Hydrocortisone (Systemic) (Lexi-Drugs)

Pronunciation

(hye droe KOR ti sone)

Brand Names: US

Cortef; Solu-CORTEF

Brand Names: Canada

Cortef; Solu-CORTEF

Pharmacologic Category

Corticosteroid, Systemic

Dosing: Adult

Note: 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.

Asthma, acute exacerbation (off-label dose): Oral: 200 mg in divided doses for 5 to 7 days (GINA 2018).

Anti-inflammatory or immunosuppressive:

IM, IV: Initial: 100 to 500 mg/dose at intervals of 2, 4, or 6 hours.

Oral: Initial: 20 to 240 mg/day.

Adrenal insufficiency, acute (adrenal crisis):

Note: Appropriate fluid resuscitation is also required (Endocrine Society [Bornstein 2016]; Gardner 2011).

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. After the initial 24 hours, may gradually taper the dose; once patient is stable, may resume oral maintenance dosing (Allolio 2015; Endocrine Society [Bornstein 2016]; Endocrine Society [Speiser 2018]; Gardner 2011).

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) (Endocrine Society [Bornstein 2016]; Endocrine Society [Fleseriu 2016]; Endocrine Society [Speiser 2018]).

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 (Endocrine Society [Neiman 2015]).

Multiple sclerosis, acute exacerbations:

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

IM, IV: 800 mg/day for 1 week, followed by 320 mg every other day for 1 month.

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

Stress dosing in patients known to be adrenally-suppressed (ie, prevention of adrenal crisis in glucocorticoid-treated patients) (off-label dose):

Sickness:

Illness with fever: Oral: Double the routine oral hydrocortisone dose until recovery for fever >38°C [100.4°F] or triple the routine oral hydrocortisone dose until recovery for fever >39°C [102.2°F]; return to standard dose within 1 to 2 days (Allolio 2015)

Gastroenteritis with vomiting and/or diarrhea: IM, SubQ: 100 mg dose given early in course of illness; repeat after 6 to 12 hours (Allolio 2015)

Severe infection (eg, pneumonia/with altered cognition): IM, SubQ: 100 mg dose given early in course of illness; repeat after 6 to 12 hours until recovery (Allolio 2015)

Surgery:

Minor stress (ie, inguinal herniorrhaphy): IV: 25 mg/day for 1 day (Coursin 2002; Salem 1994)

Moderate stress (ie, joint replacement, cholecystectomy): IV: 50 to 75 mg/day (25 mg every 8 to 12 hours) for 1 to 2 days (Coursin 2002; Salem 1994)

Major stress (pancreatoduodenectomy, esophagogastrectomy, cardiac surgery): IV: 100 to 150 mg/day (50 mg every 8 to 12 hours) for 2 to 3 days (Coursin 2002; Salem 1994)

Septic shock (off-label use): Note: Corticosteroids should only be used for septic shock that is not responsive to volume resuscitation and vasopressors (Rhodes 2017; SCCM/ESICM [Annane 2017]).

IV: 50 mg bolus every 6 hours, either as monotherapy (Sprung 2008) or in combination with fludrocortisone (Annane 2002; Annane 2018) or 200 mg/day as a continuous infusion (Venkatesh 2018). Guidelines suggest a therapy duration of ≥3 days (Rhodes 2017; SCCM/ESICM [Annane 2017]); most studies treated for up to 7 days; not all studies tapered therapy. May consider a slow taper over several days when vasopressors are no longer required to avoid possible hemodynamic deterioration which may occur with abrupt withdrawal (Keh 2003; Rhodes 2017).

Note: Low-dose hydrocortisone in septic shock patients may cause a significant increase in hyperglycemia and hypernatremia. A small study demonstrated that repetitive bolus doses of hydrocortisone caused significant hyperglycemia that was not seen during continuous infusion (Weber-Carstens 2007); practice guidelines recommend strategies for avoidance and/or detection of these side effects, such as dosing by continuous infusion (Rhodes 2017).

Thyroid storm (off-label use): IV: 300 mg loading dose, followed by 100 mg every 8 hours (ATA [Ross 2016])

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Chemotherapy Regimens

Lymphoma, non-Hodgkin (Burkitt):

CODOX-M/IVAC (NHL-Burkitt)

CODOX-M (NHL-Burkitt)

Dosing: Pediatric

Note: 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: IM, IV (preferred):

Weight-directed: Limited data available: Infants, Children, and Adolescents: Initial: 2 to 3 mg/kg; 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; may also be administered I.O. if necessary (Cameron 2012; Hegenbarth 2008; Marx 2014)

BSA-directed dosing: Limited data available: Infants, Children, and Adolescents: Initial: 50 to 100 mg/m2 once followed by 50 to 100 mg/m2/day in 4 divided doses (Ahmet 2011; Auron 2015; Hegenbarth 2008; Shulman 2007)

Age-directed dosing (fixed dosing): Limited data available (Cameron 2012; Elder 2015; Kliegman 2016):

Infants: 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): 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): 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: 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 (Kliegman 2007)

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 (Kliegman 2007)

Adolescents: Oral, IM, IV, SubQ: 15 to 240 mg every 12 hours (Kliegman 2007)

Congenital adrenal hyperplasia: Infants, Children, and Adolescents: AAP Recommendations: Note: Administer morning dose as early as possible. Tablets may result in more reliable serum concentrations than oral liquid formulation; use of oral suspension is not recommended. Individualize dose by monitoring growth, hormone levels, and bone age; mineralocorticoid (eg, fludrocortisone) and sodium supplement may be required in salt losers (AAP 2000; AAP 2010; Endocrine Society 2010)

Initial: Oral (tablets): 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 (AAP 2010; Endocrine Society 2010).

