PredniSONE (Lexi-Drugs)

Special Alerts
  Prednisone and Prednisolone Safety AlertAugust 2018
Pronunciation

(PRED ni sone)

Brand Names: US

Deltasone; predniSONE Intensol; Rayos

Brand Names: Canada

APO-PredniSONE; JAA PredniSONE [DSC]; TEVA-PredniSONE; Winpred

Pharmacologic Category

Corticosteroid, Systemic

Dosing: Adult

General dosing; anti-inflammatory/immunosuppressive/endocrine disorders: Oral: Initial: 5 to 60 mg/day:

Note: Dose depends upon condition being treated and response of patient. Consider alternate day therapy for long-term therapy. Discontinuation of long-term therapy requires gradual withdrawal by tapering the dose.

Prednisone taper (other regimens also available):

Day 1: 30 mg divided as 10 mg before breakfast, 5 mg at lunch, 5 mg at dinner, 10 mg at bedtime

Day 2: 5 mg at breakfast, 5 mg at lunch, 5 mg at dinner, 10 mg at bedtime

Day 3: 5 mg 4 times daily (with meals and at bedtime)

Day 4: 5 mg 3 times daily (breakfast, lunch, bedtime)

Day 5: 5 mg 2 times daily (breakfast, bedtime)

Day 6: 5 mg before breakfast

Indication-specific dosing:

Acute asthma (off-label dose): Oral: 40 to 60 mg/day for 3 to 10 days; administer as single or 2 divided doses (NAEPP 2007).

Antineoplastic: Oral: Usual range: 10 mg daily to 100 mg/m2/day (depending on indication). Refer to specific protocol for dosing and administration details.

Autoimmune hepatitis (off-label use): Oral: Initial: 60 mg daily for 1 week, followed by 40 mg daily for 1 week, then 30 mg daily for 2 weeks, then 20 mg daily for maintenance of remission (usual duration: <6 months as monotherapy; ≥6 months in combination with azathioprine). Half this dose should be given when used in combination with azathioprine (AASLD [Manns 2010]; Soloway 1972). Note: May taper down to maintain remission from 20 mg daily onward by 5 mg every week until 10 mg/day and further reduction by 2.5 mg/week may be considered up to 5 mg daily (AASLD [Manns 2010]).

Bell palsy (off-label use): Oral: 60 mg daily for 5 days, followed by a 5-day taper. Treatment should begin within 72 hours of onset of symptoms (OHNS [Baugh 2013]).

Chronic obstructive pulmonary disease (acute exacerbation) (off-label use for immediate release products; off-label dose): Oral: 40 mg once daily for 5 to 7 days (GOLD 2018)

Congenital adrenal hyperplasia, classic (alternative agent): Oral: 5 to 7.5 mg/day in 2 divided doses (Endocrine Society [Speiser 2018])

Crohn disease, moderate/severe (off-label dose): Oral: 40 to 60 mg daily for 7 to 14 days, followed by a taper (eg, 5 mg decrements per week until 20 mg, then 2.5 to 5 mg decrements per week) up to 3 months; taper regimens may vary (Lichtenstein 2018)

Dermatomyositis/polymyositis (off-label dose): Oral: 1 mg/kg daily (range: 0.5 to 1.5 mg/kg/day), often in conjunction with steroid-sparing therapies; depending on response/tolerance, consider slow tapering after 2 to 8 weeks depending on response; taper regimens vary widely, but often involve 5 to 10 mg decrements per week and may require 6 to 12 months to reach a low once-daily or every-other-day dose to prevent disease flare (Briemberg 2003; Hengstman 2009; Iorizzo 2008; Wiendl 2008).

Duchenne muscular dystrophy (off-label use): Oral: 0.75 mg/kg/day or 10 mg/kg/weekend, divided over 2 days. When used daily, the dose may be decreased to 0.3 mg/kg/day in patients who experience adverse reactions. Doses as high as 1.5 mg/kg/day have been studied, but there is no evidence that doses above 0.75 mg/kg/day provide greater efficacy (AAN [Gloss 2016]; Escolar 2011; Matthews 2016).

Giant cell arteritis (off-label use): Oral: Initial: 40 to 60 mg daily; typically requires 1 to 2 years of treatment, but may begin to taper after 2 to 3 months; alternative dosing of 30 to 40 mg daily has demonstrated similar efficacy (Hiratzka 2010).

Glucocorticoid remediable aldosteronism, treatment (off-label use): Oral: Initial: 2.5 to 5 mg once daily preferably at bedtime to suppress early morning ACTH surge (Funder 2016)

Gout, acute flares: Oral: 0.5 mg/kg/day for 5 to 10 days followed by discontinuation (ACR [Khanna 2012]) or 30 to 40 mg/day given once daily or in 2 divided doses until symptom improvement, followed by a 7- to 10-day taper (or 14- to 21-day taper in patients with multiple prior flares) (Becker 2018)

Graves orbitopathy (off-label use): Oral: 0.4 to 0.5 mg/kg/day, starting 1 to 3 days after radioactive iodine treatment, and continued for 1 month, then gradually taper over 2 months (Ross 2016).

Herpes zoster (off-label use): Oral: 60 mg daily for 7 days, followed by 30 mg daily for 7 days, then 15 mg daily for 7 days (Dworkin 2007).

Immune thrombocytopenia (off-label dose): Oral: 1 to 2 mg/kg/day (American Society of Hematology 1997).

Immune thrombocytopenia in pregnancy: Initial: 10 to 20 mg/day (ACOG 2016). 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 (ACOG 2016; Neunert 2011).

Lupus nephritis, induction (off-label dose): Oral:

Class III-IV lupus nephritis: 0.5 to 1 mg/kg/day (after glucocorticoid pulse) tapered after a few weeks to lowest effective dose, in combination with an immunosuppressive agent (Hahn 2012).

Class V lupus nephritis: 0.5 mg/kg/day for 6 months in combination mycophenolate mofetil; if not improved after 6 months, use 0.5 to 1 mg/kg/day (after a glucocorticoid pulse) for an additional 6 months in combination with cyclophosphamide (Hahn 2012).

Multiple myeloma (previously untreated; transplant ineligible) (off-label use): Oral:

≥65 years of age or <65 years and transplant-ineligible: 60 mg/m2/day for 4 days (days 1 to 4) every 6 weeks for 9 cycles (dexamethasone at a dose of 20 mg was substituted for prednisone on day 1 of each cycle) in combination with daratumumab, bortezomib and melphalan; after cycle 9, daratumumab is continued as a single agent (Mateos 2018) or 60 mg/m2/day for 4 days (days 1 to 4) every 6 weeks (in combination with bortezomib and melphalan) for 9 cycles (San Miguel 2008) or 2 mg/kg/day for 4 days (days 1 to 4) every 6 weeks (in combination with melphalan and thalidomide) for 12 cycles (Facon 2007)

≥65 years of age: 2 mg/kg/day for 4 days (days 1 to 4) every 6 weeks (in combination with melphalan) for 12 cycles (Facon 2006)

Multiple sclerosis, acute exacerbations:

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

Oral: 200 mg daily for 1 week, followed by 80 mg every other day for 1 month.

Pericarditis (off-label use):

Acute or recurrent pericarditis (alternative agent): Oral: 0.2 to 0.5 mg/kg/day for 2 to 4 weeks; then taper dose over 3 months (ESC [Adler 2015]; Imazio 2008; Imazio 2018).Note: Corticosteroids are not first line therapy; reserve as add-on therapy for patients with contraindications or incomplete response to aspirin/NSAIDs and colchicine (ESC [Adler 2015]).

