topical agents are preferred for managing atopic dermatitis in pregnancy; for severe symptomatic or recalcitrant atopic dermatitis, a short course of prednisolone may be used during the third trimester (Koutroulis 2011).

Uncontrolled asthma is associated with adverse events in pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes). Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy; however, systemic corticosteroids should be used to control acute exacerbations. Maternal asthma symptoms should be monitored every 4 to 6 weeks during pregnancy (ERS/TSANZ [Middleton 2020]; GINA 2024a).

Prednisolone is an alternative corticosteroid for use in pregnant patients with severe or critical COVID-19 due to limited placental transfer. Treatment algorithms are available for pregnant patients with severe or critical COVID-19 who require corticosteroids (Saad 2020; Teelucksingh 2022). In general, the treatment of COVID-19 during pregnancy is the same as in nonpregnant patients. However, because data for most therapeutic agents in pregnant patients are limited, treatment options should be evaluated as part of a shared decision-making process (NIH 2023). The risk of severe illness from COVID-19 infection is increased in symptomatic pregnant patients compared to nonpregnant patients (ACOG 2023). Information related to the treatment of COVID-19 during pregnancy continues to emerge; refer to current guidelines for the treatment of pregnant patients.

Breastfeeding Considerations

Prednisolone is present in breast milk.

Data related to the presence of prednisolone in breast milk are available from a study of 6 lactating women on maintenance treatment with prednisolone 10 to 80 mg/day. The highest breast milk concentration (317 ng/mL) was observed 1 hour following an 80 mg dose in a patient 53 days postpartum; breast milk concentrations decreased to <100 ng/mL 4 hours after the maternal dose. Using data from all women in this study, milk concentrations were 5% to 25% of the maternal serum concentration with peak concentrations occurring ~1 hour after the maternal dose. The milk/plasma ratio was found to be 0.2 with doses ≥30 mg/day and 0.1 with doses <30 mg/day (Ost 1985). Using a milk concentration of 317 ng/mL, the estimated exposure to the breastfeeding infant would be 0.05 mg/kg/day (relative infant dose 4% based on a weight-adjusted maternal dose of 80 mg/day). In general, breastfeeding is considered acceptable when the relative infant dose of a medication is <10% (Anderson 2016; Ito 2000).

One 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). Therefore, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Corticosteroids are generally considered acceptable in patients who are breastfeeding when used in usual doses; however, monitoring of the breastfeeding infant is recommended (WHO 2002). Prednisolone is classified as a nonfluorinated corticosteroid; when systemic corticosteroids are needed in a lactating patient for rheumatic disorders, low doses of nonfluorinated corticosteroids are preferred (ACR [Sammaritano 2020]). 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 breastfed infant (ACR [Sammaritano 2020]; Bae 2012; Butler 2014; ERS/TSANZ [Middleton 2020]; Leachman 2006; Ost 1985).

Dietary Considerations

Should be taken after meals or with food or milk to decrease GI upset; increase dietary intake of pyridoxine, vitamin C, vitamin D, folate, calcium, and phosphorus.

Monitoring Parameters

BP; weight; serum glucose; electrolytes; growth in pediatric patients; presence of infection; screen for hepatitis B prior to initiation; latent or active amebiasis prior to initiation in patients who have spent time in tropical climates or have unexplained diarrhea; reactivation of tuberculosis in patients with latent tuberculosis or tuberculin reactivity; bone mineral density; assess HPA axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test); Hgb, occult blood loss; chest x-ray (at regular intervals during prolonged therapy); IOP with therapy >6 weeks, eye examination (periodically during therapy [AASLD (Mack 2020)]).

Mechanism of Action

Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability; suppresses the immune system by reducing activity and volume of the lymphatic system

Pharmacokinetics (Adult Data Unless Noted)

Duration: 18 to 36 hours (Pickup 1979).

Absorption: Rapid; well-absorbed.

Distribution: Vd: 0.22 to 0.7 L/kg.

Protein binding (concentration dependent): 70% to 90% (to albumin and corticosteroid binding globulin); decreased in older adults.

Metabolism: Primarily hepatic.

Half-life elimination: 2 to 4 hours; reduced in children and prolonged in hepatic disease (Pickup 1979).

Time to peak, plasma: 1 to 2 hours; prolonged with food.

