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Medication Safety Issues
Sound-alike/look-alike issues:
Hydrocortisone may be confused with hydrocodone, hydroxychloroquine, hydrochlorothiazide
Anusol® may be confused with Anusol-HC®, Aplisol®, Aquasol®
Anusol-HC® may be confused with Anusol®
Cortef® may be confused with Coreg®, Lortab®
Cortizone® may be confused with cortisone
HCT (occasional abbreviation for hydrocortisone) is an error-prone abbreviation (mistaken as hydrochlorothiazide)
Hytone® may be confused with Vytone®
Proctocort® may be confused with ProctoCream®
ProctoCream® may be confused with Proctocort®
Solu-Cortef® may be confused with Solu-Medrol®
International issues:
Hytone® may be confused with Hysone® [Australia]
Nutracort® may be confused with Nitrocor® which is a brand name of nitroglycerin in Chile and Italy
Pronunciation
(hye droe KOR ti sone)
U.S. Brand Names
Index Terms
Generic Available
Yes: Excludes acetate foam, butyrate cream and ointment, gel as base, otic drops as base, probutate cream, sodium succinate injection
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Management of adrenocortical insufficiency; relief of inflammation of corticosteroid-responsive dermatoses (low and medium potency topical corticosteroid); adjunctive treatment of ulcerative colitis
Use: Dental
Treatment of a variety of oral diseases of allergic, inflammatory, or autoimmune origin
Use: Unlabeled/Investigational
Management of septic shock when blood pressure is poorly responsive to fluid resuscitation and vasopressor therapy
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events have been observed with corticosteroids in animal reproduction studies. Hydrocortisone crosses the placenta. Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts; adverse events in the fetus/neonate have been noted in case reports following large doses of systemic corticosteroids during pregnancy. Topical products are not recommended for extensive use, in large quantities, or for long periods of time in pregnant women.
Lactation
Enters breast milk/use caution
Breast-Feeding Considerations
Corticosteroids are excreted in breast milk and endogenous hydrocortisone is also found in human milk; the effect of maternal hydrocortisone intake is not known.
Contraindications
Hypersensitivity to hydrocortisone or any component of the formulation; serious infections, except septic shock or tuberculous meningitis; viral, fungal, or tubercular skin lesions; I.M. administration contraindicated in idiopathic thrombocytopenia purpura
Rectal suspension: Systemic fungal infections; ileocolostomy during the immediate or early postoperative period
Warnings/Precautions
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.
• Immunosuppression: Prolonged use of corticosteroids may also 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 or viral hepatitis. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only in conjunction with antituberculosis treatment).
• Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered.
• 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 or hypertension; long-term use has been associated with fluid retention 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, peptic ulcer, ulcerative colitis) due to perforation risk.
• Head injury: Increased mortality was observed in patients receiving high-dose I.V. 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. 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.
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.
• Pediatrics: May affect growth velocity; growth should be routinely monitored in pediatric patients.
Dosage form specific issues:
• Benzyl alcohol: Some dosage forms may contain benzyl alcohol which has been associated with “gasping syndrome” in neonates.
• Topical preparations: Avoid use of topical preparations with occlusive dressings or on weeping or exudative lesions.
Other warnings/precautions:
• Discontinuation of therapy: Withdraw therapy with gradual tapering of dose.
