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PrednisoLONE (Systemic)

Pronunciation

Pronunciation

(pred NISS oh lone)

Index Terms

  • Prednisolone Sod Phosphate
  • Prednisolone Sodium Phosphate
  • Prelone

Dosage Forms

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

Solution, Oral, as base:

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

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

Millipred: 10 mg/5 mL (237 mL) [alcohol free, dye free; contains edetate disodium, methylparaben, saccharin sodium; grape flavor]

Orapred: 15 mg/5 mL (20 mL [DSC], 237 mL [DSC]) [dye free; contains alcohol, usp, sodium benzoate; grape flavor]

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

Veripred 20: 20 mg/5 mL (237 mL) [alcohol free, dye free; contains edetate disodium, methylparaben, saccharin sodium; grape flavor]

Generic: 15 mg/5 mL (237 mL, 473 mL [DSC]); 25 mg/5 mL (237 mL); 5 mg/5 mL (120 mL)

Suspension, Oral, as acetate [strength expressed as base]:

Flo-Pred: 15 mg/5 mL (30 mL [DSC]) [contains butylparaben, disodium edta, propylene glycol; cherry flavor]

Syrup, Oral, as base:

Prelone: 15 mg/5 mL (240 mL [DSC]) [contains alcohol, usp, benzoic acid, brilliant blue fcf (fd&c blue #1), fd&c red #40, propylene glycol, saccharin sodium]

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

Tablet, Oral, as base:

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

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

Millipred DP 12-Day: 5 mg [scored; contains fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow), sodium benzoate]

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

Orapred ODT: 10 mg, 15 mg, 30 mg [grape flavor]

Generic: 10 mg, 15 mg, 30 mg

Brand Names: U.S.

  • Flo-Pred [DSC]
  • Millipred
  • Millipred DP
  • Millipred DP 12-Day
  • Orapred ODT
  • Orapred [DSC]
  • Pediapred
  • Prelone [DSC]
  • Veripred 20

Pharmacologic Category

  • Corticosteroid, Systemic

Pharmacology

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

Absorption

Rapid; well-absorbed

Distribution

Vd: 0.22 to 0.7 L/kg

Metabolism

Primarily hepatic

Excretion

Primarily urine (as sulfate and glucuronide conjugate)

Time to Peak

Plasma: 1 to 2 hours; prolonged with food

Duration of Action

18 to 36 hours (Pickup 1979)

Half-Life Elimination

2 to 4 hours; reduced in children and prolonged in hepatic disease (Pickup 1979)

Protein Binding

Concentration dependent: 70% to 90% (to albumin and corticosteroid binding globulin); decreased in elderly

Special Populations: Elderly

Mean unbound fraction of prednisolone was higher and Vss unbound prednisolone was reduced in elderly patients.

Use: Labeled Indications

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

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

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

GI diseases: During acute episodes of Crohn disease or ulcerative colitis.

Hematologic disorders: Acquired (autoimmune) hemolytic anemia; congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia); erythroblastopenia (RBC anemia); idiopathic thrombocytopenic purpura, pure red cell aplasia; secondary thrombocytopenia.

Neoplastic diseases: Treatment of acute leukemia and aggressive lymphomas.

Nervous system: 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 (AAN [Scott 2011]; NICE 2014).

Ophthalmic diseases: Allergic conjunctivitis; allergic corneal marginal ulcers; anterior segment inflammation; chorioretinitis; diffuse posterior uveitis and choroiditis; herpes zoster ophthalmicus; iritis and iridocyclitises; keratitis; optic neuritis; sympathetic ophthalmia; uveitis and other ocular inflammatory conditions unresponsive to topical corticosteroids.

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

Respiratory diseases: Acute exacerbations of chronic obstructive pulmonary disease (COPD); allergic bronchopulmonary aspergillosis; aspiration pneumonitis; asthma; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; hypersensitivity pneumonitis; idiopathic bronchiolitis obliterans with organizing pneumonia; idiopathic eosinophilic pneumonias; idiopathic pulmonary fibrosis; Loeffler syndrome (not manageable by other means); Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV-positive individual who is also under treatment with appropriate anti-PCP antibiotics; symptomatic sarcoidosis.

Rheumatic disorders: As adjunctive therapy for short-term administration in acute and subacute bursitis, acute gouty arthritis, acute nonspecific tenosynovitis, ankylosing spondylitis, epicondylitis, polymyalgia rheumatica/temporal arteritis, posttraumatic osteoarthritis, psoriatic arthritis, relapsing polychondritis, rheumatoid arthritis (including juvenile rheumatoid arthritis), synovitis of osteoarthritis, acute rheumatic carditis, systemic lupus erythematosus, dermatomyositis/polymyositis, Sjogren syndrome, and certain cases of vasculitis.

Miscellaneous: Acute or chronic solid organ rejection; trichinosis with neurologic or myocardial involvement; tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, tuberculosis with pleural or pericardial effusion (use appropriate antituberculous chemotherapy concurrently when treating any tuberculosis complications).

Use: Unlabeled

Severe alcoholic hepatitis; Bell’s palsy; acute exacerbations of chronic obstructive pulmonary disease (COPD)

Contraindications

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

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.

Dosing: Adult

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.

Usual dose (range): Oral: 5 to 60 mg daily

Asthma exacerbations:

Global Initiative for Asthma guidelines (GINA 2016): Management in primary care or acute care facility: 1 mg/kg/day (maximum: 50 mg daily) as a single daily dose usually given for 5 to 7 days

National Asthma Education and Prevention Program guidelines (NAEPP 2007):

Asthma exacerbations (emergency care or hospital doses): 40 to 80 mg/day in a single dose or in 2 divided doses until peak expiratory flow is 70% of predicted or personal best

Short-course outpatient "burst" (acute asthma): 40 to 60 mg/day in a single dose or in 2 divided doses for 5 to 10 days. Note: Burst should be continued until symptoms resolve and peak expiratory flow is at least 80% of personal best; usually requires 3 to 10 days of treatment; longer treatment may be required

Long-term treatment: 7.5 to 60 mg daily given as a single dose in the morning or every other day as needed for asthma control

Multiple sclerosis:

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

Acute exacerbations of chronic obstructive pulmonary disease (COPD) (off-label use): Oral: 30 to 40 mg daily for 10 to 14 days (GOLD guidelines 2013)

Bell’s palsy (off-label use): Oral: 60 mg once daily for 5 days, then taper dose downward by 10 mg daily for 5 days (total treatment duration: 10 days) (Engstrom 2008; Berg 2012) or 50 mg daily (in 1 or 2 divided doses) for 10 days (begin within 72 hours of onset of symptoms) (Baugh 2013; Sullivan 2007)

Primary adrenal insufficiency, chronic (physiologic replacement) (off-label dose; alternative to preferred therapy): Oral: 3 to 5 mg daily in 1 to 2 divided doses (ES [Bornstein 2016]).

Severe alcoholic hepatitis (Maddrey Discriminant Function [MDF] score ≥32) (off-label use): Oral: 40 mg daily for 28 days, followed by a 2-week taper (O'Shea 2010)

Dosing: Geriatric

Refer to adult dosing; use lowest effective dose.

Dosing: Pediatric

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 indicated 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.

Asthma exacerbations:

Global Initiative for Asthma guidelines (GINA 2016): Management in primary care or acute care facility:

Children ≤2 years: 1 to 2 mg/kg/day (maximum: 20 mg daily) for up to 5 days

Children 3 to 5 years: 1 to 2 mg/kg/day (maximum: 30 mg daily) for up to 5 days

Children 6 to 11 years: 1 to 2 mg/kg/day (maximum: 40 mg daily) usually given for 3 to 5 days

Children ≥12 years and Adolescents: Refer to adult dosing.

