Vaxcel Enoxaparin Sodium

Enoxaparin Na

Prophylaxis of VTE in moderate & high risk surgical patients & in medical patients w/ acute illness (eg, acute heart failure, resp insufficiency, severe infection or rheumatic diseases) & reduced mobility at increased risk of VTE. Prevention of thrombus formation in extracorporeal circulation during haemodialysis. DVT & pulmonary embolism (PE). Extended treatment & prevention of recurrent DVT & PE in patients w/ active cancer. Acute coronary syndrome: In combination w/ PO ASA for unstable angina & non-ST-segment elevation MI (NSTEMI); acute ST-segment elevation MI (STEMI) eg, patients to be managed medically or w/ subsequent percutaneous coronary intervention (PCI).

Prophylaxis of VTE in surgery Patient w/ moderate thromboembolism risk 2,000 IU SC once daily given 2 hr pre-op & maintained for min: 7-10 days. Patient w/ high thromboembolism risk 4,000 IU SC once daily initiated 12 hr pre-op. Major orthopaedic surgery Extend thromboprophylaxis up to 5 wk. Abdominal or pelvic surgery for cancer Extend thromboprophylaxis up to 4 wk. Prophylaxis of DVT in medical patient 4,000 IU SC once daily for at least 6-14 days. DVT & PE Uncomplicated patient w/ low risk of VTE recurrence 150 IU/kg SC once daily for 10 days. Patient w/ obesity, symptomatic PE, cancer, recurrent VTE or proximal (vena iliaca) thrombosis 100 IU/kg bd for 10 days. Extended treatment of DVT & PE in patient w/ active cancer 100 IU/kg SC bd for 5-10 days, followed by 150 IU/kg SC once daily up to 6 mth. Prevention of thrombus formation during hemodialysis 100 IU/kg. Patient w/ high risk of hemorrhage Reduce to 50 IU/kg for double vascular access or 75 IU/kg for single vascular access. Unstable angina & NSTEMI 100 IU/kg SC every 12 hr for 2-8 days w/ initial PO loading dose: ASA 150-300 mg daily & maintenance dose: 75-325 mg daily. Acute STEMI 3,000 IU single IV bolus + 100 IU/kg SC followed by 100 IU/kg SC every 12 hr for 8 days or until hospital discharge. Max: 10,000 IU each for 1st 2 SC doses. 1st dose should be administered between 15 min before & 30 min after start of fibrinolytic therapy. In combination w/ ASA: 75-325 mg daily. Patient managed by PCI 30 IU/kg IV bolus if last SC inj was given >8 hr before balloon inflation. Elderly ≥75 yr Acute STEMI 75 IU/kg SC every 12 hr. Max: 7,500 IU each for 1st 2 SC doses. Severe renal impairment (CrCl 15-30 mL/min) Prophylaxis of VTE 2,000 IU SC once daily. DVT, PE, extended treatment of DVT & PE in patient w/ active cancer, unstable angina & NSTEMI 100 IU/kg SC once daily. Acute STEMI Patient >75 yr 100 IU/kg SC then 100 IU/kg SC every 24 hr, <75 yr 3,000 IU IV bolus + 100 IU/kg SC then 100 IU/kg SC every 24 hr.

Hypersensitivity to enoxaparin, heparin or its derivatives, other LMWH. History of immune-mediated heparin-induced thrombocytopenia (HIT) w/in past 100 days or in presence of circulating Ab. Active clinically significant bleeding & conditions w/ high risk of haemorrhage eg, recent haemorrhagic stroke, GI ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophth surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, major intraspinal or intracerebral vascular abnormalities. Spinal, epidural or locoregional anesth when used for treatment in previous 24 hr.

Not for IM administration. Not to be used interchangeably w/ other LMWH. Discontinue use if confirmed significant decreased platelet count; skin necrosis & cutaneous vasculitis occur. Not recommended in patients w/ acute infective endocarditis. History of HIT w/o circulating Ab (>100 days); conditions w/ increased bleeding potential eg, impaired haemostasis, history of peptic ulcer, recent ischemic stroke, severe arterial HTN, recent diabetic retinopathy, neuro- or ophth surgery; traumatic or repeated epidural or spinal puncture; history of spinal surgery or spinal deformity; hyperkalaemia; DM, pre-existing metabolic acidosis. Percutaneous coronary revascularization procedures; patients w/ mechanical prosthetic heart valves. Discontinue spinal/epidural anaesth or lumbar puncture w/in 24 hr of administration. Low wt women (<45 kg) & men (<57 kg); obese patients (BMI >30 kg/m²). Measure platelet count prior to initiation & regularly thereafter. Monitor plasma K regularly. Concomitant use of medications affecting haemostasis eg, NSAIDs; post-op indwelling epidural catheters; medicinal products increasing K levels. Not recommended in ESRD (CrCl <15 mL/min) & hepatic cirrhosis. Hepatic & renal impairment; chronic renal failure. Pregnant women w/ mechanical prosthetic heart valves. Childn. Elderly ≥75 yr.

Increased hepatic enzyme. Haemorrhage, haemorrhagic anaemia, thrombocytopenia, thrombocytosis; allergic reaction; headache; urticaria, pruritus, erythema; inj site haematoma, pain & other reaction eg, oedema, haemorrhage, hypersensitivity, inflammation, mass.

Not recommended in concomitant use w/ systemic salicylates, ASA at anti-inflammatory doses, NSAIDs eg, ketorolac; other thrombolytics eg, alteplase, reteplase, streptokinase, tenecteplase, urokinase; anticoagulants. Concomitant use w/ platelet aggregation inhibitors eg, ASA at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, glycoprotein IIb/IIIa antagonists, Dextran 40, systemic glucocorticoids, medicinal products increasing K levels.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AB05 - enoxaparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.

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