Hidrocortisona Roussel

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Hidrocortisona Roussel

What is Hidrocortisona Roussel?

Hidrocortisona Roussel is a medication containing hydrocortisone, a corticosteroid that is chemically identical to the cortisol hormone produced naturally by the human adrenal glands. This hormone is essential for maintaining various bodily functions, including the regulation of metabolism, immune response, and blood pressure.

Therapeutic Purpose

This medication is primarily used as hormone replacement therapy. In individuals whose adrenal glands do not produce sufficient amounts of natural cortisol—a condition known as adrenal insufficiency—Hidrocortisona Roussel helps restore hormone levels to a physiological range. By mimicking the body's natural output, it assists in maintaining internal balance and supporting the body's response to physical stress.

Mechanism of Action

Hydrocortisone works by interacting with specific receptors within the body's cells. Once active, it influences the transcription of DNA to produce proteins that manage several physiological processes:

  • Metabolic Regulation: It helps control how the body utilizes carbohydrates, fats, and proteins.
  • Electrolyte Balance: it assists in managing the salt and water levels in the blood.
  • Systemic Support: It provides the necessary hormonal foundation for the cardiovascular and nervous systems to function correctly.

Form and Composition

Hidrocortisona Roussel is typically formulated as oral tablets. It is categorized as a short-acting corticosteroid, meaning it is absorbed and utilized by the body relatively quickly compared to synthetic derivatives, closely following the natural rhythm of human cortisol production.

What side effects are possible with Hidrocortisona Roussel?

Possible side effects and safety information

Systemic Hydrocortisone is a potent glucocorticoid, and its officially documented safety profile addresses effects across multiple physiological systems, as classified in regulatory documents from authorities such as the EMA and FDA.

Adverse reactions are organized into System-Organ Classes (SOCs), including Endocrine disorders (e.g., HPA axis suppression), Metabolism and nutrition disorders (e.g., fluid retention, hypertension), Psychiatric disorders, and Musculoskeletal disorders (e.g., osteoporosis).


Official Adverse Reaction Classification

Classification Tier Example Adverse Reaction Category
Common Sodium and fluid retention, hypertension, weight gain.
Uncommon / Rare Peptic ulceration, posterior subcapsular cataracts, aseptic necrosis of bone.

The safety profile is heavily linked to duration of exposure. Effects such as the development of Cushingoid features, osteoporosis, and glaucoma are primarily associated with long-term use. Conversely, the most critical safety concern is the risk of acute adrenal insufficiency or adrenal crisis, which is a documented risk of abrupt discontinuation following prolonged systemic therapy.

Official labeling defines specific constraints, including the contraindication against the use of systemic glucocorticoids in patients with established systemic fungal infections. Furthermore, population-specific safety notes exist, highlighting an increased risk of growth retardation in pediatric patients and a higher risk for conditions like osteoporosis in older adults, based on official regulatory texts.

Overdose and Emergency Response

Exposure to excessive amounts of Hidrocortisona Roussel (Hydrocortisone injection) is primarily managed with supportive and symptomatic therapy, as official regulatory information states that no specific antidote is documented. Overdose risks stem from the drug's high systemic activity, manifesting as documented disturbances following high-dose or chronic exposure:

Documented Manifestations Systems Affected
Fluid/Electrolyte Derangement Salt and water retention, hypokalemic alkalosis, and potential hypernatraemia.
Systemic Toxicity Manifestations of a Cushingoid state, convulsions (seizures), and peptic ulceration with risk of hemorrhage.
Vulnerable Populations The benzyl alcohol preservative is contraindicated in neonates due to the risk of severe toxicity, including metabolic acidosis and hypotension.

When to Seek Urgent Help

For any suspected overdose or experience of severe manifestations, official regulatory guidance mandates seeking immediate medical attention. Individuals must call emergency services or contact a Poison Control center immediately. Management focuses on monitoring vital signs, performing diagnostic tests (such as ECG and blood/urine analysis), and treating documented complications like electrolyte imbalance or potential congestive heart failure in susceptible patients.

Therapeutic Uses of Hidrocortisona Roussel

What Hidrocortisona Roussel Treats: Main Uses and Benefits

The injectable form of Hydrocortisone (Hidrocortisona Roussel) is a systemic medication commonly used in situations requiring prompt, short-term symptomatic assistance in clinical settings that involve acute or unstable symptom patterns.

