Clexane

Treatment of DVT w/ or w/o pulmonary embolism; unstable angina & non-Q-wave MI, administered concurrently w/ aspirin; acute ST-segment elevation MI (STEMI) including patients to be managed medically or w/ subsequent percutaneous coronary intervention (PCI). Prophylaxis of venous thrombo-embolic disease, in particular those which may be associated w/ orthopedic or general surgery; VTE in medical patients bedridden due to acute illnesses including cardiac insufficiency, resp failure, severe infections, rheumatic diseases. Prevention of thrombus formation in extracorporeal circulation during hemodialysis.

Prophylaxis of venous thrombosis in surgical patient Patient w/ moderate risk of thromboembolism (eg, abdominal surgery) 20 or 40 mg SC once daily. Give 1st inj 2 hr before surgical procedure. Duration: 7-10 days. May continue therapy for as long as there is VTE risk & until patient is ambulatory. Patient w/ high risk of thromboembolism (eg, orthopedic surgery) 40 mg SC once daily, initiated 12 hr prior to surgery or 30 mg bid, initiated 12-24 hr after surgery. Duration: 7-10 days. May continue therapy for as long as there is VTE risk & until patient is ambulatory. Continued therapy w/ 40 mg once daily for 3 wk following initial therapy has been proven beneficial in orthopedic surgery. Prophylaxis of VTE in medical patient 40 mg SC once daily for a min 6 days & continued until return to full ambulation, for max 14 days. Treatment of DVT w/ or w/o pulmonary embolism 1.5 mg/kg SC as single inj or 1 mg/kg SC bid. Duration: 10 days. Initiate oral anticoagulant therapy when appropriate & continue enoxaparin Na treatment until therapeutic anticoagulant effect has been achieved (INR 2-3). Patient w/ complicated thrombo-embolic disorder 1 mg/kg SC bid. Prevention of extracorporeal thrombus during hemodialysis 1 mg/kg introduced into the arterial line of the circuit at the beginning of dialysis session. Further dose of 0.5-1 mg/kg may be given if fibrin rings are found eg, after longer session. Patient w/ high risk of hemorrhage Reduced dose to 0.5 mg/kg for double vascular access or 0.75 mg/kg for single vascular access. Treatment of unstable angina & non-Q-wave MI 1 mg/kg SC every 12 hr w/ oral aspirin 100-325 mg once daily for min 2 days & continued until clinical stabilization. Duration: 2-8 days. Treatment of acute STEMI 30 mg single IV bolus + 1 mg/kg SC followed by 1 mg/kg SC every 12 hr. Max: 100 mg for each of the 1st 2 SC doses only, followed by 1 mg/kg SC for the remaining doses. Give between 15 min before & 30 min after start of fibrinolytic therapy when administered in conjunction w/ a fibrin/non-fibrin specific thrombolytic. Duration: 8 days or until hospital discharge, whichever comes first. Patient managed w/ PCI Last enoxaparin Na SC administration given <8 hr before balloon inflation: No additional dosing needed. Last SC administration given >8 hr before balloon inflation: Administer 0.3 mg/kg IV bolus of enoxaparin Na. Patient w/ severe renal impairment (CrCl <30 mL/min) 30 mg single IV bolus + 1 mg/kg SC followed by 1 mg/kg SC once daily. Max: 100 mg for 1st SC dose only. Elderly ≥75 yr Initially 0.75 mg/kg SC every 12 hr (max: 75 mg for each of the 1st 2 SC doses only, followed by 0.75 mg/kg SC for the remaining doses). Elderly ≥75 yr w/ severe renal impairment (CrCl <30 mL/min) 1 mg/kg SC once daily w/o initial bolus. Max: 100 mg for 1st SC dose only. All indications Severe renal impairment (CrCl <30 mL/min) Therapeutic dose range: Adjust standard dose of 1 mg/kg SC bid & 1.5 mg/kg SC once daily to 1 mg/kg SC once daily. Prophylactic dose range: Adjust standard dose of 40 or 20 mg SC once daily to 20 mg SC once daily.

Hypersensitivity to enoxaparin Na, heparin or its derivatives including other LMWH. History of immune mediated heparin-induced thrombocytopenia w/in the past 100 days or in the presence of circulating Abs. Active major bleeding & conditions w/ a high risk of uncontrolled hemorrhage including hemorrhagic stroke.

Do not administer by IM. Investigate origin of hemorrhage if bleeding occurs & institute appropriate treatment. Use w/ caution in conditions w/ increased potential for bleeding eg, impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial HTN, diabetic retinopathy, recent neuro- or ophth surgery, concomitant use of medications affecting hemostasis. Use has not been adequately studied for thromboprophylaxis in patients w/ mechanical prosthetic heart valves. Reports of neuraxial haematomas w/ concurrent use of spinal/epidural anaesth. Initiate urgent diagnosis & treatment including spinal cord decompression if signs or symptoms of spinal haematoma are suspected. Precisely adhere to the intervals recommended between enoxaparin Na doses to minimize risk of bleeding following vascular instrumentation; observe for signs of bleeding or hematoma formation at site of the procedure. Do not use LMWH interchangeably. Obese patients are at higher risk for thromboembolism. Increased aPTT & activated clotting time in higher doses. Measure platelet counts prior to initiation of & regularly thereafter during treatment; immediately discontinue treatment & switch to another therapy if a confirmed significant decrease of platelet count is observed (30-50% of initial value). Caution in patients w/ hepatic impairment. Increased risk of bleeding in patients w/ renal impairment; low-wt women (<45 kg) & men (<57 kg). Use during pregnancy only if there is an established need. Pregnant women w/ mechanical prosthetic heart valves may be at higher risk for thromboembolism. Avoid breast-feeding during treatment. Safety & efficacy have not been established in childn. Elderly (especially those ≥80 yr) may be at increased risk for bleeding complications.

Haemorrhage; thrombocytosis; increased hepatic enzymes (mainly transaminases). Thrombocytopenia; allergic reaction; urticaria, pruritus, erythema; inj site haematoma, inj site pain, other inj site reaction.

Agents which affect hemostasis (eg, systemic salicylates, ASA & NSAIDs including ketorolac; dextran 40, ticlopidine & clopidogrel; systemic glucocorticoids; thrombolytics & anticoagulants; other antiplatelet agents including glycoprotein IIb/IIIa antagonists) are recommended to be discontinued prior to enoxaparin Na therapy.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

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

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