Adverse Reactions
Systemic: Frequency not defined:
Cardiovascular: Edema, hypertension
Central nervous system: Delirium, euphoria, hallucinations, headache, insomnia, nervousness, pseudotumor cerebri, psychoses, seizure, vertigo
Dermatologic: Bruising, hyperpigmentation, skin atrophy
Endocrine & metabolic: Adrenal suppression, alkalosis, amenorrhea, Cushing's syndrome, diabetes mellitus, glucose intolerance, growth suppression, hyperglycemia, hyperlipidemia, hypokalemia, pituitary-adrenal axis suppression, sodium and water retention
Gastrointestinal: Abdominal distention, appetite increased, indigestion, nausea, pancreatitis, peptic ulcer, ulcerative esophagitis, vomiting
Hematologic: Leukocytosis (transient)
Neuromuscular & skeletal: Arthralgia, fractures, muscle weakness, osteoporosis
Ocular: Cataracts, glaucoma
Miscellaneous: Avascular necrosis, hypersensitivity reactions, infection, secondary malignancy
Topical:
>10%: Dermatologic: Eczema (12.5%)
1% to 10%: Dermatologic: Pruritus (6%), stinging (2%), dry skin (2%)
<1%: Allergic contact dermatitis, burning, dermal atrophy, folliculitis, HPA axis suppression, hypopigmentation; metabolic effects (hyperglycemia, hypokalemia); striae
Metabolism/Transport Effects
Substrate of CYP3A4 (minor); Induces CYP3A4 (weak)
Drug Interactions
Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor therapy
Aminoglutethimide: May increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy
Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Risk C: Monitor therapy
Antacids: May decrease the bioavailability of Corticosteroids (Oral). Risk D: Consider therapy modification
Antidiabetic Agents: Corticosteroids (Systemic) may diminish the hypoglycemic effect of Antidiabetic Agents. In some instances, corticosteroid-mediated HPA axis suppression has led to episodes of acute adrenal crisis, which may manifest as enhanced hypoglycemia, particularly in the setting of insulin or other antidiabetic agent use. Risk C: Monitor therapy
Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy
Aprepitant: May increase the serum concentration of Corticosteroids (Systemic). Risk D: Consider therapy modification
Barbiturates: May increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy
Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Risk C: Monitor therapy
Calcitriol: Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol. Risk C: Monitor therapy
Calcium Channel Blockers (Nondihydropyridine): May decrease the metabolism of Corticosteroids (Systemic). 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
CycloSPORINE: Corticosteroids (Systemic) may increase the serum concentration of CycloSPORINE. CycloSPORINE 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
Fluconazole: May decrease the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy
Fosaprepitant: May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect. Risk D: Consider therapy modification
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
Macrolide Antibiotics: May decrease the metabolism of Corticosteroids (Systemic). Exceptions: Azithromycin; Dirithromycin [Off Market]; Spiramycin. Risk D: Consider therapy modification
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
NSAID (COX-2 Inhibitor): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (COX-2 Inhibitor). Risk C: Monitor therapy
NSAID (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (Nonselective). Risk C: Monitor therapy
P-Glycoprotein Inducers: May decrease the serum concentration of P-Glycoprotein 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 Inhibitors: May increase the serum concentration of P-Glycoprotein 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
Primidone: May increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy
Quinolone Antibiotics: May enhance the adverse/toxic effect of Corticosteroids (Systemic). Risk of tendon-related side effects, including tendonitis and rupture, may be enhanced. Risk C: Monitor therapy
Rifamycin Derivatives: May increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy
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
Thiazide Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide Diuretics. Risk C: Monitor therapy
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Risk C: Monitor therapy
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Warfarin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Warfarin. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol (may enhance gastric mucosal irritation).
Food: Hydrocortisone interferes with calcium absorption.
Herb/Nutraceutical: St John's wort may decrease hydrocortisone levels. Avoid cat's claw, echinacea (have immunostimulant properties).
Storage
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.
Reconstitution
Sodium succinate: Reconstitute 100 mg vials with bacteriostatic water (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 (I.V. or I.M.) without further dilution.
Solutions for I.V. 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).
Compatibility
Hydrocortisone sodium phosphate: Stable in D5W, NS, fat emulsion 10%.
Y-site administration: Compatible: Allopurinol, amifostine, aztreonam, cefepime, cladribine, clarithromycin, docetaxel, etoposide, famotidine, filgrastim, fluconazole, fludarabine, gemcitabine, granisetron, melphalan, ondansetron, paclitaxel, piperacillin/tazobactam, teniposide, thiotepa, vinorelbine. Incompatible: Sargramostim.
Compatibility in syringe: Compatible: Metoclopramide. Incompatible: Doxapram.
Compatibility when admixed: Compatible: Amikacin, amphotericin B, amphotericin B with heparin, bleomycin, dacarbazine, metaraminol, sodium bicarbonate, verapamil. Variable (consult detailed reference): Mitoxantrone.
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: Compatible: Acyclovir, allopurinol, amifostine, aminophylline, amphotericin B cholesteryl sulfate complex, ampicillin, amsacrine, argatroban, atracurium, atropine, aztreonam, betamethasone sodium phosphate, bivalirudin, calcium gluconate, cefepime, chlordiazepoxide, chlorpromazine, cisatracurium, cladribine, cyanocobalamin, cytarabine, dexamethasone sodium phosphate, digoxin, diphenhydramine, docetaxel, dopamine, doxorubicin liposome, droperidol, droperidol and fentanyl, edrophonium, enalaprilat, epinephrine, esmolol, estrogens (conjugated), ethacrynate sodium, etoposide, famotidine, fentanyl, filgrastim, fludarabine, fluorouracil, foscarnet, furosemide, gatifloxacin, gemcitabine, granisetron, heparin, hydralazine, inamrinone, insulin (regular), isoproterenol, kanamycin, lidocaine, linezolid, lorazepam, magnesium sulfate, melphalan, menadiol sodium diphosphate, meperidine, methoxamine, methylergonovine, minocycline, morphine, neostigmine, nicardipine, norepinephrine, ondansetron, oxacillin, oxytocin, paclitaxel, pancuronium, penicillin G potassium, pentazocine, phytonadione, piperacillin/tazobactam, procainamide, prochlorperazine edisylate, propofol, propranolol, pyridostigmine, remifentanil, scopolamine, sodium bicarbonate, succinylcholine, tacrolimus, teniposide, theophylline, thiotepa, trimethaphan camsylate, trimethobenzamide, vecuronium, vinorelbine. Incompatible: Ciprofloxacin, diazepam, ergotamine, idarubicin, midazolam, phenytoin, sargramostim. Variable (consult detailed reference): Diltiazem, methylprednisolone sodium succinate, promethazine.
