Clinical Pharmacology Details


DALTEPARIN


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Indications & Dose:

Treatment of deep-vein thrombosis, with oralanticoagulant treatment


Treatment of pulmonary embolism,with oral anticoagulant treatment



Adult: 200 units/kg daily (max. per dose 18 000 units) until adequate oral anticoagulation established


Treatment of deep-vein thrombosis, with oral anticoagulant treatment (in patients at increased risk of haemorrhage) Treatment of pulmonary embolism,with oral anticoagulant treatment (in patients at increase risk of haemorrhage) 



Adult: 100 units/kg twice daily until adequate oral anticoagulation established


Unstable coronary artery disease



Adult: 120 units/kg every 12 hours (max. per dose10 000 units twice daily) for 5–8 days


Prevention of clotting in extracorporeal circuits Unstable coronary artery disease (includingnon-STsegment-  elevation  myocardial infarction)



Adult: 120 units/kg every 12 hours (max. per dose10 000 units twice daily) for up to 8 days


Patients with unstable coronary artery disease(including non-ST-segment-elevation myocardial infarction) awaiting angiography orrevascularisation and having already had 8days treatment with dalteparin



Adult (body-weight up to 70 kg and male): 5000 units every 12 hours until the day of the procedure(max. 45 days).


Adult (body-weight up to 80 kg and female): 5000units every 12 hours until the day of the procedure(max. 45 days).


Adult (body-weight 70 kg and above and male):7500 units every 12 hours until the day of theprocedure (max. 45 days).


Adult (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: Initially 2500 units for 1 dose, 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: Initially 2500 units for 1 dose, dose to be administered 1–2 hours before surgery, followed by 2500 units after 8–12 hours, then 5000 units every 24 hours, alternatively initially 5000 units for 1 dose, dose to be given on the evening before surgery, followed by 5000 units after 24 hours, then 5000 units every 24 hours


Prophylaxis of deep-vein thrombosis in medical patients



Adult: 5000 units every 24 hours


Treatment of deep-vein thrombosis, with oral anticoagulant treatment


Treatment of pulmonary embolism,with oral anticoagulant treatment  



Adult (body-weight up to 46 kg): 7500 units once daily until adequate oral anticoagulation established


Adult (body- weight 46–56 kg): 10 000 units once daily until adequate oral anticoagulation established


Adult (body -weight 57–68 kg): 12 500 units once daily until adequate oral anticoagulation established


Adult (body -weight 69–82 kg): 15 000 units once daily until adequate oral anticoagulation established


Adult (body-weight 83 kg and above): 18 000 units once daily until adequate oral anticoagulation established


Extended treatment and prophylaxis of venous thromboembolism in patients with solid tumours 



Adult (body-weight 40–45 kg): 7500 units once daily for 30 days, then 7500 units once daily for a further 5 months, interrupt treatment or reducedose in chemotherapy-induced thrombocytopenia—consult product literature


Adult (body-weight 46–56 kg): 10 000 units once daily for 30 days, then 7500 units once daily for a further 5 months, interrupt treatment or reduce dose in chemotherapy-induced thrombocytopenia


Adult (body-weight 57–68 kg): 12 500 units once daily for 30 days, then 10 000 units once daily for a further 5 months, interrupt treatment or reduce dose in chemotherapy-induced thrombocytopenia


Adult (body-weight 69–82 kg): 15 000 units oncedaily for 30 days, then 12 500 units once daily for a further 5 months, interrupt treatment or reduce dose in chemotherapy-induced thrombocytopenia


Adult (body-weight 83–98 kg): 18 000 units once daily for 30 days, then 15 000 units once daily for a further 5 months, interrupt treatment or reduce dose in chemotherapy -induced thrombocytopenia


Adult (body-weight 99 kg and above): 18 000 units once daily for 30 days, then 18 000 units once daily for a further 5 months, interrupt treatment or reduce dose in chemotherapy-induced thrombocytopenia


Treatment of venous thromboembolism in pregnancy



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


 

Contraindications:

Active major bleeding, thrombocytopenia associated with positive in vitro tests for antiplatelet antibody in the presence of daltaparin, known hypersensitivity to pork products

Side Effects:

HEMS: Hemorrhage, thrombocytopenia


SKIN: Pain at injection site, skin necrosis


 

Cautions:

Precautions:

History of heparin-induced thrombocytopenia; severe uncontrolled hypertension, bacterial endocarditis, congenital or acquired bleeding disorders, active ulceration and angiodysplastic gastrointestinal disease; hemorrhagic stroke or shortly after brain, spinal, or ophthalmological surgery; bleeding diathesis, thrombocytopenia or platelet defects; severe liver or kidney insufficiency; hypertensive or diabetic retinopathy; recent gastrointestinal bleeding; neuroaxial anesthesia

Interaction:

Drug Aspirin: Increased risk of hemorrhage Oral anticoagulants: Additive anticoagulant effects


 

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: