Enoxaparin STADA

Enoxaparin Na

4,000 anti-Xa IU/0.4 mL (40 mg/0.4 mL): Prevention of clotting in the extra-corporeal circulation during hemodialysis (generally as sessions of ≤4 hr). Prophylaxis of venous thrombo-embolic disease in patients undergoing an orthopedic or general surgery procedure, including cancer surgery, w/ moderate or high risk of thromboembolism; DVT in bedridden patients due to acute medical conditions eg, heart failure (NYHA class III or IV), acute resp failure, episode of acute infection or rheumatic disorder associated w/ at least 1 other risk factor for venous thromboembolic disease. 6,000 anti-Xa IU/0.6 mL (60 mg/0.6 mL): Curative treatment of established DVT, w/ or w/o pulmonary embolism, w/o clinical severity, excluding pulmonary embolism likely to require treatment w/ a thrombolytic agent or by surgery. In combination w/ aspirin as treatment for unstable angina & acute non-Q-wave MI; w/ a thrombolytic agent in patients eligible or not for subsequent coronary angioplasty as treatment for acute ST-segment elevation MI.

Prophylactic treatment of venous thromboembolic disease in surgery Patient w/ moderate risk of thromboembolism Recommended dose: 40 mg SC once daily. In general surgery: 1st inj should be given 2 hr before surgical procedure. Duration of treatment: 7-10 days; high risk of thromboembolism Recommended dose: 40 mg SC once daily, initiated 12 hr prior to surgery or 30 mg bid, initiated 12-24 hr after surgery. Patient who undergoes major orthopedic surgery w/ high venous thromboembolism risk Recommend thromboprophylaxis up to 5 wk; undergoes cancer surgery w/ high venous thromboembolism risk Recommend thromboprophylaxis up to 4 wk. Prophylactic treatment of DVT in acute medical conditions 40 mg or 4,000 anti-Xa IU/0.4 mL SC once daily. Duration of treatment: 6-14 days. Prevention of clotting in extracorporeal: Circulation/hemodialysis Patient undergoing repeated hemodialysis sessions, prevention of clotting in extrarenal purification system Initial dose: 100 anti-Xa IU/kg (1 mg/kg) in arterial line of dialysis circuit at beginning of session. Administer as single intravascular bolus inj for hemodialysis sessions of ≤4 hr. Subsequently, can be adjusted as a result of high inter- & intra-individual variability. Further dose 0.5-1 mg/kg may be given if fibrin rings are found, after a longer than normal session. Max recommended dose: 100 anti-Xa IU/kg (1 mg). In hemodialysis patients at high risk of hemorrhage (particularly pre- & post-op dialysis) or w/ active hemorrhage 50 anti-Xa IU/kg (0.5 mg/kg) (double vascular access) or 75 anti-Xa IU/kg (7.5 mg/kg) (single vascular access). Curative treatment of DVT, w/ or w/o pulmonary embolism, w/o signs of clinical severity Administer SC 150 anti-Xa IU/Kg (1.5 mg/kg) as single daily inj or 100 anti-Xa IU/kg (1 mg/kg) as bid inj. Patient w/ complicated thromboembolic disorders Recommended dose: 100 anti-Xa (1 mg) bid. DVT Duration of treatment w/ LMWH: Not to exceed 10 days. Curative treatment of unstable angina/non-Q-wave MI 100 anti-Xa IU/kg (1 mg/kg) SC bid at 12-hr interval in combination w/ aspirin 75-325 mg orally, following minimum loading dose 160 mg. Recommended duration of treatment: 2-8 days until patient is clinically stable. Treatment of acute ST-segment elevation MI in combination w/ thrombolytic agent in patients eligible or not for subsequent coronary angioplasty Initially, 3,000 anti-Xa IU (30 mg) IV bolus inj followed by 1 mg/kg SC inj w/in 15 min, then every 12 hr [max: 10,000 anti-Xa (100 mg) for each of 1st 2 SC doses followed by 1 mg/kg SC dosing for remaining doses]. Administer 1st dose at any time between 15 min before or 30 min after start of thrombolytic treatment (whether fibrin-specific or not). Recommended duration of treatment: 8 days until patient is discharged from hospital or hospitalization period is <8 days. Concomitant administration w/ aspirin Administer as soon as possible after symptoms appear & maintain at dosage between 75 mg & 325 mg daily for at least 30 days, unless otherwise indicated. Patient treated w/ coronary angioplasty If last SC in performed >8 hr before balloon inflation: Administer 30 anti-Xa IU/kg (0.3 mg) IV bolus. Recommended to dilute to 300 IU/mL (3 mg/mL) to improve accuracy of vol to be inj. If last SC inj performed <8 hr before balloon inflation: No additional administration is necessary. Patient ≥75 yr, treated for acute ST-segment MI 75 anti-Xa IU/kg (7.5 mg/kg) SC every 12 hr [max: 7,500 anti-Xa IU (75 mg) for each of 1st 2 inj only, followed by 0.75 mg/kg SC dosing for remaining doses].

