Formulary
Dalteparin sodium: Indications, Dosing, Side Effects and Interactions
Dalteparin sodium is a low molecular weight heparin that acts as an anticoagulant by enhancing the effect of antithrombin III to primarily inhibit activated...
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Dalteparin sodium: Indications, Dosing, Side Effects and Interactions
Dalteparin sodium is a low molecular weight heparin that acts as an anticoagulant by enhancing the effect of antithrombin III to primarily inhibit activated...
Drug action
Dalteparin sodium is a low molecular weight heparin that acts as an anticoagulant by enhancing the effect of antithrombin III to primarily inhibit activated factor X (factor Xa), with a lesser effect on thrombin.
Indications and dose
**Treatment of deep-vein thrombosis,Treatment of pulmonary embolism**
- **Adult** (By Subcutaneous Injection): (body-weight 83 kg and above) 18 000 units once daily until adequate oral anticoagulation with vitamin K antagonist established (at least 5 days of combined treatment is usually required).
**Treatment of deep-vein thrombosis (in patients at increased risk of haemorrhage),Treatment of pulmonary embolism (in patients at increased risk of haemorrhage)**
- **Adult** (By Subcutaneous Injection): 100 units/kg twice daily until adequate oral anticoagulation with vitamin K antagonist established (at least 5 days of combined treatment is usually required).
**Unstable coronary artery disease**
- **Adult** (By Subcutaneous Injection): 120 units/kg every 12 hours (max. per dose 10 000 units) for 5-8 days.
**Unstable coronary artery disease (including non-ST-segment-elevation myocardial infarction)**
- **Adult** (By Subcutaneous Injection): 120 units/kg every 12 hours (max. per dose 10 000 units) for up to 8 days.
**Patients with unstable coronary artery disease (including non-ST-segment-elevation myocardial infarction) awaiting angiography or revascularisation and having already had 8 days treatment with dalteparin**
- **Adult** (By Subcutaneous Injection): (body-weight 80 kg and above and female) 7500 units every 12 hours until the day of the procedure (max. 45 days).
**Prophylaxis of deep-vein thrombosis in surgical patients-moderate risk**
- **Adult** (By Subcutaneous Injection): Initially 2500 units for 1 dose, to be given 1-2 hours before surgery, then 2500 units every 24 hours.
**Prophylaxis of deep-vein thrombosis in surgical patients-high risk**
- **Adult** (By Subcutaneous Injection): Initially 2500 units for 1 dose, to be given 1-2 hours before surgery, followed by 2500 units for 1 dose, to be given 8-12 hours after first dose, then 5000 units every 24 hours, alternatively initially 5000 units for 1 dose, to be given on the evening before surgery, then 5000 units every 24 hours.
**Prophylaxis of deep-vein thrombosis in medical patients**
- **Adult** (By Subcutaneous Injection): 5000 units every 24 hours.
**Extended treatment of venous thromboembolism and prevention of recurrence in patients with solid tumours**
- **Adult** (By Subcutaneous Injection): (body-weight 99 kg and above) 18 000 units once daily for 30 days, interrupt treatment or reduce dose in chemotherapy-induced thrombocytopenia-consult product literature, then 18 000 units once daily for a further 5 months, interrupt treatment or reduce dose in chemotherapy-induced thrombocytopenia-consult product literature.
**Treatment of venous thromboembolism in pregnancy**
- **Adult** (By Subcutaneous Injection): (body-weight 90 kg and above) 10 000 units twice daily, use body-weight in early pregnancy to calculate the dose.
**Treatment of venous thromboembolism, Treatment of arterial thromboembolism for dalteparin sodium**
- **Neonate** (By subcutaneous injection): Initially 150 units/kg twice daily, dose adjusted in increments of 25 units/kg according to anti-Factor Xa plasma concentration.
- **Child 1-23 months** (By subcutaneous injection): Initially 150 units/kg twice daily, dose adjusted in increments of 25 units/kg according to anti-Factor Xa plasma concentration.
- **Child 2-7 years** (By subcutaneous injection): Initially 125 units/kg twice daily, dose adjusted in increments of 25 units/kg according to anti-Factor Xa plasma concentration.
- **Child 8-17 years** (By subcutaneous injection): Initially 100 units/kg twice daily, dose adjusted in increments of 25 units/kg according to anti-Factor Xa plasma concentration.
**Treatment of venous thromboembolism in pregnancy for dalteparin sodium**
- **Child 12-17 years (body-weight up to 50 kg)** (By subcutaneous injection): 5000 units twice daily, use body-weight in early pregnancy to calculate the dose.
