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Hydrocortisone Pharmis

Active Ingredient:
Hydrocortisone Sodium Succinate
Origin:
EU

Hydrocortisone Pharmis (Hydrocortisone Sodium Succinate)

Hydrocortisone Pharmis is an injectable solution containing hydrocortisone sodium succinate. It is supplied in a sterile liquid for intramuscular or intravenous use and is marketed in the EU as prescription‑only. The product provides a rapid rise in plasma cortisol levels, facilitating management of adrenal insufficiency and severe inflammatory states. It is indicated for emergency replacement therapy and is administered by healthcare professionals in hospital or clinic settings.

Manufacturer / TM Owner

Pharmis Biofarmacêutica, Lda.

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Indications & Clinical Uses

Hydrocortisone Pharmis is employed in situations that require rapid systemic glucocorticoid activity.

  • Acute adrenal crisis and other forms of adrenal insufficiency.
  • Severe inflammatory or allergic reactions unresponsive to other therapy.
  • Management of shock states where cortisol deficiency contributes to hemodynamic instability.
  • Peri‑operative stress dosing in patients with known adrenal insufficiency.
  • Treatment of certain severe dermatologic or rheumatologic emergencies when oral therapy is impractical.
  • Replacement therapy in patients receiving chronic glucocorticoid suppression who cannot take oral medication.

How It Works

  • Hydrocortisone sodium succinate is a pro‑drug that is rapidly hydrolyzed to hydrocortisone after intravenous or intramuscular injection. The active hydrocortisone binds intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus and interacts with glucocorticoid response elements on DNA. This modulates transcription of multiple genes, leading to decreased production of pro‑inflammatory cytokines, inhibition of leukocyte migration, and suppression of immune cell activation.

Side Effects

Adverse reactions to Hydrocortisone Pharmis may vary in frequency and severity.

Common

  • Transient hyperglycemia, especially in patients with diabetes.
  • Mild electrolyte disturbances such as mild hyponatremia or hypokalemia.
  • Local injection site reactions including pain, erythema, or swelling.
  • Headache or dizziness during rapid infusion.

Serious

  • Severe allergic reactions, including anaphylaxis or angioedema.
  • Acute adrenal suppression after abrupt discontinuation.
  • Significant infection risk due to immunosuppression, manifesting as pneumonia or sepsis.
  • Gastrointestinal bleeding or ulceration, particularly with concurrent NSAID use.
  • Psychiatric disturbances such as mood swings, depression, or psychosis.

Precautions & Warnings

When prescribing Hydrocortisone Pharmis, clinicians should consider several precautionary measures to minimize risk.

  • Assess baseline cortisol levels and adrenal function before initiating therapy.
  • Use the lowest effective dose and limit duration to reduce systemic side effects.
  • Monitor blood glucose and electrolytes, particularly in patients with diabetes or renal impairment.
  • Avoid abrupt discontinuation; taper the dose gradually to prevent adrenal crisis.
  • Evaluate for active infections, as glucocorticoids can exacerbate them.
  • Caution in pregnant or breastfeeding women; benefits must outweigh potential risks.
  • Review patient history for hypersensitivity to corticosteroids.

Avoid Interactions

Hydrocortisone Pharmis can interact with other medicines, influencing efficacy or safety.

Avoid

  • Concurrent use with potent CYP3A4 inducers (e.g., rifampin, phenytoin) that may reduce glucocorticoid levels.
  • Simultaneous administration of other systemic corticosteroids, which can increase the risk of additive adverse effects.

Use with caution

  • Non‑steroidal anti‑inflammatory drugs (NSAIDs) or anticoagulants, which may raise the risk of gastrointestinal bleeding.
  • Live vaccines, because immunosuppression can diminish vaccine efficacy.
  • Antidiabetic agents, as glucocorticoids may worsen hyperglycemia.
  • Antihypertensive drugs, particularly ACE inhibitors or diuretics, due to potential electrolyte shifts.

Frequently Asked Questions

Hydrocortisone sodium succinate is a water‑soluble pro‑drug formulated for intravenous or intramuscular injection, providing a rapid increase in plasma cortisol. Regular hydrocortisone tablets are oral formulations that are absorbed more slowly and are used for chronic replacement therapy.

Hydrocortisone Pharmis is primarily intended for acute or emergency situations requiring rapid glucocorticoid effect. Long‑term maintenance is usually managed with oral hydrocortisone preparations; however, a healthcare provider may prescribe injectable forms for patients unable to take oral medication.

After intravenous or intramuscular administration, hydrocortisone sodium succinate is rapidly converted to active hydrocortisone, leading to measurable plasma cortisol elevations within minutes and clinical effects typically observed within 30 minutes.

Patients with diabetes may experience transient hyperglycemia after receiving hydrocortisone. Blood glucose should be monitored closely, and antidiabetic therapy may need adjustment under medical supervision.

Monitoring should include vital signs, blood glucose, serum electrolytes (sodium, potassium), and signs of infection. Re‑assessment of cortisol levels may be performed to guide tapering or discontinuation.

Yes, the injectable solution can be given via a peripheral intravenous line, but it should be diluted according to the manufacturer’s instructions to avoid irritation.

If signs of an allergic reaction such as rash, swelling, or difficulty breathing occur, the infusion should be stopped immediately and emergency medical treatment, including epinephrine if indicated, should be provided.

Pediatric dosing and use should be determined by a pediatric specialist, taking into account body weight, severity of the condition, and the risk of adrenal suppression.

Because hydrocortisone can suppress the immune response, administration of live vaccines may be less effective. Vaccination timing should be coordinated with the treating physician.

If the drug has been used for more than a few days, especially at high doses, a gradual taper is recommended to allow the hypothalamic‑pituitary‑adrenal axis to recover and to prevent adrenal crisis.

The product should be stored at controlled room temperature, protected from light, and kept in the original container until use. Do not freeze.

Compatibility should be verified with the pharmacy; mixing with certain drugs (e.g., alkaline solutions) may cause precipitation or reduced efficacy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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