Version October 2024
Dosage guidance:
Dosing: Adjust dose depending upon condition being treated and response of patient. The lowest possible dose should be used to control the condition; when dose reduction is possible, the dose should be reduced gradually.
Bronchopulmonary dysplasia (BPD)/Chronic lung disease, prophylaxis: Limited data available: Note: AAP does not recommend routine use of postnatal corticosteroids; decision to use should be individualized (Ref).
Preterm neonates: GA <28 weeks and PNA ≤48 hours: IV: 1 mg/kg/day divided every 12 hours for 7 days followed by 0.5 mg/kg/day once daily for 3 days (Ref); low-dose early hydrocortisone was shown to improve survival without BPD in neonates born at GA <28 weeks (Ref). Several studies have shown hydrocortisone to be especially beneficial to neonates weighing <1 kg exposed to chorioamnionitis (Ref). Concurrent use with indomethacin is not recommended, as it has been associated with a higher incidence of GI perforation (Ref).
Bronchopulmonary dysplasia (BPD)/Chronic lung disease, treatment: Limited data available. Note: AAP does not recommend routine use of postnatal corticosteroids; decision to use should be individualized (Ref).
Preterm neonates: GA <30 weeks and PNA 7 to 14 days: IV: 5 mg/kg/day divided every 6 hours for 7 days, followed by 3.75 mg/kg/day divided every 8 hours for 5 days, followed by 2.5 mg/kg/day divided every 12 hours for 5 days, followed by 1.25 mg/kg/dose every 24 hours for 5 days (Ref). Lower cumulative doses initiated at PNA 14 to 28 days have been studied, but have not shown to have improved survival without moderate or severe BPD or neurodevelopmental impairment at 2 years corrected age or alter the severity of BPD (Ref).
Congenital adrenal hyperplasia (CAH):
Note: Individualize dose based on growth, hormone levels, and bone age; mineralocorticoid (eg, fludrocortisone) and sodium supplement may be required in salt losers. Guidelines recommend against using commercially-available oral suspension in growing individuals; however, that recommendation is based on data for a commercial suspension that is no longer available. Extemporaneously prepared hydrocortisone suspension has been shown to provide similar cortisol exposure to tablets in pediatric patients with CAH (Ref). Use caution when changing between dosage forms (eg, from compounded solution or crushed tablet to sprinkles) and monitor closely for potential differences in exposure; dosage adjustment may be necessary. When using the oral sprinkles (Alkindi), round dose to nearest 0.5 or 1 mg.
Neonates: Oral: Initial: 10 to 15 mg/m2/day in 3 divided doses; higher initial doses (20 mg/m2/day) may be required to achieve initial target hormone serum concentrations. Administer morning dose as early as possible (Ref).
Hypotension, refractory; shock: Limited data available; various regimens have been reported; optimal dose not established; use the lowest effective dose; higher doses have not been shown to increase efficacy and lead to more adverse effects (Ref):
Neonates: IV: 0.5 mg/kg/dose every 6 to 12 hours or 1 mg/kg/dose every 8 to 12 hours; duration variable but commonly reported for 1 to 5 days (Ref). Some experts recommend a 1 mg/kg test dose; if no response in 2 to 4 hours, then no further doses are given; if patient does respond, then test dose should be followed by 0.5 mg/kg/dose every 12 hours for GA <34 weeks or 0.5 mg/kg/dose every 6 to 8 hours for GA ≥34 weeks; the dose may be increased to 1 mg/kg/dose if necessary, with the interval guided by patient response. Taper hydrocortisone off as condition allows (Ref).
Dosage guidance:
Dosing: Adjust dose depending upon condition being treated and response of patient. The lowest possible dose should be used to control the condition; when dose reduction is possible, the dose should be reduced gradually. In life-threatening situations, parenteral doses larger than the oral dose may be needed.
Adrenal insufficiency, acute (adrenal crisis): Dosage regimens variable; some experts recommend using weight-directed dosing for first dose (Ref):
Weight-directed: Limited data available: Infants, Children, and Adolescents: IM, IV (preferred), Intraosseous: Initial: 2 to 3 mg/kg once; maximum dose: 100 mg/dose; then for infants: 1 to 5 mg/kg/dose every 6 hours; for children and adolescents, see BSA- or age-directed dosing (Ref).
BSA-directed dosing: Limited data available: Infants, Children, and Adolescents: IM, IV (preferred), Intraosseous: Initial: 50 to 100 mg/m2 once followed by 50 to 100 mg/m2/day in 4 divided doses (Ref).
Age-directed dosing (fixed dosing): Limited data available (Ref):
Infants: IM, IV (preferred), Intraosseous: 10 to 25 mg once followed by 10 to 25 mg/day in divided doses every 6 hours for 24 hours then subsequent dose reductions and rate determined by patient response.
Children <5 years (eg, young children): IM, IV (preferred), Intraosseous: 25 to 50 mg once followed by 25 to 50 mg/day in divided doses every 6 hours for 24 hours then subsequent dose reductions and rate determined by patient response.
Children ≥5 years (eg, older children): IM, IV (preferred), Intraosseous: 50 to 100 mg once followed by 50 mg/day in divided doses every 6 hours for 24 hours then subsequent dose reductions and rate determined by patient response.
Adolescents: IM, IV (preferred), Intraosseous: 100 mg once followed by 100 mg/day in divided doses every 6 hours for 24 hours then subsequent dose reduction and rate determined by patient response.
Anti-inflammatory or immunosuppressive: Note: Dosing range variable; individualize dose for disease state and patient response.
Infants and Children:
Oral: 2.5 to 10 mg/kg/day or 75 to 300 mg/m2/day divided every 6 to 8 hours (Ref).
IM, IV:
Manufacturer's labeling: Initial: 0.56 to 8 mg/kg/day or 20 to 240 mg/m2/day in 3 or 4 divided doses.