Tuberculosis pericarditisOral: 1 to 2 mg/kg once daily for 5 to 7 days followed by 6 to 8 weeks of tapering (Maisch 2004) or 60 mg once daily for 4 weeks, followed by 30 mg once daily for 4 weeks, 15 mg once daily for 2 weeks, and 5 mg once daily for 1 week (Reuter 2006).

Pneumocystis pneumonia (adjunctive therapy) in HIV-infected patients (off-label dose): Oral: 40 mg twice daily for 5 days beginning as early as possible and within 72 hours of PCP therapy, followed by 40 mg once daily on days 6 through 10, followed by 20 mg once daily on days 11 through 21 (DHHS [adult] 2015).

Polymyalgia rheumatica (off-label dose): Oral: Evidence to support an optimal dose and duration are lacking; recommendations provided are general guidelines only. Individualize therapy using the minimum effective dose and duration (Dejaco [EULAR/ACR 2015]):

Initial: Dosage range: 12.5 to 25 mg daily; consider higher doses within this range for patients at high risk of relapse and low risk of adverse events; consider lower doses within this range for patients with high risk factors for side effects (eg, diabetes, osteoporosis, glaucoma). Single daily doses are preferred over divided daily doses. Avoid initial doses ≤7.5 mg/day or >30 mg/day.

Tapering: For initial dosing, taper to a dose of 10 mg/day within 4 to 8 weeks. If relapse occurs, increase dosing to the pre-relapse dose and gradually taper back to the dose which relapse occurred within 4 to 8 weeks. Once remission is achieved (initial or relapse therapy), taper daily dose by 1 mg every 4 weeks (or by 1.25 mg decrements if using schedules such as 10 mg and 7.5 mg on alternate days) until discontinuation.

Prostate cancer, metastatic (off-label use): Oral: 5 mg twice daily (in combination with abiraterone) until disease progression or unacceptable toxicity (de Bono 2011; Ryan 2015) or 10 mg once daily (in combination with cabazitaxel) for up to 10 cycles (de Bono 2010) or 5 mg twice daily (in combination with docetaxel) for up to 10 cycles (Berthold 2008; Tannock 2004).

Rheumatoid arthritis (off-label dose): Oral: ≤10 mg daily (American College of Rheumatology 2002).

Subacute thyroiditis (off-label use): Oral: Initial: 40 mg/day for 1 to 2 weeks; gradually taper over 2 to 4 weeks or longer depending on clinical response (Ross 2016).

Takayasu arteritis (off-label use): Oral: Initial: 40 to 60 mg daily; taper to lowest effective dose when ESR and CRP levels are normal; usual duration: 1 to 2 years (Hiratzka 2010).

Thyrotoxicosis, type 2 amiodarone-induced (off-label use): Oral: 40 mg once daily for 14 to 28 days; gradually taper over 2 to 3 months depending on clinical response. Note:Use in combination with an antithyroid agent if etiology of thyrotoxicosis (eg type 1 or type 2) cannot be unequivocally determined or if patient is too clinically unstable to allow a trial of monotherapy (Ross 2016).

Tuberculosis, severe, paradoxical reactions (off-label dose): Oral: 1 mg/kg/day, gradually reduce after 1 to 2 weeks (AIDSinfo guidelines 2008).

Dosing: Geriatric

Refer to adult dosing; use the lowest effective dose.

Dosing: Renal Impairment: Adult

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

Hemodialysis: Supplemental dose is not necessary.

Dosing: Hepatic Impairment: Adult

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

Dosing: Chemotherapy Regimens

Note: In the US, prednisone is the preferred corticosteroid. However, in the British literature, prednisolone is often used. The oral doses of these two agents are equivalent (ie, 1 mg prednisone = 1 mg prednisolone). Also, early clinical trials gave prednisone only with the first and fourth cycles. Some clinicians give prednisone with every cycle.

Brain tumors: POC

Leukemia, acute lymphocytic:

CALGB 8811 Regimen (ALL)

CALGB 9111 Regimen (ALL)

Hyper-CVAD + Imatinib

Hyper-CVAD (Leukemia, Acute Lymphocytic)

Linker Protocol (ALL)

MTX/6-MP/VP (Maintenance)

POMP

Leukemia, chronic lymphocytic: Chlorambucil-Prednisone (CLL)

Lymphoma, Hodgkin:

BEACOPP-14 (Hodgkin)

BEACOPP Escalated (Hodgkin)

BEACOPP Escalated Plus Standard (Hodgkin)

BEACOPP Standard (Hodgkin)

C-MOPP/ABV Hybrid (Hodgkin)

Stanford V (Hodgkin)

VAMP (Hodgkin)

Lymphoma, non-Hodgkin:

EPOCH Dose-Adjusted (NHL)

EPOCH (Dose-Adjusted)-Rituximab (NHL)

PEP-C (NHL)

Lymphoma, non-Hodgkin (AIDS-Related):

CHOP (NHL-AIDS-Related)

EPOCH Dose-Adjusted (NHL-AIDS-Related)

EPOCH Dose-Adjusted-Rituximab (NHL-AIDS-Related)

Lymphoma, non-Hodgkin (DLBCL):

CEPP (NHL-DLBCL)

R-CHOP (NHL-DLBCL)

Lymphoma, non-Hodgkin (Follicular):

R-CHOP (NHL-Follicular)

R-CVP (NHL-Follicular)

Lymphoma, non-Hodgkin (Mantle Cell):

PEP-C (NHL-Mantle Cell)

VcR-CAP (NHL-Mantle Cell)

Multiple myeloma:

Daratumumab-Bortezomib-Melphalan-Prednisone (Multiple Myeloma)

Melphalan-Prednisone (Multiple Myeloma)

Melphalan-Prednisone-Thalidomide (Multiple Myeloma)

Prostate cancer:

Abiraterone-Prednisone (Prostate)

Cabazitaxel-Prednisone (Prostate)

Docetaxel-Prednisone (Prostate)

Mitoxantrone-Prednisone (Prostate)

Waldenstrom Macroglobulinemia: R-CHOP (Waldenstrom Macroglobulinemia)

Dosing: Pediatric

Note: All pediatric dosing based on immediate release products. Dose depends upon condition being treated and response of patient; dosage for infants and children should be based on disease severity and patient response rather than by rigid adherence to dosage guidelines by age, weight, or body surface area. Consider alternate day therapy for long-term therapy. Discontinuation of long-term therapy requires gradual withdrawal by tapering the dose.