Maintenance dose: 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 (Ahmet 2011; Elder 2015; Gupta 2008; Maguire 2007; Shulman 2007)

Stress dosing; supplemental: Limited data available; dosage regimens variable: Infants, Children, and Adolescents: 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) (Shulman 2007). Typically, supplementation for emotional or minimal physiological stress conditions or prior to exercise is not necessary (Elder 2010; Endocrine Society [Speiser 2010]; Shulman 2007). Dosing is generally 2 to 3 times physiologic replacement level (Elder 2010; Shulman 2007).

BSA-directed dosing (Ahmet 2011; Shulman 2007): 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 (Endocrine Society [Speiser 2010]):

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; catecholamine-refractory with suspected/proved adrenal insufficiency: Limited data available: Infants, Children, and Adolescents: IV: 50 to 100 mg/m2/day (Dellinger 2013; Marx 2014; Shulman 2007); in some cases, doses may be titrated up to 50 mg/kg/day if necessary for shock reversal; however, efficacy data variable with the higher doses (Brierley 2009; Menon 2012)

Dosing: Renal Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Use: Labeled Indications

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions, or acute noninfectious laryngeal edema (epinephrine is the drug of first choice).

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

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

Endocrine disorders: Acute adrenocortical insufficiency; congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis; primary or secondary adrenocortical insufficiency; preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful; shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.

GI diseases: To tide the patient over a critical period of the disease in ulcerative colitis and regional enteritis.

Hematologic disorders: Acquired (autoimmune) hemolytic anemia; congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia); erythroblastopenia (RBC anemia); immune thrombocytopenia (formerly known as idiopathic thrombocytopenic purpura) in adults; pure red cell aplasia; select cases of secondary thrombocytopenia.

Neoplastic diseases: Palliative management of leukemias and lymphomas (adults); acute leukemia of childhood.

Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. 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: Severe acute and chronic allergic and inflammatory processes involving the eye, such as allergic conjunctivitis; allergic corneal marginal ulcers; anterior segment inflammation; chorioretinitis; diffuse posterior uveitis and choroiditis; herpes zoster ophthalmicus; iritis and iridocyclitis; keratitis; optic neuritis; sympathetic ophthalmia; other ocular inflammatory conditions unresponsive to topical corticosteroids.

Respiratory diseases: Aspiration pneumonitis; bronchial asthma; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; idiopathic eosinophilic pneumonias; Loeffler syndrome (not manageable by other means); 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, posttraumatic osteoarthritis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis, synovitis of osteoarthritis; during an exacerbation or as maintenance therapy in acute rheumatic carditis, dermatomyositis (polymyositis), temporal arteritis, and systemic lupus erythematosus.

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

Use: Off-Label: Adult

  In-hospital cardiac arrestLevel of Evidence [C, G]

Data from two randomized controlled trials in patients experiencing in-hospital cardiac arrest (IHCA) suggest that the combination of vasopressin, epinephrine (standard dose), and methylprednisolone administered during cardiac arrest followed by hydrocortisone given after return of spontaneous circulation may be beneficial for the treatment of patients in this setting Ref. Additional trials are necessary to further define the role of this regimen and of hydrocortisone (post-arrest) for the treatment of patients who experience IHCA.

Based on the 2015 American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, the intra-arrest use of vasopressin (in combination with epinephrine and methylprednisolone) in patients with IHCA followed by hydrocortisone given after return of spontaneous circulation may be considered (based on limited evidence); however, further studies are warranted before routine administration of this combination can be recommended.

  Septic shockLevel of Evidence [B, G]

Data from two double-blind, placebo controlled, randomized trials suggest that hydrocortisone may be beneficial in patients with septic shock refractory to initial volume resuscitation and vasopressors. In these trials, hydrocortisone did not improve mortality compared to placebo but did aid in more rapid reversal of shock Ref. Two additional double-blind, placebo controlled, randomized trials suggest the combination of hydrocortisone plus fludrocortisone may be beneficial in this same population, and may also provide a mortality benefit Ref .

Based on the Surviving Sepsis Campaign International Guidelines for Management of Severe Sepsis and Septic Shock, intravenous hydrocortisone is suggested, only after adequate fluid resuscitation and vasopressor therapy are unable to restore hemodynamic stability, in adults with septic shock RefNote: Corticosteroids should not be administered for the treatment of sepsis in the absence of shock or for septic shock that is responsive to fluid resuscitation and vasopressors. Ref.

