Hydrocortisone Sodium Succinate: Uses, Dosage, Side Effects, and Pharmacological Aspects

Overview:

Hydrocortisone sodium succinate is a powerful tool for managing various inflammatory and immune-related conditions. Its rapid onset of action and effectiveness make it invaluable, especially in emergencies. Proper administration and monitoring can provide swift relief, improving the quality of life for patients with allergic reactions, inflammation, and autoimmune diseases. The US FDA (United States Food and Drug Administration) approved Hydrocortisone on August 5, 1952.

Drug Group

Hydrocortisone sodium succinate belongs to the drug group known as corticosteroids or glucocorticoids. These medications are artificial compounds designed to replicate the actions of cortisol, a hormone secreted naturally by the adrenal glands.

Indications

Hydrocortisone injection is indicated for addressing symptoms associated with low corticosteroid levels and severe allergic reactions. It finds utility in managing conditions such as multiple sclerosis (a chronic neurological disorder characterized by damage to the myelin sheath), lupus (a disease that involves the immune system attacking the body's tissues), gastrointestinal diseases, certain types of arthritis (joint pain), and others affecting the blood, skin, eyes, nervous system, thyroid, kidneys, and lungs.

Dosage Forms and Available Strengths

The sterile powder is available in the following dosage forms and strengths for intravenous or into vein (IV) or intramuscular or into muscle (IM) administration:

• Plain-Vials:

  • Strength: 100 mg (milligrams).

• Single-Dose Vial:

  • Strengths: 100 mg, 250 mg, 500 mg, and 1000 mg.

For Patients

What Does Inflammation and Allergic Reactions Mean?

• Inflammation is how the body reacts to injury or infection, causing redness, swelling, heat, and pain. It is a natural process that helps the body heal and protect itself from harmful things.

• Allergies happen when the body's defense system overreacts to things that are usually harmless, like pollen, food, or medicine. This extra-strong reaction can cause itching, swelling, rashes, trouble breathing, and, in serious cases, anaphylaxis.

How Does Hydrocortisone Sodium Succinate Work?

Hydrocortisone sodium succinate mimics the body's natural cortisol with potent anti-inflammatory and immunosuppressive effects. It suppresses the immune response, reduces inflammation, and alleviates symptoms associated with inflammatory and immune-related conditions.

What Are the Clinical Uses of Hydrocortisone Sodium Succinate?

The intravenous or intramuscular use of Hydrocortisone sodium succinate sterile powder is indicated for the following conditions:

• Allergic States: Controlling severe or incapacitating allergic conditions that do not react well to standard treatments, including asthma (inflammatory airway disease), atopic dermatitis (chronic skin inflammation), contact dermatitis (skin irritation from contact), drug hypersensitivity reactions (allergic reaction due to medications), perennial or seasonal allergic rhinitis (nasal inflammation due to year-round or seasonal allergens), serum sickness (delayed reaction to medications with protein content), and transfusion reactions (adverse responses to blood transfusions).

• Dermatologic Diseases: Treating bullous dermatitis herpetiformis (itchy blisters linked to celiac disease), exfoliative erythroderma (widespread redness and scaling), mycosis fungoides (type of skin lymphoma), pemphigus (autoimmune blisters on skin and mucous membranes), and severe erythema multiforme like Stevens-Johnson syndrome (severe skin reaction with blistering and sloughing).

• Endocrine Disorders: Managing primary or secondary adrenocortical insufficiency (low adrenal hormones due to pituitary or hypothalamus issues), congenital adrenal hyperplasia (genetic adrenal enzyme deficiency), hypercalcemia (high blood calcium levels, often from parathyroid or cancer problems) associated with cancer, nonsuppurative thyroiditis (inflammation of the thyroid gland without pus), and in infancy, providing mineralocorticoid supplementation.

• Gastrointestinal Diseases: Assisting during critical periods of regional enteritis (systemic therapy) and ulcerative colitis (chronic colon and rectum inflammation).

• Hematologic Disorders: Treating acquired (autoimmune) hemolytic anemia (rapid destruction of red blood cells), congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia, meaning genetic disorder causing low red blood cell production), idiopathic thrombocytopenic purpura (autoimmune destruction of platelets, leading to bleeding tendencies) in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia (a rare disorder of the bone marrow), and selected cases of secondary thrombocytopenia (decreased platelets).

• Miscellaneous: Managing trichinosis (a parasitic infection) with neurologic (related to the brain) or myocardial (heart muscle) involvement, tuberculous meningitis (a severe form of tuberculosis affecting the brain and spinal cord membranes) with a subarachnoid block (spinal block), or impending block when used concurrently with appropriate antituberculous chemotherapy.

• Neoplastic Diseases: Palliative management of leukemias (cancer of the blood-forming tissues) and lymphomas (cancers originating in the lymphatic system).

• Nervous System: Treating acute exacerbations of multiple sclerosis (a persistent autoimmune condition that impacts the central nervous system over time), cerebral edema (accumulation of fluid in the brain) associated with primary or metastatic brain tumors, or craniotomy (surgical opening in the skull to access the brain).

• Ophthalmic Diseases: Addressing sympathetic ophthalmia (severe eye inflammation), uveitis (inflammation of the uvea, the middle layer of the eye), and ocular inflammatory conditions unresponsive to topical corticosteroids.

• Renal Diseases: Inducing diuresis (increased urine production by the kidneys) or remission of proteinuria (occurrence of an excessive level of protein in the urine) in idiopathic nephrotic syndrome (kidney disorder marked by protein in urine, low blood protein, high cholesterol, and swelling) or due to lupus erythematosus.

• Respiratory Diseases: Managing berylliosis (bacterial infection) fulminating, or disseminated pulmonary tuberculosis (a severe form of tuberculosis) when used together with suitable antituberculous treatment, idiopathic eosinophilic pneumonia (inflammatory rare lung disorders), and symptomatic sarcoidosis (inflammatory disease affecting multiple organs).

• Rheumatic Disorders: Providing adjunctive therapy for short-term administration in acute gouty arthritis (painful joint inflammation due to uric acid crystal buildup), acute rheumatic carditis (inflammation of the heart muscles and valves), ankylosing spondylitis (chronic inflammation primarily affecting the spine), psoriatic arthritis (arthritis associated with skin condition), rheumatoid arthritis (chronic autoimmune joint inflammation), including juvenile rheumatoid arthritis, joint pain in children under 16, (selected cases may require low-dose maintenance therapy).

What Is the Dosage of the Hydrocortisone Sodium Succinate?

Hydrocortisone sodium succinate is typically administered intravenously or intramuscularly, with dosages ranging from 100 mg to 1000 mg or more, depending on the severity of the condition. Initial doses may be higher in acute, life-threatening situations, with subsequent adjustments made based on the patient's response and clinical condition.

What Are the Side Effects of Hydrocortisone Sodium Succinate?

Hydrocortisone injections can lead to side effects. Inform the doctor if any of the following symptoms persist or worsen:

• Headache.

• Dizziness.

• Delayed healing of cuts and bruises.

• Acne.

• Thinning, fragile, or dry skin.

• Red or purple blotches or lines under the skin.

• Skin depressions at the injection site.

• Changes in body fat distribution or movement.

• Trouble sleeping or staying asleep.

• Inappropriate happiness.

• Extreme mood swings or personality changes.

• Severe fatigue.

• Depression.

• Increased sweating.

• Muscle weakness.

• Joint pain.

• Irregular or absent menstrual periods.

• Increased appetite.

• Hiccups.

Some side effects require immediate medical attention.

• Sore throat, fever, chills, cough, or signs of infection.

• Seizures (unusual brain activity).

• Vision problems.

• Enlargement or puffiness of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs.

• Abdominal swelling or pain.

• Trouble breathing or swallowing.

• Shortness of breath.

• Sudden weight gain.

• Rash, hives, itching.

• Abnormal skin patches in the mouth, nose, or throat.

Children using Hydrocortisone sodium succinate injections may grow slower. The doctor will monitor their growth closely. Long-term use may raise the risk of glaucoma (eye pressure increases), cataracts (eye lenses become cloudy), and osteoporosis (weak bones). Discuss these risks with the doctor, including how often to get eye exams. Contact the doctor if one experiences any unusual issues while using this medication.

What Are the Things to Inform the Doctor Before Taking Hydrocortisone Sodium Succinate?