National Asthma Education and Prevention Program guidelines (NAEPP 2007):

Children <12 years:

Asthma exacerbations (emergency care or hospital doses): 1 to 2 mg/kg/day in 2 divided doses (maximum: 60 mg/day) until peak expiratory flow is 70% of predicted or personal best

Short-course "burst" (acute asthma): 1 to 2 mg/kg/day in single dose or 2 divided doses for 3 to 10 days; maximum dose: 60 mg/day. Note: Burst should be continued until symptoms resolve or patient achieves peak expiratory flow 80% of personal best; usually requires 3 to 10 days of treatment; longer treatment may be required

Long-term treatment: 0.25 to 2 mg/kg/day given as a single dose in the morning or every other day as needed for asthma control; maximum dose: 60 mg/day

Children ≥12 years and Adolescents: Refer to adult dosing.

Anti-inflammatory or immunosuppressive dose: Children and Adolescents: Oral: 0.1 to 2 mg/kg/day in 3 or 4 divided dose

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

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).

Bell’s palsy (off-label use): Adolescents ≥16 years: Oral: 50 mg daily (in 1 or 2 divided doses) for 10 days; treatment should begin within 72 hours of onset of symptoms (Baugh 2013; Sullivan 2007).

Dosing: Renal Impairment

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

Hemodialysis: Slightly dialyzable (7% to 17.5%) (Frey 1990).

Intermittent hemodialysis: Supplemental dose necessary (Aronoff 2007).

Peritoneal dialysis: Supplemental dose is not necessary (Aronoff 2007).

Dosing: Hepatic Impairment

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

Administration

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

Flo-Pred: Administer using the provided calibrated syringe (supplied by manufacturer) to accurately measure the dose. Syringe should be washed prior to next use.

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

Dietary Considerations

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

Storage

Flo-Pred: Store at 20°C to 25°C (68°F to 77°F). Do not refrigerate. Dispense in the original container (to avoid loss of formulation during transfer).

Millipred: Store at 20°C to 25°C (68°F to 77°F).

Orapred ODT: Store at 20°C to 25°C (68°F to 77°F) in blister pack. Protect from moisture.

Orapred, Veripred 20: Store at 2°C to 8°C (36°F to 46°F).

Pediapred: Store at 4°C to 25°C (39°F to 77°F); may be refrigerated.

Drug Interactions

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

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

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

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

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

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

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

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

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

Boceprevir: May increase the serum concentration of PrednisoLONE (Systemic). Monitor therapy

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

Carbimazole: May decrease the serum concentration of PrednisoLONE (Systemic). Monitor therapy

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

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

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

CycloSPORINE (Systemic): PrednisoLONE (Systemic) may decrease the serum concentration of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum concentration of PrednisoLONE (Systemic). PrednisoLONE (Systemic) may increase the serum concentration of CycloSPORINE (Systemic). Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of PrednisoLONE (Systemic). Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of PrednisoLONE (Systemic). 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. Monitor therapy

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

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

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

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

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

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

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

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

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

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

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

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

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

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

MethIMAzole: May decrease the serum concentration of PrednisoLONE (Systemic). Monitor therapy

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

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

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

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

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

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

NSAID (COX-2 Inhibitor): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (COX-2 Inhibitor). Monitor therapy

NSAID (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (Nonselective). Monitor therapy

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

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

Ritonavir: May increase the serum concentration of PrednisoLONE (Systemic). Management: Consider prednisolone dose reductions in patients receiving ritonavir and monitor for increased adverse effects with concomitant use. Consider therapy modification

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

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

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

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

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

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

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. Avoid combination

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

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

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

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

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

Test Interactions

May decrease response to skin tests.

Adverse Reactions

Frequency not defined.

Cardiovascular: Cardiomyopathy, CHF, edema, facial edema, hypertension

Central nervous system: Headache, insomnia, malaise, nervousness, pseudotumor cerebri, psychic disorders, seizure, vertigo

Dermatologic: Bruising, facial erythema, hirsutism, petechiae, skin test reaction suppression, thin fragile skin, urticaria

Endocrine & metabolic: Carbohydrate tolerance decreased, Cushing's syndrome, diabetes mellitus, growth suppression, hyperglycemia, hypernatremia, hypokalemia, hypokalemic alkalosis, menstrual irregularities, negative nitrogen balance, pituitary adrenal axis suppression

Gastrointestinal: Abdominal distention, increased appetite, indigestion, nausea, pancreatitis, peptic ulcer, ulcerative esophagitis, weight gain

Hepatic: LFTs increased (usually reversible)

Neuromuscular & skeletal: Arthralgia, aseptic necrosis (humeral/femoral heads), fractures, muscle mass decreased, muscle weakness, osteoporosis, steroid myopathy, tendon rupture, weakness

Ocular: Cataracts, exophthalmus, eyelid edema, glaucoma, intraocular pressure increased, irritation

Respiratory: Epistaxis

Miscellaneous: Diaphoresis increased, impaired wound healing

<1% (Limited to important or life-threatening): Venous thrombosis (Johannesdottir, 2013)

Warnings/Precautions

Concerns related to adverse effects:

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

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

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

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's 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 severe depression, euphoria, insomnia, mood swings, personality changes, and frank psychotic manifestations. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

Disease-related concerns:

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

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

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

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

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

• 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. Not recommended for the treatment of optic neuritis; may increase frequency of new episodes. Consider routine eye exams in chronic users.

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

• 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 ones.

Concurrent drug therapy issues:

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

Special populations:

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

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

Dosage form specific issues:

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

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

Other warnings/precautions:

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

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

Monitoring Parameters

Blood pressure; blood glucose, electrolytes; weight; intraocular pressure (use >6 weeks); bone mineral density; growth and development in children; chest x-ray during prolonged therapy; HPA axis suppression.

Pregnancy Risk Factor

C/D (manufacturer specific)

Pregnancy Considerations

Adverse events have been observed with corticosteroids in animal reproduction studies. Prednisolone crosses the placenta; prior to reaching the fetus, prednisolone is converted by placental enzymes to prednisone. As a result, the amount of prednisolone reaching the fetus is ~8 to 10 times lower than the maternal serum concentration (healthy women at term; similar results observed with preterm pregnancies complicated by HELLP syndrome) (Beitins 1972; van Runnard Heimel 2005). Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts (Park-Wyllie 2000; Pradat 2003). Systemic corticosteroids may also influence fetal growth (decreased birth weight); however, information is conflicting (Lunghi 2010). Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor.

When systemic corticosteroids are needed in pregnancy, it is generally recommended to use the lowest effective dose for the shortest duration of time, avoiding high doses during the first trimester (Leachman 2006; Lunghi 2010; Makol 2011; Østensen 2009). Inhaled corticosteroids are preferred for the treatment of asthma during pregnancy. Oral corticosteroids, such as prednisolone, may be used for the treatment of severe persistent asthma if needed; the lowest dose administered on alternate days (if possible) should be used (NAEPP 2005). Prednisolone 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 (Bornstein 2016). Prednisolone may be used to treat women during pregnancy who require therapy for congenital adrenal hyperplasia (Speiser 2010). Topical agents are preferred for managing atopic dermatitis in pregnancy; for severe symptomatic or recalcitrant atopic dermatitis, a short course of prednisolone may be used during the third trimester (Koutroulis 2011).

Patient Education

• 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, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of Cushing’s disease (weight gain in upper back or stomach; moon face; severe headache; or slow healing), signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), signs of 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 (pimples, stretch marks, slow healing, or hair growth), 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, angina, menstrual irregularities, joint pain, bone pain, vision 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.

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