hydrocortisone

Hydrocortisone is a synthetic formulation of cortisol, the natural steroid hormone produced in the cortex region of the adrenal glands, hence known as a corticosteroid. Hydrocortisone is used to control or reduce inflammation caused by a wide variety of conditions, to treat chronic adrenal insufficiency and to replace inadequate natural cortisol production.

Hydrocortisone has varied metabolic effects and also modifies the body’s immune response. Hydrocortisone works in multiple ways to reduce inflammation:

• Controls the rate of protein synthesis
• Inhibits release of proinflammatory substances
• Prevents migration and aggregation of polymorphonuclear leukocytes (PMN), types of white cells such as neutrophils, eosinophils and basophils that release inflammatory substances
• Reduces capillary permeability to prevent the leakage of inflammatory cells and proteins (cytokines) into the inflammation site
• Inhibits the activity of histamine, an inflammatory chemical released by immune cells
• Stabilizes the membranes of cells, and lysosomes, the organelles inside cells that contain digestive enzymes
• Prevents migration of fibroblasts, cells that form extracellular matrix, the supportive structure of tissue, and prevents scar tissue formation

Hydrocortisone may be used systemically as oral medications or injections and are also available in various forms of topical applications, used to treat allergic skin conditions. Hydrocortisone is mainly a prescription drug, though some formulations of topical applications are available over the counter (OTC). Topical hydrocortisone applications may be used in both adults and pediatric patients to treat:

• Atopic dermatitis
• Corticosteroid dermatoses (skin lesions)
• Systemic hydrocortisone uses include the following:

Adult

• Inflammation
• Status asthmaticus (acute severe asthma)
• Chronic adrenal insufficiency
• Acute adrenal crisis (off-label)
• COVID-19 in adults (off-label)
• Multiple metabolic and inflammatory conditions including:
  • Endocrine disorders
  • Rheumatic disorders
  • Collagen diseases
  • Dermatologic diseases
  • Allergic states
  • Ophthalmic diseases
  • Respiratory diseases
  • Hematologic diseases
  • Neoplastic diseases (cancers)
  • Edematous diseases (conditions that cause edema/swelling)
  • Gastrointestinal diseases
  • Tuberculous meningitis
  • Trichinosis with neurological or myocardial involvement

Pediatric

• Inflammation
• Adrenocortical insufficiency
• Acute adrenal crisis
• Other conditions include:
  • Congenital adrenal hyperplasia (Orphan designation)
  • Palliative management of acute childhood leukemia
  • Congenital hypoplastic anemia
  • Drug hypersensitivity reactions
  • Juvenile rheumatoid arthritis

• Do not administer hydrocortisone to patients with documented hypersensitivity to corticosteroids or other components in hydrocortisone
• Do not administer to patients with untreated serious infections except tuberculous meningitis or septic shock
• Do not use intramuscular administration in patients with idiopathic thrombocytopenic purpura
• Do not administer hydrocortisone as intrathecal injection
• Do not use formulations containing benzyl alcohol in premature infants
• Do not administer in patients with systemic fungal infections, hydrocortisone may exacerbate symptoms
• Do not administer live or live, attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids
• 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, gastrointestinal (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

Common side effects of systemic hydrocortisone include:

• Allergic reactions including:
  • Swelling of tissue under skin and mucous membranes (angioedema)
  • Severe allergic reaction (anaphylaxis0
• Cardiac effects including:
  • Cardiac arrest
  • Irregular heart rhythms (arrhythmia)
  • Rapid heart rate (tachycardia)
  • Slow heart rate (bradycardia)
  • Congestive heart failure
  • Myocardial rupture (in patients who have had a heart attack)
  • High blood pressure (hypertension)
  • Heart enlargement (cardiomegaly)
• Pulmonary edema
• Fainting (syncope)
• Blood clot blockage in a blood vessel (thromboembolism)
• Vein inflammation with blood clots (thrombophlebitis)
• Blood vessel inflammation (vasculitis)
• Fat globules in a blood vessel (fat embolism)
• Acne
• Impaired wound healing
• Thin fragile skin
• Facial redness (erythema)
• Hives (urticaria)
• Fluid and electrolyte disturbances including:
  • Sodium and fluid retention
  • Potassium loss (hypokalemia)
  • Hypokalemic alkalosis
• Adrenal suppression
• Cushing syndrome, a condition caused by excessive corticosteroid use over a long period
• Joint pain (arthralgia)
• Bone loss (osteoporosis)
• Muscle disease (myopathy)
• Cataract
• Nasal bleeding (epistaxis)
• Bladder dysfunction
• Abdominal distention
• Increase in appetite
• Indigestion
• Nausea
• Peptic ulcer with possible perforation and hemorrhage
• Inflammation of the pancreas (pancreatitis)
• Liver enlargement (hepatomegaly)
• Elevated liver enzymes
• Diabetes mellitus
• Abnormal male pattern hair growth in women (hirsutism)
• Menstrual irregularities
• High blood glucose levels (hyperglycemia)
• Delirium
• Depression
• Insomnia
• Psychosis
• Headache
• Malaise
• Vertigo
• Increased intracranial pressure (pseudotumor cerebri) on withdrawal
• Negative nitrogen balance due to protein catabolism
• Postmarketing Reports
• Abnormal fat deposits on or outside the spinal membrane (epidural lipomatosis)
• Fluid buildup under the retina (central serous chorioretinopathy)
• Elevated white blood cell count (leukocytosis)
• Low count of platelets (thrombocytopenia) in adults
• Idiopathic thrombocytopenic purpura (bruising) in adults
• Types of anemia such as:
  • Erythroblastopenia
  • Congenital (erythroid) hypoplastic anemia
• Side effects of topical applications include:
• Skin atrophy
• Stretch marks (striae)
• Acneiform lesions
• Skin inflammation around the mouth (perioral dermatitis)
• Follicle inflammation (folliculitis)
• Itching
• Pigmentation changes
• Hypothalamic-pituitary-adrenal (HPA) axis suppression (with higher potency used for longer than 2 weeks)

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Tablet (Cortef, generic)

• 5mg
• 10mg
• 20mg

Powder for injection (SoluCortef)

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

Capsule, immediate-release oral granules (Alkindi Sprinkle) — pediatric use

• 0.5mg
• 1mg
• 2mg
• 5mg

Topical applications (ranging from 0.1% to 2.5%)

• Cream
• Lotion
• Gel
• Ointment
• Solution

Adult

Inflammation

• 15-240 mg oral/intramuscular/intravenous (PO/IM/IV) every 12 hours
• 100-500 mg/dose IV/IM every 2 hours, 4 hours, or 6 hours

Status Asthmaticus

• 1-2 mg/kg intravenously (IV) every 6 hours initially for 24 hours; maintenance: 0.5-1 mg/kg every 6 hours

Chronic Adrenal Insufficiency

• 15-25 mg/day orally divided every 8-12 hours

Acute Adrenal Crisis Treatment (off-label)

• 100 mg intravenous (IV) bolus, then 300 mg/day IV divided every 8 hours or administered by continuous infusion for 48 hours
• When a patient is stabilized: 50 mg orally every 8 hours for 6 doses, then tapered to 30-50 mg/day orally in divided doses

COVID-19 (off-label)

• If dexamethasone is not available
• Hydrocortisone 160 mg PO/IV every day for up to 10 days or discharge, whichever comes first; use in addition to standard of care

Other metabolic and inflammatory conditions:

• Usual oral dosing range: 10-320 mg/day divided every 6-8 hours
• Usual IV/IM dosing range (sodium succinate): 100-500 mg as needed initially; may be repeated every 2 hours, 4 hours, or 6 hours as needed