This medication is used to treat symptoms of low corticosteroid levels and a wide range of other conditions and is considered relevant for easing symptoms related to inflammatory or irritative states. The primary purpose is to provide support in contexts involving heightened systemic burden.

The medication plays a role in managing symptoms across conditions such as acute adrenal crisis, severe anaphylaxis, status asthmaticus, acute exacerbations of Systemic Lupus Erythematosus, and severe inflammatory bowel disease flares. It is applied when patients experience systemic imbalance and acute, disruptive changes.

“The supportive therapeutic benefit may assist with managing symptom intensity during difficult episodes.”


Quick Fact: Relief for Acute Crisis Symptoms

Symptom Category Therapeutic Benefit
Systemic Imbalance Is relevant for managing symptoms related to systemic imbalance and may help maintain a sense of stability when symptoms are more noticeable.
Inflammatory States Contributes to easing the overall symptom load related to intense pain and swelling in severe autoimmune flares.
Respiratory Distress Helps manage symptoms where acute changes interfere with daily functioning, such as airway swelling.

Regulatory References

  1. MedlinePlus Drug Information overview

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Hydrocortisone Injection

Official regulatory labeling dictates specific rules for which populations are eligible to use systemic hydrocortisone (Hidrocortisona Roussel) and which are strictly prohibited. The medicine is primarily used for Adults and Children older than 1 month of age requiring rapid, intense corticosteroid support, such as for acute adrenocortical insufficiency.


Absolute Contraindications

Classification Exclusion Criteria
Infection Status Patients with Systemic Fungal Infections (unless specific anti-infective treatment is employed concurrently).
Allergy/Vaccination Known Hypersensitivity to any component; recipients of live or live-attenuated vaccines (if receiving immunosuppressive doses).
Route of Administration Administration by the Intrathecal or Epidural routes is formally contraindicated.

Age-Specific and Conditional Use

Age-Related Eligibility Rules:

  • Infants leq 1 month of age: Safety and efficacy have not been established.
  • Children: Use is permitted, but long-term systemic use may cause suppression of growth.
  • Older Adults: Use is permitted, but close clinical supervision is required due to the potentially more serious consequences of common corticosteroid effects.

Pregnancy and Lactation Status:

  • Pregnancy: Classified as Category C (US FDA); infants exposed to higher doses in utero should be observed for signs of hypoadrenalism.
  • Lactation: Use is generally compatible for low doses; however, prolonged high systemic doses may require risk assessment due to potential for infant adrenal suppression.

Conditional Use: Patients with conditions like Hypertension, Diabetes Mellitus, Peptic Ulceration, Renal Insufficiency, or Recent Myocardial Infarction must use the medicine with particular care and frequent patient monitoring, as these comorbidities increase the risk of complications.

What should I know about interactions with other medicines?

Interactions with Hidrocortisona Roussel (Hydrocortisone) are documented across several categories, influencing both the metabolism and the pharmacological effects of the medicine. Co-administration is contraindicated with live or live, attenuated vaccines when Hydrocortisone is being administered at doses considered immunosuppressive.

Metabolic interactions involve the CYP3A4 enzyme system. Agents classified as CYP3A4 inhibitors (such as ketoconazole or erythromycin) may decrease the metabolism of Hydrocortisone, which can lead to an increase in its serum concentration. Conversely, CYP3A4 inducers (including rifampicin, phenobarbital, and phenytoin) may enhance Hydrocortisone's metabolism, resulting in reduced systemic exposure and potentially diminishing its therapeutic effects.

Several pharmacodynamic interactions are also officially recognized. The concomitant use of Hydrocortisone with potassium-depleting agents (such as specific diuretics or Amphotericin B injection) may enhance the risk of potassium loss. Administration alongside Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) is documented to increase the overall risk of gastrointestinal adverse reactions.

Furthermore, Hydrocortisone may elevate blood glucose concentrations, necessitating that the dosage of co-administered antidiabetic agents may require adjustment. Enhanced effects of Hydrocortisone have also been officially noted in patients with hypothyroidism and cirrhosis.

Mechanism of Action

The Mechanism of Action: How Hidrocortisona Roussel Works


Hidrocortisona Roussel (hydrocortisone) exerts its action primarily by functioning as an agonist for the intracellular glucocorticoid receptors (GRs) found in target cells. The drug binds to the inactive GR complex in the cytoplasm, causing it to translocate into the nucleus. This nuclear complex interacts with specific DNA sequences, either activating or, most notably, repressing the transcription of genes that code for pro-inflammatory mediators.

