Dalteparin


Generic Medicine Info
Indications and Dosage
Intravenous
Prophylaxis of clotting in the extracorporeal circulation during haemodialysis, Prophylaxis of clotting in the extracorporeal circulation during haemofiltration
Adult: 30-40 international units/kg via bolus inj, followed by 10-15 international units/kg/hour via infusion. A single dose of 5,000 international units, either via IV or into the arterial side of the extracorporeal system at the start of the procedure, may be given for haemodialysis or haemofiltration session lasting <4 hours. For patients at high risk of bleeding or in acute renal failure: 5-10 international units/kg via bolus inj, followed by 4-5 international units/kg/hour via infusion.

Subcutaneous
Venous thromboembolism
Adult: For the treatment of established DVT and/or pulmonary embolism: 200 international units/kg daily as a single inj, or in 2 divided doses in patients with increased risk of bleeding. Max: 18,000 international units daily. Patients with symptomatic VTE and cancer: 200 international units/kg once daily for the 1st 30 days, followed by 150 international units/kg once daily for up to 5 months. Max: 18,000 international units daily. If chemotherapy-induced thrombocytopenia develops, reduce total daily dose by 2,500 international units while platelet counts are below 100,000 cells/mm3; temporarily stop treatment if platelet counts are below 50,000 cells/mm3.

Subcutaneous
Prophylaxis of venous thromboembolism during surgical procedures
Adult: Patients with moderate risk of thrombosis: 2,500 international units given 1-2 hours before the procedure, followed by 2,500 international units once daily for 5-7 days or until the patient is fully ambulant. Patients with high risk of thrombosis (e.g. undergoing orthopaedic surgery): 2,500 international units given 1-2 hours before and 8-12 hours after the procedure, followed by 5,000 international units daily. Alternatively, 5,000 international units given on the evening before the surgery, then 5,000 international units each subsequent evening. Another alternative for orthopaedic surgery (e.g. hip replacement surgery): 2,500 international units given 4-8 hours after surgery, followed by 5,000 international units daily. Continue treatment until the patient is mobilised, generally 5-7 days, or up to 5 weeks after orthopaedic surgery (e.g. hip replacement surgery).

Subcutaneous
Non-Q wave myocardial infarction, Unstable angina
Adult: 120 international units/kg 12 hourly for 5-8 days with concomitant low-dose aspirin. Max: 10,000 international units 12 hourly. For patients who require treatment longer than 8 days while awaiting revascularisation procedure: 5,000 international units (7,500 international units in men weighing ≥70 kg and women weighing ≥80 kg) 12 hourly, given until the day of the procedure but not for >45 days.

Subcutaneous
Prophylaxis of deep vein thrombosis
Adult: In patients bedridden due to a medical condition (e.g. CHF, acute respiratory failure, acute infection) who may also have predisposing risk factors (e.g. age >75 years, obesity, cancer, or previous history of VTE): 5,000 international units once daily for up to 14 days or longer.
Renal Impairment
Venous thromboembolism:
CrCl (mL/min) Dosage
<30 Dosage adjustment may be needed based on anti-factor Xa activity.
Hepatic Impairment
Severe: Dosage reduction may be needed.
Contraindications
History of confirmed or suspected heparin-induced thrombocytopenia (HIT) or HIT with thrombosis; acute or subacute septic endocarditis; active, significant haemorrhage (e.g. acute gastrointestinal ulceration or bleeding, cerebral haemorrhage), known haemorrhagic diathesis or severe coagulation disorders; recent injuries to and operations on the CNS, eyes and ears. Patients who have suffered a recent stroke (within 3 months) unless due to systemic emboli. Regional anaesthesia in elective surgical procedures (in patients receiving high doses of dalteparin for treatment rather than prophylaxis).
Special Precautions
Patient with increased risk of bleeding complications (e.g. following surgery or trauma, defective platelet function, uncontrolled hypertension, hypertensive or diabetic retinopathy); risk factors for developing hyperkalaemia (e.g. concomitant use of K-sparing diuretics, haematoma in body tissues), history of gastrointestinal ulcer. Not recommended to be used interchangeably with unfractionated heparin, other LMWHs, or synthetic polysaccharides. Not recommended for use in prosthetic heart valve thromboprophylaxis. Renal and severe hepatic impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Bleeding, hyperkalaemia, thrombocytopenia (including thrombocytopenia with thrombosis).
General disorders and administration site conditions: Inj site haematoma and pain.
Immune system disorders: Hypersensitivity.
Investigations: Transient increase of transaminases.
Musculoskeletal and connective tissue disorders: Osteoporosis (long-term use).
Skin and subcutaneous tissue disorders: Urticaria, pruritus.
Potentially Fatal: Epidural or spinal haematomas that may result in chronic or permanent paralysis (in patients receiving neuraxial anaesthesia or undergoing spinal puncture); severe haemorrhage.
Parenteral/SC: B
Monitoring Parameters
Monitor platelet count, plasma K (in patients at risk of hyperkalaemia), Hb, haematocrit, stool occult blood; anti-factor Xa levels (particularly in patients who are very thin or obese, pregnant, those with renal failure, or at increased risk of bleeding); serum creatinine at baseline and during therapy. Assess for signs and symptoms of bleeding; neurological impairment (if necessary).
Overdosage
Symptoms: May lead to haemorrhagic complications. Management: Administer protamine sulfate via slow IV inj at a dose of 1 mg for every 100 international units (anti-factor Xa) of dalteparin given. If aPTT remains prolonged after 2-4 hours of initial infusion, a second infusion of 0.5 mg protamine sulfate per 100 international units (anti-factor Xa) of dalteparin may be given.
Drug Interactions
Enhanced anticoagulant effect with other anticoagulants (e.g. vitamin K antagonists), thrombolytics, antiplatelet agents (e.g. aspirin, dipyridamole, glycoprotein IIb/IIIa receptor antagonists), NSAIDs, cytostatics, dextran, sulfinpyrazone, probenecid, etacrynic acid. Reduced anticoagulant effect with antihistamines, cardiac glycosides, tetracycline, and ascorbic acid.
Action
Description:
Mechanism of Action: Dalteparin, an antithrombotic agent, acts mainly through its ability to potentiate the inhibition of factor Xa and thrombin by antithrombin. It has a higher ability to potentiate factor Xa inhibition than to prolong aPTT.
Onset: Anti-factor Xa activity: Within 1-2 hours.
Duration: >12 hours.
Pharmacokinetics:
Absorption: Almost completely absorbed (SC). Bioavailability: Approx 87% (SC). Time to peak plasma concentration: Approx 4 hours (SC).
Distribution: Volume of distribution: 40-60 mL/kg.
Excretion: Via kidneys. Terminal half-life: Approx 2 hours (IV); 3-5 hours (SC).
Storage
Store between 15-30°C. Storage recommendations may vary among individual products. Refer to specific product guidelines.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
References
Anon. Dalteparin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/08/2022.

Buckingham R (ed). Dalteparin Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/08/2022.

Fragmin 10,000 IU/1 mL Solution for Injection (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 24/10/2022.

Fragmin 100,000 IU/4 mL Multidose Vial Solution for Injection (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 05/08/2022.

Fragmin 5,000 IU/0.2 mL Solution for Injection (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 28/11/2022.

Fragmin 7,500 IU/0.3 mL Solution for Injection (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 05/08/2022.

Fragmin Injection (Pfizer Laboratories Div Pfizer Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/08/2022.

Joint Formulary Committee. Dalteparin Sodium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/08/2022.

Disclaimer: This information is independently developed by MIMS based on Dalteparin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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