Pediatric

Inflammation

• Children below 12 years of age: 2.5-10 mg/kg/day orally divided every 6-8 hours, or 1-5 mg/kg/day IM/IV divided every 12-24 hours
• Children 12 years of age and above: 15-240 mg oral/intramuscular/intravenous/subcutaneous (PO/IM/IV/SC) every 12 hours

Status asthmaticus

• 1-2 mg/kg IV every 6 hours for 24 hours; not to exceed 250 mg
• IV Maintenance: 2 mg/kg/day IV divided every 6 hours
• Oral Maintenance: 0.5-1 mg/kg every 6 hours

Adrenocortical insufficiency

• 8-10 mg/m²/day oral/intramuscular/intravenous (PO/IM/IV) divided every 8 hours

Acute adrenal crisis

• Children of age 1 month-1 year
• 25 mg intravenous (IV) bolus, then 50 mg/m²/day by continuous IV drip or divided every 6-8 hours
• Alternative: 1-2 mg/kg IV bolus, then 25-150 mg/kg/day IV divided every 6-8 hours
• Children 1-12 years of age
• 50-100 mg rapid intravenous (IV) bolus, then 50 mg/m²/day by continuous IV drip or divided every 6-8 hours
• Alternative: 1-2 mg/kg IV bolus, then 150-250 mg/day divided every 6-8 hours

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe Interactions of hydrocortisone include:
  • mifepristone
• Hydrocortisone has serious interactions with at least 75 different drugs.
• Hydrocortisone has moderate interactions with at least 240 different drugs.
• Hydrocortisone has mild interactions with at least 128 different drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There are no adequate and well-controlled studies for use of hydrocortisone in women of child-bearing potential, pregnant or breastfeeding women.
• Hydrocortisone may be used in pregnant women if potential benefits outweigh potential risks to the mother and fetus.
• Systemic hydrocortisone appears in breast milk and must be used with caution in nursing mothers.
• Some suggestions (not fully substantiated) of slightly increased cleft palate risk if corticosteroids are used in pregnancy

• Blood clot blockages in blood vessels (thromboembolisms) and muscle damage or weakness (myopathy) may occur
• High dose corticosteroids are associated with increased bone loss and osteoporotic fractures
• Anaphylactoid (serious allergic) reactions have been reported
• Delayed wound healing is possible
• Patients on corticosteroids should avoid chickenpox or measles-infected persons if unvaccinated
• Latent tuberculosis may be reactivated (patients with positive tuberculin test should be monitored)
• Prolonged corticosteroid use may result in eye conditions such as elevated intraocular pressure, glaucoma, or cataracts
• Killed or inactivated vaccines may be administered with caution; however, the response to such vaccines cannot be predicted
• Immunization procedures may be undertaken in patients who are receiving hydrocortisone as replacement therapy in low doses because of natural deficiency (e.g., for Addison's disease)
• Pheochromocytoma (a type of cancer that affects adrenal glands) crisis, which can be fatal, reported after administration of systemic corticosteroids
• Corticosteroid effects are enhanced  in patients with hypothyroidism and in those with cirrhosis; may need dosage adjustments when changes in thyroid status occur
• Myopathy reported with high dose corticosteroids; mostly in patients with neuromuscular transmission disorders; likely to affect ocular and/or respiratory muscles
• Occurrence of Kaposi sarcoma, a type of cancer, is  associated with prolonged corticosteroid treatment; consider discontinuing therapy if it occurs
• Thinning and fragility of skin (atrophy)  may occur at the site of injection
• Corticosteroids should be used cautiously in patients with herpes simplex eye infections  because of possible corneal perforation
• Prolonged use of corticosteroids may increase the incidence of secondary infections
• Sodium retention with edema and potassium loss may occur with corticosteroid use; must be used with caution in patients with hypertension, congestive heart failure or renal insufficiency
• Safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids