Dalteparin Sodium

Dalteparin Sodium is an antithrombotic agent, which acts mainly through its ability to potentiate the inhibition of factor Xa and thrombin by antithrombin. It has a relatively higher ability to potentiate factor Xa inhibition than to prolong aPTT. It prevents harmful blood clots, stops existing clots getting any bigger and stops new ones forming in the legs, lungs, brain or heart.

• Venous thromboembolism
• Acute coronary syndrome (unstable angina)
• Deep vein thrombosis
• Pulmonary embolism
• Prophylaxis of venous thromboembolism during surgical procedures
• Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration

Dalteparin Sodium is an antithrombotic agent, which acts mainly through its ability to potentiate the inhibition of factor Xa and thrombin by antithrombin. It has a relatively higher ability to potentiate factor Xa inhibition than to prolong aPTT.

Dalteparin Sodium binds to antithrombin, potentiating the inhibition of factor Xa and thrombin, thereby preventing thrombin formation and fibrin clot formation.

Adult - Venous thromboembolism: 200 U/kg daily as a single or in 2 divided doses (pregnant and high-risk patients). Max: 18,000 U/day.

Adult - Surgical VTE prophylaxis (Moderate risk): 2,500 U given 1-2 hr before surgery, then 2,500 U once daily for 5-7 days.

Adult - Surgical VTE prophylaxis (High risk): 2,500 U given 1-2 hr before and 8-12 hr after surgery, then 5,000 U daily.

Adult - Unstable angina: 120 U/kg every 12 hours for 5-8 days (with low-dose aspirin). Max: 10,000 U every 12 hours.

Adult - Haemodialysis (IV): 30-40 U/kg IV injection, then 10-15 U/kg/hr IV infusion.

This medicine is given as a subcutaneous injection or intravenous infusion. Your doctor or nurse will guide you how to use this medicine.

If you miss a dose of Dalteparin Sodium, please consult your doctor.

Common Side Effects:

• Injection site pain or reaction
• Allergic reactions (pruritus, rash, fever)
• Elevated AST and ALT
• Thrombocytopenia
• Bleeding

Serious Side Effects:

• Epidural or spinal haematomas (may cause permanent paralysis)
• Severe haemorrhage

• Risk of bleeding is increased; inform your doctor if bleeding from gums, nose or wounds lasts more than 15 minutes, or blood appears in urine, stool or vomit.
• Caution is required with other anticoagulant/antiplatelet agents.
• Risk of spinal/epidural haematoma with neuraxial anaesthesia or spinal puncture.
• Do not stop taking the medication suddenly without talking to your doctor.

• Hypersensitivity
• Active major bleeding
• Severe coagulation disorders
• Lumbar puncture
• Sympathetic block
• Brain, spinal cord, eye or ear surgery
• Severe hypertension

Anticoagulant/Antiplatelet agents (aspirin, NSAIDs, warfarin, thrombolytics): Increased risk of haemorrhage.

Antihistamines, cardiac glycosides, tetracycline, ascorbic acid: Reduced anticoagulant effect.

It is unsafe to consume alcohol with Dalteparin Sodium (increases risk of stomach bleeding).

Pregnancy Category B. Dalteparin Sodium is generally considered safe during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies.

Dalteparin Sodium is probably safe during breastfeeding. It is released in small amounts in breast milk and does not represent any significant risk to the baby.

Safety and efficacy in pediatric populations have not been established.

No specific dosage adjustment is necessary for elderly patients. However, caution should be exercised.

Renal impairment: Use with caution in severe kidney disease (CrCl <30 mL/min). Dosage adjustment needed based on anti-Factor Xa activity.

Hepatic impairment: Use with caution in severe liver disease. Dose adjustment may be needed.

Overdose may lead to haemorrhagic complications. Administer protamine sulfate by slow IV injection at a dose of 1 mg for every 100 anti-Xa U of dalteparin sodium given.

Store between 20-25°C. Keep out of reach of children.

Dalteparin Sodium