Tinzaparin sodium: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

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.

Pregnancy Category (US FDA)

Parenteral/SC: B

Monitoring Parameters

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.

MIMS Class

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

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.

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