This genomic modulation results in the suppression of pro-inflammatory mediator synthesis, such as cytokines and chemokines. The drug also influences cell-mediated signaling dynamics, modifying pathways essential for the activation and proliferation of immune cells, leading to a reduction of circulating immune cell number and activity.

Furthermore, the presence of the drug engages the negative feedback loop of the Hypothalamic-Pituitary-Adrenal (HPA) axis. This mechanistic engagement leads to the suppression of the body's natural production of corticosteroids, resulting in the alteration of systemic corticosteroid activity levels via the neuroendocrine pathway.

Dosage and Administration Information

How to Use Hidrocortisona Roussel

Hidrocortisona Roussel is an injectable preparation of hydrocortisone sodium succinate, designed for rapid, systemic administration in clinical settings. The instructions for its use focus on precise routes, dose ranges, and administration protocols.

Administration Routes and Frequency

The medication is administered via intravenous (IV) injection, intravenous (IV) infusion, and intramuscular (IM) injection. The choice of method, particularly IV injection, is typically reserved for situations requiring the most immediate systemic action. Dosing is highly concentrated and delivered frequently; the administration may be repeated at intervals of 2, 4, or 6 hours to ensure consistently high systemic levels. The total daily dosage often involves 3 to 4 administrations within a 24-hour period.

Standard Dosing and Duration

For adults, the typical starting dose ranges from 100 mg to 500 mg of hydrocortisone equivalent. Dosing is determined by the severity of the patient's condition. The high-dose, acute phase of therapy is generally short-term, intended to continue only until stabilization, usually not exceeding 48 to 72 hours. Following stabilization, the protocol includes a gradual dose reduction to transition off the medicine, preventing abrupt cessation.

Preparation and Delivery Protocol

The medication is supplied as a sterile powder that requires reconstitution with a specific diluent prior to use. For administration, a 100 mg dose may be delivered as an IV injection over a minimum of 30 seconds, while larger doses up to 500 mg or more are injected over 1 to 10 minutes. For IV infusion, the reconstituted solution must be diluted further using compatible fluids, such as 5% dextrose in water or isotonic saline. The product must not be mixed with other solutions due to physical incompatibilities.

Recent Clinical Evidence

Research evidence / Overview of studies for Hidrocortisona Roussel

Evidence for Use in Acute Adrenal Crisis (Adrenocortical Insufficiency)

Research examining the evaluation of this injection for acute adrenal crisis relies primarily on clinical consensus guidelines and observational data, given the critical nature of the condition, which makes placebo-controlled trials often not feasible. Studies have monitored outcomes monitoring physiological strain, such as measured changes in blood pressure and circulatory metrics, along with patient survival rates during the acute episode. Research describes this medicine’s evaluation during periods of extreme physiological stress.

Studies conducted in this research scenario consistently report patterns of measured change in vital signs during the short-term follow-up period of the crisis. Findings describe that this medicine is part of the broader evidence landscape for acute patient care.


Evidence for Use in Acute Asthma and Systemic Inflammatory States

This part outlines the structure of evidence for conditions characterized by heightened symptom activity and outcomes linked to inflammatory or irritative states, such as severe asthma exacerbations and acute flares of systemic conditions.

Acute Asthma and Respiratory Distress

Research for acute asthma includes short-term Randomized Controlled Trials (RCTs) where the injection was studied alongside bronchodilator therapy in both adult and pediatric populations. These trials examined outcomes related to systemic or functional imbalance, specifically measuring patient metrics like pulmonary function scores and tracking hospital admission rates. Some patterns indicate that the observable effects on lung function may be delayed for several hours following administration. The evidence is limited on the comparative findings of the injectable form versus high-dose oral corticosteroids after the initial emergency phase.

Systemic Autoimmune and Inflammatory Flares

For conditions associated with acute or disruptive episodes, research has included clinical trials and retrospective studies. These studies explored whether the evaluation of systemic corticosteroids, including the injectable form, was associated with changes in disease activity scores and monitored endpoints like the requirement for rescue therapies. Research describes patterns related to its evaluation during periods of increased symptom activity. The results apply only to the populations studied who were experiencing severe, acute flares.


