Dalteparin Sodium

Anticoagulant/Antiplatelet · Low molecular weight heparin (LMWH)

Indications

Peri- or post-operative surgical thromboprophylaxis. Prolonged thromboprophylaxis in hip replacement surgery. Prevention of clotting in extracorporeal circulation during haemodialysis or haemofiltration. Treatment of deep venous thrombosis and/or pulmonary embolism. With low dose aspirin in unstable coronary artery disease.

Dosage

Adults: General surgery: 2500 IU by SC inj into abdominal wall or lateral part of thigh 1 to 2 hr pre-op., then 2500 IU daily until fully mobile (generally 5-7 days or longer). High risk surgery: 2500 IU by SC inj into abdominal wall or lateral part of thigh 1 to 2 hr pre-op., repeated 8-12 hr later; or 5000 IU by SC Inj on the evening pre-op. Then 5000 IU daily until fully mobile (generally 5-7 days or longer). Hip surgery: 5000 IU by SC Inj on the evening prior to surgery, then 5000 IU each evening for next 5 wk. Haemodialysis/haemofiltration: If no additional bleeding risk, 30-40 IU/kg by IV bolus then 10-15 IU/kg/hr by IV infusion. Alternatively if procedure less than 4 hr, as above or 5000 IU by IV bolus. If high bleeding risk, 5-10 IU/kg by IV bolus then 4-5 IU/kg/hr by IV infusion. DVT and PE: Adults: If no additional bleeding risk, 200 IU/kg by SC inj as a single daily dose; max…

Administration

Administer deep SC only. May be injected in a U-shape to the area surrounding the navel, the upper outer side of the thigh, or the upper outer quadrangle of the buttock. Vary injection site daily. Use thumb and forefinger to lift a fold of skin when injecting dalteparin to the navel area or thigh. Insert needle at a 45 to 90 degree angle the entire length of needle should be inserted. Apply pressure to injection site. Do not massage. Compatibility: Dalteparin injection should not be mixed with other injections or infusions unless specific compatibility data are available that support such mixing. Stability: Store at 20°C-25°C (68°F-77°F). After first penetration of the rubber stopper, store the multi dose vials at room temperature for upto two weeks. Discard any unused solution after two weeks.

Adverse Effects

Bleeding at high doses. Heparin like side effects, transient raised liver enzyme, thrombocytopenia, haematoma at inj site.

Risk Factor (Pregnancy/Lactation)

Pregnancy: No evidence of risk in humans. Lactation: Caution advised or effect undetermined. Contraindications: History of immunologically mediated heparin-induced thrombocytopenia. Acute duodenal ulcer, cerebral haemorrhage, haemorrhagic diathesis, septic endocarditis, injuries or surgery to CNS, eyes or ears, serious coagulation disorders. Recent stroke (within 3 months) unless due to systemic emboli. Precautions: Patients with high bleeding risk. Monitor platelets before and during therapy. Risk of adrenal suppression leading to hypoaldosteronism and hyperkalaemia, particularly in diabetes, chronic renal failure or metabolic acidosis; monitor serum potassium. Spinal or epidural anaesthesia. Liver impairment. Primary or metastatic tumours of the brain. Elderly.

Interactions

Other anticoagulants, antiplatelet agents, aspirin, vit K antagonists, dextran, dipyridamole, indomethacin, sulfinpyrazone, probenecid, ethacrynic acid, cytostatics, antihistamines, ascorbic acid, cardiac glycosides, tetracyclines, digoxin. Avoid other IM preps if dalteparin dose >5,000IU/day.

Advice to Patient

To be injected in lying or sitting position. Contact prescriber if there is unusual fever, unusual bleeding or bruising, dark stool, joint pain, back pain, severe headache, skin rash, redness, shortness of breath, swelling or pain at injection site. Use soft brush for teeth, waxed dental floss, electric razor, avoid scissors and sharp knives. Avoid alcohol during therapy. During treatment, bleeding tendency is increased so activities that may cause bruising or bleeding must be avoided.

Pharmacokinetics

Onset of action: Anti-Xa activity: Within 1-2 hrs. Duration: >12 hrs. Bioavailability: SC: 87% ± 6%. Half-life elimination (route dependant): IV: Mean terminal half-life: 2.1 ± 0.3 hrs (40 unit/kg/dose) to 2.3 ± 0.4 hrs (60 unit/kg/dose); mean terminal half-life (anti-Xa activity): 5.7 ± 2.0 hrs. SC: Mean terminal half-life: 3-5 hrs. Time to peak, serum: SC: Anti-Xa activity: Approx. 4 hrs. Excretion: Primarily renal.

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