hydrocortisone (Rx)

Brand and Other Names:Alkindi Sprinkle, Cortef, more...SoluCortef
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet (Cortef, generic)

  • 5mg
  • 10mg
  • 20mg

powder for injection (SoluCortef)

  • 100mg/vial
  • 250mg/vial
  • 500mg/vial
  • 1g/vial

Inflammation

20-240 mg PO qDay

100-500 mg/dose IV/IM q2hr, q4hr, or q6hr

Status Asthmaticus

1-2 mg/kg IV q6hr initially for 24 hours; maintenance: 0.5-1 mg/kg q6hr  

Acute Adrenal Crisis (Off-label)

100 mg IV bolus, then 200 mg over 24hr by continuous infusion or divided q6hr; then 100 mg over 24 hr the following day

When patient is stabilized: 50 mg PO q8hr for 6 doses, then tapered to 30-50 mg/day PO in divided doses

Chronic Adrenal Insufficiency

15-25 mg/day PO divided q8-12hr

COVID-19 (Off-label)

NIH guidelines recommend corticosteroids (preferably dexamethasone) to reduce mortality in hospitalized patients with COVID-19 disease who are receiving either invasive mechanical ventilation or oxygen alone, but not among those receiving no respiratory support

If dexamethasone is unavailable, use alternant glucocorticoids (eg, prednisone, methylprednisolone, or hydrocortisone)

Hydrocortisone 160 mg PO/IV qDay for up to 10 days or discharge, whichever comes first; use in addition to standard of care

Consider hydrocortisone use as follows

  • Supplement oxygen, but not requiring oxygen delivery through high-flow device, noninvasive ventilation, invasive mechanical ventilation, or ECMO
  • Requires oxygen delivery through high-glow device or noninvasive ventilation
  • Requires invasive mechanical ventilation or ECMO

Dosing Considerations

Usual PO dosing range: 10-320 mg/day divided q6-8hr

Usual IV/IM dosing range (sodium succinate): 100-500 mg PRN initially; may be repeated q2hr, q4hr, or q6hr PRN

Examples of additional indications

  • Endocrine disorders
    • Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)
    • Congenital adrenal hyperplasia
    • Nonsuppurative thyroiditis
    • Hypercalcemia associated with cancer
  • Rheumatic disorders
    • As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
    • Psoriatic arthritis
    • Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
    • Ankylosing spondylitis
    • Acute and subacute bursitis
    • Acute nonspecific tenosynovitis
    • Acute gouty arthritis
    • Post-traumatic osteoarthritis
    • Synovitis of osteoarthritis
    • Epicondylitis
  • Collagen diseases
    • During an exacerbation or as maintenance therapy in selected cases of:
    • Systemic lupus erythematosus
    • Systemic dermatomyositis (polymyositis)
    • Acute rheumatic carditis
  • Dermatologic diseases
    • Pemphigus
    • Bullous dermatitis herpetiformis
    • Severe erythema multiforme (Stevens-Johnson syndrome)
    • Exfoliative dermatitis
    • Mycosis fungoides
    • Severe psoriasis
    • Severe seborrheic dermatitis
  • Allergic states
    • Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
    • Seasonal or perennial allergic rhinitis
    • Serum sickness
    • Bronchial asthma
    • Contact dermatitis
    • Atopic dermatitis
    • Drug hypersensitivity reactions
  • Ophthalmic diseases
    • Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
    • Allergic conjunctivitis
    • Keratitis
    • Allergic corneal marginal ulcers
    • Herpes zoster ophthalmicus
    • Iritis and iridocyclitis
    • Chorioretinitis
    • Anterior segment inflammation
    • Diffuse posterior uveitis and choroiditis
    • Optic neuritis
    • Sympathetic ophthalmia
  • Respiratory diseases
    • Symptomatic sarcoidosis
    • Loeffler’s syndrome not manageable by other means
    • Berylliosis
    • Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
    • Aspiration pneumonitis
  • Hematologic disorders
    • Idiopathic thrombocytopenic purpura in adults
    • Secondary thrombocytopenia in adults
    • Acquired (autoimmune) hemolytic anemia
    • Erythroblastopenia (RBC anemia)
    • Congenital (erythroid) hypoplastic anemia
  • Neoplastic diseases
    • For palliative management of:
    • Adult leukemias and lymphomas
    • Childhood acute leukemia
  • Edematous states
    • Diuresis induction or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus
  • Gastrointestinal diseases
    • Temporary treatment for critical period of disease in:
    • Ulcerative colitis
    • Regional enteritis
  • Other
    • Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
    • Trichinosis with neurologic or myocardial involvement

Dosage Forms and Strengths

tablet (Cortef, generic)

  • 5mg
  • 10mg
  • 20mg

capsule, immediate-release oral granules (Alkindi Sprinkle)

  • 0.5mg
  • 1mg
  • 2mg
  • 5mg

powder for injection (SoluCortef)

  • 100mg/vial
  • 250mg/vial
  • 500mg/vial
  • 1g/vial

Inflammation

<12 years: 2.5-10 mg/kg/day PO divided q6-8hr or 1-5 mg/kg/day IM/IV divided q12-24hr  

&ge:12 years:

  • 20-240 mg PO qDay
  • 100-500 mg/dose IV/IM q2hr, q4hr, or q6hr

Status Asthmaticus

1-2 mg/kg IV q6hr for 24 hr; not to exceed 250 mg  

IV Maintenance: 2 mg/kg/day IV divided q6hr

PO Maintenance: 0.5-1 mg/kg IV q6hr

Adrenocortical Insufficiency

Indicated for physiologic replacement therapy in patients with diseases causing adrenocortical insufficiency

Initial dose: 8-10 mg/m²/day PO divided q8-12hr  

Individualize dose, using lowest possible dosage

Higher doses may be needed based on age and disease symptoms

Lower starting doses may be sufficient in patients with residual, but decreased endogenous cortisol production

Divide total daily dose in 3 doses; older patients may be dosed twice daily

Monitor for symptoms of under and/or overtreatment including signs and symptoms of adrenocortical insufficiency, linear growth and weight gain; adjust doses accordingly

When switching from oral tablet to oral granules (sprinkles), use the same total daily dose

See Oral Administration for complete instructions for how to administer oral granules

Acute Adrenal Crisis

>1 month-1 year

  • 25 mg IV bolus, then 50 mg/m²/day by continuous IV drip or divided q6-8hr  
  • Alternative: 1-2 mg/kg IV bolus, then 25-150 mg/day IV divided q6-8 hr  

1-12 years

  • 50-100 mg rapid IV bolus, then 50 mg/m²/day by continuous IV drip or divided q6-8hr
  • Alternative: 1-2 mg/kg IV bolus, then 150-250 mg/day divided q6-8hr

Congenital Adrenal Hyperplasia (Orphan)

Chronocort, modified release capsules

Sponsor

  • Diurnal LTD; Cardiff Medicentre; Cardiff CF14 4UJ, UK

Dosing Considerations

Monitor for symptoms of under and/or overtreatment including signs and symptoms of adrenocortical insufficiency, linear growth and weight gain; adjust doses accordingly

Increased doses may be needed during episodes of acute febrile illness, gastroenteritis, surgery, or major trauma

Examples of additional indications

  • Congenital adrenal hyperplasia
  • Palliative management of acute childhood leukemia
  • Congenital (erythroid) hypoplastic anemia
  • Drug hypersensitivity reactions
  • Juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
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Interactions

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            Adverse Effects

            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

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            Warnings

            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
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            Pregnancy & Lactation

            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.

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            Pharmacology

            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)

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            Administration

            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
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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