Before getting a Hydrocortisone injection:

• Inform the doctor and pharmacist about any allergies to Hydrocortisone, medications, Benzyl alcohol, or any ingredients in the injection.

• Please share any current prescriptions, non-prescription medications, vitamins, supplements, and herbal products with the doctor and pharmacist.

• Notify the doctor if they have had tuberculosis, cataracts, glaucoma, diabetes (high blood sugar levels), high blood pressure, heart issues, mental health conditions, osteoporosis, seizures (unusual electrical brain activity), ulcers, liver, kidney, thyroid diseases, or any infections.

• If one is pregnant, planning to become pregnant, or breastfeeding, discuss it with the doctor.

• Before surgery, inform the surgeon or dentist about the Hydrocortisone injection.

• Avoid vaccinations without consulting the doctor.

• Hydrocortisone injections can weaken the immune system. Avoid sick people, wash hands often, and avoid those with chickenpox or measles (viral infections). If exposed, contact the doctor right away.

Dietary Considerations

Follow the doctor's instructions to adhere to a low-sodium regimen or a diet rich in potassium or calcium. Additionally, prescriptions or recommendations for calcium or potassium supplements may be provided. Adhere to these directions diligently.

Missed Dose

If one misses a dose of Hydrocortisone sodium succinate, contact the healthcare provider for guidance.

Overdose

In cases of acute overdose, treatment involves supportive and symptomatic therapy. For chronic overdose in severe conditions requiring continuous steroid therapy, the corticosteroid dosage may be temporarily reduced, or alternate-day treatment may be considered.

Product Availability

Hydrocortisone sodium succinate sterile powder is provided in the following packaging options:

• 100 mg plain.

• 100 mg (single-dose vial) 2 mL or milliliter (25 vials).

• 250 mg (single-dose vial) 2 mL (25 vials).

• 500 mg (single-dose vial).

• 1000 mg (single-dose vial).

Storage Instructions

• Keep the product in its original form at room temperature between 68 to 77 degrees Fahrenheit.

• Store the solution at room temperature between 68 to 77 degrees Fahrenheit and shield it from light.

• Only use the solution if it is clear. Dispose of any unused solution after three days.

For Doctors

Chemical Taxonomy

• Chemical Name: Hydrocortisone sodium succinate

• Molecular Weight: 484.51 g/mol or grams per mole.

• Description: White solid, soluble in water, odorless.

• pH Adjustment: Sodium hydroxide regulates pH (7 to 8).

How Are Hydrocortisone Sodium Succinate Administered?

The drug is only available by prescription. Here is an overview of its administration.

• Before administering, look at it for any particles or color changes.

• It can be given through a needle in a vein (intravenous), through a drip into a vein (intravenous infusion), or into a muscle (intramuscular).

• In emergencies, use a vein injection first.

• The dose depends on the illness, usually between 100 and 500 mg at the start.

• High doses are for up to 48 to 72 hours, then switch if needed to avoid sodium issues.

• The amount may change depending on how the patient reacts and the illness. If stopping is necessary, do it gradually.

• The dose for children depends on their weight and illness.

• Once mixed, the solution is good for about four hours.

Preparation: For injections, add 2 mL (milliliter) of bacteriostatic water to 100 mg of Hydrocortisone. For infusion, mix with 100 to 1000 mL of fluid. Use a specialized system for mixing and withdrawal. No further dilution is needed for injection. For infusion, mix 100 mg with 100 to 1000 mL, 250 mg with 250 to 1000 mL, 500 mg with 500 to 1000 mL, or 1000 mg with 1000 mL. Adding 100 to 3000 mg to 50 mL of fluid allows for smaller volumes. Solutions are stable for at least four hours and can be given directly or through IV piggyback.

Warnings and Precautions

• This product contains benzyl alcohol, which can be toxic, especially to newborns and preterm infants. Excessive exposure may lead to hypotension (low blood pressure), metabolic acidosis (excess of acid in the body), and increased risk of kernicterus (a rare condition where bilirubin accumulates in the brain).

• Injection of Hydrocortisone sodium succinate may cause skin changes at the injection site, so recommended doses should not be exceeded.

• Rare anaphylactoid reactions have been reported with corticosteroid therapy.