Excretion: Primarily urine (as sulfate and glucuronide conjugate).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Older adult: Mean unbound fraction of prednisolone was higher and Vss unbound prednisolone was reduced in older adults.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Deltacortril | Gupisone | Isolone | Predo | Wysolone;
  • (AT) Austria: Aprednislon | Prednihexal | Prednisolon | Prednisolon Agepha;
  • (AU) Australia: Panafcortelone | Predsolone | Redipred | Solone;
  • (BD) Bangladesh: Bexipred | Cortan | Cortisol | Deltacort | Deltapred | Inflagic | Pednisol | Precodil | Pred | Prednelan | Prednicortil | Solone;
  • (BE) Belgium: Deltacortril | Prednicortelone;
  • (BG) Bulgaria: Prednisolon | Prednisolon cortico;
  • (BR) Brazil: Oralpred | Percoide | Pred gran | Prednisolona | Predsigma | Predsim | Prelone | Preni;
  • (CH) Switzerland: Prednisolon | Prednisolon Amino | Prednisolon galepharm | Prednisolon Medinova | Prednisolon Streuli | Prednisolon Wiedenmann AG | Prednisolone Labatec | Spiricort;
  • (CL) Chile: Preventan;
  • (CO) Colombia: Pentasol | Prednisolona | Prednisolona mk | Scherisolona | Tebonal | Uniplen;
  • (DE) Germany: Decortin h | Dermosolon | Predni H | Prednisolon | Prednisolon acis | Prednisolon al | Prednisolon blue | Prednisolon dura | Prednisolon galen | Prednisolon jenapharm | Prednisolon stada;
  • (DK) Denmark: Prednisolon dlf;
  • (DO) Dominican Republic: Alertine | Amcort | Bronal | Inflavir | Kamelox | Lexidrol | Lonapred | Neo predsol | Prednabene | Prednisil | Prednisolona | Prelone | Prinosi | Revir | Solupred;
  • (EC) Ecuador: Predis | Prednimax | Prednisolona | Prednisolona etical | Prednisolona mk | Ramacort;
  • (EE) Estonia: Prednisolon | Prednisolon al | Prednisolon galen | Prednisolon jenapharm | Prednisolon richter | Prednisolon stada | Prednisolon-ratiopharm | Prednisolut l;
  • (EG) Egypt: Deltacortril | Disprelone d | Epicopred | Predilon | Predilone | Prednisolone evapharma | Predsol | Predsol forte | Solupred | Unipricort | Unipridol | Xilon | Xilone | Xilone forte;
  • (ES) Spain: Dacortin h | Normonsona;
  • (FI) Finland: Delta hycortol | Prednisolon | Prednisolon alternova | Prednisolon Frederiksberg | Prednisolon nuriso;
  • (FR) France: Hydrocortancyl | Prednisolone accord | Prednisolone actavis | Prednisolone apotex | Prednisolone Arrow | Prednisolone biogaran | Prednisolone cristers | Prednisolone dci | Prednisolone EG | Prednisolone qualimed | Prednisolone ranbaxy | Prednisolone Teva;
  • (GB) United Kingdom: Codelcortone | Delta Cortef | Deltacortril | Deltalone | Deltastab | Dilacort | Parisilon | Pevanti | Precortisyl | Prednisolone Almus | Prednisolone Arrow | Prednisolone cox | Prednisolone dc | Prednisolone kent;
  • (GR) Greece: Adelcort | Deltacortril | Prezolon;
  • (HK) Hong Kong: Delcorlon | Desolone | Dhasolone | Emsolone | Eurocortone | Panadin | Panafcortelone | Preconin | Prednioval | Prelone | Prenol | Presone | Presurin | Setsolone | U Prednisolone | Uni Solone | Vick prednisolone | Xepasone;
  • (HN) Honduras: Predin ona;
  • (HU) Hungary: Prednisolon;
  • (IE) Ireland: Deltacortril;
  • (IL) Israel: Danalone | Prelone;
  • (IN) India: Acticort | Apred | Balsolone | Besone | Delsone | Deltacortril | Emsolone | Jupred | Kid pred | Monocortil | Nephcorte | Nisolone | Nucort | Omnacortil | Pednisol | Prado | Predcip | Predicort | Prediwell | Predniheal | Prednij | Prednilix | Prednisafe | Prednitop | Predone | Rivsole | Safecort | Solon | Syntacort | Wysolone;
  • (IQ) Iraq: As prislone | Pisolon | Prednicort | Prednisolonawa | Presilon d | Presol | Presoldain | Prilone | Prisolone;
  • (IT) Italy: Cison | Idelt;
  • (JO) Jordan: Corotrope | Predone;
  • (JP) Japan: Codelcortone | Delta prenin | Deltacortril | Donisolone | Prednisolon.fujimo | Prednisolon.isei | Prednisolon.kob.ka | Prednisolon.sankei | Prednisolon.sho.s | Prednisolon.sho.y | Prednisolon.tobish | Predohan | Predonine | Prelon | Scherisolon;
  • (KE) Kenya: Astolon | Dawasolone | P solon | Pedsol | Plone | Pred paed | Predilone | Predimed | Prednifil | Predsol | Predsol forte | Prelone;