Compatibility in syringe: Compatible: Diatrizoate meglumine 52%, diatrizoate sodium 8%, diatrizoate sodium 60%, iohexol, iopamidol, iothalamate meglumine 60%, ioxaglate meglumine 39.3%, ioxaglate sodium 19.6%, metoclopramide, thiopental. Incompatible: Doxapram.
Compatibility when admixed: Compatible: Amikacin, aminophylline, amphotericin B, calcium chloride, calcium gluconate, chloramphenicol, clindamycin, corticotropin, daunorubicin, diphenhydramine, dopamine, erythromycin lactobionate, floxacillin, lidocaine, magnesium sulfate, mephentermine, metronidazole, metronidazole with sodium bicarbonate, mitomycin, mitoxantrone, norepinephrine, penicillin G potassium, penicillin G sodium, piperacillin, polymyxin B sulfate, potassium chloride, procaine, sodium bicarbonate, theophylline, thiopental, vancomycin, verapamil, vitamin B complex with C. Incompatible: Aminophylline with cephalothin, bleomycin, colistimethate, ephedrine, hydralazine, nafcillin, pentobarbital, phenobarbital, prochlorperazine edisylate, promethazine. Variable (consult detailed reference): Amobarbital, ampicillin, cytarabine, dimenhydrinate, furosemide, heparin, kanamycin, metaraminol.
Mechanism of Action
Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability
Pharmacodynamics/Kinetics
Onset of action:
Hydrocortisone acetate: Slow
Hydrocortisone sodium succinate (water soluble): Rapid
Duration: Hydrocortisone acetate: Long
Absorption: Rapid by all routes, except rectally
Metabolism: Hepatic
Half-life elimination: Biologic: 8-12 hours
Excretion: Urine (primarily as 17-hydroxysteroids and 17-ketosteroids)
Dosage
Dose should be based on severity of disease and patient response
Adrenal hyperplasia (congenital): Children: Oral: Initial: 10-20 mg/m2/day in 3 divided doses; a variety of dosing schedules have been used. Note: Inconsistencies have occurred with liquid formulations; tablets may provide more reliable levels. Doses must be individualized by monitoring growth, bone age, and hormonal levels. Mineralocorticoid and sodium supplementation may be required based upon electrolyte regulation and plasma renin activity.
Adrenal insufficiency (acute): I.M., I.V.:
Infants and young Children: Succinate: 1-2 mg/kg/dose bolus, then 25-150 mg/day in divided doses every 6-8 hours
Older Children: Succinate: 1-2 mg/kg bolus then 150-250 mg/day in divided doses every 6-8 hours
Adults: Succinate: 100 mg I.V. bolus, then 300 mg/day in divided doses every 8 hours or as a continuous infusion for 48 hours; once patient is stable change to oral, 50 mg every 8 hours for 6 doses, then taper to 30-50 mg/day in divided doses
Adrenal insufficiency (chronic): Adults: Oral: 20-30 mg/day
Anti-inflammatory or immunosuppressive:
Infants and Children:
Oral: 2.5-10 mg/kg/day or 75-300 mg/m2/day every 6-8 hours
I.M., I.V.: Succinate: 1-5 mg/kg/day or 30-150 mg/m2/day divided every 12-24 hours
Adolescents and Adults: Oral, I.M., I.V.: Succinate: 15-240 mg every 12 hours
Physiologic replacement: Children:
Oral: 0.5-0.75 mg/kg/day or 20-25 mg/m2/day every 8 hours
I.M.: Succinate: 0.25-0.35 mg/kg/day or 12-15 mg/m2/day once daily
Rheumatic diseases: Adults:
Intralesional, intra-articular, soft tissue injection: Acetate:
Large joints: 25 mg (up to 37.5 mg)
Small joints: 10-25 mg
Tendon sheaths: 5-12.5 mg
Soft tissue infiltration: 25-50 mg (up to 75 mg)
Bursae: 25-37.5 mg
Ganglia: 12.5-25 mg
Septic shock (unlabeled use): I.V.: 50 mg every 6 hours (Annane, 2002; Marik, 2008). Taper slowly (for total of 11 days) and do not stop abruptly. Note: Fludrocortisone is optional with use of hydrocortisone.
