hydrocortisone (Rx)

Frequency Not Defined

Acne

Adrenal suppression

Arthralgia

Bladder dysfunction

Cardiomegaly

Cataract

Cushing syndrome

Delayed wound healing

Delirium

Depression

Diabetes mellitus

Epistaxis

Fat embolism

Hirsutism

Hyperglycemia

Hypokalemic alkalosis

Increased appetite

Indigestion

Insomnia

Malaise

Myocardial rupture (post myocardial infarction)

Myopathy

Osteoporosis

Pseudotumor cerebri (on withdrawal)

Psychosis

Syncope

Tachycardia

Thromboembolism

Vasculitis

Vertigo

Postmarketing Reports

Epidural lipomatosis

Central serous chorioretinopathy

Leukocytosis

Secondary thrombocytopenia in adults

Idiopathic thrombocytopenic purpura in adults

Erythroblastopenia (RBC anemia)

Congenital (erythroid) hypoplastic anemia

Contraindications

Untreated serious infections (except tuberculous meningitis or septic shock)

Idiopathic thrombocytopenic purpura (IM administration only)

Intrathecal administration (injection)

Use in premature infants (formulations containing benzyl alcohol only)

Documented hypersensitivity

Systemic fungal infections

Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids

Cautions

Use with caution in cirrhosis, ocular herpes simplex, hypertension, diverticulitis, myasthenia gravis, peptic ulcer disease, ulcerative colitis, psychotic tendencies, renal insufficiency, pregnancy, diabetes mellitus, congestive heart failure, thromboembolic disorders, GI disorders

Use caution in head injury; increased mortality reported in patients receiving high-dose corticosteroids; not for use as part of head injury management

Thromboembolic disorders and myopathy may occur

High dose corticosteroids associated with increased bone loss and osteoporotic fractures; use caution

May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis in patients receiving high doses for prolonged periods and in young children, which may lead to adrenal crisis; use caution when transferring patients from corticosteroids to inhaled products (may precipitate withdrawal symptoms); fatalities resulting from adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids, reported

Anaphylactoid reactions reported in patients receiving corticosteroids

Delayed wound healing is possible

Patients receiving corticosteroids should avoid chickenpox or measles-infected persons if unvaccinated

Latent tuberculosis may be reactivated (patients with positive tuberculin test should be monitored)

Some suggestion (not fully substantiated) of slightly increased cleft palate risk if corticosteroids are used in pregnancy

Prolonged corticosteroid use may result in elevated intraocular pressure, glaucoma, or cataracts

Seizure reported with adrenal crisis; use with caution in patients with history of seizures

Killed or inactivated vaccines may be administered; however, the response to such vaccines cannot be predicted

Pheochromocytoma crisis, which can be fatal, reported after administration of systemic corticosteroids; in patients with suspected pheochromocytoma, consider risk of pheochromocytoma crisis prior to administering corticosteroids

There is enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis; may need dosage adjustments when changes in thyroid status occur; metabolic clearance of corticosteroids may occur in patients with hyperthyroidsm; it may decrease in hypothoroid patients

Myopathy reported with high dose corticosteroids; mostly in patients with neuromuscular transmission disorders; likely to affect ocular and/or respiratory muscles; monitor creatinine kinase

Kaposi sarcoma occurrence associated with prolonged corticosteroid treatment; consider discontinuing therapy if it occurs

Dermal and/or subdermal skin atrophy may occur at site of injection may occur

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after stressful situations is indicated

Prolonged use of corticosteroids may increase incidence of secondary infection; rule out latent or active amebiasis in any patient with recent travel to tropical climates or unexplained diarrhea prior to initiating corticosteroid therapy; corticosteroids may mask some signs of infection, and new infections may appear during their use; with increasing doses of corticosteroids, rate of occurrence of infectious complications increases; there may be decreased resistance and inability to localize infection when corticosteroids are used

Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy in physiologic doses (eg, for Addison’s disease)

Pediatric patients

• As in adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis
• Pediatric patients treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in growth velocity; this negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression (ie, cosyntropin stimulation and basal cortisol plasma levels)
• Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function
• The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives; in order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose
• Hypertrophic cardiomyopathy was reported after administration of hydrocortisone to prematurely born infants, therefore appropriate diagnostic evaluation and monitoring of cardiac function and structure should be performed

Epidural injection

• Serious neurologic events, some resulting in death, have been reported with epidural injection
• Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke
• These serious neurologic events have been reported with and without use of fluoroscopy
• Safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use

Pregnancy category: C

Lactation: Drug enters breast milk; use with caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Glucocorticoid; elicits mild mineralocorticoid activity and moderate anti-inflammatory effects; controls or prevents inflammation by controlling rate of protein synthesis, suppressing migration of polymorphonuclear leukocytes (PMNs) and fibroblasts, and reversing capillary permeability

