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 215° 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 are formulated for oral administration, with each tablet containing 20 mg of hydrocortisone. Inactive ingredients include calcium stearate, corn starch, lactose monohydrate, and sucrose.

Uses and Indications

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

Endocrine Disorders Hydrocortisone Tablets are 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 medication is indicated as adjunctive therapy for short-term administration in acute episodes or exacerbations of psoriatic arthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, and epicondylitis.

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

Dermatologic Diseases This drug is indicated for the treatment of pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, and severe seborrheic dermatitis.

Allergic States Hydrocortisone Tablets are 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 This medication 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 Hydrocortisone Tablets are indicated for 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 This drug 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 Hydrocortisone Tablets are indicated for the palliative management of leukemias and lymphomas in adults, as well as acute leukemia of childhood.

Edematous States This medication 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 Hydrocortisone Tablets are indicated to manage critical periods of ulcerative colitis and regional enteritis.

Miscellaneous This drug 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.

Limitations of Use 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, depending on the specific disease entity being treated. In cases of less severe conditions, lower doses are typically sufficient, while selected patients may require higher initial doses. The initial dosage should be maintained or adjusted based on the patient's response until a satisfactory clinical outcome is achieved.

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

Upon achieving a favorable response, the appropriate maintenance dosage should be established by gradually decreasing the initial dosage in small increments at suitable 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 remissions or exacerbations of the disease, individual drug responsiveness, or exposure to stressful situations unrelated to the disease. In such stressful circumstances, it may be necessary to temporarily increase the dosage of hydrocortisone in accordance with the patient's condition.

For patients undergoing long-term therapy, it is advised 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 ensure adequate management of the patient's condition during periods of heightened physiological demand.

Corticosteroids have the potential to mask signs of infection, which can lead to the emergence of new infections during treatment. Infections caused by various pathogens—including viral, bacterial, fungal, protozoan, or helminthic organisms—may occur in patients receiving corticosteroids, either alone or in conjunction with other immunosuppressive agents that compromise cellular immunity, humoral immunity, or neutrophil function. While some infections may present as mild, they can escalate to severe and potentially fatal complications. It is important to note that the risk of infectious complications increases with higher doses of corticosteroids, which may also result in decreased resistance to infections and an impaired ability to localize infectious processes.

Furthermore, prolonged corticosteroid use is associated with the development of posterior subcapsular cataracts and glaucoma, which may lead to optic nerve damage. Additionally, there is an increased risk of secondary ocular infections, particularly those caused by fungi or viruses. Healthcare professionals should monitor patients for these ocular complications and consider regular ophthalmologic evaluations as part of the management plan for individuals on long-term corticosteroid therapy.

Side Effects

Adverse reactions associated with corticosteroid use can be categorized by seriousness and frequency, encompassing a range of physiological systems.

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, potassium loss and hypokalemic alkalosis have been observed. Neurological effects may manifest as increased intracranial pressure with papilledema (pseudotumor cerebri), convulsions, and vertigo. The potential for psychiatric effects is significant, with reports of euphoria, insomnia, mood swings, personality changes, severe depression, and even psychotic manifestations. In patients with existing emotional instability or psychotic tendencies, corticosteroids may exacerbate these conditions.

Musculoskeletal adverse reactions include muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, and an increased risk of tendon rupture, particularly of the Achilles tendon. Patients may also experience vertebral compression fractures, aseptic necrosis of the femoral and humeral heads, and pathologic fractures of long bones.

Gastrointestinal reactions can be severe, including peptic ulcer with possible perforation and hemorrhage, pancreatitis, and abdominal distention. Laboratory abnormalities such as increases in alanine transaminase (ALT), aspartate transaminase (AST), and alkaline phosphatase have been noted, although these changes are typically small, reversible upon discontinuation, and not associated with clinical syndromes.

Dermatologic reactions may include impaired wound healing, thin fragile skin, petechiae, ecchymoses, facial erythema, and increased sweating. Corticosteroids may also suppress reactions to skin tests.

Endocrine effects can lead to the development of a Cushingoid state, suppression of growth in children, and secondary adrenocortical and pituitary unresponsiveness, particularly during periods of stress such as trauma or surgery. Menstrual irregularities, decreased carbohydrate tolerance, and manifestations of latent diabetes mellitus have also been reported, along with increased requirements for insulin or oral hypoglycemic agents in diabetic patients.

Ophthalmic adverse reactions include central serous chorioretinopathy, posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos.

Metabolic disturbances may result in a negative nitrogen balance due to protein catabolism, while blood and lymphatic system disorders may present as leukocytosis.