Shock: I.M., I.V.: Succinate:
Children: Initial: 50 mg/kg, then repeated in 4 hours and/or every 24 hours as needed
Adolescents and Adults: 500 mg to 2 g every 2-6 hours
Status asthmaticus: Children and Adults: I.V.: Succinate: 1-2 mg/kg/dose every 6 hours for 24 hours, then maintenance of 0.5-1 mg/kg every 6 hours
Stress dosing (surgery) in patients known to be adrenally-suppressed or on chronic systemic steroids: I.V.: Adults:
Minor stress (ie, inguinal herniorrhaphy): 25 mg/day for 1 day
Moderate stress (ie, joint replacement, cholecystectomy): 50-75 mg/day (25 mg every 8-12 hours) for 1-2 days
Major stress (pancreatoduodenectomy, esophagogastrectomy, cardiac surgery): 100-150 mg/day (50 mg every 8-12 hours) for 2-3 days
Dermatosis: Children >2 years and Adults: Topical: Apply to affected area 2-4 times/day (Buteprate: Apply once or twice daily). Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.
Ulcerative colitis: Adults: Rectal: 10-100 mg 1-2 times/day for 2-3 weeks
Dosage: Combination Regimens
Prostate cancer:
Estramustine + Docetaxel + Hydrocortisone
Mitoxantrone + Hydrocortisone
Dental Usual Dosing
Treatment of a variety of oral diseases of allergic, inflammatory, or autoimmune origin: Children >2 years and Adults: Topical: Apply to affected area 2-4 times/day (Buteprate: Apply once or twice daily). Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.
Administration: Oral
Administer with food or milk to decrease GI upset.
Administration: I.V.
Parenteral: Hydrocortisone sodium succinate may be administered by I.M. or I.V. routes.
I.V. bolus: Dilute to 50 mg/mL and administer over 30 seconds or over 10 minutes for doses ?500 mg
I.V. intermittent infusion: Dilute to 1 mg/mL and give over 20-30 minutes.
Note: Should be administered in a 0.1-1 mg/mL concentration due to stability problems.
Administration: Topical
Apply a thin film sparingly to clean, dry skin and rub in gently.
Administration: I.V. Detail
pH: Hydrocortisone sodium succinate: 7-8
Monitoring Parameters
Blood pressure, weight, serum glucose, and electrolytes
Reference Range
Therapeutic: AM: 5-25 mcg/dL (SI: 138-690 nmol/L), PM: 2-9 mcg/dL (SI: 55-248 nmol/L) depending on test, assay
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. Sodium content of 1 g (sodium succinate injection): 47.5 mg (2.07 mEq)
Patient Education
Systemic: Take as directed; do not increase doses and do not stop abruptly without consulting prescribed. Dosage of systemic hydrocortisone is usually tapered off gradually. Take oral dose with food to reduce GI upset. Avoid alcohol. Hydrocortisone may cause immunosuppression and mask symptoms of infection; avoid exposure to contagion and notify prescriber of any signs of infection (eg, fever, chills, sore throat, injury) and notify dentist or surgeon (if necessary) that you are taking this medication. You may experience increased appetite, indigestion, or increased nervousness. Report any sudden weight gain (>5 lb/week), swelling of extremities or respiratory difficulty, abdominal pain, severe vomiting, black or tarry stools, fatigue, anorexia, weakness, or unusual mood swings. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.
Topical: Before applying, wash area gently and thoroughly. Apply a thin film to cleansed area and rub in gently until medication vanishes. Avoid use of occlusive dressings over topical application unless directed by a prescriber. Avoid use on weeping or exudative lesions. Avoid exposing affected area to sunlight; you will be more sensitive and severe sunburn may occur. Consult prescriber if breast-feeding.
Rectal: Gently insert suppository as high as possible with gloved finger while lying down. Avoid injury with long or sharp fingernails. Remain in resting position for 10 minutes after insertion.
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.
Additional Information
Hydrocortisone base topical cream, lotion, and ointments in concentrations of 0.25%, 0.5%, and 1% may be OTC or prescription depending on the product labeling.