  Thyroid stormLevel of Evidence [G]

Based on the American Thyroid Association guidelines for the diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis, a multimodal approach including beta blockade, antithyroid drug therapy, inorganic iodide, corticosteroid therapy, aggressive cooling with acetaminophen and cooling blankets, volume resuscitation, nutritional and respiratory support, and monitoring in an intensive care unit is effective and suggested when treating thyroid storm.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Asthma:

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

Congenital Adrenal Hyperplasia:

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

Critical Illness-Related Corticosteroid Insufficiency:

Society of Critical Care Medicine/European Society of Intensive Care Medicine, “Guidelines for the Diagnosis and Management of Critical Illness-Related Corticosteroid Insufficiency in Critically Ill Patients,” December 2017

Cushing Syndrome:

Endocrine Society, “Treatment of Cushing’s Syndrome” August 2015

Hyperthyroidism:

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

Hypopituitarism:

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

Primary Adrenal Insufficiency:

Endocrine Society, “Diagnosis and Treatment of Primary Adrenal Insufficiency,” February 2016

Sepsis:

“Clinical Practice Parameters for Hemodynamic Support of Pediatric and Neonatal Septic Shock,” February 2007

“Surviving Sepsis Campaign: International Guidelines for the Management of Severe Sepsis and Septic Shock: 2012,” February 2013

“Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016,” March 2017

Ulcerative Colitis:

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

Administration: IM

Avoid injection into deltoid muscle (high incidence of subcutaneous atrophy). Dermal and/or subdermal skin depression may occur at injection site.

Administration: IV

Dermal and/or subdermal skin depression may occur at injection site.

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.

Administration: Injectable Detail

pH: Hydrocortisone sodium succinate: 7 to 8

Administration: Oral

Administer with food or milk to decrease GI upset.

Administration: Pediatric

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) (Elder 2015)

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 (Miller 1980)

Dietary Considerations

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.

Storage/Stability

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

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.

Preparation for Administration: Adult

IV bolus or IM administration: Reconstitute 100 mg vials with bacteriostatic water or bacteriostatic sodium chloride (not >2 mL).

IV infusion administration: Add reconstituted solutions to an appropriate volume of D5W, NS, or D5NS (100 to 1,000 mL for a 100 mg solution; 250 to 1,000 mL for a 250 mg solution; 500 to 1,000 mL for a 500 mg solution; 1,000 mL for a 1,000 mg solution). In cases where administration of a small volume of fluid is desirable, 100 to 3,000 mg of hydrocortisone may be added to 50 mL of D5W or NS.

Act-O-Vial: Press the activator to force diluent into the powder compartment. Following gentle agitation, solution may be withdrawn via syringe through a needle inserted into the center of the stopper.

Preparation for Administration: Pediatric

Parenteral: Reconstitute vial with appropriate diluent, either bacteriostatic water or NS (see manufacturer’s labeling for details). For the commonly used 100 mg vial, reconstitute with a volume of diluent not to exceed 2 mL resulting in a concentration ≥ 50 mg/mL. Act-O-Vial (self-contained powder for injection plus diluent [preservative free SWFI]) may be reconstituted by pressing the activator to force diluent into the powder compartment. Following gentle agitation, solution may be withdrawn via syringe through a needle inserted into the center of the stopper. May be administered (IV or IM) without further dilution.

Intermittent IV infusion: Reconstituted solutions may be further diluted in an appropriate volume of compatible solution for infusion. Concentration should generally not exceed 1 mg/mL. In pediatric patients, a concentration of 5 mg/mL has been used (Miller 1980). The manufacturer suggests, in cases where administration of a small volume of fluid is desirable, concentrations up to 60 mg/mL (100 to 3,000 mg in 50 mL of D5W or NS; stability limited to 4 hours) may be used.

Compatibility

See Trissel’s IV Compatibility Database

Extemporaneously Prepared

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.

Chong G, Decarie D, Ensom MHH. Stability of hydrocortisone in extemporaneously compounded suspension. J Inform Pharmacother. 2003;13:100-110.

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.

Fawcett JP, Boulton DW, Jiang R, et al. Stability of hydrocortisone oral Suspensions prepared from tablets and powder. Ann Pharmacother. 1995;29(10):987-990.[PubMed 8845559]

Medication Patient Education with HCAHPS Considerations

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

• Patient may experience nausea, vomiting, insomnia, or agitation. Have patient report immediately to prescriber signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss); signs of infection; signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit); signs of 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 Cushing’s disease (weight gain in upper back or abdomen; moon face; severe headache; or slow healing); severe loss of strength and energy; irritability; tremors; tachycardia; confusion; dizziness; sweating a lot; shortness of breath; excessive weight gain; swelling of arms or legs; signs of skin changes (acne, stretch marks, slow healing, or hair growth); moon face; buffalo hump; severe headache; passing out; muscle weakness; bone pain; joint pain; menstrual changes; angina; vision changes; eye pain; severe eye irritation; mood changes; behavioral changes; depression; seizures; 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 healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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

Hypersensitivity to 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).

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)

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

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. 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 latent tuberculosis and/or TB reactivity; restrict use in active TB (only fulminating or disseminated TB in conjunction with antituberculosis treatment). Latent or active amebiasis should be ruled out in any patient with recent travel to 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. Pre-existing 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.

• 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. 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.

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

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

• Septic shock or sepsis syndrome: Corticosteroids should not be administered for the treatment of sepsis in the absence of shock (SCCM/ESICM [Annane 2017]).

