Tinzaparin parenteral low strength
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of tinzaparin of low strength (10,000units/ml).
Drugs List
Therapeutic Indications
Uses
Haemodialysis - prevention of clotting in extracorporeal circulation
Venous thromboembolism in medical patients: prophylaxis
Venous thromboembolism in surgical patients: prophylaxis
Unlicensed Uses
Treatment of VTE in pregnancy
Dosage
Adults
Prevention of thromboembolic events
Patients undergoing general surgery (low to moderate risk)
3500units subcutaneously given 2 hours before surgery, repeated once daily for as long as the patient is considered to be at risk of VTE.
High risk surgical patients e.g. orthopaedic or cancer surgery
4500units subcutaneously given 12 hours before surgery, repeated once daily for as long as the patient is considered to be at high risk.
The following unlicensed alternative dosing schedule may be suitable:
50unit/kg subcutaneously given 2 hours before surgery, repeated once daily.
Non-surgical patients immobilised due to acute medical illness 3500units subcutaneously given once daily in patients at moderate risk of VTE.
OR
4500units subcutaneously given once daily in patients at high risk of VTE.
Administration should continue for as long as the patient is considered to be at risk of VTE.
Prevention of clotting during haemodialysis and haemofiltration
Short-term dialysis (up to 4 hours)
Bolus dose of 2000units to 2500units at the start of dialysis into the arterial side of the dialyser (or intravenously).
Long-term dialysis (more than 4 hours)
Bolus dose of 2500units at the start of dialysis into the arterial side of the dialyser (or intravenously), followed by 750units per hour infused into the extracorporeal circuit.
The bolus dose may be adjusted by 250units to 500units until a satisfactory response is obtained. Additional tinzaparin sodium (500units to 1000units) may be given if concentrated red cells or blood transfusions are given during dialysis or additional treatment beyond the normal dialysis duration is employed.
Treatment of venous thromboembolism in pregnancy (unlicensed)
175units/kg subcutaneously once daily (based on early pregnancy bodyweight).
Children
Prophylaxis of thromboembolism (unlicensed)
50units/kg subcutaneously once daily.
Treatment of thromboembolism (unlicensed)
Children aged 10 to 18 years: 175units/kg subcutaneously once daily.
Children aged 5 to 10 years: 200units/kg subcutaneously once daily.
Children aged 1 to 5 years: 240units/kg subcutaneously once daily.
Children aged 2 months to 1 year: 250units/kg subcutaneously once daily.
Children aged 1 to 2 months: 275units/kg subcutaneously once daily.
Treatment of venous thromboembolism in pregnancy (unlicensed)
Children aged 12 to 18 years: 175units/kg subcutaneously once daily (based on early pregnancy bodyweight).
Tinzaparin sodium may contain benzyl alcohol and therefore should not be used in neonates or premature babies.
Additional Dosage Information
Dose monitoring during haemodialysis and haemofiltration
Determination of plasma anti-Factor Xa may be used to monitor the tinzaparin dose during haemodialysis. Plasma anti-Factor Xa one hour after dosing should be within the range 0.4unit/ml to 0.5unit/ml.
Underweight and overweight patients
An alternative dosage schedule may be 50units/kg once daily. See product literature for more information.
Administration
Prevention of thromboembolic events
For subcutaneous injection.
Prevention of clotting during haemodialysis
The dose should be given into the arterial side of the dialyser or intravenously. The dialyser can be primed by flushing with 500ml to 1000ml isotonic sodium chloride (9mg/ml) containing 5000 anti-Factor Xa unit per litre.
