Product image of Heparina Sódica Sala (Heparin Sodium) supplied by GNH India

Heparina Sódica Sala

Active Ingredient:
Heparin Sodium
Origin:
EU

Heparina Sódica Sala (Heparin Sodium)

Heparina Sódica Sala contains the active ingredient heparin sodium, supplied in an unspecified strength and dosage form. It is a prescription anticoagulant medication used in clinical settings to inhibit clot formation by enhancing antithrombin III activity. Originating from the European Union market, this product belongs to the antithrombotic therapeutic class and is administered via haemodialysis, intra‑arterial, or intravenous routes.

Manufacturer / TM Owner

Laboratorio Reig Jofre, S.A.

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Indications & Clinical Uses

Heparina Sódica Sala is employed in several medical situations where anticoagulation is required. It is commonly selected for its rapid onset and reversible action.

  • Anticoagulation during haemodialysis procedures to prevent circuit clotting.
  • Prevention and treatment of venous thromboembolism, including deep‑vein thrombosis and pulmonary embolism.
  • Intra‑arterial anticoagulation during interventional cardiology or radiology procedures.
  • Intravenous anticoagulation in surgical or critical‑care settings to reduce thrombotic risk.
  • Management of acute coronary syndromes when rapid anticoagulation is indicated.

Side Effects

Heparina Sódica Sala may cause a range of adverse reactions, most of which are dose‑related and reversible upon discontinuation.

Common

  • Minor bleeding at injection or catheter sites.
  • Bruising or hematoma formation.
  • Mild thrombocytopenia (platelet count reduction).
  • Elevated liver enzymes.
  • Local irritation or erythema.

Serious

  • Major hemorrhage, including intracranial or gastrointestinal bleeding.
  • Heparin‑induced thrombocytopenia (HIT) with paradoxical clot formation.
  • Allergic reactions such as urticaria, angioedema, or anaphylaxis.
  • Spontaneous spinal or epidural hematoma.
  • Severe hypotension due to systemic bleeding.

Precautions & Warnings

Before using Heparina Sódica Sala, clinicians should assess patient‑specific risk factors and monitor relevant laboratory parameters.

  • Verify baseline coagulation tests (aPTT, PT/INR) and platelet count.
  • Adjust dose in patients with renal or hepatic impairment.
  • Use cautiously in individuals with a history of bleeding disorders or recent surgery.
  • Avoid use in patients with known hypersensitivity to heparin or pork products.
  • Monitor for signs of heparin‑induced thrombocytopenia during therapy.
  • Counsel pregnant or lactating patients only after risk‑benefit evaluation.

Avoid Interactions

Heparina Sódica Sala can interact with several medications, affecting bleeding risk or anticoagulant efficacy.

Avoid

  • Concurrent use of other anticoagulants (e.g., warfarin, direct oral anticoagulants) without close monitoring.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs) or antiplatelet agents that increase bleeding.
  • High‑dose aspirin or clopidogrel in patients at high hemorrhagic risk.

Use with caution

  • Thrombolytic agents (e.g., alteplase) during acute clot dissolution.
  • Certain antibiotics (e.g., vancomycin) that may potentiate anticoagulant effect.
  • Hormonal therapies (e.g., estrogen) that affect coagulation balance.
  • Herbal supplements such as ginkgo biloba or garlic that may increase bleeding tendency.

Frequently Asked Questions

Heparina Sódica Sala contains heparin sodium, which potentiates antithrombin III, leading to inhibition of thrombin (IIa) and factor Xa, thereby reducing clot formation.

It is commonly used for anticoagulation during haemodialysis, intra‑arterial procedures, intravenous anticoagulation in surgery or critical care, and for preventing and treating thromboembolic disorders.

Dose adjustment and careful monitoring are recommended for patients with renal impairment because clearance may be reduced, increasing bleeding risk.

Activated partial thromboplastin time (aPTT), platelet count, and occasionally anti‑Xa levels are monitored to ensure therapeutic anticoagulation and detect adverse effects.

Signs include a sudden drop in platelet count (usually >50% from baseline) occurring 5–10 days after exposure, accompanied by new thrombosis or skin lesions at injection sites.

The safety profile in pregnancy is not fully established; clinicians should weigh potential benefits against risks and consider alternative anticoagulants when appropriate.

Store in a controlled room temperature environment, protected from light and moisture, and keep the container tightly closed when not in use.

Immediate discontinuation of the drug, supportive measures, and administration of protamine sulfate as an antidote may be required under medical supervision.

The primary routes listed are haemodialysis, intra‑arterial, and intravenous; subcutaneous administration is not a standard route for this product.

Concurrent use of other anticoagulants, high‑dose NSAIDs, antiplatelet agents, and certain antibiotics that enhance anticoagulant effects should be avoided or closely monitored.

Heparina Sódica Sala is unfractionated heparin with a broader molecular weight range, requiring aPTT monitoring, whereas low‑molecular‑weight heparins have more predictable pharmacokinetics and often do not require routine monitoring.

It is administered intravenously into the dialysis circuit to maintain anticoagulation and prevent clot formation within the extracorporeal system.

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GNH India Pharmaceuticals Limited

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Last updated:

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