- **Child 12-17 years (body-weight 50-69 kg)** (By subcutaneous injection): 6000 units twice daily, use body-weight in early pregnancy to calculate the dose.
- **Child 12-17 years (body-weight 70-89 kg)** (By subcutaneous injection): 8000 units twice daily, use body-weight in early pregnancy to calculate the dose.
- **Child 12-17 years (body-weight 90 kg and above)** (By subcutaneous injection): 10 000 units twice daily, use body-weight in early pregnancy to calculate the dose.
**Prophylaxis of thromboembolism for dalteparin sodium**
- **Neonate** (By subcutaneous injection): 100 units/kg once daily.
- **Child 1 month-11 years** (By subcutaneous injection): 100 units/kg once daily.
- **Child 12-17 years** (By subcutaneous injection): 2500-5000 units once daily.
Cautions
Elderly; risk of bleeding; severe hypertension
Contraindications
Acute bacterial endocarditis; after major trauma; avoid injections containing benzyl alcohol in neonates; epidural anaesthesia with treatment doses; haemophilia or other haemorrhagic disorders; peptic ulcer; recent cerebral haemorrhage; recent surgery to eye; recent surgery to nervous system; spinal anaesthesia with treatment doses; thrombocytopenia (including history of heparin-induced thrombocytopenia) Contra-indications For dalteparin sodium Mechanical prosthetic heart valve
Side effects
Common or very common Haemorrhage; heparin-induced thrombocytopenia; skin reactions Rare or very rare Alopecia; hyperkalaemia; osteoporosis (following long term use); spinal haematoma Side-effects, further information Haemorrhage If haemorrhage occurs it is usually sufficient to withdraw heparin or a low molecular weight heparin, but if rapid reversal of the effects of the heparin is required, protamine sulfate is a specific antidote (but only partially reverses the effects of low molecular weight heparins). Heparin-induced thrombocytopenia Clinically important heparin-induced thrombocytopenia is immune-mediated and can be complicated by thrombosis. Signs of heparin-induced thrombocytopenia include a 30% reduction of platelet count, thrombosis, or skin allergy. If heparin-induced thrombocytopenia is strongly suspected or confirmed, the heparin should be stopped and an alternative anticoagulant, such as danaparoid, should be given. Ensure platelet counts return to normal range in those who require warfarin. Hyperkalaemia Inhibition of aldosterone secretion by heparin or a low molecular weight heparin can result in hyperkalaemia; patients with diabetes mellitus, chronic renal failure, acidosis, raised plasma potassium or those taking potassium-sparing drugs seem to be more susceptible. The risk appears to increase with duration of therapy. Side-effects For dalteparin sodium Frequency not known Epidural haematoma; hypoaldosteronism; intracranial haemorrhage; prosthetic cardiac valve thrombosis
Interactions
**Other interactions (3):**
- Drugs Increasing Effects of Dalteparin The possibility of the following interactions with Fragmin should be considered: i) An enhancement of the anticoagulant effect by other...
- Andexanet alfa, a recombinant modified human coagulation factor Xa used for reversal of anticoagulation with apixaban or rivaroxaban, has been shown to bind to heparin-bound anti-thrombin III...
- Other Interactions As heparin has been shown to interact with intravenous nitroglycerine, high dose penicillin, quinine and tobacco smoking interaction cannot be ruled out for dalteparin.
Pregnancy
Treatment of venous thromboembolism in pregnancy for Fragmin single-dose syringes By subcutaneous injection Adult (body-weight up to 50 kg) 5000 units twice daily, use body-weight in early pregnancy to calculate the dose. Adult (body-weight 50-69 kg) 6000 units twice daily, use body-weight in early pregnancy to calculate the dose. Adult (body-weight 70-89 kg) 8000 units twice daily, use body-weight in early pregnancy to calculate the dose. Adult (body-weight 90 kg and above) 10 000 units twice daily, use body-weight in early pregnancy to calculate the dose.
Breast feeding
Due to the relatively high molecular weight and inactivation in the gastro-intestinal tract, passage into breast-milk and absorption by the nursing infant are likely to be negligible, however manufacturers advise avoid.
Hepatic impairment
Manufacturer advises caution in severe impairment (increased risk of bleeding complications). Dose adjustments Manufacturer advises consider dose reduction in severe impairment.
Renal impairment
Use of heparin may be preferable. Dose adjustments Risk of bleeding may be increased-dose reduction may be required.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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