  • (KR) Korea, Republic of: Delta Cortef | Deltacortril | Dresol | Hostacortin h | Korus prednisolone | Nisolone | Prd | Prednisolon | Prednisolone | Predron | Preron | Preson | Scherisolon | Sintisone | Solondo | Union pednisolone;
  • (KW) Kuwait: Gupisone | Predo;
  • (LB) Lebanon: Orapred | Predalone | Predo;
  • (LT) Lithuania: Decortin h | Prednisolon | Prednisolone polfa | Solupred;
  • (LU) Luxembourg: Deltacortril | Prednicortelone;
  • (LV) Latvia: Prednisolon | Prednisolon richter;
  • (MA) Morocco: Anapred | Hostacortin h | Isolone | Polypred | Siprozone;
  • (MX) Mexico: Prednidib | Prednisolona;
  • (MY) Malaysia: Asisolone | Axcel prednisolone | Deltasolone | Dhasolone | Nisolon | Prednisa | Prednisyn | Predsolone | Prelone | Prisolone | Rexolone | Setsolone | Sp cortil | Sterosone | Triosolone | Xepasone | Xilone | Zoralone;
  • (NG) Nigeria: Astra prednisolone | Colo | Dizpharm prednisolone | Jawapred | Kpi prednisolone | Nelb prednisolone | Perel | Pilolin | Predicure | Predilin | Predni j | Prednisam | Predsone | Prolone | Rcpred | Rgi prednisolone | Sivopred | Sparlone | Talibex prednisolone | Zonason prednisolone;
  • (NL) Netherlands: Prednisolon | Prednisolon CF | Prednisolon merck | Prednisolon Sandoz;
  • (NO) Norway: Prednisolon | Prednisolon acis | Prednisolon alternova | Prednisolon campus | Prednisolon dak | Prednisolon EQL Pharma | Prednisolon galen | Prednisolon jenapharm | Prednisolon stada | Prednisolone accord | Spiricort;
  • (PE) Peru: Meprecort | Neocortiprex | Predomin | Prenhixin;
  • (PH) Philippines: Impresol | Kidsolone | Liquipred | Liquisone | Medsone | Optipred;
  • (PK) Pakistan: Deltacortril | Inflagic | Persolon | Rapicort | Steron;
  • (PL) Poland: Decortin h | Deltacortril | Encortolon | Predasol | Prednisolon | Solupred;
  • (PR) Puerto Rico: Prednisolone | Prelone;
  • (PT) Portugal: Lepicortinolo | Prednisolona;
  • (PY) Paraguay: Etisona | Ultracort;
  • (QA) Qatar: Corotrope | Gupisone | Omnacortil | Omnacortil Forte | Prednilon | Prednisolone Jenapharm | Predo Syrup | Solupred;
  • (RU) Russian Federation: Medopred | Prednisol | Prednisolon | Prednisolone nycomed;
  • (SA) Saudi Arabia: Deltacortril | Gupison | Gupisone | Pms prednisolone | Predo | Respred | Zylone;
  • (SE) Sweden: Prednisolon actavis | Prednisolon alternova | Prednisolon EQL Pharma | Prednisolon fermenta | Prednisolon pfizer | Prednisolon pilum | Prednisolon Recip;
  • (SG) Singapore: Deltasolone | Dhasolone | Prelone | Sp cortil | Unisolone | Walesolon | Xepasone;
  • (SI) Slovenia: Prednisolon | Prednisolon Agepha | Prednisolon jenapharm;
  • (SR) Suriname: Precortisyl | Prednisolon | Prednisolon actavis | Prednisolon Sandoz | Prednisolon teva;
  • (TH) Thailand: Chlorsolone | Cureral | Deltacorsolone | Di adreson f | Fortisone | Frisoca | Lesolone | Medisolone | Medsolone | Minisolone | Neosolone | Precortisyl | Predil | Predisole | Predman | Prednersone | Prednibemed | Prednidon | Prednisil | Predsirup | Predso | Predsomed | Predsone | Predstar | Presoga | Privalone | Rp Solone | S.co.sone | Shornisone | Sintisone | Starpred;
  • (TN) Tunisia: Copred | Orocort | Prednicort | Vitapred;
  • (TR) Turkey: Codelton | Corlto | Deltacortril | Neocorten | Prednisolon;
  • (TW) Taiwan: Compesolon | Delta Cortef | Deltalone | Docan | Donison | Kingcort | Paloson | Pidonin | Polenin | Preanin | Preconin | Pred | Prednisolon | Predonine | Predron | Prein | Prekilinen | Prelon | Prelone | Prenilone | Prenin | Presolone | Preson | Presurin | Prithmon | Prithmow | Procosone | Pyreson | Sintisone | Siulon | Sunpred | Tonfonrin | Zesanine;
  • (UA) Ukraine: Prednisolon | Prednisolon Rivopharm;
  • (UG) Uganda: Agopred | Astolon | Dawasolone | Kam predsol | Predilone | Prednimax | Prednova | Predsone;
  • (UY) Uruguay: Neocortiprex | Scherisolona;
  • (VE) Venezuela, Bolivarian Republic of: Amcort | Predet | Predna | Prednisolona | Prelone;
  • (VN) Viet Nam: Cbipreson | Cetecocenvadia | Deltal amtex | Prencoid | Soluboston | Sovepred;
  • (ZA) South Africa: Capsoid | Lenisolone | Preflam | Prelone;
  • (ZM) Zambia: Adnicor | Be-tabs prednisolone | Ednisol | Kampred | Lenisolone | Metapred | Prednifil | Prelone
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