Alternate dosing: Limited data available: 1 to 5 mg/kg/day or 30 to 150 mg/m2/day divided every 12 to 24 hours (Ref).
Adolescents: Oral, IM, IV, SubQ: 15 to 240 mg every 12 hours (Ref).
Congenital adrenal hyperplasia (CAH); chronic:
Note: Administer morning dose as early as possible. Individualize dose by monitoring growth, hormone levels, and bone age; mineralocorticoid (eg, fludrocortisone) and sodium supplement may be required in salt losers. Guidelines recommend against using commercially-available oral suspension in growing individuals; however, that recommendation is based on data for a commercial suspension that is no longer available. Extemporaneously prepared hydrocortisone suspension has been shown to provide similar cortisol exposure to tablets in pediatric patients with CAH (Ref). Use caution when changing between dosage forms (eg, from compounded solution or crushed tablet to sprinkles) and monitor closely for potential differences in exposure; dosage adjustment may be necessary. When using the oral sprinkles (Alkindi), round dose to nearest 0.5 or 1 mg; when using regular oral tablets, the smallest available dose is 2.5 mg (1/2 of 5 mg tablet). See "Stress dosing; supplemental" for management of patients with CAH during times of physiological stress.
Infants, Children, and Adolescents:
BSA-directed dosing: Oral (tablets, sprinkles): Initial: 8 to 15 mg/m2/day in 3 divided doses; usual range: 10 to 15 mg/m2/day; higher initial doses (20 mg/m2/day) may be required to achieve initial target hormone serum concentrations; older patients may be able to transition to twice-daily dosing (Ref).
Fixed dosing (Ref): Oral (tablets): Usual requirement:
Infants: 2.5 to 5 mg/dose 3 times/day.
Children: 5 to 10 mg/dose 3 times/day.
Adolescents (fully grown): 15 to 25 mg/day divided in 2 to 3 daily doses.
Physiologic replacement: Infants and Children: Oral: 8 to 10 mg/m2/day divided every 8 hours; up to 12 mg/m2/day in some patients; to replicate diurnal variation, the highest doses are typically administered in the morning and midday dose with the lower dose in the evening (Ref).
Stress dosing; supplemental: Limited data available; dosage regimens variable:
Note: Dosing based on the level of physiological stress related to condition; dose should be individualized based on patient and continued until resolution of stressful condition (usually 24 to 48 hours). Typically, supplementation for emotional or minimal physiological stress conditions or prior to exercise is not necessary. Dosing is generally 2 to 3 times physiologic replacement level (Ref).
Infants, Children, and Adolescents:
BSA-directed dosing (Ref): Oral, IM, IV:
Mild to moderate stress: 20 to 50 mg/m2/day divided into 3 or 4 doses; doses on the lower end of the range (20 to 30 mg/m2/day) may be divided twice daily.
Major stress or surgery: 100 mg/m2/day in divided doses every 6 hours.
Planned surgery: Pre-anesthesia of 50 mg/m2 IV or IM administered 30 to 60 minutes prior to surgery followed by second dose of 50 mg/m2 as a continuous IV infusion or in divided doses every 6 hours for at least 24 hours.
Age-directed for moderate stress in patients with congenital adrenal hyperplasia (Ref):
Infants and preschool children: IV: Initial dose: 25 mg once, followed by a daily dose that is 3 to 4 times the patient's standard maintenance dose in divided doses every 6 hours.
School-age children: IV: Initial dose: 50 mg once, followed by a daily dose that is 3 to 4 times the patient's standard maintenance dose in divided doses every 6 hours.
Adolescents: IV: Initial dose: 100 mg once, followed by a daily dose that is 3 to 4 times the patient's standard maintenance dose in divided doses every 6 hours.
Septic shock, fluid and catecholamine-refractory with suspected/proven adrenal insufficiency: Limited data available:
BSA-directed dosing : Infants, Children, and Adolescents: IV: 50 to 100 mg/m2/day. Note: The maximum adult daily dose is 200 mg/day (~100 mg/m2/day) (Ref). In some cases, doses may be titrated up to 50 mg/kg/day as a continuous IV infusion, if necessary, for shock reversal in the short term; however, efficacy data variable with the higher doses (Ref).
Weight- directed dosing (Ref): Note: Use if BSA not available:
Infants, Children, and Adolescents: IV, Intraosseous: 2 mg/kg as a single bolus dose; maximum dose: 100 mg/dose.
Age- directed dosing (Ref): Note: Use if BSA and weight are not available:
Infants and Children <3 years: IV, Intraosseous: 25 mg as a single bolus dose.
Children ≥3 to <12 years: IV, Intraosseous: 50 mg as single bolus dose.
Children ≥12 years and Adolescents: IV, Intraosseous: 100 mg as a single bolus dose.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
(For additional information see "Hydrocortisone (systemic): Drug information")
Dosage guidance:
Dosing: Adjust dose depending upon condition being treated and response of patient. Use the lowest possible dose to control the condition; when dose reduction is possible, reduce the dose gradually. In patients taking chronic oral hydrocortisone who are in life-threatening situations, parenteral doses larger than the oral dose may be needed.
Adrenal insufficiency, adrenal crisis, treatment and prevention:
Treatment:
Note: For use in patients presenting with adrenal crisis, or in patients with myxedema coma whom adrenal crisis has not been ruled out (Ref). Appropriate fluid resuscitation is also required (Ref).
IV: 100 mg IV bolus given immediately, followed by 25 to 75 mg IV every 6 hours or 200 mg/24 hours as a continuous IV infusion for the first 24 hours. Reassess patient after the initial 24 hours; if clinical status has improved may begin gradually tapering the dose. Once patient is stable, may resume chronic maintenance oral dosing (Ref).
Prevention (ie, stress dosing):
Note: For use in patients with known adrenal insufficiency or suspected adrenal insufficiency (eg, Cushingoid appearance, prolonged glucocorticoid therapy ≥5 mg/day of prednisone or equivalent) to prevent development of adrenal crisis (Ref).
