Tinzaparin sodium


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Prophylaxis of clotting in the extracorporeal circulation during haemodialysis Short-term dialysis (≤4 hr): 2,000-2,500 U as a single dose. Long-term dialysis (>4 hr): Initial: 2,500 U followed by an infusion of 750 U/hr. Dose may also be given into the arterial side of the dialyser. SC Prophylaxis of post-op venous thromboembolism Low or intermediate risk patients: 3,500 U given 2 hr before surgery, then 3,500 U once daily. High risk patients: Initial: 50 U/kg given 2 hr before surgery, or a fixed dose of 4,500 U given 12 hr before surgery followed by a once daily dose. Alternatively, 75 U/kg once daily post-op. Venous thromboembolism 175 U/kg once daily for at least 6 days and until adequate oral anticoagulation is established.
Dosage Details
Intravenous
Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration
Adult: Short-term dialysis (≤4 hr): 2,000-2,500 U as a single dose. Long-term dialysis (>4 hr): Initially, 2,500 U followed by an infusion of 750 U/hr. Dose may also be given into the arterial side of the dialyser. The dialyser can be primed w/ 500-1,000 mL NaCl 0.9% containing 5,000 U tinzaparin Na/L.

Subcutaneous
Prophylaxis of postoperative venous thromboembolism
Adult: Low or intermediate risk patients: 3,500 U given 2 hr before surgery, followed by 3,500 U once daily. High risk patients: Initially, 50 U/kg given 2 hr before surgery, or a fixed dose of 4,500 U given 12 hr before surgery followed by a once daily dose; alternatively, 75 U/kg once daily, started after surgery.

Subcutaneous
Venous thromboembolism
Adult: 175 U/kg once daily for at least 6 days and until adequate oral anticoagulation is established. Pregnant patients: Early-pregnancy body wt should be used to calculate dose.
Contraindications
Active major haemorrhage or conditions predisposing to major haemorrhage, current or history of immune-mediated heparin-induced thrombocytopenia (type II), severe endocarditis; locoregional anaesth in elective surgical procedure in patients receiving treatment doses.
Special Precautions
Patient at risk of haemorrhage. Patient undergoing peridural or spinal anaesth or spinal puncture. Patient w/ history of GI ulcer. Hepatic and severe renal impairment (CrCl <30 mL/min). Pregnancy and lactation.
Adverse Reactions
Thrombocytopenia, increased AST and ALT; local reactions (e.g. mild irritation, pain, haematoma, ecchymosis), hypersensitivity. Rarely, hyperkalaemia, angioedema, anaphylaxis, skin necrosis, Stevens-Johnson syndrome.
Potentially Fatal: Haemorrhage.
Parenteral/SC: B
MonitoringParameters
Monitor CBC including platelet count and haematocrit or Hb, stool tests for occult blood.
Overdosage
Symptoms: Haemorrhage, hypovolaemia. Management: Severe haemorrhage may be treated w/ protamine sulfate. Manage hypovolaemia by transfusion of fresh plasma, if needed.
Drug Interactions
Enhanced anticoagulant effect w/ other drugs affecting the coagulation system including platelet inhibitors (e.g. acetylsalicylic acid and other NSAIDs), thrombolytic agents, vit K antagonists, activated protein C, direct factor Xa and IIa inhibitors.
Action
Description: Tinzaparin Na exerts its antithrombotic activity by binding to antithrombin III, thus enhancing the inhibition of several activated coagulation factors, esp Factors Xa and IIa (thrombin).
Onset: 2-3 hr.
Duration: Detectable anti-Xa activity: Up to 24 hr.
Pharmacokinetics:
Absorption: Absorbed after SC inj. Bioavailability: Approx 90%. Time to peak plasma concentration: W/in 4-6 hr.
Distribution: Volume of distribution: 3.1-5 L.
Metabolism: Partially metabolised via desulphation and depolymerisation.
Excretion: Primarily via urine. Elimination half-life: Approx 90 min.
Storage
Store between 15-25°C.
ATC Classification
B01AB10 - tinzaparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
References
Anon. Tinzaparin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/03/2016.

Buckingham R (ed). Tinzaparin Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/03/2016.

Innohep Injection, Solution (Leo Pharma Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/03/2016.

Disclaimer: This information is independently developed by MIMS based on Tinzaparin 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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