Dalteparin sodium


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration 30-40 U/kg IV inj, then 10-15 U/kg/hr as IV infusion. SC Venous thromboembolism 200 U/kg/day as a single or in 2 divided doses in pregnant and high-risk patients. Max: 18,000 U/day. Prophylaxis of venous thromboembolism during surgical procedures Moderate risk: 2,500 U given 1-2 hr pre-op then 2,500 U once daily for 5-7 days or until the patient is fully ambulant. High risk: 2,500 U given 1-2 hr before and 8-12 hr after the procedure then 5,000 U daily. Unstable angina 120 U/kg 12 hrly continued for 5-8 days w/ low-dose aspirin. Max: 10,000 U 12 hrly.
Dosage Details
Intravenous
Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration
Adult: 30-40 U/kg IV inj, followed by an IV infusion of 10-15 U/kg/hr. A single dose of 5,000 U may be given for haemodialysis or haemofiltration session lasting <4 hr. For patients at high risk of bleeding or in acute renal failure: 5-10 U/kg IV inj followed by an infusion of 4-5 U/kg/hr.

Subcutaneous
Unstable angina
Adult: 120 U/kg 12 hrly continued for 5-8 days w/ concomitant low-dose aspirin. Max: 10,000 U 12 hrly. For patients who require treatment longer than 8 days while awaiting revascularisation procedure: 5,000 U (7,500 U in men weighing ≥70 kg and women weighing ≥80 kg) 12 hrly for up to 45 days until the procedure is performed.

Subcutaneous
Prophylaxis of venous thromboembolism during surgical procedures
Adult: Moderate risk patients: 2,500 U given 1-2 hr before the procedure followed by 2,500 U once daily for 5-7 days or until the patient is fully ambulant. High risk patients: 2,500 U given 1-2 hr before and 8-12 hr after the procedure followed by 5,000 U daily. Alternatively, 5,000 U given in the evening before surgery followed by 5,000 U each subsequent evening for 5-10 days, or up to 5 wk after hip replacement surgery. Medical patients: 5,000 U once daily for 14 days or longer.

Subcutaneous
Venous thromboembolism
Adult: 200 U/kg daily as a single or in 2 divided doses in pregnant and high-risk patients. Max: 18,000 U/day. Patients w/ symptomatic thromboembolism and cancer: 200 U/kg once daily for 30 days, followed by 150 U/kg once daily for up to 5 mth; if chemotherapy induced thrombocytopenia develops, reduce dose to 2,500 U while platelet counts are below 100,000 cells/mm3, temporarily stop treatment if platelet counts are below 50,000 cells/mm3.
Renal Impairment
CrCl <30 mL/min: Dosage adjustment needed based on anti-Factor Xa activity.
Contraindications
History of confirmed or suspected immunologically mediated heparin induced thrombocytopenia (type II); acute gastroduodenal ulcer; cerebral haemorrhage; known haemorrhagic diathesis or other active haemorrhage; serious coagulation disorders; acute or subacute septic endocarditis; haemorrhagic pericardial effusion and haemorrhagic pleural effusion; injuries to and operations on the CNS, eyes and ears. Local and/or regional anaesth in elective surgical procedures (in patients receiving treatment rather than prophylaxis). Cancer patients weighing <40 kg. Patients who have suffered a recent (w/in 3 mth) stroke unless due to systemic emboli.
Special Precautions
Patient w/ increased risk of bleeding complications (e.g. following surgery or trauma, haemorrhagic stroke, thrombocytopenia or defective platelet function, uncontrolled HTN, hypertensive or diabetic retinopathy). Increased risk of spinal or epidural haematomas in patient undergoing neuraxial anaesth or spinal puncture esp w/ post-op use of indwelling epidural catheters. Hepatic and renal impairment. Pregnancy and lactation.
Adverse Reactions
Elevated serum transaminase levels (AST and ALT), allergic reactions (e.g. pruritus, rash, fever, inj site reaction, bullous eruption), pain on inj site.
Potentially Fatal: Epidural or spinal haematomas that may result in permanent paralysis, severe haemorrhage, thrombocytopenia.
Parenteral/SC: B
Patient Counseling Information
Use of preservative-free formulation is recommended in pregnant women.
MonitoringParameters
Monitor CBC including platelet count; stool occult blood tests.
Overdosage
Symptoms: Haemorrhagic complications. Management: Administer protamine sulfate by slow IV inj at a dose of 1 mg for every 100 anti-Xa U of dalteparin Na given.
Drug Interactions
Increased risk of haemorrhage w/ other anticoagulant/antiplatelet agents (e.g. aspirin/dipyridamole, glycoprotein IIb/IIIa receptor antagonists, vit K antagonists, NSAIDs, cytostatics, dextran, thrombolytics, sulfinpyrazone, probenecid, etacrynic acid). Reduced anticoagulant effect w/ antihistamines, cardiac glycosides, tetracycline and ascorbic acid.
Action
Description: Dalteparin Na is an antithrombotic agent, which acts mainly through its ability to potentiate the inhibition of factor Xa and thrombin by antithrombin. It has a relatively higher ability to potentiate factor Xa inhibition than to prolong aPTT.
Onset: Anti-Xa activity: W/in 1-2 hr.
Duration: >12 hr.
Pharmacokinetics:
Absorption: Almost completely absorbed (SC). Bioavailability: Approx 87%. Time to peak plasma concentration: Approx 4 hr.
Distribution: Volume of distribution: 0.4-0.6 L/kg. Plasma protein binding: Low.
Excretion: Via kidneys. Terminal half-life: Approx 2 hr (IV); 3-5 hr (SC).
Storage
Store between 20-25°C.
Disclaimer: This information is independently developed by MIMS based on Dalteparin sodium 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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