Hypersensitivity to enoxaparin Na, heparin or its derivatives including other LMWH. Not to be used at curative doses for intracerebral hemorrhage; in patients w/ spinal or epidural anesth under LMWH treatment. Bleeding or tendency to bleed related to impaired hemostasis. Organic lesion likely to bleed. Active major bleeding & conditions w/ a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke. History of immune mediated heparin-induced thrombocytopenia (HIT) w/in the past 100 days or in the presence of circulating Abs.

Not to be administered via IM route. LMWH should not be used interchangeably. Not advisable at curative doses in patients w/ acute extensive ischemic stroke, w/ or w/o impaired consciousness; acute infectious endocarditis (except for some emboligenic cardiac conditions); mild to moderate kidney failure (CrCl between 30 & 60 mL/min); at prophylactic doses in patients w/ severe renal failure (CrCl approx 30 mL/min); in cases during 1st 24 hr following intracerebral hemorrhage; at curative doses in subjects of any age & prophylactic doses in ≥65 yr in combination w/ ASA, analgesic, antipyretic & anti-inflammatory doses, NSAIDs (systemic use), dextran 40 (parenteral use). Serious hemorrhagic events may occur in patients w/ renal failure, bodywt <40 kg; during treatment lasting longer than the recommended duration of 10 days; elderly patients particularly due to age-related renal impairment; non-compliance w/ treatment recommendations (particularly treatment duration) & dose adjustment based on bodywt in curative treatment; co-administration w/ drugs increasing risk of hemorrhage. Higher risk of intraspinal hematomas in epidural anesth w/ a catheter than in spinal anesth; bleeding in low wt women (<45 kg), men (<57 kg); for thromboembolism in obese patients (BMI >30 kg/m²). Patients w/ history of immune mediated HIT w/in past 100 days or in presence of circulating Abs. Conditions w/ increased potential for bleeding. Close neurological monitoring is recommended due to risk of intraspinal hematoma. Initiate prophylactic treatment w/in 6-8 hr after anesth or removal of catheter, under neurological monitoring in almost all patients. Delay placement or removal of a catheter for at least 12 hr after administration of lower doses (20 mg once daily, 30 mg once or bid or 40 mg once daily) & at least 24 hr after administration of higher doses (0.75 mg/kg bid, 1 mg/kg bid, or 1.5 mg/kg once daily). Patients receiving 0.75 mg/kg bid dose or 1 mg/kg bid dose should not receive 2nd dose in bid regimen to allow a longer delay before catheter placement or removal. Consider doubling the timing of removal of catheter, at least 24 hr for lower prescribed dose (30 mg once daily) & at least 48 hr for higher dose (1 mg/kg/day) in patients w/ CrCl <30 mL/min. Frequent monitoring to detect any signs & symptoms of neurological impairment eg, midline back pain, sensory & motor deficits (lower limbs numbness or weakness), bowel &/or bladder dysfunction if physician decided to administer anticoagulation in the context of epidural/spinal anesth or lumbar puncture. Perform urgent diagnosis & treatment including spinal cord decompression if signs or symptoms of spinal haematoma are suspected; hemostasis at vascular puncture site following coronary angioplasty. Monitor puncture site to detect any signs of bleeding or hematoma. Investigate the origin of hemorrhage & institute appropriate treatment if bleeding