hydrocortisone (AHydrocort, Alphosyl, Aquacort, Cortef, Cortenema, SoluCortef)

Dosing and uses of AHydrocort, Alphosyl (hydrocortisone)

• Adult
• Pediatric

 

Adult dosage forms and strengths

tablet

• 5mg
• 10mg
• 20mg

powder for injection

• 100mg
• 250mg
• 500mg
• 1g

 

Inflammation

15-240 mg PO/IM/IV q12hr

 

Status Asthmaticus

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

 

Acute Adrenal Insufficiency

100 mg IV bolus, then 300 mg/day IV divided q8hr or administered by continuous infusion for 48 hours

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

 

Dosage 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

 

Pediatric dosage forms and strengths

tablet

• 5mg
• 10mg
• 20mg

powder for injection

• 100mg
• 250mg
• 500mg
• 1g

 

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: 15-240 mg PO/IM/IV/SC q12hr

 

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

 

Physiologic Replacement

8-10 mg/m²/day PO/IV/IM divided q8hr

 

Acute Adrenal Crisis (Off-label)

>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/kg/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

 

Adrenal Insufficiency (Orphan)

Hydrocortisone oral granules (Infacort)

Orphan designation for treatment of pediatric adrenal insufficiency for ages birth through 16 yr

Sponsor

• Diurnal Limited; Cardiff Medicentre, Cardiff CF14 4UJ; United Kingdom

 

AHydrocort, Alphosyl (hydrocortisone) adverse (side) 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

 

Warnings

Contraindications

Untreated serious infections (except tuberculous meningitis or septic shock)

Idiopathic thrombocytopenic purpura

Intrathecal administration (injection)

Documented hypersensitivity

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, hypothyroidism, myasthenia gravis, peptic ulcer disease, osteoporosis, ulcerative colitis, psychotic tendencies, renal insufficiency, pregnancy, diabetes mellitus, congestive heart failure, thromboembolic disorders, GI disorders

Thromboembolic disorders and myopathy may occur

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

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

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

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)

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 and 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.

 

Pharmacology of AHydrocort, Alphosyl (hydrocortisone)

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)

 

Administration

IV Incompatibilities

Sodium phosphate

• Syringe: Doxapram
• Y-site: Sargramostim

Sodium succinate

• 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

Sodium phosphate

• Additive: Amikacin, amphotericin B, amphotericin-heparin, bleomycin, metaraminol, mitoxantrone, verapamil
• Syringe: Metoclopramide
• Y-site: Allopurinol, amifostine, aztreonam, cefepime, cladribine, clarithromycin, docetaxel, etoposide phosphate, famotidine, filgrastim, fluconazole, fludarabine, gemcitabine, granisetron, melphalan, ondansetron, paclitaxel, piperacillin-tazobactam, teniposide, thiotepa, vinorelbine

Sodium succinate

• 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

Sodium phosphate

• Intermittent infusion: Dilute in dextrose injections or NS

Sodium succinate

• 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

Sodium succinate

• IV push: Over 0.5-10 min
• Intermittent infusion: Over 30 minutes