General dosing; anti-inflammatory or immunosuppressive: Infants, Children, and Adolescents: Oral 0.05 to 2 mg/kg/day divided every 6 to 24 hours (Bertsias 2012; Kliegman 2007)

Asthma, acute exacerbation:

NAEPP 2007:

Infants and Children <12 years: Oral:

Emergency care or hospital doses: 1 to 2 mg/kg/day in 2 divided doses; maximum daily dose: 60 mg/day; continue until peak expiratory flow is 70% of predicted or personal best

Short-course “burst” (Outpatient): 1 to 2 mg/kg/day in divided doses 1 to 2 times daily for 3 to 10 days; maximum daily dose: 60 mg/dayNote: Burst should be continued until symptoms resolve or patient achieves peak expiratory flow 80% of personal best; usually requires 3 to 10 days of treatment (~5 days on average); longer treatment may be required

Children ≥12 years and Adolescents: Oral:

Emergency care or hospital doses: 40 to 80 mg/day in divided doses 1 to 2 times daily until peak expiratory flow is 70% of predicted or personal best

Short-course “burst” (Outpatient): 40 to 60 mg/day in divided doses 1 to 2 times daily for 3 to 10 days; Note: Burst should be continued until symptoms resolve and peak expiratory flow is at least 80% of personal best; usually requires 3 to 10 days of treatment (~5 days on average); longer treatment may be required

GINA 2014:

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 2 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

Asthma, maintenance therapy (nonacute) (NAEPP 2007):

Infants and Children <12 year: Oral: 0.25 to 2 mg/kg/day administered 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 administered as a single dose in the morning or every other day as needed for asthma control

Autoimmune hepatitis (monotherapy or in combination with azathioprine): Limited data available: Infants, Children, and Adolescents: Oral: Initial: 1 to 2 mg/kg/day for 2 weeks; maximum daily dose: 60 mg/day; taper upon response over 6 to 8 weeks to a dose of 0.1 to 0.2 mg/kg/day or 2.5 to 5 mg daily; an alternate day schedule to decrease risk of adverse effect has been used; however, a higher incidence of relapse has been observed in some cases and use is not suggested (AASLD [Manns 2010]; Della Corte 2012).

Bell palsy: Limited data available:

Infants, Children, and Adolescents <16 years: Oral: 1 mg/kg/day for 1 week, then taper over 1 week; ideally start within the 72 hours of onset of symptoms; maximum daily dose: 60 mg/day (Kliegman 2011)

Adolescents ≥16 years: Oral: 60 mg daily for 5 days, followed by a 5-day taper. Treatment should begin within 72 hours of onset of symptoms (OHNS [Baugh 2013]).

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 (AAP 2000; Endocrine Society [Speiser] 2010):

Infants, Children and Adolescents (actively growing): Not recommended because impedes statural growth more so than shorter-acting systemic glucocorticoid (ie, hydrocortisone) (Endocrine Society [Speiser] 2010)

Adolescents (fully grown): Oral: 5 to 7.5 mg daily in divided doses 2 times daily (Endocrine Society [Speiser] 2010)

Crohn disease: 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 (Kliegman 2011; Rufo 2012; Sandhu 2010)

Dermatomyositis, moderately severe; initial treatment: Limited data available: Children and Adolescents: Oral: Initial: 2 mg/kg/day divided once or twice daily; maximum daily dose: 60 mg/day; continue for 4 weeks then if adequate patient response, begin taper; most recommend an initial 20% reduction in dose with subsequent wean based upon response; use in combination with other immunosuppressants (eg, methotrexate) (CARRA [Huber 2010])

Immune thrombocytopenia (ITP): Infants, Children, and Adolescents: Oral: 1 to 2 mg/kg/day; titrate dose according to platelet count; when and if able, a rapid taper is recommended; a maximum duration of therapy of 14 days has been suggested; others have used a higher dose with shorter course of 4 mg/kg/day for 3 to 4 days (Neunert 2011; Provan 2010)

Juvenile idiopathic arthritis: Infants ≥ 6 months, Children and Adolescents: Oral: Initial: 1 mg/kg/day administered once daily (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 prednisone, if unchanged then continue current prednisone 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 prednisone 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 (prednisone dose <50% starting dose), continue taper and reassess monthly; if patient remains unchanged (prednisone dose >50% of starting dose) or worsened, additional therapy should be considered (CARRA [Dewitt 2012])

Lupus nephritis: Children and Adolescents: Oral: Initial therapy:

With concurrent methylprednisolone pulse therapy: Prednisone: 0.5 to 1.5 mg/kg/day; maximum daily dose: 60 mg/day, taper usually over 6 months to a dose ≤10 mg/day according to clinical response; use in combination with cyclophosphamide or mycophenolate (Bertsias 2012; KDIGO 2012; KDOQI 2013; Mina 2012)

Without concurrent methylprednisolone pulse therapy: Prednisone: 2 mg/kg/day for 6 weeks, maximum daily dose variable: for weeks 1 to 4: maximum daily dose: 80 mg/dayand for weeks 5 and 6: 60 mg/day; taper over 6 months; use in combination with cyclophosphamide or mycophenolate (Mina 2012)

Malignancy (antineoplastic): Note: Used for various types of malignancy and neoplasm; see specific protocols for details concerning dosing in combination regimens.

Hodgkin lymphoma (BEACOPP regimen): Children and Adolescents: Oral: 40 mg/m2/day in 2 divided doses on days 0 to 13; in combination with bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, and procarbazine (Kelly 2002; Kelly 2011)

Nephrotic syndrome; steroid-sensitive (SSNS): Children and Adolescents: Note: Obese patients should be dosed based on ideal body weight: Oral:

Initial episode: 2 mg/kg/day or 60 mg/m2/day once daily, maximum daily dose: 60 mg/day for 4 to 6 weeks; then adjust to an alternate-day schedule of 1.5 mg/kg/dose or 40 mg/m2/dose on alternate days as a single dose, maximum dose: 40 mg/dose (Gipson 2009; KDIGO 2012; KDOQI 2013); duration of therapy based on patient response.

Relapse: 2 mg/kg/day or 60 mg/m2/day once daily, maximum daily dose: 60 mg/day continue until complete remission for at least 3 days; then adjust to an alternate-day schedule of 1.5 mg/kg/dose or 40 mg/m2/dose on alternate days as a single dose, maximum dose: 40 mg/dose, recommended duration of alternate day dosing is variable: may continue for at least 4 weeks then taper. Longer duration of treatment may be necessary in patients who relapse frequently, some patients may require up to 3 months of treatment (Gipson 2009; KDIGO 2012; KDOQI 2013).

Maintenance therapy for frequently relapsing SSNS: Taper previous dose down to lowest effective dose which maintains remission using an alternate day schedule; usual effective range: 0.1 to 0.5 mg/kg/dose on alternating days; other patients may require doses up to 0.7 mg/kg/dose every other day (KDIGO 2012, KDOQI 2013)

Physiologic replacement: Children and Adolescents: Oral: 2 to 2.5 mg/m2/day (Ahmet 2011; Gupta 2008). Note: Hydrocortisone is generally preferred in growing children and adolescents due to its lower growth suppressant effects compared to prednisone (Gupta 2008).

Pneumocystis jirovecii pneumonia (PCP), treatment; HIV-exposed/-positive: Note: Begin as soon as possible after diagnosis and within 72 hours of PCP therapy initiation.

Infants and Children: Oral: 1 mg/kg/dose twice daily on days 1 to 5, then 0.5 to 1 mg/kg/dose twice daily on days 6 to 10, then 0.5 mg/kg/dose once daily for days 11 to 21 (DHHS [pediatric] 2013)

Adolescents: Oral: 40 mg twice daily on days 1 to 5, followed by 40 mg once daily on days 6 to 10, followed by 20 mg once daily on days 11 to 21 or until antimicrobial regimen is completed (DHHS [adult] 2014).

