Nadroparin


Generic Medicine Info
Indications and Dosage
Intra-arterial
Prophylaxis of clotting in the extracorporeal circulation during haemodialysis
Adult: In haemodialysis sessions lasting <4 hours: As 9,500 anti-Xa IU/mL inj in patients weighing <50 kg: 2,850 anti-Xa IU; 50-69 kg: 3,800 anti-Xa IU; ≥70 kg: 5,700 anti-Xa IU. Doses are administered as a single dose into the arterial line of the circuit at the start of dialysis. May give additional dose if session last for >4 hours. Adjust dose in subsequent dialysis sessions as necessary according to patient response.  In patients at high risk of haemorrhage: Reduce dose to half.

Intravenous, Subcutaneous
Non-Q wave myocardial infarction, Unstable angina
Adult: As 9,500 anti-Xa IU/mL inj in combination with aspirin: Initially, 86 anti-Xa IU/kg given via IV bolus inj. Subsequent doses are given via SC inj 12 hourly. Usual treatment duration: 6 days. Dosage may be adjusted according to individual bodyweight (refer to detailed product guidelines).

Subcutaneous
Prophylaxis of thromboembolic disorder
Adult: As 9,500 anti-Xa IU/mL inj: For general surgery: Initially, 2,850 anti-Xa IU given 2-4 hours prior to surgery, then once daily on subsequent days for at least 7 days or until the patient is ambulant. For orthopaedic surgery: Initially, 38 anti-Xa IU/kg given 12 hours before, and 12 hours after surgery, then once daily until Day 3 post-op. Then, increase dose by 50% or up to 57 anti-Xa IU/kg once daily starting Day 4 post-op. Continue treatment until the patient is ambulant for at least 10 days. For high-risk patients weighing ≤70 kg: 3,800 anti-Xa IU once daily; >70 kg: 5,700 anti-Xa IU once daily. Continue treatment throughout the risk period.
Elderly: For high-risk patients: May reduce dose to 2,850 anti-Xa IU once daily.

Subcutaneous
Thromboembolic disorders
Adult: As 9,500 anti-Xa IU/mL inj: 86 anti-Xa IU/kg 12 hourly. As 19,000 anti-Xa IU/mL inj: 171 anti-Xa IU/kg once daily. Usual treatment duration: 10 days. Dosage is adjusted according to individual bodyweight (refer to detailed product guidelines).
Renal Impairment
Prophylaxis of thromboembolic disorder:
CrCl (mL/min)
Dosage
≥30 to <50 and <30
Reduce dose by 25-33%.

Thromboembolic disorders; Unstable angina; Non-Q wave myocardial infarction:
CrCl (mL/min)
Dosage
≥30 to <50
Reduce dose by 25-33%.
<30
Contraindicated.
Contraindications
Active bleeding or increased risk of haemorrhage related to haemostasis disorders (except disseminated intravascular coagulation not heparin-induced); haemorrhagic CVA, organic lesions likely to bleed (e.g. active peptic ulcer), history of thrombocytopenia with nadroparin; acute infectious endocarditis. Severe renal impairment (CrCl <30 mL/min) when used for the treatment of thromboembolic disorders, unstable angina, and non-Q wave MI.
Special Precautions
Patient with severe arterial hypertension, history of gastrointestinal ulceration, vascular disorder of chorio-retina, hepatic failure, risk factors for hyperkalaemia (e.g. diabetes mellitus, metabolic acidosis, haematoma in body tissues, use of ACE inhibitors, NSAIDs, K-sparing diuretics or K supplements). Patients who are undergoing knee surgery, spinal puncture, or receiving neuraxial anaesthesia (spinal or epidural anaesthesia); postoperative period after brain, spinal cord or eye surgery. Not interchangeable (unit for unit) with any other LMWHs or heparin. Not intended for IM administration. Hepatic and moderate renal (CrCl ≥30 to <50 mL/min) impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Haemorrhage at any site, thrombocytopenia with thrombosis, heparin-induced thrombocytopenia, hyperkalaemia, prosthetic valve thrombosis; epidural or spinal haematomas including subsequent chronic or permanent paralysis (in patients receiving neuraxial anaesthesia or undergoing spinal puncture). Rarely, cutaneous necrosis (preceded by purpura, infiltrated or painful erythematous blotches).
Blood and lymphatic system disorders: Rarely, eosinophilia (reversible).
General disorders and administration site conditions: Inj site haematoma and reaction.
Immune system disorders: Rarely, hypersensitivity reactions.
Investigations: Increased transaminases (transient).
Nervous system disorders: Headache, migraine.
Reproductive system and breast disorders: Rarely, priapism.
Skin and subcutaneous tissue disorders: Rarely, rash, erythema, urticaria, pruritus.
Monitoring Parameters
Monitor platelet count at baseline and twice weekly during treatment; antifactory Xa levels at least 4 hours postdose as clinically indicated; stool occult blood tests, Hb, LFT, renal function; plasma K levels in patients at risk of hyperkalaemia. Closely monitor for signs and symptoms of bleeding, thrombocytopenia with thrombosis and neurological impairment, and clotting in the dialysis circuit (when used during haemodialysis).
Overdosage
Symptom: Haemorrhage. Management: Administer protamine sulfate (0.6 mL neutralises approx 950 anti-Xa IU nadroparin) in serious cases. Monitor platelet and other coagulation parameters.
Drug Interactions
Increased risk of bleeding with aspirin, antiplatelet agents and NSAIDs. May enhance the hyperkalaemic effect of ACE inhibitors and K-sparing diuretics.
Action
Description: Nadroparin is a LMWH with an average molecular weight of approx 4,300 daltons. It binds to antithrombin III, thereby accelerating the inhibition of several clotting factors, specifically factor Xa.
Pharmacokinetics:
Absorption: Bioavailability: Approx 88% (SC). Time to peak plasma concentration: Within 10 minutes (IV); 3-6 hours (SC).
Distribution: Volume of distribution: 3.59 L.
Metabolism: Metabolised in the liver.
Excretion: Mainly via urine. Elimination half-life: Approx 3.5 hours (SC).
Storage
Store between 15-30°C. Do not refrigerate or freeze.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AB06 - nadroparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
References
Anon. Nadroparin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/09/2021.

Buckingham R (ed). Nadroparin Calcium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/09/2021.

Fraxiparine (Aspen Medical Products Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/09/2021.

Fraxiparine/Fraxiparine Forte (Aspen Pharmacare). MIMS Singapore. http://www.mims.com/singapore. Accessed 07/09/2021.

Disclaimer: This information is independently developed by MIMS based on Nadroparin 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 © 2022 MIMS. All rights reserved. Powered by MIMS.com
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