Anesthesia and Critical Care Concerns/Other Considerations
Clinical Pearls/Comments: Hydrocortisone is a long-acting corticosteroid with minimal sodium-retaining potential.
Evidence-Based Information:
Neuromuscular Effects: ICU-acquired paresis was recently studied in 5 ICUs (3 medical and 2 surgical ICUs) at 4 French hospitals. All ICU patients without pre-existing neuromuscular disease admitted from March 1999 through June 2000 were evaluated (De Jonghe, 2002). Each patient had to be mechanically ventilated for ?7 days and was screened daily for awakening. The first day the patient was considered awake was Study Day 1. Patients with severe muscle weakness on Study Day 7 were considered to have ICU-acquired paresis. Among the 95 patients who were evaluated, about 25% developed ICU-acquired paresis. Independent predictors included: female gender, the number of days with ?2 organ dysfunction, and administration of corticosteroids. Further studies may be required to verify and characterize the association between the development of ICU-acquired paresis and use of corticosteroids. Concurrent use of a corticosteroid and muscle relaxant appears to increase the risk of certain ICU myopathies; avoid or administer the corticosteroid at the lowest dose possible.
Adrenal Insufficiency: Patients will often have steroid-induced adverse effects on glucose tolerance and lipid profiles. When discontinuing steroid therapy in patients on long-term steroid supplementation, it is important that the steroid therapy be discontinued gradually. Abrupt withdrawal may result in adrenal insufficiency with hypotension and hyperkalemia. Patients on long-term steroid supplementation will require higher corticosteroid doses when subject to stress (eg, trauma, surgery, severe infection). Guidelines for glucocorticoid replacement during various surgical procedures have been published (Coursin, 2002; Salem, 1994).
Septic Shock: Annane, et al (2002) randomized 300 septic shock patients to either hydrocortisone (50 mg I.V. push every 6 hours) and fludrocortisone (50 mcg tablet daily via nasogastric tube) or matching placebos for 7 days. The mean Simplified Acute Physiology Score II (SAPS II) was 57 ± 19 in the placebo group and 60 ± 19 in the active treatment group. The Logistic Organ Dysfunction score was 9 ± 3 in the placebo group and 9 ± 3 in the active treatment group. In patients who did not appropriately respond to corticotropin (nonresponders), there were significantly fewer deaths in the active treatment group. Vasopressor therapy was withdrawn more frequently in this subset of the active treatment group. Adverse events were similar in both groups.
In the CORTICUS trial (Sprung, 2008), 484 septic shock patients were randomized within 72 hours of onset to receive either hydrocortisone (50 mg I.V. push every 6 hours) or placebo for 5 days followed by a 6-day taper. The primary endpoint was 28 day mortality in patients who did not respond to corticotropin. The SAPS II score in the treatment group was 49.5 ± 17.8 and 48.6 ± 16.7 in the placebo group. The Sequential Organ Failure Assessment scores were 10.6 ± 3.4 in the treatment group and 10.6 ± 3.2 in the placebo group. Different than the Annane study, in the patients who did not respond to corticotropin, there was no mortality difference at 28 days; 39.2% (95% CI: 30.5-47.9) mortality in the hydrocortisone group and 36.1 % (95% CI: 26.9-45.3, P=0.69) mortality in the placebo group. A trend towards increased incidence of superinfection was noted in hydrocortisone patients. New septic shock episodes, hyperglycemia, and hypernatremia were more frequent in the hydrocortisone group. Hydrocortisone did not improve survival in this population of septic shock patients regardless of corticotropin response.
The 2008 Surviving Sepsis Campaign Guidelines suggest the following: Intravenous hydrocortisone be given only to adult septic shock patients after blood pressure is identified to be poorly responsive to fluid resuscitation and vasopressor therapy (Grade 2C); ACTH stimulation test not be used to identify the subset of adults with septic shock who should receive hydrocortisone (Grade 2B); patients with septic shock should not receive dexamethasone if hydrocortisone is available (Grade 2B); the addition of fludrocortisone if hydrocortisone is not available and the steroid that is substituted does not have significant mineralocorticoid activity (Grade 2C); doses of corticosteroids comparable to >300 mg hydrocortisone daily not be used in severe sepsis or septic shock for the purpose of treating septic shock (Grade 1A). They also recommend corticosteroids not be administered for the treatment of sepsis in the absence of shock. There is, however, no contraindication to continuing maintenance steroid therapy or to using stress dose steroids if the patient's endocrine or corticosteroid administration history warrants (Grade 1D).