Acute physiologic stress/illness:
Febrile illness: Oral: Double the chronic maintenance dose for fever 38°C (100.4°F) to 39°C (102.2°F) or triple the chronic maintenance oral dose for fever >39°C (102.2°F), then return to baseline dose within 1 to 3 days following recovery of fever (Ref).
Patients unable to tolerate oral medication (eg, due to vomiting or diarrhea): IM, SUBQ: 100 mg dose given early in course of illness; repeat after 6 to 12 hours (Ref).
Labor/Delivery: IM, IV: Dosing is individualized (Ref). One example regimen includes 100 mg IV loading dose at the onset of active labor (or immediately before anesthesia in patients undergoing caesarean section), followed by 50 to 100 mg every 6 hours (given as IM or IV injections) or 200 mg/day given as a continuous IV infusion until delivery; taper dose over 1 to 2 days after delivery before resuming baseline dose (Ref). Usual dosing range: 50 to 100 mg every 6 to 8 hours or 200 to 300 mg/24 hours (Ref).
Surgical stress:
Minor surgical stress (eg, hernia repair, procedures with local anesthetic): IV, Oral: Continue chronic maintenance dose administered orally or IV (no additional supplementation needed) (Ref); may give an additional oral dose (eg, 20 mg) postoperatively if signs or symptoms of adrenal insufficiency are present (Ref).
Moderate surgical stress (eg, joint replacement, cholecystectomy): IV: 50 to 75 mg/day (25 mg every 8 to 12 hours) for 1 to 2 days (Ref).
Major surgical stress (eg, major bowel surgery, cardiothoracic surgery, cesarean delivery): IV, IM:
100 to 150 mg/day (50 mg every 8 to 12 hours) (Ref).
or
100 mg IV loading dose immediately before anesthesia, followed by 50 to 100 mg every 6 hours (given as IM or IV injection) or 200 mg/day given as a continuous IV infusion (Ref).
Note: Taper dose and resume oral regimen as clinical status improves (eg, after 1 to 3 days) (Ref).
Adrenal insufficiency, chronic (eg, primary, secondary, classic congenital adrenal hyperplasia) : Oral: 15 to 25 mg/day in 2 to 3 divided doses. Administer the largest dose in the morning upon awakening, followed by next dose 2 hours after lunch (2-dose regimen) or next dose at lunch, followed by smallest dose in the afternoon no later than 4 to 6 hours before bedtime (3-dose regimen) (Ref).
Adrenal insufficiency (temporary), physiologic replacement following resection of an ACTH-producing tumor or unilateral adrenalectomy (off-label dose): Oral: 10 to 12 mg/m2/day in 2 to 3 divided doses, with the first dose taken as soon as possible after waking; continue hydrocortisone until HPA axis recovers, generally 6 to 12 months following resection of ACTH-producing tumors or 18 months following unilateral adrenalectomy (Ref).
Adrenal insufficiency associated with immune checkpoint inhibitor therapy: Note: For oral hydrocortisone, usually 2/3 of the dose is administered in the morning and 1/3 of the dose is administered in the early afternoon (Ref).
Initial:
Grade 1: Oral: 15 to 20 mg/day in divided doses; if there are residual symptoms, titrate up to a maximum of 30 mg/day (Ref).
Grade 2: Oral: 30 to 50 mg/day in divided doses (Ref).
Grade 3 or 4: IV: 50 to 100 mg every 6 to 8 hours; taper down to oral maintenance corticosteroids over 5 to 7 days (Ref).
Maintenance: Oral: 15 to 20 mg/day in divided doses (Ref).
Anti-inflammatory or immunosuppressive (alternative agent):
IM, IV: Initial: 100 to 500 mg/dose at intervals of 2, 4, or 6 hours.
Oral: Initial: 20 to 240 mg/day.
Asthma, acute exacerbation (alternative agent) (off-label dose): Note: Alternative to other corticosteroids in moderate to severe exacerbations or in patients who do not respond promptly and completely to short-acting beta-agonists; administer within 1 hour of presentation to emergency department (Ref).
Oral: 200 mg in divided doses for 5 to 7 days (Ref).
COVID-19, hospitalized patients (alternative agent) (off-label use):
Note: Hydrocortisone is recommended for treatment of COVID-19 in hospitalized patients requiring supplemental oxygen or ventilatory support when dexamethasone is not available or there are specific indications for hydrocortisone. Dosing is extrapolated from a study that used dexamethasone; the equivalent dose of hydrocortisone (or other glucocorticoid) may be substituted if necessary (Ref).
IV, Oral: 50 mg every 8 hours for up to 10 days (or until discharge if sooner) as part of an appropriate combination regimen (Ref).
Hypophysitis associated with immune checkpoint inhibitor therapy:
Initial:
Grade 1: Oral: 15 to 20 mg/day in divided doses; if there are residual symptoms, titrate up to a maximum of 30 mg/day (Ref).
Grade 2: Oral: 30 to 50 mg/day in divided doses (Ref).
Grade 3 or 4: IV: 50 to 100 mg every 6 to 8 hours; taper down to oral maintenance corticosteroids over 5 to 7 days (Ref).
Maintenance: Oral: 15 to 20 mg/day in divided doses (Ref) or 10 to 12 mg/m2/day (Ref).
Iodinated contrast media allergic-like reaction, prevention: Note: Generally reserved for patients with a prior allergic-like or unknown-type iodinated contrast reaction who will be receiving another iodinated contrast agent. Nonurgent premedication with an oral corticosteroid is generally preferred when contrast administration is scheduled to begin in ≥12 hours; however, IV hydrocortisone may be considered in patients unable to take oral medications. Consider an urgent (accelerated) regimen with an IV corticosteroid for patients requiring contrast in <12 hours (Ref).
Nonurgent regimen (alternative agent): IV: 200 mg administered 13 hours, 7 hours, and 1 hour before contrast medium administration in combination with oral or IV diphenhydramine (Ref).
Urgent (accelerated) regimen: IV: 200 mg immediately, then 200 mg every 4 hours until contrast medium administration in combination with oral or IV diphenhydramine. In emergent situations (ie, <4 to 5 hours until contrast is required), may consider hydrocortisone 200 mg in combination with IV diphenhydramine 1 hour prior to contrast (Ref).
Septic shock, inadequate response to fluid resuscitation and vasopressor therapy (off-label use):
IV: 50 mg bolus every 6 hours or 100 mg every 8 hours for 5 to 7 days (Ref). Consider a taper over several days to avoid possible hemodynamic deterioration, which may occur with abrupt withdrawal (Ref). Infrequently used in combination with fludrocortisone (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Note: The pharmacokinetics and pharmacodynamics of hydrocortisone in kidney impairment are not well understood (Ref). Cortisone metabolism and excretion may be impaired with kidney dysfunction (cortisone in its free form and its breakdown products are excreted in the urine) (Ref). The clinical implications of these pharmacokinetic alterations are unclear.
Altered kidney function: Mild to severe impairment: No dosage adjustment necessary (Ref).
Hemodialysis, intermittent (thrice weekly): No supplemental dose or dosage adjustment necessary (Ref).
Peritoneal dialysis: No dosage adjustment necessary (Ref).
CRRT: No dosage adjustment necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Frequency not defined:
Cardiovascular: Bradycardia, cardiac arrhythmia, cardiomegaly, circulatory shock, embolism (fat), heart failure, hypertension, hypertrophic cardiomyopathy (premature infants), syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis
Dermatologic: Acne vulgaris, allergic dermatitis, atrophic striae, burning sensation of skin (especially in the perineal area after IV injection), desquamation, diaphoresis, ecchymoses, epidermal thinning, erythema of skin, facial erythema, fragile skin, hyperpigmentation, hypertrichosis, hypopigmentation, inadvertent suppression of skin test reaction, skin atrophy (including cutaneous atrophy, subcutaneous atrophy), skin edema, skin rash, thinning hair, urticaria, xeroderma
Endocrine & metabolic: Adrenocortical insufficiency (secondary unresponsiveness, particularly during trauma, surgery, or illness), Cushing syndrome, cushingoid appearance (fat accumulation in cheeks and temporal fossae), decreased glucose tolerance, decreased serum potassium, fluid retention, growth suppression, hirsutism, HPA-axis suppression, hyperglycemia (including increased requirements for insulin or oral hypoglycemic agents in diabetes mellitus), hypokalemic alkalosis, menstrual disease, negative nitrogen balance (due to protein catabolism), pituitary insufficiency (secondary unresponsiveness, particularly during trauma, surgery, or illness), prediabetes, protein catabolism, sodium retention, weight gain
Gastrointestinal: Abdominal distention, gastrointestinal perforation (small and large intestine, particularly in patients with inflammatory bowel disease), hiccups, impaired intestinal carbohydrate absorption, increased appetite, nausea, pancreatitis, peptic ulcer (with possible perforation and hemorrhage), ulcerative esophagitis
Genitourinary: Asthenospermia, glycosuria, oligospermia
Hematologic & oncologic: Leukocytosis, petechia
Hepatic: Hepatomegaly, increased liver enzymes (usually reversible on discontinuation)
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, angioedema, nonimmune anaphylaxis)
Infection: Increased susceptibility to infection, sterile abscess
Local: Postinjection flare (intra-articular use)
Nervous system: Depression, emotional lability, euphoria, headache, increased intracranial pressure (with papilledema; usually following discontinuation), insomnia, malaise, myasthenia, neuritis, neuropathy, paresthesia, personality changes, psychic disorder, seizure, tingling of skin (especially in the perineal area after IV injection), vertigo
Neuromuscular & skeletal: Amyotrophy, aseptic necrosis of femoral head, aseptic necrosis of humeral head, Charcot arthropathy, lipodystrophy, osteoporosis, pathological fracture (long bones), rupture of tendon (particularly rupture of Achilles tendon), steroid myopathy, vertebral compression fracture
Ophthalmic: Blindness (periocular injection), exophthalmos, glaucoma, increased intraocular pressure, retinopathy (central serous chorioretinopathy), subcapsular posterior cataract
Respiratory: Pulmonary edema
Miscellaneous: Wound healing impairment
Hypersensitivity to hydrocortisone or any component of the formulation; systemic fungal infections; use in premature infants (formulations containing benzyl alcohol only); idiopathic thrombocytopenia purpura (IM administration only); intrathecal administration; live or live, attenuated virus vaccines (with immunosuppressive doses of corticosteroids).
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Canadian labeling: Additional contraindications (not in US labeling): Herpes simplex of the eye (except for short-term or emergency therapy); vaccinia and varicella (except for short-term or emergency therapy)
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.
• Anaphylactoid reactions: Rare cases of anaphylactoid reactions have been observed in patients receiving corticosteroids.
• Dermal changes: Avoid injection or leakage into the dermis; dermal and/or subdermal skin depression may occur at the site of injection. Avoid deltoid muscle injection; subcutaneous atrophy may occur.
• 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 for cerebral malaria, fungal infections, or viral hepatitis. Close observation is required in patients with tuberculosis (TB) infection (latent TB) and/or TB reactivity; restrict use in TB disease (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 tropical 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 psychotic manifestations. Symptoms usually occur within a few days or weeks of initiation of treatment and usually resolve with dose reduction or discontinuation; monitor for signs and symptoms of behavioral or mood changes. 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.
• GI 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; risk may be increased with concurrent use of nonsteroidal anti-inflammatory drugs.
• Head injury: Increased mortality was observed in patients receiving high-dose IV methylprednisolone; high-dose corticosteroids should not be used for the management of head injury.
• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention.
• Kidney impairment: Use with caution in patients with kidney impairment; fluid retention may occur.
• Myasthenia gravis: Use may cause transient worsening of myasthenia gravis (MG) (eg, within first 2 weeks of treatment); monitor for worsening MG (AAN [Narayanaswami 2021]).
• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Oral steroid treatment is not recommended for the treatment of acute optic neuritis; may increase frequency of new episodes and does not affect short- or long-term visual outcomes. Use with caution in patients with ocular herpes simplex; corneal perforation may occur; do not use in active ocular herpes simplex. Consider routine eye exams in chronic users.
• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.
• Pheochromocytoma: Pheochromocytoma crisis has been reported with corticosteroids (may be fatal). Consider the risk of pheochromocytoma crisis prior to administering corticosteroids in patients with suspected pheochromocytoma.
• Seizure disorders: Use corticosteroids with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.
• Septic shock or sepsis syndrome: Corticosteroids should not be administered for the treatment of sepsis in the absence of shock (SCCM/ESICM [Annane 2017]).
• Systemic sclerosis: Use with caution in patients with systemic sclerosis; an increase in scleroderma kidney crisis incidence has been observed with corticosteroid use. Monitor BP and kidney function in patients with systemic sclerosis treated with corticosteroids (EULAR [Kowal-Bielecka 2017]).
• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in patients with hyperthyroidism and decreases in patients with hypothyroidism.
Special populations:
• Older adults: Use with caution in the older adult 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: Diluent for injection may contain benzyl alcohol and 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 and/or benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.
• Capsule: Sprinkles are therapeutically equivalent to tablets; however, compounding tablets into a suspension, or crushing or splitting tablets could lead to a relative difference in exposure on the same nominal dose leading to symptoms of adrenal insufficiency. Dosage adjustments of oral sprinkles may be needed if adrenal insufficiency occurs.
Other warnings/precautions:
• Discontinuation of therapy: Withdraw therapy with gradual tapering of dose.
• Epidural injection: Corticosteroids are not approved for epidural injection. Serious neurologic events (eg, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke), some resulting in death, have been reported with epidural injection of corticosteroids, with and without use of fluoroscopy.
• Stress: Patients may require higher doses when subject to stress (ie, trauma, surgery, severe infection).
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). In premature neonates, reports of gastrointestinal perforation in the hydrocortisone treatment arm have resulted in the closure of two large bronchopulmonary dysplasia (BPD) clinical trials (Peltoniemi 2005; Watterberg 2004); concomitant use with indomethacin or ibuprofen may increase the risk and should be avoided in this population (Seri 2006). 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). Hypertrophic cardiomyopathy has been reported in premature neonates.
In premature neonates, the use of high-dose dexamethasone (approximately >0.5 mg/kg/day) for the prevention or treatment of BPD has been associated with adverse neurodevelopmental outcomes, including higher rates of cerebral palsy without additional clinical benefit over lower doses; current data does not support use of high doses. Data specific to hydrocortisone use in this population has shown that use <7 days of therapy does not appear to be associated with adverse neurodevelopmental outcomes (Needelman 2010). Early initiation (ie, PNA <24 hours) of low-dose hydrocortisone for BPD prevention was shown to improve survival without BPD in neonates born at GA <28 weeks and was not associated with a statistically significant difference in neurodevelopment at 2 years corrected age compared to placebo; a secondary analysis looking at neurodevelopment according to gestation showed a statistically significant improvement in neurodevelopmental outcomes in neonates at 24 to 25 weeks gestation receiving hydrocortisone; the incidence of moderate to severe neurodevelopmental impairment was 2% in this group compared to 18% in the placebo group; no differences in neurodevelopmental outcomes were seen in neonates at 26 to 27 weeks gestation (Baud 2016; Baud 2017; Baud 2019a). Similar to early initiation, when hydrocortisone was initiated later (ie, PNA 14 to 28 days) in neonates born at <30 weeks gestation, no adverse neurodevelopmental effects were seen at 2 years corrected age compared to placebo (Watterberg 2022).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule Sprinkle, Oral:
Alkindi Sprinkle: 0.5 mg, 1 mg, 2 mg, 5 mg
Solution Reconstituted, Injection, as sodium succinate [strength expressed as base, preservative free]:
Solu-CORTEF: 100 mg (1 ea); 250 mg (1 ea); 500 mg (1 ea); 1000 mg (1 ea)
Tablet, Oral, as base:
Cortef: 5 mg, 10 mg, 20 mg [scored]
Generic: 5 mg, 10 mg, 20 mg
May be product dependent
Capsule, sprinkles (Alkindi Sprinkle Oral)
0.5 mg (per each): $10.55
1 mg (per each): $21.10
2 mg (per each): $42.19
5 mg (per each): $105.48
Solution (reconstituted) (Solu-CORTEF Injection)
100 mg (per each): $24.48
250 mg (per each): $45.30
500 mg (per each): $90.64
1000 mg (per each): $181.22
Tablets (Cortef Oral)
5 mg (per each): $1.21
10 mg (per each): $2.04
20 mg (per each): $3.86
Tablets (Hydrocortisone Oral)
5 mg (per each): $0.34 - $1.02
10 mg (per each): $0.57 - $2.15
20 mg (per each): $1.09 - $3.26
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Injection, as sodium succinate [strength expressed as base]:
Solu-CORTEF: 100 mg (1 ea); 250 mg (1 ea); 500 mg (1 ea); 1000 mg (1 ea)
Tablet, Oral, as base:
Cortef: 10 mg, 20 mg [contains corn starch]
Generic: 10 mg, 20 mg
2 mg/mL Oral Suspension (ASHP Standard Concentration) (ASHP 2017)
A 2 mg/mL oral suspension may be made with 10 mg tablets and a 1:1 mixture of Ora-Sweet and Ora-Plus. Crush ten 10 mg hydrocortisone tablets in a mortar and reduce to a fine powder. Add a small amount of vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 50 mL; transfer to a calibrated amber bottle, rinse mortar with vehicle, and add sufficient quantity of vehicle to make 50 mL. Label “shake well.” Stable under refrigeration or at room temperature for 90 days.