• High doses of systemic corticosteroids, including Hydrocortisone sodium succinate, should not be used for traumatic brain injury treatment.

• Corticosteroids can elevate blood pressure, cause fluid retention, and affect potassium levels.

• Corticosteroid use can suppress the adrenal glands and lead to hormonal imbalances.

• Corticosteroid therapy increases patients' susceptibility to infections, which may be severe or fatal. Fungal infections should be treated cautiously.

• Corticosteroids should be used carefully in patients with certain infections, such as tuberculosis and Strongyloides infestation.

• Live vaccines are not recommended for patients on corticosteroids.

• Chickenpox and measles can have severe outcomes in patients on corticosteroids, so exposure should be avoided.

• Corticosteroids may cause ocular complications and psychiatric side effects.

Precautions:

• Corticosteroid doses should be minimized to reduce potential complications.

• Use caution in patients with heart, kidney, or gastrointestinal issues.

• Adrenal function should be monitored during corticosteroid therapy; gradual dosage reduction is recommended.

• Patients should be educated about the risks of abrupt discontinuation of corticosteroids and exposure to certain infections, such as chickenpox or measles.

What Are the Pharmacological Actions of Hydrocortisone Sodium Succinate?

• Pharmacodynamics: Hydrocortisone sodium succinate acts as a potent anti-inflammatory and immunosuppressive agent by binding to glucocorticoid receptors and regulating gene transcription, leading to the suppression of inflammatory mediators and immune cell activity.

• Mechanism of Action: Upon administration, Hydrocortisone sodium succinate is rapidly converted to Hydrocortisone, its active form, which binds to intracellular glucocorticoid receptors. This adjusts gene expression related to inflammation and immune response, leading to symptom relief.

• Pharmacokinetics: Hydrocortisone sodium succinate is rapidly absorbed and distributed following parenteral administration. It undergoes metabolism in the liver to yield active Hydrocortisone, which is then eliminated primarily through renal clearance, with a rapid elimination half-life.

Non-Clinical Toxicity:

There have not been enough animal studies to determine if corticosteroids could lead to cancer or genetic mutations. In some patients, steroids might affect sperm movement and quantity.

What Are the Contraindications Of Hydrocortisone Sodium Succinate?

• Hypersensitivity to Hydrocortisone sodium succinate sterile powder and its constituents.

• Intramuscular corticosteroid preparations are not recommended for idiopathic thrombocytopenic purpura.

• Use in premature infants due to the inclusion of Benzyl alcohol in the formulation.

What Are the Drug Interactions of Hydrocortisone Sodium Succinate?

• Aminoglutethimide.

• Amphotericin B and Potassium-depleting agents.

• Antibiotics (Macrolides).

• Anticholinesterases.

• Oral anticoagulants (Warfarin).

• Antidiabetic agents.

• Antitubercular drugs (Isoniazid).

• Cholestyramine.

• Cyclosporine.

• Digitalis glycosides.

• Estrogens (including oral contraceptives).

• Hepatic enzyme inducers.

• Hepatic enzyme inhibitors.

• Ketoconazole.

• NSAIDs (non-steroidal anti-inflammatory drugs).

• Skin tests.

• Vaccines.

Clinical Studies

Various clinical studies have examined how well and safely Hydrocortisone sodium succinate works in different health issues like adrenal insufficiency, allergies, inflammation, and shock. The studies tested it in different forms (like through a vein, into a muscle, or by mouth) and doses to find the best ways to use it. The studies found that it can help reduce inflammation, ease symptoms, and improve outcomes, especially in conditions like septic shock and adrenal crisis. However, like any medicine, it can also have risks and side effects, which scientists have also studied in clinical trials.

Use in Specific Populations

• Pregnancy: Corticosteroids (Category C) may pose risks during pregnancy, so should be based on benefits versus risks. Babies exposed should be monitored for hypoadrenalism.

• Nursing Mothers: Corticosteroids can pass into breast milk, potentially affecting infant growth. Nursing mothers should weigh risks versus benefits.

• Pediatric Use: Benzyl alcohol in this product can lead to severe issues in children. Corticosteroids can be used in children but need careful consideration, especially in premature infants.

• Geriatric Use: Caution is advised for the elderly due to potential age-related changes and health conditions, despite similar responses seen in studies.