Contraindications
Heparin treatment with concurrent locoregional anaesthesia
Neonates under 1 month
Recent trauma
Severe haemorrhage
Central nervous system trauma
Coagulopathy
Haemophilia
History of heparin-induced thrombocytopenia
Infective endocarditis
Ocular surgery
Ocular trauma
Peptic ulcer
Prosthetic heart valve with pregnancy
Recent central nervous system surgery
Recent cerebral haemorrhage
Severe hepatic impairment
Thrombocytopenia
Uncontrolled severe hypertension
Precautions and Warnings
Children 1 month to 18 years
Elderly
Haemorrhage
Obesity
Predisposition to bleeding complications
Spinal/epidural anaesthesia
Underweight patients
Breastfeeding
Chronic renal failure
Diabetes mellitus
Hyperkalaemia
Metabolic acidosis
Pregnancy
Prosthetic heart valve
Severe renal impairment
Not recommended for anticoagulation with prosthetic heart valves
Some presentations may contain benzyl alcohol
Avoid concurrent intramuscular injections - risk of haematoma
Do not use if any signs of precipitate or particulate matter apparent
Monitor platelets before starting and during treatment
Monitor anti-Factor Xa levels during haemodialysis
Monitor for bleeding during treatment
Monitor patients undergoing spinal or epidural anaesthesia closely
Monitor plasma potassium in patients at risk of hyperkalaemia
Adrenal suppression may occur leading to hyperkalaemia
Discontinue if thrombocytopenia occurs
Spinal anaesthesia: tell patient-report symptoms of neurological impairment
Discontinue if severe skin reaction occurs
In patients undergoing peridural or spinal anaesthesia or spinal puncture, the concurrent prophylactic use of heparin may be rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis. This risk is increased by the use of a peridural or spinal catheter for anaesthesia, by the concurrent use of drugs affecting haemostasis (such as NSAIDs, platelet inhibitors, or anticoagulants), and by traumatic or repeated puncture.
If neuraxial anaesthesia is anticipated, a minimum delay of 12 hours should be allowed between the last prophylactic dose and the placement of the catheter or needle. Tinzaparin may only be continued 4 to 6 hours after the use of spinal anaesthesia or after the catheter has been removed. Therefore, the 2 hours preoperative prophylactic dose is not compatible with neuraxial anaesthesia.
If renal impairment is suspected, estimated creatinine clearance level should be assessed.
Low molecular weight heparins (LMWH) are not interchangeable and therefore switching to an alternative LMWH must be exercised with caution.
Pregnancy and Lactation
Pregnancy
Use tinzaparin with caution in pregnancy.
The manufacturer advises caution if tinzaparin is used during pregnancy. Tinzaparin does not cross the placenta and therefore cannot directly affect the embryo or foetus, through its effect on the mother. As such, available reports indicate no increased risk of teratogenic or developmental effects. Schaefer (2015) notes that LMWHs are preferred over unfractionated heparins in pregnant women due to their decreased risk of maternal osteoporosis, allergy, and heparin-induced thrombocytopenia.
Maternal death has been reported in pregnant women with prosthetic heart valves receiving full doses of tinzaparin and other LMWHs. Tinzaparin is therefore not recommended for use in pregnant women with prosthetic heart valves.
If spinal or epidural anaesthesia is anticipated, tinzaparin must be avoided. Epidural anaesthesia in pregnant women should always be delayed until at least 24 hours after administration of the last dose of tinzaparin. Prophylactic doses may be given with a minimum of 12 hours between the last administration of tinzaparin and the needle or catheter placement.
The multidose vial contains benzyl alcohol and therefore should not be used in pregnancy.
Lactation
Use tinzaparin with caution during breastfeeding.
The manufacturer advises caution during breastfeeding. The presence of tinzaparin in human breast milk is expected to be very low and therefore oral absorption of tinzaparin in the infant is very unlikely. Effects on exposed infants are unknown.
The multidose vial contains benzyl alcohol and therefore should not be used during breastfeeding.
Side Effects
Anaemia
Anaphylaxis
Angioedema
Bruising
Dermatitis
Ecchymosis
Haematoma
Haemorrhage
Hyperkalaemia
Hypersensitivity reactions
Hypoaldosteronism
Immunologically mediated thrombocytopenia
Increases in hepatic enzymes
Injection site reactions
Osteoporosis
Priapism
Pruritus
Purpura
Rash
Skin necrosis
Stevens-Johnson syndrome
Thrombocytopenia
Thrombocytosis
Toxic skin reaction
Urticaria
Valve thrombosis in patients with prosthetic heart valves
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: February 2016
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Summary of Product Characteristics: Tinzaparin sodium 10,000 IU/ml solution for injection vials. Revised January 2022.
Summary of Product Characteristics: Tinzaparin sodium syringe 10,000 iu/ml. Leo Laboratories Ltd. Revised October 2015.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 September 2017
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