Absorption

Bioavailability: PO, 96%

Duration: Short-acting

Distribution

Protein bound: 90%

Vd: 34 L

Metabolism

Metabolized in tissues and liver

Metabolites: Glucuronide and sulfates (inactive)

Elimination

Half-life: Plasma, 1-2 hr; biologic, 8-12 hr

Excretion: Urine (mainly), feces (minimally)

IV Incompatibilities

Additive: Amobarbital(?), ampicillin(?), bleomycin, colistimethate, cytarabine(?), dimenhydrinate (may be compatible at low concentrations of both), ephedrine, heparin in D5W, hydralazine, kanamycin(?), metaraminol, nafcillin, pentobarbital, phenobarbital, prochlorperazine, promethazine

Syringe: Doxapram

Y-site: Ciprofloxacin, diazepam, idarubicin, methylprednisolone(?), midazolam, phenytoin, promethazine(?; may be diluent-dependent), sargramostim

IV Compatibilities

Solution: dextrose-Ringer, dextrose-lactated Ringer, dextrose-saline, D5W, D10W, fructose 10%, Ringer, lactated Ringer, NS, 0.5NS, sodium lactate 1/6M

Additive: Amikacin, aminophylline, amphotericin B, calcium chloride, calcium gluconate, chloramphenicol, clindamycin, corticotropin, daunorubicin, diphenhydramine, dopamine, erythromycin, floxacillin, furosemide, heparin in NS, lidocaine, magnesium sulfate, mephentermine, metronidazole, mitomycin, mitoxantrone, netilmicin, norepinephrine, penicillin G potassium/sodium, piperacillin, polymyxin B, potassium chloride, procaine, theophylline, thiopental, vancomycin, verapamil, vitamins B and C

Syringe: Diatrizoate, iohexol, iopamidol, ioxaglate, iothalamate. thiopental

Y-site (partial list): Acyclovir, allopurinol, amifostine, aminophylline, amphotericin B cholesteryl sulfate, ampicillin, argatroban, atracurium, atropine, aztreonam, betamethasone, bivalirudin, calcium gluconate, cefepime, chlordiazepoxide, cisatracurium, cladribine, cytarabine, dexamethasone sodium phosphate, digoxin, diltiazem, diphenhydramine, dopamine, esmolol, conjugated estrogens, fentanyl, fluorouracil, hydralazine, heparin, inamrinone, linezolid, morphine sulfate, magnesium sulfate, ondansetron, propofol, propranolol, scopolamine, succinylcholine, tacrolimus, vecuronium

IV Preparation

100-mg vial: Reconstitute in ≤2 mL SWI/BWI

Act-O-Vial: Follow instructions (final concentration, 50-125 mg/mL)

Infusion: Dilute in D5W, NS, or D5/NS to 0.1-1 mg/mL

IV Administration

IV push: Over 0.5-10 min

Intermittent infusion: Over 30 minutes

IM Administration

Act-O-Vial: Mix according to instructions and inject IM

Oral Administration

Administer with food or mild to decrease GI symptoms

Capsule, immediate-release oral granules

• Oral granules are contained within capsules; do not swallow capsules; do not chew or crush granules
• Round dose to nearest 0.5 mg or 1 mg; contents of more than 1 capsule may be needed to supply dose
• Do not administer granules in nasogastric or gastric tubes as they may cause tube blockage
• Do not add granules to liquid as this can result in reductions in the administered dose and result in a bitter taste

• Open capsule and administer granules as follows

  • Hold capsule so the printed strength is at the top and tap to ensure all the granules are in lower half of capsule
  • Gently squeeze bottom of capsule and twist off top of capsule
  • Granules may be administered by pouring directly onto the patient’s tongue, pouring onto a spoon and placing in the patient’s mouth, or sprinkling onto a spoonful of cold or room temperature soft food (eg, yogurt, fruit puree)
  • Administer and swallow granules within 5 minutes to avoid a bitter taste, as the outer taste masking cover can dissolve
  • Tap capsule to ensure all granules are emptied
  • Avoid wetting capsule on tongue or soft food as this may result in granules remaining in the capsule
  • Immediately follow administration with ingestion of fluids (eg, water, milk, breastmilk, formula) to ensure all granules are swallowed

Storage

Parenteral

• Unopened vials: Store at controlled room temperature 20-25ºC (68-77ºF)
• Reconstituted solution: Store at controlled room temperature 20-25ºC (68-77ºF) and protect from light; discard unused solution after 3 days

Tablets

• Store at controlled room temperature 20-25ºC (68-77ºF)

Capsule, immediate-release oral granules

• Store at controlled room temperature 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
• Store in original bottle to protect from light
• Use capsules within 60 days after opening bottle