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

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

Dosage form specific issues:

• Benzyl alcohol and derivatives: 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.

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).

Geriatric Considerations

Because of the risk of adverse effects, systemic corticosteroids should be used cautiously in the elderly, in the smallest possible dose, and for the shortest possible time. Given the role of glucocorticoids in the treatment of many conditions (past and present), a good medication history assessment is appropriate in the older adult to ascertain risk for glucocorticoid-induced diseases (eg, osteoporosis, glaucoma) (O’Connell 2015).

Warnings: Additional Pediatric Considerations

May cause osteoporosis (at any age) or inhibition of bone growth in pediatric patients. Use with caution in patients with osteoporosis. In a population-based study of children, risk of fracture was shown to be increased with >4 courses of corticosteroids; underlying clinical condition may also impact bone health and osteoporotic effect of corticosteroids (Leonard 2007). In premature neonates, reports of gastrointestinal perforation in the hydrocortisone treatment arm have resulted in the closure of two large 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.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed with corticosteroids in animal reproduction studies. 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 women 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, and stress doses may be required during active labor. Pregnant women with adrenal insufficiency should be monitored at least once each trimester (ES [Bornstein 2016]; ES [Fleseriu 2016]; ES [Speiser 2018]).

Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications (ACOG 2008; GINA 2018). Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy; however, systemic corticosteroids should be used to control acute exacerbations or treat severe persistent asthma (ACOG 2008; GINA 2018; Namazy 2016). Women who require systemic corticosteroids for management of their asthma should be given intravenous corticosteroids, such as hydrocortisone, during labor and for 24 hours after delivery to prevent adrenal crisis (ACOG 2008).

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

For dermatologic disorders in pregnant women, systemic corticosteroids are generally not preferred for initial therapy; should be avoided during the first trimester; and used during the second or third trimester at the lowest effective dose (Bae 2012; Leachman 2006).

Breast-Feeding Considerations

Corticosteroids are present in breast milk.

The manufacturer notes that when used systemically, maternal use of corticosteroids have the potential to cause adverse events in a breastfed infant (eg, growth suppression, interfere with endogenous corticosteroid production). Single doses of hydrocortisone are considered acceptable for use in breastfeeding females; data is not available following prolonged use (WHO 2002). Corticosteroids are generally considered acceptable in breastfeeding females when used in usual doses (Götestam Skorpen 2016; WHO 2002); however, monitoring of the infant is recommended (WHO 2002).

If there is concern about exposure to the infant, some guidelines recommend waiting 4 hours after the maternal dose of an oral systemic corticosteroid before breastfeeding in order to decrease potential exposure to the breastfed infant (based on a study using prednisolone) (Bae 2012; Butler 2014; Götestam Skorpen 2016; Leachman 2006; Makol 2011; Ost 1985).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency not defined.

Cardiovascular: Atheromatous embolism, bradycardia, cardiac arrhythmia, cardiac failure (especially in susceptible patients), cardiomegaly, circulatory shock, hypertension, hypertrophic cardiomyopathy (premature infants), myocardial rupture (post-myocardial infarction), syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis

Central nervous system: Arachnoiditis (intrathecal administration), depression, emotional lability, euphoria, headache, increased intracranial pressure (with pseudotumor cerebri; usually following discontinuation), insomnia, malaise, meningitis (intrathecal administration), myasthenia, neuritis, neuropathy, paraplegia (intrathecal administration), paresthesia, personality changes, psychic disorder, seizure, sensory disturbance (intrathecal administration), tingling of skin (especially in the perineal area after IV injection), vertigo

Dermatologic: Acne vulgaris, allergic dermatitis, alopecia, atrophic striae, burning sensation of skin (especially in the perineal area after IV injection), diaphoresis, ecchymosis, erythema (including facial), exfoliation of skin, hyperpigmentation, hypertrichosis, hypopigmentation, skin atrophy, skin rash, suppression of skin test reaction, urticaria, xeroderma

Endocrine & metabolic: Adrenal suppression, Cushing syndrome, diabetes mellitus (latent), fluid retention, glycosuria, growth suppression, hirsutism, HPA-axis suppression, hypercalcemia (associated with cancers), hyperglycemia (including increased requirements for insulin or oral hypoglycemic agents in diabetes mellitus), hypokalemia, hypokalemic alkalosis, impaired glucose tolerance, lipodystrophy, lipomatosis (epidural), menstrual disease (menstrual irregularities), moon face, negative nitrogen balance, protein catabolism, sodium retention, weight gain

Gastrointestinal: Abdominal distention, carbohydrate intolerance, dyspepsia, gastrointestinal disease (intrathecal administration), gastrointestinal perforation (small and large intestine, particularly in patients with inflammatory bowel disease), hiccups, increased appetite, nausea, pancreatitis, peptic ulcer (with possible perforation and hemorrhage), ulcerative esophagitis, vomiting

Genitourinary: Asthenospermia, bladder dysfunction (intrathecal administration)

Hematologic & oncologic: Leukocytosis, petechia

Hepatic: Hepatomegaly, increased serum transaminases (usually mild elevations and reversible on discontinuation)

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction

Infection: Increased susceptibility to infection, infection, sterile abscess

Local: Atrophy at injection site (cutaneous and subcutaneous), postinjection flare (intra-articular use), skin edema

Neuromuscular & skeletal: Amyotrophy, Charcot-like arthropathy, lower extremity weakness (intrathecal administration), osteonecrosis (aseptic necrosis of femoral and humoral heads), osteoporosis, pathological fracture (long bones), rupture of tendon (particularly Achilles tendon), steroid myopathy, vertebral compression fracture

Ophthalmic: Cataract (posterior subcapsular), exophthalmos, glaucoma, increased intraocular pressure, retinopathy (central serous chorioretinopathy)

Respiratory: Pulmonary edema

Miscellaneous: Wound healing impairment

<1%, postmarketing, and/or case reports: Anaphylactoid reaction, blindness (periocular injection)

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP3A4 (minor), P-glycoprotein/ABCB1; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

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

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

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

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

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

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

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

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

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

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

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

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

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Risk X: Avoid combination

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

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

Cosyntropin: 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

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

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Corticosteroids (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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Risk C: Monitor therapy

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

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

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

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

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

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

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

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

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

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

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

P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy

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

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

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

Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Risk C: Monitor therapy

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

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

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

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

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Risk C: Monitor therapy

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

Somatropin: Corticosteroids (Systemic) may diminish the therapeutic effect of Somatropin. 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): May enhance the adverse/toxic effect of Immunosuppressants. Risk X: Avoid combination

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

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

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

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

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

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

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

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

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

Test Interactions

May decrease response to skin tests

Monitoring Parameters

Serum glucose, electrolytes; blood pressure, weight, presence of infection; monitor IOP with therapy >6 weeks; bone mineral density; assess HPA axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test); growth in pediatric patients.

Advanced Practitioners Physical Assessment/Monitoring

Obtain blood glucose and electrolytes. Obtain intraocular pressure with prolonged therapy (>6 weeks). Monitor blood pressure and weight. Evaluate for signs and symptoms of infection. Monitor growth with long-term use in pediatric patients. Assess for signs and symptoms of HPA axis suppression/adrenal insufficiency. Assess for ocular changes. Assess other medicines patient may be taking; alternate therapy or dosage adjustments may be needed.

Nursing Physical Assessment/Monitoring

Check lab results and report abnormalities. Instruct patient to report signs and symptoms of infection. Instruct patient on importance of slowing tapering dose and frequency when discontinuing.

Dosage Forms: US

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

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

Dosage Forms: Canada

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

Solution Reconstituted, Injection:

Generic: 250 mg (1ea[DSC]); 500 mg (1ea[DSC]); 1000 mg (1ea[DSC])

Solution Reconstituted, Injection, as sodium succinate [strength expressed as base]:

Solu-CORTEF: 100 mg (1ea, 2ml); 250 mg (1ea); 500 mg (1ea); 1000 mg (1ea)

Generic: 100 mg (1ea[DSC])

Tablet, Oral, as base:

Cortef: 10 mg, 20 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • A01AC03
  • A07EA02
  • H02AB09
Generic Available (US)

May be product dependent

Pricing: US

Solution (reconstituted) (Solu-CORTEF Injection)

100 mg (per each): $16.11

250 mg (per each): $29.81

500 mg (per each): $59.63

1000 mg (per each): $119.24

Tablets (Cortef Oral)

5 mg (per each): $1.19

10 mg (per each): $2.01

20 mg (per each): $3.80

Tablets (Hydrocortisone Oral)

5 mg (per each): $0.34

10 mg (per each): $0.57

20 mg (per each): $1.09

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Short-acting corticosteroid with minimal sodium-retaining potential; decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability

Pharmacodynamics/Kinetics

Onset of action: IV: 1 hour

Absorption: Rapid

Bioavailability: Oral: 96% ± 20% (Czock 2005)

Distribution: Vd: IV: 27 ± 7 L (Czock 2005)

Protein binding: IV: 92% ± 2% (Czock 2005)

Metabolism: Hepatic

Half-life elimination: IV: 2 ± 0.3 hours; Oral: 1.8 ± 0.5 hours (Czock 2005)

Time to peak, plasma: Oral: 1.2 ± 0.4 hours (Czock 2005)

Excretion: Urine (Czock 2005)

Dental Use

Treatment of a variety of oral diseases of allergic, inflammatory, or autoimmune origin

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

A-hydroCort; Compound F; Cortisol; Hydrocortisone Sodium Succinate

FDA Approval Date
December 15, 1952
References

ACOG Committee on Practice Bulletins-Obstetrics, “ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists Number 90, February 2008: Asthma in Pregnancy,” Obstet Gynecol, 2008, 111(2 Pt 1):457-64.[PubMed 18238988]

Abraham E and Evans T, “Corticosteroids and Septic Shock [editorial],” JAMA, 2002, 288(7):886-7.[PubMed 12186608]

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

Ahmet A, Kim H, and Spier S. Adrenal suppression: A practical guide to the screening and management of this under-recognized complication of inhaled corticosteroid therapy. Allergy Asthma Clin Immunol. 2011;7:13. doi: 10.1186/1710-1492-7-13.[PubMed 21867553]

A-Hydrocort (hydrocortisone injection) [prescribing information]. Lake Forest, IL: Hospira; October 2005.

