Hydrocortisone

Description

Hydrocortisone tablets, USP contain hydrocortisone, a glucocorticoid. Hydrocortisone is a white to practically white, odorless, crystalline powder with a melting point of approximately 215º C. It is very slightly soluble in water and ether, sparingly soluble in acetone and alcohol, and slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-, and its molecular weight is 362.46. Hydrocortisone tablets, USP are available for oral administration in two strengths: each tablet contains either 5 mg or 10 mg of hydrocortisone. Inactive ingredients include colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

Uses and Indications

Hydrocortisone tablets are indicated for the treatment of various conditions across multiple medical disciplines.

Endocrine Disorders Hydrocortisone is indicated for primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, non-suppurative thyroiditis, and hypercalcemia associated with cancer. In infants, mineralocorticoid supplementation is particularly important.

Rheumatic Disorders This drug serves as adjunctive therapy for short-term administration during acute episodes or exacerbations of psoriatic arthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis, with selected cases possibly requiring low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, and epicondylitis.

Collagen Diseases Hydrocortisone is indicated during exacerbations or as maintenance therapy in selected cases of systemic lupus erythematosus, systemic dermatomyositis (polymyositis), and acute rheumatic carditis.

Dermatologic Diseases Indications include pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, and severe seborrheic dermatitis.

Allergic States This drug is indicated for the control of severe or incapacitating allergic conditions that are intractable to adequate trials of conventional treatment, including seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, and drug hypersensitivity reactions.

Ophthalmic Diseases Hydrocortisone is indicated for 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, and sympathetic ophthalmia.

Respiratory Diseases Indications include symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis (when used concurrently with appropriate antituberculous chemotherapy), and aspiration pneumonitis.

Hematologic Disorders Hydrocortisone is indicated for idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), and congenital (erythroid) hypoplastic anemia.

Neoplastic Diseases This drug is indicated for the palliative management of leukemias and lymphomas in adults, as well as acute leukemia of childhood.

Edematous States Hydrocortisone is indicated to induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

Gastrointestinal Diseases Indications include use during critical periods of ulcerative colitis and regional enteritis.

Miscellaneous Hydrocortisone is indicated for tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, and for trichinosis with neurologic or myocardial involvement.

No specific teratogenic or nonteratogenic effects have been mentioned.

Dosage and Administration

The initial dosage of hydrocortisone tablets may range from 20 mg to 240 mg per day, tailored to the specific disease entity being treated. In less severe cases, lower doses are typically adequate, while certain patients may require higher initial doses. The initial dosage should be maintained or adjusted based on the patient's clinical response until a satisfactory outcome is achieved.

If a satisfactory clinical response is not observed after a reasonable period, hydrocortisone tablets should be discontinued, and the patient should be transitioned to alternative therapy. Dosage requirements are variable and must be individualized, taking into account the disease being treated and the patient's response.

Once a favorable response is noted, the maintenance dosage should be established by gradually decreasing the initial dosage in small increments at appropriate intervals until the lowest effective dose that maintains adequate clinical response is identified. Continuous monitoring of the drug dosage is essential.

Dosage adjustments may be necessary in response to changes in the patient's clinical status due to disease remissions or exacerbations, individual drug responsiveness, and exposure to stressful situations unrelated to the disease. In instances of stress, it may be required to temporarily increase the dosage of hydrocortisone tablets in accordance with the patient's condition.

For patients undergoing long-term therapy, it is recommended that hydrocortisone be withdrawn gradually rather than abruptly when discontinuation is necessary.

Contraindications

Use is contraindicated in patients with systemic fungal infections and in individuals with known hypersensitivity to any components of the product.

Warnings and Precautions

In patients undergoing corticosteroid therapy, it is essential to recognize that unusual stress may necessitate an increased dosage of rapidly acting corticosteroids before, during, and after the stressful event. This adjustment is critical to manage the physiological demands placed on the body during such times.

Corticosteroids have the potential to mask signs of infection, and new infections may emerge during their use. Infections caused by various pathogens—including viral, bacterial, fungal, protozoan, or helminthic organisms—can occur in patients receiving corticosteroids, either alone or in conjunction with other immunosuppressive agents that impact cellular and humoral immunity, as well as neutrophil function. While some infections may present as mild, they can escalate to severe or even fatal complications. The risk of infectious complications increases with higher doses of corticosteroids, which may also lead to decreased resistance and challenges in localizing infections.

Prolonged corticosteroid use is associated with ocular complications, including posterior subcapsular cataracts and glaucoma, which may result in optic nerve damage. Additionally, there is an increased risk of secondary ocular infections due to fungi or viruses.

The safety of corticosteroids during pregnancy, lactation, or in women of childbearing potential has not been established through adequate human studies. Therefore, the potential benefits of corticosteroid therapy must be carefully weighed against the risks to the mother and the developing embryo or fetus. Infants born to mothers who received substantial corticosteroid doses during pregnancy should be monitored closely for signs of hypoadrenalism. Furthermore, corticosteroids have been shown to impair fertility in male rats, which should be considered when prescribing these medications.

Patients receiving average to large doses of hydrocortisone or cortisone may experience elevated blood pressure, salt and water retention, and increased potassium excretion. Dietary salt restriction and potassium supplementation may be necessary, as all corticosteroids are known to increase calcium excretion.

The administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. While killed or inactivated vaccines may be given, the immune response to these vaccines may be diminished in such patients.

In cases of active tuberculosis, the use of hydrocortisone tablets should be limited to fulminating or disseminated tuberculosis, where corticosteroids are part of a comprehensive antituberculous regimen. For patients with latent tuberculosis or tuberculin reactivity, close monitoring is essential, as there is a risk of disease reactivation. Prophylactic chemotherapeutic measures should be implemented during prolonged corticosteroid therapy in these individuals.

Patients on immunosuppressive therapy are at an increased risk for infections compared to healthy individuals. For instance, chickenpox and measles can lead to more severe or fatal outcomes in non-immune children or adults receiving corticosteroids. Special precautions should be taken to avoid exposure in these populations. If exposure to chickenpox occurs, prophylaxis with varicella zoster immune globulin (VZIG) may be warranted. Similarly, exposure to measles may necessitate prophylaxis with pooled intramuscular immunoglobulin (IG). Should chickenpox develop, antiviral treatment may be considered.

Corticosteroids must be administered with caution in patients with known or suspected Strongyloides (threadworm) infestation. The immunosuppressive effects of corticosteroids can precipitate Strongyloides hyperinfection and dissemination, leading to widespread larval migration, severe enterocolitis, and potentially fatal gram-negative septicemia.

Side Effects

Adverse reactions associated with corticosteroid therapy can be categorized based on their seriousness and frequency.

Serious adverse reactions include fluid and electrolyte disturbances such as sodium retention, fluid retention, and hypertension. In susceptible patients, these disturbances may lead to congestive heart failure. Additionally, corticosteroids can cause significant musculoskeletal issues, including muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, and tendon ruptures, particularly of the Achilles tendon. Other serious musculoskeletal effects include vertebral compression fractures, aseptic necrosis of the femoral and humeral heads, and pathologic fractures of long bones.

Gastrointestinal complications may also arise, with serious conditions such as peptic ulceration that can lead to perforation and hemorrhage, as well as pancreatitis. Participants in clinical trials have shown increases in liver enzymes, including alanine transaminase (ALT), aspartate transaminase (AST), and alkaline phosphatase, which are typically small, reversible upon discontinuation, and not associated with clinical syndromes.

Neurological adverse reactions can manifest as increased intracranial pressure with papilledema (pseudotumor cerebri), convulsions, vertigo, headaches, and epidural lipomatosis. Endocrine effects include the development of a Cushingoid state, suppression of growth in children, secondary adrenocortical and pituitary unresponsiveness during stress, menstrual irregularities, decreased carbohydrate tolerance, and increased insulin or oral hypoglycemic agent requirements in diabetic patients.

Ophthalmic adverse reactions may include central serous chorioretinopathy, posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos. Metabolic effects such as negative nitrogen balance due to protein catabolism and hematological changes like leukocytosis have also been reported.

Corticosteroids may mask signs of infection, leading to the emergence of new infections, which can be mild or severe, and potentially fatal. The risk of infectious complications increases with higher doses. Prolonged use of corticosteroids is associated with the development of posterior subcapsular cataracts and glaucoma, which may damage optic nerves and enhance the risk of secondary ocular infections.

Psychic derangements, ranging from euphoria and mood swings to severe depression and psychotic manifestations, may occur. Existing emotional instability or psychotic tendencies can be exacerbated by corticosteroid use. In patients with suspected pheochromocytoma, the risk of a fatal crisis should be considered prior to administration.

It is important to note that drug-induced secondary adrenocortical insufficiency may persist for months after therapy discontinuation, necessitating hormone therapy during periods of stress. Caution is advised when administering corticosteroids to patients with hypothyroidism or cirrhosis, as they may experience enhanced effects. Additionally, corticosteroids should be used cautiously in patients with ocular herpes simplex due to the risk of corneal perforation. Growth and development in infants and children on prolonged corticosteroid therapy should be closely monitored. Reports of Kaposi's sarcoma have been noted in patients receiving corticosteroid therapy, with clinical remission observed upon discontinuation.

Drug Interactions

Phenobarbital, phenytoin, and rifampin are known to increase the clearance of corticosteroids. This interaction may necessitate dosage adjustments to achieve the desired therapeutic response.