2.5 mg/mL Oral Suspension
A 2.5 mg/mL oral suspension may be made with either tablets or powder and a vehicle containing sodium carboxymethylcellulose (1 g), syrup BP (10 mL), hydroxybenzoate 0.1% preservatives (0.1 g), polysorbate 80 (0.5 mL), citric acid (0.6 g), and water. To make the vehicle, dissolve the hydroxybenzoate, citric acid, and syrup BP in hot water. Cool solution and add the carboxymethylcellulose; leave overnight. Crush twelve-and-one-half 20 mg hydrocortisone tablets (or use 250 mg of powder) in a mortar and reduce to a fine powder while adding polysorbate 80. Add small portions of vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 100 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add sufficient quantity of vehicle to make 100 mL. Label “shake well” and “refrigerate.” Stable for 90 days.
Cortef oral suspension was reformulated in July 1998; the suspending agent was changed from tragacanth to xanthan gum; this suspension was found not to be bioequivalent to hydrocortisone tablets in the treatment of children with congenital adrenal hyperplasia; children required higher doses of the suspension (19.6 mg/m2/day) compared to the tablets (15.2 mg/m2/day); based on these findings, Cortef suspension was voluntarily recalled from the market on July 18, 2000 (Merke 2001).
Oral: Administer with food or milk to decrease GI upset; for physiologic replacement in pediatric patients, higher doses are typically administered in the morning and midday with lower doses in the evening to replicate diurnal variation; early evening doses (18:00) may be necessary in some children (doses too close to bedtime can interfere with sleep) (Ref).
Sprinkles (Alkindi): Do not swallow capsule whole. Hold capsule so numeric strength section of the capsule is at the top and tap capsule to ensure all granules in lower section, then open the capsule by squeezing the bottom section and twisting the top off. Granules may be administered by any of the following methods: Pouring granules directly onto patient's tongue; pouring granules onto a spoon and placing in patient's mouth; or sprinkling granules onto a spoon containing a soft food (eg, yogurt, fruit puree) that is cold or at room temperature and then having patient consume preferably within 5 minutes to avoid bitter taste. Avoid getting capsule wet (if capsule is wet, granules may stick and not get delivered in dose). Do not crush or chew granules. Ingest fluids (eg, water, milk, breast milk, infant formula) after dose is administered to ensure all granules swallowed. Do not add granules directly to a liquid; may result in reduced dose delivered as well as a bitter taste. Do not administer through NG or gastric tubes; granules will clog tube.
Parenteral: Hydrocortisone sodium succinate may be administered by IM or IV routes. Dermal and/or subdermal skin depression may occur at the site of injection.
IM: Avoid injection into deltoid muscle (high incidence of SubQ atrophy).
IV bolus: Administer undiluted over at least 30 seconds; for large doses (≥500 mg), administer over 10 minutes.
Intermittent IV infusion: Further dilute in a compatible fluid and administer over 20 to 30 minutes (Ref).
Oral: Administer with food or milk to decrease GI upset.
Parenteral: For IM or IV administration: Dermal and/or subdermal skin depression may occur at injection site.
IM: Avoid injection into deltoid muscle (high incidence of subcutaneous atrophy).
IV bolus: Administer undiluted over at least 30 seconds; for large doses (≥500 mg), administer over 10 minutes.
IV intermittent infusion: Further dilute in a compatible fluid and administer over 20 to 30 minutes.
SUBQ (off-label route): Divide injections >1 mL (>50 mg) into 2 or more separate injections (Ref).
Capsule: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Store in original container to protect from light. Use within 60 days of opening bottle.
Injection: Store intact vials at 20°C to 25°C (68°F to 77°F); protect from light. Heat sensitive; do not autoclave vial. Reconstituted solutions are stable for 3 days at 20°C to 25°C (68°F to 77°F); protect from light. Solutions prepared for IV infusion are stable for at least 4 hours.
Tablet: Store at 20°C to 25°C (68°F to 77°F).
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Alkindi Sprinkle: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213876s001lbl.pdf#page=14
Anti-inflammatory or immunosuppressant agent in the treatment of a variety of diseases, including those of allergic, hematologic, dermatologic, gastrointestinal, ophthalmic, neoplastic, rheumatic, autoimmune, nervous system, renal, and respiratory origin (FDA approved in pediatric patients [age not specified] and adults); treatment of primary or secondary adrenocorticoid deficiency (drug of choice) (FDA approved in pediatric patients [age not specified] and adults); has also been used for management of septic shock and in neonates for treatment of hypotension and prevention of bronchopulmonary dysplasia.
Hydrocortisone may be confused with hydrocodone, hydroxychloroquine, hydroCHLOROthiazide
Cortef may be confused with Coreg, Lortab
Solu-CORTEF may be confused with SOLU-Medrol
HCT is an error-prone abbreviation (mistaken as hydroCHLOROthiazide)
Substrate of CYP3A4 (minor), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Abrocitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Abrocitinib. Management: The use of abrocitinib in combination with other immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider therapy modification
Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor therapy
Aldesleukin: Corticosteroids (Systemic) may diminish the therapeutic 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
Antithymocyte Globulin (Equine): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of systemic corticosteroid is reduced. Corticosteroids (Systemic) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Baricitinib. Management: The use of baricitinib in combination with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider therapy modification
BCG Products: Corticosteroids (Systemic) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Risk C: Monitor therapy
Brincidofovir: Corticosteroids (Systemic) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Corticosteroids (Systemic). Risk X: Avoid combination
Calcitriol (Systemic): Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic). Risk C: Monitor therapy
CAR-T Cell Immunotherapy: Corticosteroids (Systemic) may enhance the adverse/toxic effect of CAR-T Cell Immunotherapy. Specifically, the severity and duration of neurologic toxicities may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of CAR-T Cell Immunotherapy. Management: Avoid use of corticosteroids as premedication before treatment with CAR-T cell immunotherapy agents. Corticosteroids are indicated and may be required for treatment of toxicities such as cytokine release syndrome or neurologic toxicity. Risk D: Consider therapy modification
Chikungunya Vaccine (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Cladribine: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Corticosteroids (Systemic) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing systemic corticosteroids (dosed at 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks) several weeks prior to coccidioides immitis skin antigen testing. Risk D: Consider therapy modification
Corticorelin: Corticosteroids (Systemic) may 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: Hydrocortisone (Systemic) may diminish the diagnostic effect of Cosyntropin. Management: Patients receiving hydrocortisone should omit their pre-test dose on the day selected for cosyntropin testing. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters) Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Corticosteroids (Systemic) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of Hydrocortisone (Systemic). Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of Hydrocortisone (Systemic). Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Hydrocortisone (Systemic). 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
Dengue Tetravalent Vaccine (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect of Corticosteroids (Systemic). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and systemic corticosteroids. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification
Desirudin: Corticosteroids (Systemic) may 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
Deucravacitinib: May enhance the immunosuppressive effect of Corticosteroids (Systemic). Management: The use of deucravacitinib in combination with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider therapy modification
Dinutuximab Beta: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Dinutuximab Beta. Management: Corticosteroids are not recommended for 2 weeks prior to dinutuximab beta, during therapy and for 1 week after treatment. Doses equivalent to over 2 mg/kg or 20 mg/day of prednisone (persons over 10 kg) for 2 or more weeks are considered immunosuppressive Risk D: Consider therapy modification
Estrogen Derivatives: May increase the serum concentration of Hydrocortisone (Systemic). Estrogen Derivatives may decrease the serum concentration of Hydrocortisone (Systemic). Risk C: Monitor therapy
Etrasimod: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Etrasimod. Risk C: Monitor therapy
Filgotinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Filgotinib. Management: Coadministration of filgotinib with systemic corticosteroids at doses equivalent to greater than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks is not recommended. Risk D: Consider therapy modification
Gallium Ga 68 Dotatate: Corticosteroids (Systemic) may diminish the diagnostic effect of Gallium Ga 68 Dotatate. Risk C: Monitor therapy
Growth Hormone Analogs: Corticosteroids (Systemic) may diminish the therapeutic effect of Growth Hormone Analogs. Growth Hormone Analogs may decrease serum concentrations of the active metabolite(s) of Corticosteroids (Systemic). Risk C: Monitor therapy
Hyaluronidase: Corticosteroids (Systemic) 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
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Corticosteroids (Systemic) may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Management: Carefully consider the need for corticosteroids, at doses of a prednisone-equivalent of 10 mg or more per day, during the initiation of immune checkpoint inhibitor therapy. Use of corticosteroids to treat immune related adverse events is still recommended Risk D: Consider therapy modification
Indium 111 Capromab Pendetide: Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Risk X: Avoid combination
Inebilizumab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Corticosteroids (Systemic) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiation of systemic corticosteroids at immunosuppressive doses. Influenza vaccines administered less than 14 days prior to or during such therapy should be repeated 3 months after therapy. Risk D: Consider therapy modification
Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Risk C: Monitor therapy
Leflunomide: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as systemic corticosteroids. Risk D: Consider therapy modification
Licorice: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy
Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy
Lutetium Lu 177 Dotatate: Corticosteroids (Systemic) may diminish the therapeutic effect of Lutetium Lu 177 Dotatate. Management: Avoid repeated use of high-doses of corticosteroids during treatment with lutetium Lu 177 dotatate. Use of corticosteroids is still permitted for the treatment of neuroendocrine hormonal crisis. The effects of lower corticosteroid doses is unknown. Risk D: Consider therapy modification
Macimorelin: Corticosteroids (Systemic) may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination
MetyraPONE: Corticosteroids (Systemic) may diminish the diagnostic effect of MetyraPONE. Management: Consider alternatives to the use of the metyrapone test in patients taking systemic corticosteroids. Risk D: Consider therapy modification
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 (eg, for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment. Risk X: Avoid combination
Mumps- Rubella- or Varicella-Containing Live Vaccines: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Natalizumab. 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. Management: If concomitant therapy is required, use the lowest dose for the shortest duration to limit the risk of myopathy or neuropathy. Monitor for new onset or worsening muscle weakness, reduction or loss of deep tendon reflexes, and peripheral sensory decriments Risk D: Consider therapy modification
Nicorandil: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Risk C: Monitor therapy
Nirmatrelvir and Ritonavir: May increase the serum concentration of Hydrocortisone (Systemic). Risk C: Monitor therapy
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
Nonsteroidal Anti-Inflammatory Agents (Topical): May enhance the adverse/toxic effect of Corticosteroids (Systemic). Specifically, the risk of gastrointestinal bleeding, ulceration, and perforation may be increased. Risk C: Monitor therapy
Ocrelizumab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Ozanimod: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ozanimod. Risk C: Monitor therapy
Pidotimod: Corticosteroids (Systemic) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Corticosteroids (Systemic). Risk X: Avoid combination
Pneumococcal Vaccines: Corticosteroids (Systemic) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Polymethylmethacrylate. Specifically, the risk for hypersensitivity or implant clearance may be increased. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Quinolones: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Risk C: Monitor therapy
Rabies Vaccine: Corticosteroids (Systemic) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Ritodrine: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Ritodrine. Risk C: Monitor therapy
Ruxolitinib (Topical): Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
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: Corticosteroids (Systemic) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing immunosuppressants, such as systemic corticosteroids, prior to initiating sipuleucel-T therapy. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone given for 2 or more weeks are immunosuppressive. Risk D: Consider therapy modification
Sodium Benzoate: Corticosteroids (Systemic) may diminish the therapeutic effect of Sodium Benzoate. Risk C: Monitor therapy
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Corticosteroids (Systemic). Risk C: Monitor therapy
Succinylcholine: Corticosteroids (Systemic) may enhance the neuromuscular-blocking effect of Succinylcholine. Risk C: Monitor therapy
Tacrolimus (Systemic): Corticosteroids (Systemic) may decrease the serum concentration of Tacrolimus (Systemic). Conversely, when discontinuing corticosteroid therapy, tacrolimus concentrations may increase. Risk C: Monitor therapy
Tacrolimus (Topical): Corticosteroids (Systemic) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Corticosteroids (Systemic) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy
Tofacitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider therapy modification
Typhoid Vaccine: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Upadacitinib. Management: Coadministration of upadacitinib with systemic corticosteroids at doses equivalent to greater than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks is not recommended. Risk D: Consider therapy modification
Urea Cycle Disorder Agents: Corticosteroids (Systemic) may 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 (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone > 2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines 4 weeks prior to therapy if possible. Risk D: Consider therapy modification
Vaccines (Non-Live/Inactivated/Non-Replicating): Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Corticosteroids (Systemic) may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Yellow Fever Vaccine: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Systemic use of corticosteroids may require a diet with increased potassium, vitamins A, B6, C, D, folate, calcium, zinc, phosphorus, and decreased sodium. Some products may contain sodium.
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 treating patients with adrenal insufficiency (primary or central or congenital adrenal hyperplasia) during pregnancy, hydrocortisone is the preferred corticosteroid. Doses may need to be adjusted as pregnancy progresses. Pregnant patients with adrenal insufficiency should be monitored at least once each trimester (ES [Bornstein 2016]; ES [Fleseriu 2016]; ES [Speiser 2018]).
High doses of hydrocortisone (ie, stress doses) may be required to prevent adrenal crisis during labor in patients with known or suspected adrenal insufficiency (eg, Cushingoid appearance, prolonged glucocorticoid therapy) (ES [Bornstein 2016]; ES [Fleseriu 2016]; ES [Speiser 2018]; ESE [Luger 2021]). Patients who require systemic corticosteroids for management of asthma should also be given IV corticosteroids, such as hydrocortisone, during labor and for 24 hours after delivery to prevent adrenal crisis (ACOG [Dombrowski 2008]; ERS/TSANZ [Middleton 2020]). Patients using chronic low dose steroids for rheumatic disorders generally do not need a stress dose of hydrocortisone at the time of vaginal delivery; however, stress dosing may be needed in women with multiple comorbidities treated with chronic high dose steroid therapy. Stress dosing is recommended prior to cesarean delivery (ACR [Sammaritano 2020]).
Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes). Maternal asthma symptoms should be monitored monthly during pregnancy. Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy; however, systemic corticosteroids should be used to control acute exacerbations or treat severe persistent asthma. Hydrocortisone may be used when parenteral administration is required (ERS/TSANZ [Middleton 2020]; GINA 2023).
Hydrocortisone is approved for the treatment of rheumatic disorders, however, when systemic corticosteroids are needed in pregnancy, nonfluorinated corticosteroids (eg, prednisone) are preferred (ACR [Sammaritano 2020]).
For dermatologic disorders in pregnant patients, systemic corticosteroids are generally not preferred for initial therapy; should be avoided during the first trimester; and used during the second or third trimester at the lowest effective dose (Leachman 2006).
In nonpregnant patients, hydrocortisone is recommended off label as an alternative corticosteroid for the management of COVID-19 (NIH 2023). In general, the treatment of COVID-19 during pregnancy is the same as in nonpregnant patients. However, because data for most therapeutic agents in pregnant patients are limited, treatment options should be evaluated as part of a shared decision-making process. Hydrocortisone is also an alternative for use in pregnant patients with severe or critical COVID-19 due to limited placental transfer. Suggested treatment algorithms are available for pregnant patients with severe or critical COVID-19 requiring corticosteroids (Saad 2020; Teelucksingh 2022). The risk of severe illness from COVID-19 infection is increased in symptomatic pregnant patients compared to nonpregnant patients (ACOG 2023). Information related to the treatment of COVID-19 during pregnancy continues to emerge; refer to current guidelines for the treatment of pregnant patients.
Blood pressure; weight; serum glucose; electrolytes; growth in pediatric patients; presence of infection, bone mineral density; assess hypothalamic pituitary adrenal (HPA) axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test). Signs and symptoms of behavioral or mood changes; signs and symptoms of Cushing syndrome every 6 months (pediatric patients <1 year of age may require monitoring every 3 to 4 months). Monitor intraocular pressure with therapy >6 weeks.
Hydrocortisone (normal endogenous morning levels): 4 to 30 mcg/mL
Short-acting corticosteroid with minimal sodium-retaining potential; decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability
Onset of action: IV: 1 hour.
Absorption: Rapid.
Bioavailability: Oral: 96% ± 20% (Czock 2005); oral sprinkles: ~87%.
Distribution: Vd: IV: 27 ± 7 L (Czock 2005).
Protein binding: IV: 92% ± 2% (Czock 2005); oral sprinkles: ≥90%.
Metabolism: Hepatic.
Half-life elimination: IM: 2.2 ± 1.5 hours (Hahner 2013); IV: 2 ± 0.3 hours; Oral: 1.8 ± 0.5 hours (Czock 2005); SubQ: 4.7 ± 4.7 hours (Hahner 2013).
Time to peak, plasma: IM: 66 ± 51 minutes (Hahner 2013); Oral: 1.2 ± 0.4 hours (Czock 2005); SubQ: 91 ± 34 minutes (Hahner 2013).
Excretion: Urine (Czock 2005).
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