occurs. Perform platelet counts before administration or at latest w/in 24 hr of initiating treatment, then twice a wk during usual treatment duration. Schedule platelet counts twice a wk during 1st mth of treatment (higher risk period & then once a wk until treatment discontinuation if long term treatment is necessary in certain specific cases ie, hip surgery, 2nd & 3rd trimesters of high-risk pregnancy. Perform immediate platelet counts for verification; discontinuation of heparin treatment; prevention or treatment of HIT-related thrombotic complications if decrease in platelets is observed. Intensify monitoring of treatment as it may moderately increase aPTT in following cases eg, hepatic insufficiency, history of GI ulcers or any other organic lesion likely to bleed, chorioretinal vascular disease, post-op following cerebral or spinal cord surgery lumbar puncture, bleeding, concomitant use of medicinal products affecting hemostasis. Evaluate renal function by determining CrCl particularly in subjects ≥75 yr before LMWH treatment initiation. Intensify clinical monitoring & lab tests (prothrombin time as INR) to monitor oral anticoagulants effect during replacement of heparin by oral anticoagulants. Monitor anti-Xa activity in managing the risk of bleeding in certain clinical conditions often associated w/ risk of overdose. Replace heparin by an antithrombotic agent of different group eg, Na danaparoid or hirudin if continued anticoagulant therapy appears to be essential. Co-administration w/ other drugs affecting hemostasis (specifically NSAIDs, aspirin). Moderate (CrCl 30-50 mL/min) & mild (CrCl 50-80 mL/min) renal impairment. Hepatic impairment. Higher risk of thromboembolic events in pregnant women w/ mechanical prosthetic heart valves. Avoid breastfeeding. Not recommended in childn. Special monitoring in elderly &/or patients w/ renal failure as well as during treatment prolonged >10 days. Increased risk for bleeding complications w/ therapeutic dosage ranges in elderly patients (especially ≥80 yr). Prophylactic treatment: Not to be administered during 1st trimester. If epidural anesth is planned, interrupt preventive heparin treatment whenever possible w/in 12 hr before anesth at the latest. Curative treatment: Not recommended throughout pregnancy. Never perform spinal or epidural anesth.

Haemorrhage, thrombocytosis, increased hepatic enzymes (mainly transaminases; transaminases levels >3x ULN). Thrombocytopenia, allergic reaction, urticaria, pruritus, erythema, inj site haematoma, pain, & other inj site reaction.

Hyperkalemia w/ K salts & K-sparing diuretics, enzyme inhibitors, AIIA, NSAIDs, heparin (LMWH or unfractionated), ciclosporin & tacrolimus, trimethoprim. Increased risk of bleeding w/ ASA, NSAIDs (systemic use), dextran 40 (parenteral use) & platelet aggregation inhibitors (abciximab, beraprost, clopidogrel, eptifibatide, iloprost, ticlopidine, tirofiban). Potentiated effects w/ oral anticoagulants. Discontinue use w/ agents that affect hemostasis eg, systemic salicylates, ASA & NSAIDs including ketorolac, dextran 40, ticlopidine & clopidogrel, systemic glucocorticoids, thrombolytics, anticoagulants & other anti-platelet agents including glycoprotein IIb/IIIa antagonists prior therapy unless strictly indicated.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

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

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