Conversely, troleandomycin and ketoconazole can inhibit the metabolism of corticosteroids, resulting in decreased clearance. In such cases, careful dose titration may be required to prevent potential toxicity.

Corticosteroids may also influence the pharmacokinetics of chronic high-dose aspirin, potentially leading to decreased salicylate serum levels. This interaction raises the risk of salicylate toxicity, particularly upon withdrawal of corticosteroids.

The interaction between corticosteroids and oral anticoagulants is variable, with some reports indicating both enhanced and diminished anticoagulant effects. Therefore, it is essential to monitor coagulation indices closely to ensure the maintenance of the desired anticoagulant effect.

Packaging & NDC

The table below lists all NDC Code configurations of Hydrocortisone, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Hydrocortisone is indicated for the treatment of juvenile rheumatoid arthritis, which may necessitate low-dose maintenance therapy in select pediatric cases. It is essential to monitor the growth and development of infants and children undergoing prolonged corticosteroid therapy closely.

Infants born to mothers who received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Caution is advised in pediatric patients with known or suspected Strongyloides infestation, as corticosteroid-induced immunosuppression may lead to severe complications.

Children receiving immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles, as these infections can result in more severe or even fatal outcomes in non-immune children. In the event of exposure to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. Similarly, if exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be warranted.

It is important to note that corticosteroids may suppress growth in children, necessitating careful monitoring throughout treatment.

Geriatric Use

Elderly patients may not require specific dosage adjustments or safety considerations when using hydrocortisone tablets, as the prescribing information does not indicate any particular recommendations for this population. However, healthcare providers should remain vigilant in monitoring for potential adverse effects, as the pharmacokinetics and pharmacodynamics of medications can differ in geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure safe and effective use of hydrocortisone tablets.

Pregnancy

The use of corticosteroids during pregnancy requires careful consideration of the potential benefits and risks to both the mother and the developing embryo or fetus, as adequate human reproduction studies have not been conducted. Healthcare professionals should weigh these factors when prescribing corticosteroids to pregnant patients, nursing mothers, or women of childbearing potential.

Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be closely monitored for signs of hypoadrenalism, as these medications can affect the newborn's adrenal function. Additionally, animal studies have indicated that corticosteroids may impair fertility in male rats, suggesting potential reproductive risks that warrant further investigation.

In summary, the decision to use corticosteroids in pregnant patients should involve a thorough assessment of the individual circumstances, with an emphasis on monitoring for any adverse effects in both the mother and the infant.

Lactation

Lactating mothers should be aware that adequate human reproduction studies have not been conducted with corticosteroids. Therefore, the use of these drugs during lactation requires careful consideration of the potential benefits against the possible risks to the mother and the breastfed infant.

Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be closely monitored for signs of hypoadrenalism. This observation is crucial to ensure the health and safety of the breastfed infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further management.

Nonclinical Toxicology

The use of corticosteroids during pregnancy, in nursing mothers, or in women of childbearing potential necessitates careful consideration of the potential benefits against the risks to both the mother and the developing embryo or fetus, as adequate human reproduction studies have not been conducted. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be closely monitored for signs of hypoadrenalism.

Corticosteroids have been demonstrated to impair fertility in male rats, indicating a potential risk to reproductive health in this population.

No additional specific details regarding nonclinical toxicology or animal pharmacology and toxicology are available.

Postmarketing Experience

Infections with various pathogens, including viral, bacterial, fungal, protozoan, or helminthic infections, have been reported in association with the use of corticosteroids, either alone or in combination with other immunosuppressive agents that impact cellular immunity, humoral immunity, or neutrophil function. These infections can range from mild to severe and, in some cases, may be fatal. The incidence of infectious complications appears to increase with higher doses of corticosteroids. Additionally, the use of corticosteroids may lead to decreased resistance to infections and an impaired ability to localize infections.

Prolonged corticosteroid therapy has been associated with the development of posterior subcapsular cataracts and glaucoma, which may result in damage to the optic nerves. Furthermore, prolonged use may facilitate the establishment of secondary ocular infections caused by fungi or viruses.

Reports have also indicated that Kaposi's sarcoma can occur in patients undergoing corticosteroid therapy, with clinical remission observed upon discontinuation of corticosteroids. Additionally, pheochromocytoma crisis, which can be fatal, has been documented following the administration of systemic corticosteroids.

Patient Counseling

Healthcare providers should advise patients on the importance of avoiding exposure to chicken pox or measles, particularly for those who are receiving immunosuppressant doses of corticosteroids. It is crucial for patients to understand that their immune system may be compromised, increasing their susceptibility to infections.

In the event of exposure to either chicken pox or measles, patients should be instructed to seek medical advice promptly. This proactive approach is essential to ensure appropriate management and to mitigate potential complications associated with these infections.

Storage and Handling

The product is supplied in accordance with the following specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in compliance with USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by Chartwell RX, LLC.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)