Dalteparin sodium.JPG

Dalteparin sodium

CLINICAL USE

  • Peri- and postoperative surgical and medical thromboprophylaxis
  • Prevention of clotting in extracorporeal circuits
  • Treatment of DVT
  • Acute coronary syndrome

    DOSE IN NORMAL RENAL FUNCTION

  • Dose according to risk of thrombosis: Moderate risk: 2500 IU daily —High risk and medical: 5000 IU daily
  • Dose for >4 hour session: IV bolus of 30–40 IU/kg, followed by infusion of 10–15 IU/kg/hourDose for <4 hour session: as above or —single IV bolus injection of 5000 IUIf at increased risk of bleeding: IV —bolus of 5–10 IU/kg, followed by infusion of 4–5 IU/kg/hour
  • 200 IU/kg daily (maximum 18 000 units as a single dose) or 100 IU/kg twice daily
  • 120 IU/kg every 12 hours maximum 10 000 IU twice daily for 5–8 days

    PHARMACOKINETICS

  • Molecular weight                           :Average 6000
  • %Protein binding                           :No data
  • %Excreted unchanged in urine     : No data
  • Volume of distribution (L/kg)       :0.04–0.06
  • half-life – normal/ESRD (hrs)      :IV: 2; SC: 3.5–4/Prolonged

    DOSE IN RENAL IMPAIRMENT

    GFR (mL/MIN)

  • 20 to 50     : Dose as in normal renal function
  • 10 to 20     : Dose as in normal renal function only for prophylaxis doses. See ‘Other Information’
  • <10           : Dose as in normal renal function only for prophylaxis doses. See ‘Other Information’

    DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

  • CAPD                :Not dialysed. Dose as in GFR <10 mL/min
  • HD                     :Not dialysed. Dose as in GFR <10 mL/min
  • HDF/high flux   :Dialysed. Dose as in GFR
  • <10           : mL/min
  • CAV/VVHD      :Not dialysed. Dose as in GFR=10–20 mL/min

    IMPORTANT DRUG INTERACTIONS

    Potentially hazardous interactions with other drugs
  • Analgesics: increased risk of bleeding with NSAIDs, avoid concomitant use with IV diclofenac; increased risk of haemorrhage with ketorolac – avoid concomitant use
  • Nitrates: anticoagulant effect reduced by infusions of glyceryl trinitrate
  • Drotrecogin alfa: manufacturer advises to avoid use of high doses of heparin with drotrecogin alfa
  • Use with care in patients receiving oral anticoagulants, platelet aggregation inhibitors, aspirin or dextran

    ADMINISTRATION

    Reconstition

    Route

    SC injection into abdominal wall (pre- filled syringes)IV bolus/infusion (ampoules)

    Rate of Administration

    Comments

    Dalteparin solution for injection (ampoules) is compatible with sodium chloride 0.9% and glucose 5%

    OTHER INFORMATION

  • Low molecular weight heparins are renally excreted and hence accumulate in severe renal impairment. While the doses recommended for prophylaxis against DVT and prevention of thrombus formation in extracorporeal circuits are well tolerated in patients with ERF, the doses recommended for treatment of DVT and PE have been associated with severe, sometimes fatal, bleeding episodes in such dalteparin sodium (LMWh)patients. Hence the use of unfractionated heparin would be preferable in these instances
  • In patients with GFR ≤ 30 mL/ min, monitoring for anti-Xa levels is recommended to determine the appropriate dalteparin dose. Target anti-Xa range is 0.5-1.5 IU/m
  • When monitoring anti-Xa in these patients, sampling should be performed 4–6 hrs after dosing and only after the patient has received 3–4 doses
  • Antifactor-Xa levels should be regularly monitored in new patients on haemodialysis, during the first weeks; later, less frequent monitoring is generally required. Consult manufacturer’s literature
  • Additional doses may be required if using LMWHs for anticoagulation in HDF
  • Bleeding may occur especially at high doses corresponding with antifactor-Xa levels greater than 1.5 IU/mL
  • The prolongation of the APTT induced by dalteparin is fully neutralised by protamine, but the anti-Xa activity is only neutralised to about 25–50%
  • 1 mg of protamine inhibits the effect of 100 IU (antifactor-Xa) of dalteparinHeparin can suppress adrenal secretion of aldosterone leading to hypercalcaemia, particularly in patients with chronic renal impairment and diabetes mellitus