Ulcerative colitis: Children and Adolescents: Oral: 1 to 2 mg/kg/day administered in the morning; maximum daily dose: 60 mg/day; if no response after 7 to 14 days optimal dosing and compliance should be assessed (Kliegman 2011; Rufo 2012; Turner 2012)

Dosing: Renal Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling. Prednisone is inactive and must be metabolized by the liver to prednisolone. This conversion may be impaired in patients with liver disease; however, prednisolone levels are observed to be higher in patients with severe liver failure than in normal patients. Therefore, compensation for the inadequate conversion of prednisone to prednisolone occurs.

Use: Labeled Indications

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in drug hypersensitivity reactions, seasonal or perennial allergic rhinitis; serum sickness.

Dermatologic diseases: Atopic dermatitis; bullous dermatitis herpetiformis; contact dermatitis; exfoliative dermatitis/erythroderma; mycosis fungoides; pemphigus; severe erythema multiforme (Stevens-Johnson syndrome).

Immediate-release only: Severe psoriasis, severe seborrheic dermatitis.

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

GI diseases: During acute episodes in regional enteritis (Crohn disease) and ulcerative colitis.

Hematologic disorders: Acquired (autoimmune) hemolytic anemia; congenital (erythroid) hypoplastic anemia/Diamond-Blackfan anemia; immune thrombocytopenia (formerly known as idiopathic thrombocytopenic purpura) in adults; secondary thrombocytopenia in adults.

Delayed-release only: Pure red cell aplasia.

Immediate-release only: Erythroblastopenia (red blood cell anemia).

Neoplastic diseases:

Delayed-release only: Treatment of acute leukemia and aggressive lymphomas.

Immediate-release only: Palliative management of leukemias and lymphomas in adults; acute leukemia of childhood.

Nervous system (delayed-release only): Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Note: Treatment guidelines recommend the use of high dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (Scott 2011; NICE 2014).

Ophthalmic diseases:

Delayed-release only: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as sympathetic ophthalmia; uveitis and ocular inflammatory conditions unresponsive to topical steroids.

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

Renal diseases: To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that is caused by lupus erythematosus.

Respiratory diseases: Aspiration pneumonitis; asthma; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy; symptomatic sarcoidosis.

Delayed-release only: Acute exacerbations of chronic obstructive pulmonary disease (COPD); allergic bronchopulmonary aspergillosis; hypersensitivity pneumonitis; idiopathic bronchiolitis obliterans with organizing pneumonia; idiopathic eosinophilic pneumonias; idiopathic pulmonary fibrosis; Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV-positive individual who is also under treatment with appropriate anti-PCP antibiotics.

Immediate-release only: Berylliosis; Loeffler syndrome not manageable by other means.

Rheumatic disorders:

Maintenance therapy:

Delayed-release only: During an exacerbation or as maintenance therapy in selected cases of ankylosing spondylitis, dermatomyositis/polymyositis, polymyalgia rheumatica, psoriatic arthritis, relapsing polychondritis, rheumatoid arthritis including juvenile rheumatoid arthritis, Sjögren syndrome, systemic lupus erythematosus, vasculitis.

Immediate-release only: During an exacerbation or as maintenance therapy in selected cases of acute rheumatic carditis, systemic dermatomyositis (polymyositis), systemic lupus erythematosus.

Short-term therapy:

Delayed release only: As adjunctive therapy for short-term administration in acute gout flares.

Immediate-release only: As adjunctive therapy for short-term administration in acute and subacute bursitis; acute gout flares; acute nonspecific tenosynovitis; ankylosing spondylitis; epicondylitis; posttraumatic osteoarthritis; psoriatic arthritis; rheumatoid arthritis including juvenile rheumatoid arthritis; synovitis of osteoarthritis.

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

Delayed-release only: Acute or chronic solid organ rejection.

Use: Off-Label: Adult

  Autoimmune hepatitisLevel of Evidence [B, G]

Data from randomized, double-blind, prospective studies support the use of prednisone alone or in combination with azathioprine for the treatment of autoimmune hepatitis Ref.

Based on the American Association for the Study of Liver Diseases (AASLD) guidelines for the diagnosis and management of autoimmune hepatitis, the use of prednisone alone or in combination with azathioprine is an effective and recommended regimen in the management of this condition.

  Bell palsyLevel of Evidence [G]

Based on the American Academy of Otolaryngology, Head and Neck Surgery, Clinical Practice Guideline: Bell’s Palsy, prednisone given for Bell palsy is effective and recommended in the management of this condition.

  Chronic obstructive pulmonary disease (COPD) (acute exacerbation)Level of Evidence [G]

Based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018 update to the guidelines for the management of COPD, prednisone given for acute exacerbation of COPD is effective and recommended in the management of this condition. Short-term treatment with systemic corticosteroids has been shown to reduce recovery time, risk of early relapse, treatment failure, and length of hospital stay, as well as to improve lung function. However, long-term use is associated with significant adverse effects Ref.

  Duchenne muscular dystrophyLevel of Evidence [B, G]

Data from a meta-analysis, randomized controlled trials and retrospective cohort studies supports the use of prednisone for increasing muscular strength and function, improving pulmonary function, decreasing timed motor function, delaying development of scoliosis or cardiomyopathy, and delaying surgery for scoliosis in patients with Duchenne muscular dystrophy Ref.

Based on the American Academy of Neurology guidelines for corticosteroid treatment of Duchenne muscular dystrophy, prednisone probably improves muscle strength and pulmonary function and possibly improves timed motor function, slows the development of scoliosis, reduces the need for scoliosis surgery by age 18, and delays the onset of cardiomyopathy Ref.

  Glucocorticoid remediable aldosteronism, treatmentLevel of Evidence [G]

Based on the Endocrine Society guidelines for the management of primary aldosteronism, prednisone is an effective and recommended treatment to lower ACTH levels in patients with glucocorticoid remediable aldosteronism.

  Graves orbitopathyLevel of Evidence [G]

Based on the American Thyroid Association guidelines for the diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis, glucocorticoids may be used in select patients being treated with radioiodine therapy to delay development or progression of Graves orbitopathy (GO). Glucocorticoids should be used in patients with active and mild GO who have additional risk factors for worsening GO and may be considered in patients with active and mild GO but without additional risk factors. In patients who smoke but who have no evidence of GO, there is insufficient evidence to recommend for or against prophylactic use of glucocorticoids. Glucocorticoids should not be used in patients with inactive GO or as prophylaxis in patients who do not smoke.

  Multiple myeloma (previously untreated; transplant-ineligible)Level of Evidence [A]

Data from a large multicenter randomized phase III study support the use of prednisone as a treatment component (in combination with daratumumab, bortezomib and melphalan) in the management of previously untreated multiple myeloma in patients who are ineligible for autologous stem cell transplant Ref. Data from a randomized phase III study support the use of prednisone as a treatment component (in combination with bortezomib and melphalan) for management of symptomatic multiple in previously untreated patients who were not candidates for transplantation Ref. Data from another large randomized phase III study support the use of prednisone as a treatment component (in combination with melphalan and thalidomide) for management of multiple myeloma in elderly patients who are ineligible for transplant Ref. A multicenter randomized parallel study supports the use of prednisone (in combination with melphalan) as a treatment option in previously untreated elderly patients with multiple myeloma who are not transplant candidates Ref.