Allolio B. Extensive expertise in endocrinology. Adrenal crisis. Eur J Endocrinol. 2015 Mar;172(3):R115-R24.[PubMed 25288693]

American Academy of Pediatrics. Technical report: congenital adrenal hyperplasia. Section on Endocrinology and Committee on Genetics. Pediatrics. 2000;106(6):1511-1518.[PubMed 11099616]

American Academy of Pediatrics. Statement of endorsement: congenital adrenal hyperplasia due to steroid 21-hydroxylase deficiency. Pediatrics. 2010;126(5):1051. http://pediatrics.aappublications.org/cgi/content/extract/126/5/1051. Accessed May 10, 2011.

Annane D, Pastores SM, Rochwerg B, et al. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Crit Care Med. 2017;45(12):2078-2088. doi: 10.1097/CCM.0000000000002737.[PubMed 28938253]

Annane D, Renault A, Brun-Buisson C, et al. Hydrocortisone plus fludrocortisone for adults with septic shock. N Engl J Med. 2018;378(9):809-818. doi: 10.1056/NEJMoa1705716.[PubMed 29490185]

Annane D, Sebille V, Charpentier C, et al, “Effect of Treatment With Low Doses of Hydrocortisone and Fludrocortisone on Mortality in Patients With Septic Shock,” JAMA, 2002, 288(7):862-71.[PubMed 12186604]

Arlt W and Allolio B, “Adrenal Insufficiency,” Lancet, 2003, 361(9372):1881-93.[PubMed 12788587]

Bae YS, Van Voorhees AS, Hsu S, et al, “Review of Treatment Options For Psoriasis in Pregnant or Lactating Women: From the Medical Board of the National Psoriasis Foundation,” J Am Acad Dermatol, 2012, 67(3):459-77.[PubMed 22018758]

Beck RW, Cleary PA, Anderson MM Jr, et al, “A Randomized, Controlled Trial of Corticosteroids in the Treatment of Acute Optic Neuritis. The Optic Neuritis Study Group,” N Engl J Med, 1992, 326(9):581-8.[PubMed 1734247]

Bornstein SR, Allolio B, Arlt W, et al. Diagnosis and treatment of primary adrenal insufficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2016;101(2):364-389. doi: 10.1210/jc.2015-1710.[PubMed 26760044]

Bratton SL, Chestnut RM, Ghajar J, et al, “Guidelines for the Management of Severe Traumatic Brain Injury. XV. Steroids,” J Neurotrauma, 2007, 24(Suppl 1):91-5.[PubMed 17511554]

Brierley J, Carcillo JA, Choong K, et al, “Clinical Practice Parameters for Hemodynamic Support of Pediatric and Neonatal Septic Shock: 2007 Update from the American College of Critical Care Medicine,” Crit Care Med, 2009, 37(2):666-88.[PubMed 19325359]

Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014;70(3):417.[PubMed 24528912]

Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]

Cooper MS and Stewart PM, “Corticosteroid Insufficiency in Acutely Ill Patients,” N Engl J Med, 2003, 348(8):727-34.[PubMed 12594318]

Cortef (hydrocortisone tablets) [prescribing information]. New York, NY: Pfizer; September 2016.

Cortef (hydrocortisone tablets) [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada Inc; November 2018.

Coursin DB and Wood KE, “Corticosteroid Supplementation for Adrenal Insufficiency,” JAMA, 2002, 287(2):236-40.[PubMed 11779267]

Czock D, Keller F, Rasche FM, Häussler U. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44(1):61-98.[PubMed 15634032]

de Jonghe B, Sharshar T, Lefaucheur JP, et al, “Paresis Acquired in the Intensive Care Unit. A Prospective Multicenter Study,” JAMA, 2002, 288(22):2859-67.[PubMed 12472328]

Dellinger RP, Levy MM, Rhodes A, et al. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.[PubMed 23353941]

Edwards P, Arango M, Balica L, et al, “Final Results of MRC Crash, A Randomized Placebo-Controlled Trial of Intravenous Corticosteroid in Adults With Head Injury – Outcomes at 6 Months,” Lancet, 2005, 365(9475):1957-9.[PubMed 15936423]

Elder CJ, Dimitri P. Arch Dis Child Educ Pract Ed. 2015;100(5):272-276. doi: 10.1136/archdischild-2014-307325.[PubMed 25561746]

Fleseriu M, Hashim IA, Karavitaki N, et al. Hormonal replacement in hypopituitarism in adults: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2016;101(11):3888-3921. doi: 10.1210/jc.2016-2118.[PubMed 27736313]

Gardner DG, Chapter 24. Endocrine Emergencies, Greenspan’s Basic & Clinical Endocrinology, 9ed. 2011.

Global Initiative for Asthma (GINA). GINA report, Global Strategy for Asthma Management and Prevention. https://ginasthma.org/2018-gina-report-global-strategy-for-asthma-management-and-prevention/. Updated 2018. Accessed September 30, 2018.

Goedert JJ, Vitale F, Lauria C, et al. Risk factors for classical Kaposi’s sarcoma. J Natl Cancer Inst. 2002;94(22):1712-1718.[PubMed 12441327]

Götestam Skorpen C, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75(5):795-810.[PubMed 26888948]

Gupta P and Bhatia V. Corticosteroid physiology and principles of therapy. Indian J Pediatr. 2008;75(10):1039-1044. doi: 10.1007/s12098-008-0208-1.[PubMed 19023528]

Hotchkiss RS and Karl IE, “The Pathophysiology and Treatment of Sepsis,” N Engl J Med, 2003, 348(2):138-50.[PubMed 12519925]

“Inactive” ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Keh D, Boehnke T, Weber-Cartens S, et al. Immunologic and hemodynamic effects of “low-dose” hydrocortisone in septic shock: a double-blind, randomized, placebo-controlled, crossover study. Am J Respir Crit Care Med. 2003;167(4):512-20. doi: 10.1164/rccm.200205-446OC[PubMed 12426230]

Kliegman RM, Stanton BF. Nelson Textbook of Pediatrics, 20th ed. Philadelphia, PA: Elsevier; 2016.

Kornbluth A and Sachar DB, “Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee,” Am J Gastroenterol, 2010, 105(3):501-23.[PubMed 20068560]

Leachman SA and Reed BR, “The Use of Dermatologic Drugs in Pregnancy and Lactation,” Dermatol Clin, 2006, 24(2):167-97, vi.[PubMed 16677965]

Lunghi L, Pavan B, Biondi C, et al, “Use of Glucocorticoids in Pregnancy,” Curr Pharm Des, 2010, 16(32):3616-37.[PubMed 20977425]

Maguire AM, Ambler GR, Moore B, et al. Prolonged hypocortisolemia in hydrocortisone replacement regimens in adrenocorticotrophic hormone deficiency. Pediatrics. 2007;120(1):e164-e171.[PubMed 17576782]

Makol A, Wright K, and Amin S, “Rheumatoid Arthritis and Pregnancy: Safety Considerations in Pharmacological Management,” Drugs, 2011, 71(15):1973-87.[PubMed 21985166]

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

Menon, K. Use of hydrocortisone for refractory shock in children. Crit Care Med. 2013;41(10):e294-295.[PubMed 24060796]

Mentzelopoulos SD, Malachias S, Chamos C, et al. Vasopressin, steroids, and epinephrine and neurologically favorable survival after in-hospital cardiac arrest: a randomized clinical trial. JAMA. 2013;310(3):270-279.[PubMed 23860985]

Mentzelopoulos SD, Zakynthinos SG, Tzoufi M, et al. Vasopressin, epinephrine, and corticosteroids for in-hospital cardiac arrest. Arch Intern Med. 2009;169(1):15-24.[PubMed 19139319]

Namazy J, Schatz M. The treatment of allergic respiratory disease during pregnancy. J Investig Allergol Clin Immunol. 2016;26(1):1-7.[PubMed 27012010]

National Institute for Health and Care Excellence (NICE). Multiple sclerosis in adults: management. NICE clinical guideline CG186. London, UK: National Institute for Health and Care Excellence; October 2014. https://www.nice.org.uk/guidance/cg186. Accessed October 21, 2016.

Neumar RW, Shuster M, Callaway CW, et al. Part 1: Executive Summary: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015;132(suppl 2):S315-S367.[PubMed 26472989]

Nicholson G, Burrin JM, Hall GM. Peri-operative steroid supplementation. Anaesthesia. 1998;53(11):1091-1104.[PubMed 10023279]

Nieman LK, Biller BM, Findling JW, et al; Endocrine Society. Treatment of Cushing’s Syndrome: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100(8):2807-2831. doi: 10.1210/jc.2015-1818.[PubMed 26222757]

O’Connell MB, Fritsch MA. Musculoskeletal and connective tissue disorders. Fundamentals of Geriatric Pharmacotherapy, 2nd ed. Hutchison LC, Sleeper RB, Eds. ASHP Publications, 2015.

Østensen M and Forger F, “Management of RA Medications in Pregnant Patients,” Nat Rev Rheumatol, 2009, 5(7):382-90.[PubMed 19506586]

Ost L, Wettrell G, Bjorkhem I, et al, “Prednisolone Excretion in Human Milk,” J Pediatr, 1985, 106(6):1008-11.[PubMed 3998938]

Park-Wyllie L, Mazzotta P, Pastuszak A, et al, “Birth Defects After Maternal Exposure to Corticosteroids: Prospective Cohort Study and Meta-Analysis of Epidemiological Studies,” Teratology, 2000, 62(6):385-92.[PubMed 11091360]

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

Rhodes A, Evans LE, Alhazzani W, et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017;43(3):304-377. doi: 10.1007/s00134-017-4683-6.[PubMed 28101605]

Roberts I, Yates D, Sandercock P, et al, “Effect of Intravenous Corticosteroids on Death Within 14 days in 10,008 Adults With Clinically Significant Head Injury (MRC CRASH trial): Randomised Placebo-Controlled Trial,” Lancet, 2004, 364(9442):1321-8.[PubMed 15474134]

Ross DS, Burch HB, Cooper DS, et al. 2016 American Thyroid Association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis. Thyroid. 2016;26(10):1343-1421. doi 10.1089/thy.2016.0229.[PubMed 27521067]

Salem M, Tainsh RE Jr, Bromberg J, et al, “Perioperative Glucocorticoid Coverage. A Reassessment 42 Years After Emergence of a Problem,” Ann Surg, 1994, 219(4):416-25.[PubMed 8161268]

Scott TF, Frohman EM, De Seze J, Gronseth GS, Weinshenker BG; Therapeutics and Technology Assessment Subcommittee of American Academy of Neurology. Evidence-based guideline: clinical evaluation and treatment of transverse myelitis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2011;77(24):2128-2134.[PubMed 22156988]

Shulman DI, Palmert MR, Kemp SF; Lawson Wilkins Drug and Therapeutics Committee. Adrenal insufficiency: still a cause of morbidity and death in childhood. Pediatrics. 2007;119(2):e484-e494.[PubMed 17242136]

Solu-Cortef (hydrocortisone sodium) [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada Inc; April 2018.

Solu-Cortef preservative free (hydrocortisone sodium) [prescribing information]. New York, NY: Pfizer; July 2016.

Speiser PW, Arlt W, Auchus RJ, et al. Congenital adrenal hyperplasia due to steroid 21-hydroxylase deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018;103(11):4043-4088. doi: 10.1210/jc.2018-01865.[PubMed 30272171]

Speiser PW, Azziz R, Baskin LS, et al. Congenital adrenal hyperplasia due to steroid 21-hydroxylase deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010;95(9):4133-4160. doi: 10.1210/jc.2009-2631[PubMed 20823466]

Sprung CL, Annane D, Keh D, et al, “Hydrocortisone Therapy for Patients With Septic Shock,” N Engl J Med, 2008, 358(2):111-24.[PubMed 18184957]

“Technical Report: Congenital Adrenal Hyperplasia,” American Academy of Pediatrics, Section on Endocrinology and Committee on Genetics, Pediatrics, 2000, 106(6):1511-8.

The COIITSS Study Investigators, “Corticosteroid Treatment and Intensive Insulin Therapy for Septic Shock in Adults,” JAMA, 2010, 303(4):341-48.[PubMed 20103758]

Venkatesh B, Finfer S, Cohen J, et al. Adjunctive glucocorticoid therapy in patients with septic shock. N Engl J Med. 2018;378(9):797-808. doi: 10.1056/NEJMoa1705835.[PubMed 29347874]

Weber-Carstens S, Deja M, Bercker S, et al. Impact of bolus application of low-dose hydrocortisone on glycemic control in septic shock patients. Intensive Care Med. 2007;33(4):730-733.[PubMed 17325831 ]

World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. Available at http://www.who.int/maternal_child_adolescent/documents/55732/en/

Brand Names: International

Actocortina (ES); Aftasone (ES); Arvisone (IN); Biocort (PH); Cipcorlin (IN); Clovisone (PH); Colifoam (AE, AT, AU, DE, DK, FI, GB, GR, IE, IT, MT, NZ, PT, SE); Colofoam (FR); Corhydron (PL); Coripen (UY); Cort-S (ET, IN, LK); Cortaject (ZA); Cortef (BB, BD, HR, HU, TH); Cortifoam (IL); Cortin (PH); Cortis-100 (PH); Cortisol (PK, UY); Cortisol L.C.H. (CL); Cortisona (BR); Covocort (ZA); Dhartisone-100 (ID); Drosodin (MX); Efcorlin (IN); Entofoam (IN); Fartison (ID); Flebocortid (IT, MX); Flemex (MX); Fridalit (AR); Harond (KR); Hidrocort (VE); Hidrocortif (EC); Hidrocortizon (RO); Hidrotisona (AR); Hison (BD); Hycort (BD, PH); Hycortil (PH); Hydrocort (IL); Hydrocortistab (CY); Hydrosone (SA); Hydrotopic (PH); Hyson (TW); Hysone (AU, KR); Kortef (UA); Lyo-Cortin (GR); M-Cort (IN); Nositrol (MX); Oralsone (AR); Plenadren (BE, CZ, DE, DK, EE, ES, GB, HR, HU, IS, LT, LV, MT, NL, NO, PL, PT, SE, SK); Primacor (LK); Primacort (PE); Rapicort (PT); Rapison (JP, KR); Rolak (GR); Samcort (LK); Saxizon (JP); Solhidrol (MX); Solu Cortef (AE, BD, BE, BH, BR, CH, CL, CO, CY, DK, EC, EE, ET, FI, GB, GR, HK, HN, HR, HU, IE, IS, IT, JO, KR, KW, LB, LU, LV, MY, NL, NO, PE, PH, PK, PT, QA, RU, SA, SE, SG, TH, TR, TW, UA, ZA, ZW); Solu-Cortef (AU, BB, CN, JP, MT, NZ, VE, VN); Solu-Tisone (TW); Stericort (PH); Unicort (BD); Zonac (PY); Zycort (MY)

Hydrocortisone (Systemic) (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(hye droe KOR ti sone)

Brand Names: US

Cortef; Solu-CORTEF

Brand Names: Canada

Cortef; Solu-Cortef

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

(hye droe KOR ti sone)

Brand Names: US

Cortef; Solu-CORTEF

Brand Names: Canada

Cortef; Solu-Cortef

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