Corticosteroids may mask signs of infection, with new infections potentially arising during treatment. Infections of any type, including viral, bacterial, fungal, protozoan, or helminthic, may occur, and the risk of severe or fatal infections increases with higher doses. Prolonged use can lead to posterior subcapsular cataracts, glaucoma, and an increased risk of secondary ocular infections.

Additional adverse reactions include reports of Kaposi's sarcoma in patients receiving corticosteroid therapy, with clinical remission observed upon discontinuation. Pheochromocytoma crisis, which can be fatal, has also been reported following systemic corticosteroid administration, necessitating careful consideration of this risk in patients with suspected pheochromocytoma prior to treatment.

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 toxicity.

Corticosteroids may also influence the pharmacokinetics of chronic high-dose aspirin, potentially increasing its clearance. This interaction can lead to decreased salicylate serum levels or an increased risk of salicylate toxicity upon withdrawal of corticosteroids. Therefore, monitoring is advised when corticosteroids are used in conjunction with high-dose aspirin.

Aspirin should be administered with caution alongside corticosteroids in patients with hypoprothrombinemia due to the potential for significant interactions.

The interaction between corticosteroids and oral anticoagulants is variable, with some reports indicating both enhanced and diminished anticoagulant effects. 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. Careful monitoring of growth and development is essential for infants and children undergoing prolonged corticosteroid therapy.

Infants born to mothers who received substantial doses of corticosteroids during pregnancy should be closely observed for signs of hypoadrenalism. Additionally, corticosteroids can mask certain signs of infection, and new infections may emerge during treatment, particularly in children receiving immunosuppressive doses.

Pediatric patients who have not had chicken pox or measles should exercise caution to avoid exposure, as these infections can present with more severe or potentially fatal outcomes. In the event of exposure to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be warranted. Similarly, if exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) should be considered.

Corticosteroids must be administered with caution in patients with known or suspected Strongyloides infestation, as immunosuppression may lead to serious complications.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of corticosteroids. Due to potential reductions in kidney function and other age-related physiological changes, dosage adjustments may be necessary for this population. Caution is advised when prescribing corticosteroids to geriatric patients, particularly those with comorbid conditions such as hypertension, osteoporosis, and renal insufficiency.

To minimize the risk of adverse effects, it is recommended that the lowest effective dose be utilized in elderly patients. Additionally, close monitoring of geriatric patients undergoing corticosteroid therapy is essential to detect any adverse reactions or complications at an early stage.

Pregnancy

The use of corticosteroids during pregnancy, nursing, or in women of childbearing potential should be approached with caution, as adequate human reproduction studies have not been conducted. Healthcare professionals must weigh the potential benefits of corticosteroid therapy against the possible risks to the mother and the developing embryo or fetus.

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 adrenal function of the newborn. Additionally, animal studies have indicated that corticosteroids may impair fertility in male rats, suggesting potential reproductive risks that warrant consideration in the context of treatment decisions for women of childbearing potential.

Lactation

The use of these drugs in lactating mothers requires careful consideration of the potential benefits against the possible hazards to both 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.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

Nonclinical Toxicology

The use of corticosteroids during pregnancy, nursing, 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.

Administration of average and large doses of hydrocortisone or cortisone may lead to elevated blood pressure, salt and water retention, and increased potassium excretion. These adverse effects are less likely to occur with synthetic derivatives, except when administered in large doses. Additionally, all corticosteroids are associated with increased calcium excretion.

No specific details regarding animal pharmacology and toxicology are provided in the available data.

Postmarketing Experience

Postmarketing experience has identified a range of infections associated with the use of corticosteroids, either alone or in combination with other immunosuppressive agents that impact cellular and humoral immunity, as well as neutrophil function. These infections can involve various pathogens, including viral, bacterial, fungal, protozoan, or helminthic agents, and may occur in any location within the body. While some infections may present as mild, others can be severe and potentially fatal. The incidence of infectious complications appears to increase with higher doses of corticosteroids, which may also lead to decreased resistance and an impaired ability to localize infections.

Additionally, prolonged corticosteroid use has been linked to the development of posterior subcapsular cataracts and glaucoma, which may result in damage to the optic nerves. There is also a potential for enhanced susceptibility to secondary ocular infections caused by fungi or viruses. Furthermore, cases of Kaposi's sarcoma have been reported in patients undergoing corticosteroid therapy, with clinical remission observed upon discontinuation of 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 these patients to understand the heightened risk associated with such exposures due to their compromised immune systems.

Additionally, healthcare providers should emphasize that if patients do come into contact with chicken pox or measles, they should seek medical advice promptly. This proactive approach is essential to manage any potential complications that may arise from exposure to these infectious diseases.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F), as per United States Pharmacopeia (USP) 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)