  PericarditisLevel of Evidence [B, G]

Use of corticosteroids in the treatment of pericarditis remains controversial. The European Society of Cardiology (ESC) Guidelines for the diagnosis and management of pericardial diseases state that systemic corticosteroids are not first line agents for acute or recurrent pericarditis and should only be considered in patients with contraindications or failure on a non-steroidal anti-inflammatory agent and colchicine. Infectious etiologies of pericarditis should be ruled out before initiating corticosteroids, with the exception of tuberculous pericarditis. Corticosteroids may be considered in patients with or at high risk for constrictive tuberculous pericarditis Ref, especially in HIV-seronegative patients Ref. It is important to note that if prednisone is used, it should be started at the appropriate dose and tapered off slowly. Access Full Off-Label Monograph

  Prostate cancer (metastatic)Level of Evidence [A]

Data from 2 large randomized phase III studies support the use of prednisone (in combination with abiraterone) in the treatment of metastatic castration-resistant prostate cancer Ref. Data from a randomized phase III study supports the use of prednisone (in combination with cabazitaxel) in the treatment of metastatic castration-resistant prostate cancer which has progressed during or following docetaxel-based therapy Ref. Data from a randomized phase III study supports the use of prednisone (in combination with docetaxel) in the treatment of hormone-refractory metastatic prostate cancer Ref.

  Thyroiditis, subacuteLevel of Evidence [G]

Based on the American Thyroid Association guidelines for the diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis, corticosteroids are recommended for the treatment of subacute thyroiditis in patients who fail to respond to initial NSAID therapy or in patients with moderate to severe pain and/or thyrotoxic symptoms on initial presentation.

  Thyrotoxicosis (type 2 amiodarone-induced)Level of Evidence [G]

Based on the American Thyroid Association guidelines for the diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis, corticosteroid therapy is recommended in patients with overt thyrotoxicosis (type 2 amiodarone-induced). Use in combination with an antithyroid agent if etiology of thyrotoxicosis (eg type 1 or type 2) cannot be unequivocally determined or if patient is too clinically unstable to allow a trial of monotherapy.

  Additional Off-Label Uses

Adjunctive therapy for pain management in immunocompetent patients with herpes zoster; Takayasu arteritis; Giant cell arteritis

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Asthma:

Canadian Thoracic Society, “Asthma Management Continuum – 2010 Consensus Summary for Children Six Years of Age and over, and Adults,” January/February 2010

Global Strategy for Asthma Management and Prevention (GINA), 2018 Update

NHLBI and NAEPP, The Expert Panel Report 3: “Guidelines for the Diagnosis and Management of Asthma,” Full Report 2007

Autoimmune Hepatitis:

AASLD, Diagnosis and Management of Autoimmune Hepatitis, June 2010

Bell Palsy:

American Academy of Neurology, “Evidence-based Guideline Update: Steroids and Antivirals for Bell Palsy, 2012

American Academy of Otolaryngology, Head and Neck Surgery, Clinical Practice Guideline: Bell’s Palsy, 2013

Bronchiolitis Obliterans Syndrome:

International Society for Heart and Lung Transplantation, American Thoracic Society, and European Respiratory Society (ISHLT/STS/ERS), “An International ISHLT/ATS/ERS Clinical Practice Guideline: Diagnosis and Management of Bronchiolitis Obliterans Syndrome,” August 2014

Congenital Adrenal Hyperplasia:

The Endocrine Society, Congenital Adrenal Hyperplasia Due to Steroid 21-Hydroxylase Deficiency, November 2018

COPD:

ACCP/CTS, “Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease: American College of Chest Physicians and Canadian Thoracic Society Guideline,” 2014

Canadian Thoracic Society Recommendations for Management of Chronic Obstructive Pulmonary Disease, 2007 Update

Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD), 2018 Update

Crohn Disease:

American College of Gastroenterology (ACG), “Management of Crohn’s Disease in Adults,” March 2018

Duchenne Muscular Dystrophy:

American Academy of Neurology, “Practice Guideline Update Summary: Corticosteroid Treatment of Duchenne Muscular Dystrophy,” 2016

Gout:

3e Initiative, Guidelines for the Management of Gout, 2014

American College of Rheumatology (ACR), Guideline for the Management of Acute Gout, 2012

EULAR, 2016 Updated Recommendations for the Management of Gout, 2016

Hyperthyroidism:

ATA, “Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis,” 2016.

Hypopituitarism:

Endocrine Society, “Hormonal Replacement in Hypopituitarism in Adults,” 2016

Juvenile Idiopathic Arthritis:

American College of Rheumatology, “2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis,” 2013

Lupus Nephritis:

American College of Rheumatology, “American College of Rheumatology Guidelines for Screening, Treatment, and Management of Lupus Nephritis,” June 2012

Neurocysticercosis:

IDSA/ASTMH, “Diagnosis and Treatment of Neurocysticercosis,” 2018

Oncology:

American Society of Clinical Oncology (ASCO)/Cancer Care Ontario Practice Guideline, “Systemic Therapy in Men with Metastatic Castration-Resistant Prostate Cancer,” September 2014

National Comprehensive Cancer Network® (NCCN), Clinical Practice Guidelines in Oncology™, Prostate Cancer

Opportunistic Infections:

HHS, Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV-Exposed and HIV-Infected Children, November 2013Note: Information contained within this monograph is pending revision based on these more recent guidelines.

HHS, Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, September 2015

Pericarditis:

ESC, Guidelines for the diagnosis and management of pericardial diseases: The task force for the diagnosis and management of pericardial disease of the European Society of Cardiology (ESC), November 2015

Polymyalgia Rheumatica:

European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR), “2015 Recommendations for the Management of Polymyalgia Rheumatica,” 2015

Primary Aldosteronism:

Endocrine Society, “The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment,” March 2016

Thoracic Aortic Disease:

“ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM Guidelines for the Diagnosis and Management of Patients with Thoracic Aortic Disease,” March 2010

Ulcerative Colitis:

ACG “Ulcerative Colitis Practice Guidelines in Adults,” January 2010

Administration: Oral

Administer after meals or with food or milk to decrease GI upset. May administer antacids between meals to help prevent peptic ulcers.

Delayed-release tablets: Swallow whole; do not break, divide, crush, or chew.

Oral solution, concentrate: Administer only with provided calibrated dropper.

Administration: Pediatric

Oral: Administer after meals or with food or milk to decrease GI upset. Delayed release tablet (Rayos) should be swallowed whole; do not crush, divide, or chew.

Dietary Considerations

May require increased dietary intake of pyridoxine, vitamin C, vitamin D, folate, calcium, and phosphorus; may require decreased dietary intake of sodium and potassium supplementation

Storage/Stability

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.

Oral solution, concentrate: Discard opened bottle after 90 days.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, insomnia, or agitation. Have patient report immediately to prescriber signs of infection; signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit); signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss); signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat); signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting); signs of skin changes (acne, stretch marks, slow healing, or hair growth); signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities); severe loss of strength and energy; irritability; tremors; tachycardia; confusion; sweating a lot; dizziness; shortness of breath; excessive weight gain; swelling of arms or legs; round face; buffalo hump; severe headache; bradycardia; abnormal heartbeat; angina; menstrual changes; joint pain; bone pain; vision changes; mood changes; behavioral changes; depression; seizures; burning or numbness feeling; bruising; bleeding; severe abdominal pain; black, tarry, or bloody stools; or vomiting blood (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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

Hypersensitivity to prednisone or any component of the formulation; administration of live or live attenuated vaccines with immunosuppressive doses of prednisone; systemic fungal infections

Canadian labeling: Additional contraindications (not in US labeling): Herpes simplex of the eye, measles, or chickenpox (except when being used for short-term or emergency therapy); peptic ulcer; nonspecific ulcerative colitis; diverticulitis; viral or bacterial infection not controlled by anti-infectives

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

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. 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: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to killed or inactivated vaccines. Exposure to chickenpox or measles should be avoided. Corticosteroids should not be used to treat viral hepatitis or cerebral malaria. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only fulminating or disseminated TB in conjunction with antituberculosis treatment). Latent or active amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to corticosteroid initiation. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination and fatalities have occurred.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

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

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including euphoria, insomnia, mood swings, personality changes, severe depression or 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; long-term use has been associated with electrolyte disturbances, fluid retention, and hypertension. Use with caution in patients with a recent history of myocardial infarction (MI); left ventricular free wall rupture has been reported after the use of corticosteroids.

• 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 [nonspecific]) due to perforation risk.

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

• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; effects may be enhanced.

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

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Use with caution in patients with a history of ocular herpes simplex; corneal perforation has occurred; do not use in active ocular herpes simplex. Consider routine eye exams in chronic users.

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

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

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

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

Concurrent drug therapy issues:

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

Special populations:

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

• Pediatric: May affect growth velocity; growth and development 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 [“Inactive” 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).

Geriatric Considerations

Because of the risk of adverse effects, systemic corticosteroids should be used cautiously in the elderly, in the smallest possible dose, and for the shortest possible time. For long-term use, monitor bone mineral density and institute fracture prevention strategies.

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 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.

Pregnancy Risk Factor

C/D (product specific)

Pregnancy Considerations

Adverse events have been observed with corticosteroids in animal reproduction studies. Prednisone and its metabolite, prednisolone, cross the human placenta. In the mother, prednisone is converted to the active metabolite prednisolone by the liver. Prior to reaching the fetus, prednisolone is converted by placental enzymes back to prednisone. As a result, the level of prednisone remaining in the maternal serum and reaching the fetus are similar; however, the amount of prednisolone reaching the fetus is ~8 to 10 times lower than the maternal serum concentration (healthy women at term) (Beitins 1972).

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

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

For dermatologic disorders in pregnant women, systemic corticosteroids are generally not preferred for initial therapy; should be avoided during the first trimester; and used during the second or third trimester at the lowest effective dose (Bae 2012; Leachman 2006). Prednisone is preferred by some guidelines when an oral corticosteroid is needed because placental enzymes limit passage to the embryo (Murase 2014).

Pregnant women with poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used medications. Uncontrolled asthma is associated with an increased risk of perinatal mortality, preeclampsia, preterm birth, and low birth weight infants. Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy; however, systemic corticosteroids, including prednisone, should be used to control acute exacerbations or treat severe persistent asthma (ACOG 2008; GINA 2018; Namazy 2016).

Prednisone may be used to treat lupus nephritis in pregnant women who have active nephritis or substantial extrarenal disease activity (Hahn 2012). Prednisone is recommended for use in fetal-neonatal alloimmune thrombocytopenia and pregnancy-associated immune thrombocytopenia (ACOG 2016). Prednisone may be used (alternative agent) to treat primary adrenal insufficiency (PAI) in pregnant women. Pregnant women with PAI should be monitored at least once each trimester (Endocrine Society [Bornstein 2016]).

The Transplant Pregnancy Registry International (TPR) is a registry that follows pregnancies that occur in maternal transplant recipients or those fathered by male transplant recipients. The TPR encourages reporting of pregnancies following solid organ transplant by contacting them at 1-877-955-6877 or https://www.transplantpregnancyregistry.org.

Breast-Feeding Considerations

Prednisone and its metabolite, prednisolone, are present in breast milk. Actual concentrations are dependent upon maternal dose (Berlin 1979; Katz 1975; Sagraves 1981). Peak concentrations of prednisone and prednisolone in breast milk occur ~2 hours after an oral maternal dose (Berlin 1979; Sagraves 1981); the half-life in breast milk is 1.9 hours (prednisone) and 4.2 hours (prednisolone) (Sagraves 1981).

In a study which included six mother-infant pairs, adverse events were not observed in nursing infants (maternal prednisone dose not provided) (Ito 1993).

The manufacturer notes that when used systemically, maternal use of corticosteroids have the potential to cause adverse events in a breastfeeding infant (eg, growth suppression, interfere with endogenous corticosteroid production) and therefore, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother. Corticosteroids are generally considered acceptable in breastfeeding women when used in usual doses (Götestam Skorpen 2016; WHO 2002); however, monitoring of the breastfeeding infant is recommended (WHO 2002). Prednisone is one of the oral corticosteroids preferred for use in breastfeeding women (Butler 2014). If there is concern about exposure to the infant, some guidelines recommend waiting 4 hours after the maternal dose of an oral systemic corticosteroid before breastfeeding in order to decrease potential exposure to the breastfeeding infant (based on a study using prednisolone) (Bae 2012; Butler 2014; Götestam Skorpen 2016; Leachman 2006; Makol 2011; Ost 1985).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency not defined.

Cardiovascular: Cardiac failure (in susceptible patients), hypertension

Central nervous system: Emotional lability, headache, increased intracranial pressure (with papilledema), myasthenia, psychiatric disturbance (including euphoria, insomnia, mood swings, personality changes, severe depression), seizure, vertigo

Dermatologic: Diaphoresis, facial erythema, skin atrophy, urticaria

Endocrine & metabolic: Cushing’s syndrome, decreased serum potassium, diabetes mellitus, fluid retention, growth suppression (children), hypokalemic alkalosis, hypothyroidism (enhanced), menstrual disease, negative nitrogen balance (due to protein catabolism), sodium retention

Gastrointestinal: Abdominal distention, carbohydrate intolerance, pancreatitis, peptic ulcer (with possible perforation and hemorrhage), ulcerative esophagitis

Hematologic & oncologic: Bruise, Kaposi’s sarcoma, petechia

Hepatic: Increased serum alkaline phosphatase, increased serum ALT, increased serum AST

Hypersensitivity: Anaphylaxis, hypersensitivity reaction

Infection: Infection

Neuromuscular & skeletal: Amyotrophy, aseptic necrosis of bones (femoral and humeral heads), osteoporosis, pathological fracture (long bones), rupture of tendon (particularly Achilles tendon), steroid myopathy, vertebral compression fracture

Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, subcapsular posterior cataract

Miscellaneous: Wound healing impairment

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

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

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

Drug Interactions 

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

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

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

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

Antacids: May decrease the bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects. Risk D: Consider therapy modification

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

Aprepitant: May increase the serum concentration of Corticosteroids (Systemic). Management: No dose adjustment is needed for single 40 mg aprepitant doses. For other regimens, reduce oral dexamethasone or methylprednisolone doses by 50%, and IV methylprednisolone doses by 25%. Antiemetic regimens containing dexamethasone reflect this adjustment. Risk D: Consider therapy modification

Axicabtagene Ciloleucel: Corticosteroids (Systemic) may diminish the therapeutic effect of Axicabtagene Ciloleucel. Management: Avoid use of corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity. Risk D: Consider therapy modification

Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Risk D: Consider therapy modification

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

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

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

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

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy

Cosyntropin: Corticosteroids (Systemic) may diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy

CycloSPORINE (Systemic): May increase serum concentrations of the active metabolite(s) of PredniSONE. PredniSONE may decrease the serum concentration of CycloSPORINE (Systemic). PredniSONE may increase the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of PredniSONE. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of PredniSONE. Risk C: Monitor therapy