Evidence for Adjuvant Use in Severe Allergic Reactions (Anaphylaxis)

The research base for this injection's evaluation in severe allergic reactions is characterized by observational studies, systematic reviews, and clinical consensus guidelines, as definitive RCTs are often deemed impractical in this emergency setting. Research has explored the observation of measured symptom changes, but the onset of effects was observed to be delayed, with action occurring several hours after administration. Findings from observational studies were often mixed or inconsistent regarding whether its evaluation was associated with a reduction in the rate of biphasic reactions. Therefore, certainty remains low, and comparative evidence is lacking to firmly establish its individual contribution to short-term outcomes beyond supportive care.


What is Still Uncertain About Hidrocortisona Roussel

A research limitation is the lack of high-quality RCTs in life-threatening emergencies like adrenal crisis and anaphylaxis. Comparative evidence is lacking to definitively weigh this injection against similar intravenous corticosteroids across all approved acute indications. Furthermore, research focused on the acute administration provides limited information for long-term outcomes or how its short-term evaluation may be associated with other health metrics over time. Subgroup findings, particularly for specific comorbid conditions or very narrow age ranges, remain uncertain and would require further study.

Key Studies & References

  1. Emergency treatment of anaphylaxis Guidelines for healthcare providers - Resuscitation Council

Frequently Asked Questions (FAQ)

Common questions about Hidrocortisona Roussel (FAQ)


Q: Is Hidrocortisona Roussel considered a strong or weak steroid medicine?

Hydrocortisone, the active ingredient, is classified as a short-acting glucocorticoid. Official documents describe it as the reference standard against which other steroid medicines are compared for strength. Many synthetic steroids have a higher potency per milligram than hydrocortisone, placing this medicine within the category of short-acting systemic steroids.


Q: How quickly does Hidrocortisona Roussel start to show its effect?

According to official product information, when administered intravenously, the systemic effects of this medicine are typically observed within one hour of injection. The drug is engineered for rapid action to provide immediate support during acute medical situations.


Q: Is Hidrocortisona Roussel used for treating low adrenal function?

This specific injectable form is officially indicated for the treatment of conditions requiring urgent, intense corticosteroid support, such as an acute adrenal crisis (adrenal gland failure). For the long-term, ongoing replacement of chronic low adrenal function, oral forms of hydrocortisone are generally used.


Q: Can Hidrocortisona Roussel be used for skin conditions like eczema or psoriasis?

The injectable form is indicated for managing severe or acute flares of allergic and inflammatory conditions, which can include certain severe skin disorders, especially when oral medicine is not feasible. Mild or localized skin conditions are typically managed with topical (applied to the skin) hydrocortisone preparations.


Q: Is it normal to experience increased appetite when taking this medicine?

Increased appetite is a documented side effect associated with the use of systemic hydrocortisone. This type of effect is often linked to the way the drug alters the body’s metabolic processes.


Q: Does Hidrocortisona Roussel cause weight gain?

Weight gain is a documented side effect associated with systemic hydrocortisone use. Official safety information indicates this may be due, in part, to the medicine causing sodium and fluid accumulation in the body.


Q: What kinds of mood changes or psychological effects are associated with taking this drug?

Official labeling notes that systemic corticosteroids are associated with various psychiatric effects, which are classified as psychiatric disorders. These can include a range of mood disturbances, such as feelings of depression, anxiety, or euphoria. These effects are often dependent on the specific dosage and the duration of the treatment.


Q: Can Hidrocortisona Roussel affect your sleep?

Trouble sleeping or insomnia has been reported as a documented side effect associated with the use of systemic hydrocortisone.


Q: Are there specific blood tests needed while taking Hidrocortisona Roussel long-term?

When using this medicine for a prolonged time, official recommendations suggest periodic monitoring. This may include regular checks of blood glucose (sugar) levels, blood pressure, and periodic eye examinations. Other electrolyte levels, such as calcium and potassium, may also be monitored.


Q: Can this medicine cause muscle weakness or pain?

Muscle weakness is listed in official documents as a common adverse reaction associated with systemic hydrocortisone use. Additionally, muscle pain may be experienced as a symptom of withdrawal after stopping prolonged steroid therapy.


Q: What are the signs of adrenal gland problems that I should be aware of?