The 2008 Recommendations for the diagnosis and management of corticosteroid insufficiency in critically ill adult patients suggest a diagnosis of critical illness related corticosteroid insufficiency can be made by a delta cortisol level (after 250 mcg cosyntropin) of <9 mcg/dL or a random cortisol <10 mcg/dL (Grade 2B). However, they recommend against the use of ACTH stimulation test to determine if septic shock or ARDS patients should receive steroid therapy (Grade 2B). They recommend to consider using hydrocortisone in septic shock patients who have responded poorly to resuscitation and vasopressors (Grade 2B) and glucocorticoid treatment should be tapered slowly and not stopped abruptly (Grade 2B). Dexamethasone is not recommended for the treatment of septic shock or ARDS (Grade 1B). Fludrocortisone therapy is considered optional (Grade 2B).
Cardiovascular Considerations
Long-term steroid therapy is associated with a fluid retention and hypertension. Glucocorticoid agents have some mineralocorticoid activity with consequent hemodynamic effects. Patients will often have steroid-induced adverse effects on glucose tolerance and lipid profiles. In discontinuing steroid therapy in patients on long-term steroid supplementation, it is important that steroid therapy be discontinued gradually. Abrupt withdrawal may result in adrenal insufficiency with hypotension and hyperkalemia.
Oral and intravenous steroid therapy in patients with heart failure should be administered cautiously with special attention given to signs and symptoms of fluid retention.
Although glucocorticoids can provide relief from pericarditis postmyocardial infarctions, these drugs may cause thinning of the developing scar and myocardial rupture.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
Insomnia and nervousness are common; rare reports of delirium, euphoria, hallucinations, and mood swings
Mental Health: Effects on Psychiatric Treatment
Barbiturates may increase the metabolism of hydrocortisone; lithium has been used to treat mood swings associated with hydrocortisone
Nursing: Physical Assessment/Monitoring
Monitor laboratory results, effects and interactions of other medications patient may be taking, response to therapy and adverse effects according to diagnosis, formulation of hydrocortisone, dosage, and extent of time used. Systemic administration and long-term use will require close and frequent monitoring, especially for Cushing's syndrome. Assess for signs of fluid retention. Taper dosage when discontinuing. Assess/teach patient appropriate use, interventions for possible adverse reactions, and symptoms to report. Topical absorption may be minimal.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Aerosol, rectal, as acetate:
Cortifoam®: 10% (15 g) [90 mg/applicator]
Cream, rectal, as acetate:
Nupercainal® Hydrocortisone Cream: 1% (30 g) [strength expressed as base]
Cream, topical, as acetate: 0.5% (9 g, 30 g, 60 g) [available with aloe]; 1% (30 g, 454 g) [available with aloe]
Cream, topical, as base: 0.5% (30 g); 1% (1.5 g, 30 g, 114 g, 454 g); 2.5% (20 g, 30 g, 454 g)
Anusol-HC®: 2.5% (30 g) [contains benzyl alcohol]
Caldecort®: 1% (30 g) [contains aloe vera gel]
Cortaid® Intensive Therapy: 1% (60 g)
Cortaid® Maximum Strength: 1% (15 g, 30 g, 40 g, 60 g) [contains aloe vera gel and benzyl alcohol]
Cortaid® Sensitive Skin: 0.5% (15 g) [contains aloe vera gel]
Cortizone-10® Maximum Strength: 1% (15 g, 30 g, 60 g) [contains aloe]
Cortizone-10® Maximum Strength Intensive Healing Formula: 1% (28 g, 56 g) [contains aloe, benzyl alcohol]
Cortizone-10® Plus Maximum Strength: 1% (30 g, 60 g) [contains vitamins A, D, E and aloe]
Dermarest® Dricort®: 1% (15 g, 30 g)
HydroZone Plus, Proctocort®, Procto-Pak™: 1% (30 g)
Hytone®: 1% (30 g), 2.5% (30 g, 60 g) [DSC]
IvySoothe®: 1% (30 g) [contains aloe]
Post Peel Healing Balm: 1% (23 g)
Preparation H® Hydrocortisone: 1% (27 g) [contains sodium benzoate]
ProctoCream® HC: 2.5% (30 g) [contains benzyl alcohol]
Procto-Kit™: 1% (30 g) [packaged with applicator tips and finger cots]; 2.5% (30 g) [packaged with applicator tips and finger cots]
Proctosol-HC®, Proctozone-HC™: 2.5% (30 g)
Summer's Eve® SpecialCare™ Medicated Anti-Itch Cream: 1% (30 g) [DSC]
Cream, topical, as butyrate:
Locoid®: 0.1% (15 g, 45 g)
Locoid Lipocream®: 0.1% (15 g, 45 g)
Cream, topical, as probutate:
Pandel®: 0.1% (15 g, 45 g, 80 g)
Cream, topical, as valerate: 0.2% (15 g, 45 g, 60 g)
Westcort®: 0.2% (15 g, 45 g, 60 g)
Gel, topical, as base:
Corticool®: 1% (45 g)
Cortizone-10® Maximum Strength Cooling Relief: 1% (28 g) [contains aloe, ethanol 15%]
Injection, powder for reconstitution, as sodium succinate:
A-Hydrocort®: 100 mg [contains monobasic sodium phosphate 0.8 mg, anhydrous dibasic sodium phosphate 8.73 mg; strength expressed as base]
Solu-Cortef®: 100 mg, 250 mg, 500 mg, 1 g [diluent contains benzyl alcohol; strength expressed as base]
Lotion, topical, as base [spray]:
Cortizone-10® Maximum Strength Easy Relief: 1% (36 mL) [contains aloe, ethanol 45%]
Lotion, topical, as base: 1% (120 mL); 2.5% (60 mL)
Aquanil™ HC: 1% (120 mL)
Beta-HC®
Cetacort® [DSC]
HydroZone Plus: 1% (120 mL)
Hytone®: 2.5% (60 mL) [DSC]
Nutracort®: 1% (60 mL, 120 mL); 2.5% (60 mL, 120 mL)
Sarnol®-HC: 1% (60 mL)
Lotion, topical, as butyrate:
Locoid®: 0.1% (60 mL)
Ointment, topical, as acetate: 1% (30 g) [strength expressed as base; available with aloe]
Anusol® HC-1: 1% (21 g) [strength expressed as base]
Cortaid® Maximum Strength: 1% (15 g, 30 g) [strength expressed as base]
Ointment, topical, as base: 0.5% (30 g); 1% (30 g, 454 g); 2.5% (20 g, 30 g, 454 g)
Cortizone-10® Maximum Strength: 1% (30 g, 60 g)
Hytone®: 2.5% (30 g) [DSC]
Ointment, topical, as butyrate:
Locoid®: 0.1% (15 g, 45 g)
Ointment, topical, as valerate: 0.2% (15 g, 45 g, 60 g)
Westcort®: 0.2% (15 g, 45 g, 60 g)
Powder, for prescription compounding [micronized]:
Hydro-Rx: USP (10 g, 25 g, 50 g, 100 g)
Powder, for prescription compounding, as acetate [micronized]: USP (10 g, 25 g, 50 g)
Solution, otic, as base:
EarSol® HC: 1% (30 mL) [contains alcohol 44%, benzyl benzoate, yerba santa]
Solution, topical, as base: 2.5% (30 mL)
Texacort®: 2.5% (30 mL) [contains ethanol 48%]
Solution, topical, as butyrate: 0.1% (20 mL, 60 mL)
Locoid®: 0.1% (20 mL, 60 mL) [contains alcohol 50%]
Solution, topical, as base [spray]:
Cortaid® Intensive Therapy: 1% (60 mL) [contains alcohol]
Cortizone-10® Quick Shot: 1% (44 mL) [contains benzyl alcohol] [DSC]
Dermtex® HC: 1% (52 mL) [contains menthol 1%]
Suppository, rectal, as acetate: 25 mg (12s [DSC]; 24s, 100s)
Anucort-HC®, Tucks® Anti-Itch: 25 mg (12s, 24s, 100s) [strength expressed as base; Anucort-HC® renamed Tucks® Anti-Itch]
Anusol-HC®, Proctosol-HC®: 25 mg (12s, 24s)
Encort™, Proctocort®: 30 mg (12s)
Hemril®-30, Proctosert: 30 mg (12s, 24s)
Suspension, rectal, as base: 100 mg/60 mL (1s, 7s)
Colocort®, Cortenema®: 100 mg/60 mL (1s, 7s)
Tablet, as base: 20 mg
Cortef®: 5 mg, 10 mg, 20 mg
Pricing: U.S. (www.drugstore.com)
Cream (Anusol-HC)
2.5% (30): $92.57
Cream (Hydrocortisone)
0.5% (28.35): $4.99
1% (15): $11.99
1% (28): $11.99
2.5% (30): $13.67
Cream (Hydrocortisone Butyrate)
0.1% (45): $42.99
Cream (Hydrocortisone Valerate)
0.2% (15): $19.99
0.2% (45): $33.99
0.2% (60): $44.99
Cream (Locoid)
0.1% (15): $67.49
Cream (Locoid Lipocream)
0.1% (15): $69.44
0.1% (45): $176.35
0.1% (60): $254.24
Cream (Pandel)
0.1% (15): $128.31
Cream (Proctocort)
1% (28.35): $110.87
Cream (ProctoCream-HC)
2.5% (30): $59.40
Cream (Proctozone-HC)
2.5% (30): $22.99
Cream (Westcort)
0.2% (15): $21.99
Enema (Colocort)
100 mg/60 mL (420): $71.99
Enema (Hydrocortisone)
100 mg/60 mL (420): $70.01
Foam (Cortifoam)
90 mg (15): $125.83
Lotion (Hydrocortisone)
1% (118): $15.99
2.5% (59): $39.99
2.5% (60): $33.99
Ointment (Hydrocortisone)
2.5% (28.35): $13.68
Ointment (Hydrocortisone Acetate)
1-1% (30): $11.99
Ointment (Hydrocortisone Valerate)
0.2% (15): $24.18
0.2% (45): $34.99
0.2% (60): $44.90
Ointment (Locoid)
0.1% (15): $62.04
0.1% (45): $164.29
Ointment (Tucks Anti-Itch)
1% (19.8): $4.99
Ointment (Westcort)
0.2% (15): $25.20
0.2% (45): $46.97
0.2% (60): $55.00
Solution (Locoid)
0.1% (20): $79.28
0.1% (60): $219.43
Solution (Texacort)
2.5% (30): $67.79
Suppository (Anucort-HC)
25 mg (24): $12.99
Suppository (Hydrocortisone Acetate)
25 mg (12): $14.99
Suppository (Proctosert HC)
30 mg (12): $44.99
Tablets (Cortef)
5 mg (50): $27.31
10 mg (30): $27.29
20 mg (30): $38.49
Tablets (Hydrocortisone)
10 mg (100): $39.99
20 mg (30): $12.99
References
Abraham E and Evans T, “Corticosteroids and Septic Shock [editorial],” JAMA, 2002, 288(7):886-7.
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.
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
Cooper MS and Stewart PM, “Corticosteroid Insufficiency in Acutely Ill Patients,” N Engl J Med, 2003, 348(8):727-34.
Coursin DB and Wood KE, “Corticosteroid Supplementation for Adrenal Insufficiency,” JAMA, 2002, 287(2):236-40.
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.
Dellinger RP, Levy MM, Carlet JM, et al, “Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2008,” Intensive Care Med, 2008, 34(1):17-60. Available at http://www.survivingsepsis.org/system/files/images/2008_20International_20SSC_20Guidelines_1_.pdf
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.
Gamsu HR, Mullinger BM, Donnai P, et al, “Antenatal Administration of Betamethasone to Prevent Respiratory Distress Syndrome in Preterm Infants: Report of a UK Multicentre Trial,” Br J Obstet Gynaecol, 1989, 96(4):401-10.
Goedert JJ, Vitale F, Lauria C, et al, “Risk Factors for Classical Kaposi's Sarcoma,” J Natl Cancer Inst, 2002, 94(22):1712-8.
Hotchkiss RS and Karl IE, “The Pathophysiology and Treatment of Sepsis,” N Engl J Med, 2003, 348(2):138-50.
Liggins GC and Howie RN, “A Controlled Trial of Antepartum Glucocorticoid Treatment of Respiratory Distress Syndrome in Premature Infants,” Pediatrics, 1972, 50:515-25.
Marik PE, Pastores SM, Annane D, et al, “Recommendations for the Diagnosis and Management of Corticosteroid Insufficiency in Critically Ill Adult Patients: Consensus Statements From an International Task Force by the American College of Critical Care Medicine,” Crit Care Med, 2008, 36(6):1937-49.
McGee S and Hirschmann J, “Use of Corticosteroids in Treating Infectious Diseases,” Arch Intern Med, 2008, 168(10):1034-46.
Ostensen M, “Optimisation of Antirheumatic Drug Treatment in Pregnancy,” Clin Pharmacokinet, 1994, 27(6):486-503.
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.
Reed BR, “Dermatologic Drugs, Pregnancy, and Lactation. A Conservative guide,” Arch Dermato, 1997, 133(7):894-8.
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.
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.
Sprung CL, Annane D, Keh D, et al, “Hydrocortisone Therapy for Patients With Septic Shock,” N Engl J Med, 2008, 358(2):111-24.
“Technical Report: Congenital Adrenal Hyperplasia,” American Academy of Pediatrics, Section on Endocrinology and Committee on Genetics, Pediatrics, 2000, 106(6):1511-8.
International Brand Names
Lexi-Comp.com
Last full review/revision July 2009
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