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

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

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

Desirudin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Risk D: Consider therapy modification

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

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

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

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

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Risk D: Consider therapy modification

Fluconazole: May increase the serum concentration of PredniSONE. Risk C: Monitor therapy

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

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Risk D: Consider therapy modification

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

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

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

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Risk D: Consider therapy modification

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Ritonavir: May increase the serum concentration of PredniSONE. Risk C: Monitor therapy

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

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

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

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

Somatropin: May diminish the therapeutic effect of PredniSONE. Growth hormone may reduce the conversion of prednisone to the active prednisolone metabolite. Risk D: Consider therapy modification

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

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

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

Tesamorelin: May decrease serum concentrations of the active metabolite(s) of PredniSONE. Risk D: Consider therapy modification

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

Tisagenlecleucel: Corticosteroids (Systemic) may diminish the therapeutic effect of Tisagenlecleucel. Management: Avoid use of corticosteroids as premedication or at any time during treatment with tisagenlecleucel, except in the case of life-threatening emergency (such as resistant cytokine release syndrome). Risk D: Consider therapy modification

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Risk D: Consider therapy modification

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

Urea Cycle Disorder Agents: Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range.Risk C: Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Risk D: Consider therapy modification

Vaccines (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Risk D: Consider therapy modification

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

Test Interactions

Decreased response to skin tests

Monitoring Parameters

Blood pressure; weight; serum glucose; electrolytes; growth in pediatric patients; presence of infection, bone mineral density; assess HPA axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test); Hgb, occult blood loss, leukopenia and thrombocytopenia (every 6 months when used in combination with azathioprine [Manns 2010]); chest x-ray (at regular intervals during prolonged therapy); IOP with therapy >6 weeks, eye examination (periodically during therapy [Manns 2010]).

Advanced Practitioners Physical Assessment/Monitoring

Obtain hemoglobin, occult blood loss, electrolytes, and blood glucose. Monitor growth with long-term use in pediatric patients. Assess for signs and symptoms of HPA axis suppression/adrenal insufficiency or infection. Assess for ocular changes and obtain IOP with therapy >6 weeks. Obtain chest x-ray at regular intervals in patients on prolonged therapy. Assess other medicines patient may be taking; alternate therapy or dosage adjustments may be needed.

Nursing Physical Assessment/Monitoring

Check ordered labs and tests and report abnormalities. Caution patients with diabetes to monitor glucose levels closely. Educate patient to monitor weight and report excessive gains/losses; signs of infection, or visual changes. Monitor growth in children closely. Educate patient about alerting surgeons and other healthcare providers to use.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Concentrate, Oral:

predniSONE Intensol: 5 mg/mL (30 mL) [contains alcohol, usp; unflavored flavor]

Solution, Oral:

Generic: 5 mg/5 mL (120 mL, 500 mL)

Tablet, Oral:

Deltasone: 20 mg [scored; contains fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

Generic: 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 50 mg

Tablet Delayed Release, Oral:

Rayos: 1 mg, 2 mg, 5 mg

Tablet Therapy Pack, Oral:

Generic: 10 mg (21 ea, 48 ea); 5 mg (21 ea, 48 ea)

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Winpred: 1 mg

Generic: 1 mg, 5 mg, 50 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • A07EA03
  • H02AB07
Generic Available (US)

May be product dependent

Pricing: US

Concentrate (predniSONE Intensol Oral)

5 mg/mL (per mL): $5.20

Solution (predniSONE Oral)

5 mg/5 mL (per mL): $0.80

Tablet Therapy Pack (predniSONE Oral)

5MG (21) (per each): $0.80

5MG (48) (per each): $0.58

10MG (21) (per each): $1.39

10MG (48) (per each): $0.86

Tablet, EC (Rayos Oral)

1 mg (per each): $105.32

2 mg (per each): $105.32

5 mg (per each): $105.32

Tablets (Deltasone Oral)

20 mg (per each): $6.00

Tablets (predniSONE Oral)

1 mg (per each): $0.25 – $0.63

2.5 mg (per each): $0.16 – $0.18

5 mg (per each): $0.20 – $0.73

10 mg (per each): $0.21 – $0.91

20 mg (per each): $0.16 – $1.50

50 mg (per each): $0.41 – $0.42

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.

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; suppresses adrenal function at high doses. Antitumor effects may be related to inhibition of glucose transport, phosphorylation, or induction of cell death in immature lymphocytes. Antiemetic effects are thought to occur due to blockade of cerebral innervation of the emetic center via inhibition of prostaglandin synthesis.

Pharmacodynamics/Kinetics

Absorption: 50% to 90% (may be altered in hepatic failure, chronic renal failure, inflammatory bowel disease, hyperthyroidism, and in the elderly) (Frey 1990)

Protein binding (concentration dependent): <50% (Frey 1990)

Metabolism: Hepatic to metabolite prednisolone (active)

Half-life elimination: 2 to 3 hours

Time to peak: Oral: Immediate-release tablet: 2 hours; Delayed-release tablet: 6 to 6.5 hours

Excretion: Urine (as conjugates)

Pharmacodynamics/Kinetics: Additional Considerations

Hepatic function impairment: Prednisone is inactive and must be metabolized by the liver to prednisolone. This conversion may be impaired in patients with liver disease; however, prednisolone levels are observed to be higher in patients with severe liver failure than in normal patients.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Dental Health Professional Considerations

Preoperative steroid use, particularly in patient on longer term corticosteroids (>2 weeks), increases the risk of infection and delays wound healing.

Effects on Dental Treatment

No significant effects or complications reported (see Dental Health Professional Considerations)

Effects on Bleeding

No information available to require special precautions

Index Terms

Deltacortisone; Deltadehydrocortisone; Deltasone

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Matthews E, Brassington R, Kuntzer T, Jichi F, Manzur AY. Corticosteroids for the treatment of Duchenne muscular dystrophy. Cochrane Database Syst Rev. 2016;(5):CD003725. doi: 10.1002/14651858.CD003725.pub4.[PubMed 27149418]

McGee S and Hirschmann J, “Use of Corticosteroids in Treating Infectious Diseases,” Arch Intern Med, 2008, 168(10):1034-46.[PubMed 18504331]

Moxley RT 3rd, Ashwal S, Pandya S, et al, “Practice Parameter: Corticosteroid Treatment of Duchenne Dystrophy: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society,” Neurology, 2005, 64(1):13-20.[PubMed 15642897]

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National Asthma Education and Prevention Program (NAEPP) Working Group Report on “Managing Asthma During Pregnancy: Recommendations for Pharmacologic Treatment,” National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 05-5236, March 2005. Available at http://www.nhlbi.nih.gov/health/prof/lung/asthma/astpreg/astpreg_full.pdf

National Institute for Health and Care Excellence (NICE). Multiple sclerosis in adults: management. Published October 8, 2014. Available at http://www.nice.org.uk/guidance/cg186.

Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA; American Society of Hematology. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;117(16):4190-4207. doi: 10.1182/blood-2010-08-302984.[PubMed 21325604]

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Pradat P, Robert-Gnansia E, Di Tanna GL, et al, “First Trimester Exposure to Corticosteroids and Oral Clefts,” Birth Defects Res A Clin Mol Teratol, 2003, 67(12):968-70.[PubMed 14745915]

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Brand Names: International

Alfacort (UY); Apo-Prednisone (NZ); Cortancyl (FR); Cortiol (PT); Cortiprex (CL, PE, PY); Cutason (DE); Dacortin (CH, ES); Decortin (DE, HR); Decortisyl (IE); Dehydrocortison (BG); Delcortin (DK); Deltacortene (IT); Deltasone (HK); Deltison (SE); Ednapron (CR, DO, GT, HN, MX, NI, PA, SV); Encorton (PL); Hostacortin (EG, ID); Lexacort (ID); Lodotra (AU, ES, GB, HU, KR, LU, RO, SG, SK, TR); Me-Korti (FI); Meticorten (AR, BR, CL, CO, CR, DO, GT, HN, MX, NI, PA, PE, PT, SV, VE); Metilpres (AR); Nisona (PE); Nizon (HR); Norapred (MX); Nurison (NL); Orapred (PE); Panafcort (AU, ZA, ZW); Parmenison (AT); Pehacort (ID); Predicor (LB); Prednicort (BE, LU, PY); Prednidib (MX); Predniment (NL); Prednimut (NL); Prednison (FI, NO); Prednison Galepharm (CH); Prednison Streuli (CH); Prednison ”Dak” (DK); Prednisone (CY); Predone (SA); Predoral (PH); Predsone (AU, PH); Presacor (EC); Prolix 20 (PH); Pulmison (ZA); Qualisone (PH); Rectodelt (HU, UA); Sone (AU); Systocor (PH)

Last Updated 3/27/19
Prednisone (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(PRED ni sone)

Brand Names: US

Deltasone; predniSONE Intensol; Rayos

Brand Names: Canada

Winpred

What is this drug used for?
  • It is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that this drug may be used for. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to prednisone or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have a herpes infection of the eye.
  • If you have any of these health problems: A fungal infection or malaria infection in the brain.
  • If you have recently spent time in the tropics and have unexplained diarrhea.
  • If you have nerve problems in the eye.
  • If you are breast-feeding or plan to breast-feed.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This drug may affect allergy skin tests. Be sure your doctor and lab workers know you take this drug.
  • You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
  • Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.
  • Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like this drug. Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
  • If you have or may have threadworms, talk with your doctor.
  • This drug may lower how much natural steroid is in your body. If you have a fever, an infection, surgery, or you are hurt, talk with your doctor. You may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you need extra steroids.
  • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
  • Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
  • Have your eye pressure checked if you are on this drug for a long time. Talk with your doctor.
  • This drug may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
  • Have a bone density test as you have been told by your doctor. Talk with your doctor.
  • Talk with your doctor before getting any vaccines. Use of some vaccines with this drug may either raise the chance of an infection or make the vaccine not work as well.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Tell your doctor if you get signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Talk with your doctor before you drink alcohol.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • If you used this drug when you were pregnant, tell your baby’s doctor.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if you missed a dose or recently stopped this drug.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Skin changes (pimples, stretch marks, slow healing, hair growth).
  • Round face.
  • A fatty pad or hump between the shoulders.
  • Fast or slow heartbeat.
  • A heartbeat that does not feel normal.
  • Chest pain or pressure.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • Period (menstrual) changes.
  • Bone or joint pain.
  • Feeling very tired or weak.
  • Change in eyesight.
  • Change in the way you act.
  • Low mood (depression).
  • Seizures.
  • A burning, numbness, or tingling feeling that is not normal.
  • Very bad belly pain.
  • Any unexplained bruising or bleeding.
  • Black, tarry, or bloody stools.
  • Throwing up blood or throw up that looks like coffee grounds.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Upset stomach or throwing up.
  • Not able to sleep.
  • Restlessness.
  • Sweating a lot.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Take this drug with food or milk.
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
  • You may need to lower how much salt is in your diet and take extra potassium. Talk with your doctor.
  • Tablets, liquid (solution), and liquid (concentrate):
  • Take in the morning if taking once a day.
  • Long-acting tablets:
  • Swallow whole. Do not chew, break, or crush.
  • Liquid (solution):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Liquid (concentrate):
  • Only use the measuring device that comes with this liquid drug.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Liquid (concentrate):
  • Throw away any part not used after 3 months.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Prednisone (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(PRED ni sone)

Brand Names: US

Deltasone; predniSONE Intensol; Rayos

Brand Names: Canada

Winpred

What is this drug used for?
  • It is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that this drug may be used for. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has a herpes infection of the eye.
  • If your child has any of these health problems: Malaria infection in the brain or a fungal infection.
  • If your child has recently spent time in the tropics and has unexplained diarrhea.
  • If your child has nerve problems in the eye.
  • If your child is breast-feeding a baby:
  • Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This drug may affect allergy skin tests. Be sure the doctor and lab workers know your child takes this drug.
  • Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of signs of withdrawal. If your child needs to stop this drug, you will want to slowly stop it as ordered by the doctor.
  • Your child may have more chance of getting an infection. Some infections have been deadly. Have your child wash hands often. Have your child stay away from people with infections, colds, or flu.
  • Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like this drug. Avoid having your child near anyone with chickenpox or measles if your child has not had these health problems before. If your child has been exposed to chickenpox or measles, talk with the doctor.
  • If your child has or may have threadworms, talk with your child’s doctor.
  • This drug may lower how much natural steroid is in your child’s body. If your child has a fever, an infection, surgery, or is hurt, talk with the doctor. Your child may need extra doses of oral steroids. These extra steroids will help your child’s body deal with these stresses. Carry a warning card saying that there may be times when your child needs extra steroids.
  • High blood pressure has happened with this drug. Have your child’s blood pressure checked as you have been told by the doctor.
  • Long-term use may raise the chance of cataracts, glaucoma, or weak bones (osteoporosis). Talk with your child’s doctor.
  • Your child may need to have a bone density test. Talk with the doctor.
  • Have your child’s eye pressure checked if your child is on this drug for a long time. Talk with the doctor.
  • Talk with the doctor before your child gets any vaccines. Use of some vaccines with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
  • If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • You may need to lower how much salt is in your child’s diet and give your child extra potassium. Talk with your child’s doctor.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • If your child is pregnant:
  • Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
  • If your child used this drug when she was pregnant, tell the baby’s doctor.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if a dose was missed or the drug was recently stopped.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Skin changes (pimples, stretch marks, slow healing, hair growth).
  • Round face.
  • A fatty pad or hump between the shoulders.
  • Fast or slow heartbeat.
  • A heartbeat that does not feel normal.
  • Chest pain or pressure.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • Bone or joint pain.
  • Feeling very tired or weak.
  • Change in eyesight.
  • Change in the way your child acts.
  • Low mood (depression).
  • Seizures.
  • A burning, numbness, or tingling feeling that is not normal.
  • Very bad belly pain.
  • Any unexplained bruising or bleeding.
  • Black, tarry, or bloody stools.
  • Throwing up blood or throw up that looks like coffee grounds.
  • If your child has menstrual periods:
  • Period (menstrual) changes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Upset stomach or throwing up.
  • Not able to sleep.
  • Restlessness.
  • Sweating a lot.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Give this drug with food or milk.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Tablets, liquid (solution), and liquid (concentrate):
  • Give in the morning if giving once a day.
  • Long-acting tablets:
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • Liquid (solution):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Liquid (concentrate):
  • Only use the measuring device that comes with this liquid drug.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Liquid (concentrate):
  • Throw away any part not used after 3 months.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.