(hye droe KOR ti sone)
Primarily as an anti-inflammatory or immunosuppressant agent in the treatment of a variety of diseases including those of dermatologic, endocrine, GI, hematologic, allergic, inflammatory, neoplastic, neurologic, ophthalmic, renal, respiratory, and autoimmune origin.
Hypersensitivity to hydrocortisone or any component of the formulation; systemic fungal infections; serious infections, except septic shock or tuberculous meningitis; viral, fungal, or tubercular skin lesions; IM administration contraindicated in idiopathic thrombocytopenia purpura; intrathecal administration of injection
Dose should be based on severity of disease and patient response.
Adrenal insufficiency:
Acute adrenal insufficiency (adrenal crisis) (off-label dose):100 mg IV bolus, immediately followed by 200 mg over 24 hours as a continuous IV infusion or in divided doses (IM or IV) every 6 hours, then 100 mg over 24 hours the following day (Allolio 2015; ES [Bornstein 2016]). Alternatively, may administer 100 mg IV bolus, then 50 to 75 mg IV every 6 hours for 24 hours, followed by a slow taper over the next 72 hours (administering doses every 4 to 6 hours during taper) (Gardner 2011). Note: Appropriate fluid resuscitation is also required (ES [Bornstein 2016]; Gardner 2011).
Chronic primary adrenal insufficiency (physiologic replacement) (off-label dose): Oral: 15 to 25 mg daily in 2 to 3 divided doses. Administer the largest dose in the morning upon awakening, followed by next dose 2 hours after lunch (two-dose regimen) or next dose at lunch, followed by smallest dose in the afternoon no later than 4 to 6 hours before bedtime (three-dose regimen) (ES [Bornstein 2016]).
Temporary 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 (ES [Neiman 2015]).
Anti-inflammatory or immunosuppressive: Oral, IM, IV: 15 to 240 mg every 12 hours
Congenital adrenal hyperplasia (off-label dose): Oral: 15 to 25 mg/day in 2 to 3 divided doses (Speiser, 2010)
Status asthmaticus: IV: 1 to 2 mg/kg/dose every 6 hours for 24 hours, then maintenance of 0.5 to 1 mg/kg every 6 hours
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): IV: 50 mg every 6 hours (Annane, 2002; COIITSS Study Investigators, 2010). Practice guidelines suggest administering 200 mg daily as a continuous infusion over 24 hours to prevent adverse effects (eg, hyperglycemia) (Dellinger 2013; Weber-Carstens 2007); however, the impact of continuous infusion on patient outcomes has not been formally evaluated. Taper slowly (over several days) when vasopressors are no longer required; do not stop abruptly. Note: Hydrocortisone should be used alone (ie, without fludrocortisone) (Dellinger 2013).
Thyroid storm (off-label use): IV: 300 mg loading dose, followed by 100 mg every 8 hours (Bahn 2011)
Refer to adult dosing.
Dose should be based on severity of disease and patient response.
Anti-inflammatory or immunosuppressive:
Infants and Children:
Oral: 2.5-10 mg/kg/day or 75-300 mg/m2/day every 6-8 hours
IM, IV: 1-5 mg/kg/day or 30-150 mg/m2/day divided every 12-24 hours
Adolescents: Oral, IM, IV: 15-240 mg every 12 hours
Congenital adrenal hyperplasia (off-label dose): Oral: Note: Doses must be individualized by monitoring growth, bone age, and hormonal levels.
Children: 10-15 mg/m2/day in 3 divided doses; higher initial doses may be required to achieve initial target hormone serum concentrations in infancy (Speiser, 2010)
Adolescents: Refer to adult dosing.
Physiologic replacement: Children: Oral: 8-10 mg/m2/day divided every 8 hours; up to 12 mg/m2/day in some patients (Ahmet, 2011; Gupta, 2008; Maguire, 2007)
Status asthmaticus: Children: IV: 1-2 mg/kg/dose every 6 hours for 24 hours, then maintenance of 0.5-1 mg/kg every 6 hours.
Septic shock (off-label use): Children: IV: Initial: 1-2 mg/kg/day (intermittent or as continuous infusion); may titrate up to 50 mg/kg/day for shock reversal (Brierley, 2009); alternative dosing suggests 50 mg/m2/day (Dellinger, 2008). Note: Use recommended only in fluid refractory, catecholamine-resistant shock, and suspected or proven absolute (classic) adrenal insufficiency.
There are no dosage adjustments provided in the manufacturer 's labeling; use with caution.
There are no dosage adjustments provided in the manufacturer 's labeling.
Sodium succinate: IV bolus or IM administration: Reconstitute 100 mg vials with bacteriostatic water or bacteriostatic sodium chloride (not >2 mL). Act-O-Vial (self-contained powder for injection plus diluent) 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.
Solutions for IV infusion: Reconstituted solutions may be added to an appropriate volume of compatible solution for infusion. Concentration should generally not exceed 1 mg/mL. However, in cases where administration of a small volume of fluid is desirable, 100-3000 mg may be added to 50 mL of D5W or NS (stability limited to 4 hours).
Oral: Administer with food or milk to decrease GI upset.
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. Avoid injection into deltoid muscle (high incidence of subcutaneous atrophy).
IV bolus: Administer over 30 seconds or over 10 minutes for doses ≥500 mg
IV intermittent infusion: Administer over 20-30 minutes
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.
Store at controlled room temperature 20 � �C to 25 � �C (68 � �F to 77 � �F). Protect from light. Hydrocortisone sodium phosphate and hydrocortisone sodium succinate are clear, light yellow solutions which are heat labile.
Sodium succinate: After initial reconstitution, hydrocortisone sodium succinate solutions are stable for 3 days at room temperature or under refrigeration when protected from light. Stability of parenteral admixture (Solu-Cortef � �) at room temperature (25 � �C) and at refrigeration temperature (4 � �C) is concentration-dependent:
Stability of concentration 1 mg/mL: 24 hours
Stability of concentration 2 mg/mL to 60 mg/mL: At least 4 hours
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Injection, as sodium succinate [strength expressed as base]:
A-Hydrocort: 100 mg (1 ea)
Solu-CORTEF: 100 mg (1 ea)
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
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):987-90.[PMID: 8845559]Hydrocortisone sodium succinate: Stable in dextran 6% in dextrose, dextran 6% in NS, D5LR, D51/4NS, D51/2NS, D5NS, D5W, D10W, D20W, LR, 1/2NS, NS, fat emulsion 10%.
Y-site administration: Incompatible with ciprofloxacin, diazepam, idarubicin, midazolam, phenytoin, sargramostim.
Compatibility in syringe: Incompatible with doxapram, oxytocin, pantoprazole.
Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Monitor therapy
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy
Androgens: Corticosteroids (Systemic) may enhance the fluid-retaining effect of Androgens. Monitor therapy
Antacids: May decrease the bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects. Consider therapy modification
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy
Aprepitant: May increase the serum concentration of Corticosteroids (Systemic). Management: No dose adjustment is needed for single 40 mg aprepitant doses. For other regimens, reduce oral dexamethasone or methylprednisolone doses by 50%, and IV methylprednisolone doses by 25%. Antiemetic regimens containing dexamethasone reflect this adjustment. Consider therapy modification
BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Monitor therapy
Calcitriol (Systemic): Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic). Monitor therapy
Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of Hydrocortisone (Systemic). Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy
Deferasirox: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy
Desirudin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Consider therapy modification
DiltiaZEM: May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification
Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy
Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification
Fosaprepitant: May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect. Consider therapy modification
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
Indacaterol: May enhance the hypokalemic effect of Corticosteroids (Systemic). Monitor therapy
Indium 111 Capromab Pendetide: Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Avoid combination
Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Monitor therapy
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification
Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy
Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy
MiFEPRIStone: May diminish the therapeutic effect of Corticosteroids (Systemic). MiFEPRIStone may increase the serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (e.g., for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment. Avoid combination
Mitotane: May decrease the serum concentration of Corticosteroids (Systemic). Consider therapy modification
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination
Neuromuscular-Blocking Agents (Nondepolarizing): May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Consider therapy modification
Nicorandil: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Monitor therapy
Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification
NSAID (COX-2 Inhibitor): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (COX-2 Inhibitor). Monitor therapy
NSAID (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (Nonselective). Monitor therapy
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.). 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.). Monitor therapy
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Quinolone Antibiotics: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolone Antibiotics. Specifically, the risk of tendonitis and tendon rupture may be increased. Monitor therapy
Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy
Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification
Salicylates: May enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Monitor therapy
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Telaprevir: Corticosteroids (Systemic) may decrease the serum concentration of Telaprevir. Telaprevir may increase the serum concentration of Corticosteroids (Systemic). Management: Concurrent use of telaprevir and systemic corticosteroids is not recommended. When possible, consider alternatives. If used together, employ extra caution and monitor closely for excessive corticosteroid effects and diminished telaprevir effects. Consider therapy modification
Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Avoid combination
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy
Urea Cycle Disorder Agents: Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range. Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification
Vaccines (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Consider therapy modification
Warfarin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Warfarin. Monitor therapy
Serum glucose, electrolytes; blood pressure, weight, presence of infection; monitor IOP with therapy >6 weeks; bone mineral density, growth in children
Interferes with skin tests
Frequency not defined.
Cardiovascular: Atheromatous embolism, bradycardia, cardiac arrhythmia, cardiac failure, cardiomegaly, circulatory shock, edema, hypertension, hypertrophic cardiomyopathy (premature infants), myocardial rupture (post-myocardial infarction), syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis
Central nervous system: Delirium, depression, emotional lability, euphoria, hallucination, headache, increased intracranial pressure, insomnia, malaise, myasthenia, nervousness, neuritis, neuropathy, personality changes, pseudotumor cerebri, psychic disorder, psychosis, seizure, tingling of skin, vertigo
Dermatologic: Acne vulgaris, allergic dermatitis, alopecia, atrophic striae, burning sensation of skin, diaphoresis, erythema, exfoliation of skin, hyperpigmentation, hypopigmentation, skin atrophy, skin rash, sterile abscess, suppression of skin test reaction, urticaria, xeroderma
Endocrine & metabolic: Abnormalities in sperm motility (decreased/increased motility), adrenal suppression, alkalosis, amenorrhea, Cushings syndrome, diabetes mellitus, fluid retention, growth suppression, hirsutism, HPA-axis suppression, hyperglycemia, hyperlipidemia, hypokalemia, hypokalemic alkalosis, impaired glucose tolerance, menstrual disease, negative nitrogen balance, protein catabolism, sodium retention, spermatozoa disorder (spermatogenesis decreased/increased), weight gain
Gastrointestinal: Abdominal distention, carbohydrate intolerance, dyspepsia, gastrointestinal perforation, hiccups, increased appetite, intestinal disease (intrathecal administration), nausea, pancreatitis, peptic ulcer, ulcerative esophagitis, vomiting
Genitourinary: Bladder dysfunction (intrathecal administration)
Hematologic & oncologic: Bruise, leukocytosis (transient), metastases, petechia
Hepatic: Hepatomegaly, increased serum transaminases
Hypersensitivity: Anaphylaxis, hypersensitivity reaction
Infection: Infection
Local: Atrophy at injection site, post-injection flare (intra-articular use), skin edema
Neuromuscular & skeletal: Abnormal fat deposits, amyotrophy, arthralgia, bone fracture, Charcot-like arthropathy, myopathy, osteonecrosis (femoral and humoral heads), osteoporosis, rupture of tendon, vertebral compression fracture
Ophthalmic: Cataract, exophthalmos, glaucoma, increased intraocular pressure
Miscellaneous: Tissue necrosis (avascular), wound healing impairment
Concerns related to adverse effects:
- Adrenal suppression: May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.
- Anaphylactoid reactions: Rare cases of anaphylactoid reactions have been observed in patients receiving corticosteroids.
- 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 vaccines. Exposure to chickenpox should be avoided; corticosteroids should not be used to treat ocular herpes simplex. 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). Amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiation of corticosteroids.
- 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.
- 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 depression, euphoria, insomnia, mood swings, and personality changes. 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.
- Diabetes: Use 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, intestinal anastomoses, peptic ulcer, ulcerative colitis) due to perforation risk. Avoid ethanol may enhance gastric mucosal irritation.
- Head injury: Increased mortality was observed in patients receiving high-dose IV methylprednisolone; high-dose corticosteroids should not be used for the management of head injury.
- Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention.
- Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred especially during initial treatment with corticosteroids.
- Myocardial infarct (MI): Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.
- 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. Consider routine eye exams in chronic users.
- Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.
- Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.
- Seizure disorders: Use with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.
- Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Special populations:
- Elderly: Because of the risk of adverse effects, systemic corticosteroids should be used cautiously in the elderly in 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).
C
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 (Park-Wyllie, 2000; Pradat, 2003). Systemic corticosteroids may also influence fetal growth (decreased birth weight); however, information is conflicting (Lunghi, 2010). Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy (monitor). When systemic corticosteroids are needed in pregnancy, it is generally recommended to use the lowest effective dose for the shortest duration of time, avoiding high doses during the first trimester (Leachman, 2006; Lunghi, 2010; Makol, 2011; � �stensen, 2009).
Short-acting corticosteroid with minimal sodium-retaining potential; decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability
Rapid
Hepatic
Urine (primarily as 17-hydroxysteroids and 17-ketosteroids)
Hydrocortisone sodium succinate (water soluble): Rapid
Biologic: 8 to 12 hours
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience nausea, vomiting, insomnia, or agitation. Have patient report immediately to prescriber signs of infection, signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of 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), severe loss of strength and energy, irritability, tremors, tachycardia, confusion, dizziness, sweating, shortness of breath, excessive weight gain, swelling of arms or legs, skin changes, moon face, buffalo hump, severe headache, bone pain, joint pain, menstrual irregularities, angina, vision changes, mood changes, behavioral changes, depression, seizures, burning or numbness feeling, bruising, bleeding, severe abdominal pain; black, tarry, or bloody stools; vomiting blood; or injection site irritation (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.