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

See how to identify renal failure stages according to GFR calculation

See how to diagnose irreversible renal disease

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