If systemic therapy is stopped too quickly, there is a risk of acute adrenal insufficiency (adrenal crisis). Signs of this severe reaction may involve symptoms like severe dizziness, unrelenting nausea, vomiting, or muscle weakness. Official guidance often recommends that individuals at risk of adrenal suppression carry a Steroid Emergency Card.


Q: Is it common to have fluid retention or swelling (edema) with this medication?

Yes, sodium and fluid retention are listed in official documents as common adverse reactions. This effect, which can lead to swelling (edema), is due to the drug’s reported effect on salt and water balance (mineralocorticoid activity).


Q: What is meant by the phrase 'adrenal suppression' in relation to this drug?

Adrenal suppression refers to the temporary, reduced function of the body’s own hormone production system (the HPA axis). When an external source of the hormone, like this medicine, is given, the body naturally slows its own production of cortisol.


Q: Can Hidrocortisona Roussel affect a child's growth and development?

Official labeling states that long-term use of systemic corticosteroids in children is documented to potentially cause growth retardation. This means that the child's growth rate may slow down during treatment.


Q: Is Hidrocortisona Roussel safe to use during pregnancy?

The medicine is classified in the US as Pregnancy Category C. Official documents advise that infants who were exposed in utero, particularly to high maternal doses, should be observed for signs of hypoadrenalism (low adrenal function) after birth.


Q: Is it true that this drug can affect my salt and potassium levels?

Yes, the official product information indicates that systemic corticosteroids can cause changes in the body’s electrolyte balance. This includes changes such as salt and water retention and may be associated with increased excretion of potassium.


Q: Does Hidrocortisona Roussel affect the ability to receive vaccinations?

Official contraindication statements describe that administration is not recommended with live or live, attenuated vaccines if the steroid is being given at doses considered immunosuppressive.


Q: Are there any dietary restrictions or supplements (like calcium) often recommended with this medicine?

Due to the drug's effects on the body, dietary salt restriction and potassium supplementation may be considered. Due to the documented risk of osteoporosis with long-term use, official sources indicate that calcium supplementation is often considered.


Q: Is Hidrocortisona Roussel typically taken with or without food?

This medicine is supplied and administered as a solution for injection—either intravenously or intramuscularly—so the concept of taking it 'with or without food,' which applies to oral tablets, is not relevant to this specific product.


Q: Are there specific times of day when this medication is recommended to be taken?

For acute injection use, the medicine is administered at intervals of 2, 4, or 6 hours as required by the patient's critical condition. For non-acute steroid replacement therapy, regulatory guidelines often reference mimicking the body's natural release by administering a higher dose in the morning.


Q: Can this medicine affect wound healing time?

Delayed wound healing is noted in regulatory and associated literature as an adverse effect associated with corticosteroid use, particularly when used in high doses or for prolonged courses.


Q: Can this medicine cause a change in my eyesight or blurred vision?

Yes, official safety information states that blurred vision and other changes in eyesight have been reported. Long-term systemic use is specifically associated with the development of cataracts (clouding of the lens) and glaucoma (increased eye pressure).


Q: Why is it important to carry a 'Steroid Treatment' card when taking this drug?

Official guidance indicates that individuals receiving systemic corticosteroids, especially for an extended period, should carry a Steroid Emergency Card. This card informs healthcare professionals that the patient may be at risk of developing an adrenal crisis during times of severe stress, injury, or illness.


Q: Can Hidrocortisona Roussel interact with contraceptive pills?

Official documents state that estrogen-containing products, such as oral contraceptives, may alter the metabolism and effects of corticosteroids. This interaction can potentially lead to increased systemic exposure of the hydrocortisone.

How should Hidrocortisona Roussel be stored and disposed of?

How to Store and Dispose of Hidrocortisona Roussel?

The storage and disposal instructions for Hidrocortisona Roussel (Hydrocortisone Sodium Succinate for injection) are strictly regulated to maintain product stability.


Storage Conditions

Item Requirement
Unreconstituted Vial Store at Controlled Room Temperature (20 C to 25 C).
Protection Do not refrigerate or freeze. Keep the vial in its original carton to protect from light.

Stability and Disposal

Once the powder is mixed (reconstituted), the solution's stability is limited. The solution must be used or discarded within 12 hours at room temperature or 24 hours if refrigerated, depending on the specific label. The medicine must be kept out of the sight and reach of children. All unused or expired product must be disposed of in accordance with local regulations, avoiding disposal into wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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