Enoxane

Enoxane

enoxaparin sodium

Manufacturer:

Hebei Changshan Biochemical

Distributor:

Sonchel

Marketer:

Ambica
Concise Prescribing Info
Contents
Enoxaparin Na
Indications/Uses
Prophylaxis of thromboembolic disorders of venous origin, particularly those which may be associated w/ orthopedic or general surgery; venous thromboembolism in patients bedridden due to acute illness. Venous thromboembolic disease presenting w/ DVT, pulmonary embolism or both. Unstable angina & non-Q-wave MI, administered concurrently w/ aspirin. Acute ST-segment elevation MI (STEMI) including patients w/ subsequent percutaneous coronary intervention (PCI) in conjunction w/ thrombolytic drugs (fibrin or non-fibrin specific). Prevention of thrombus formation in the extracorporeal circulation during hemodialysis.
Dosage/Direction for Use
Adult Prophylaxis of venous thromboembolism Patient w/ low to moderate risk of venous thromboembolism 20 mg (2,000 IU) SC once daily for 7-10 days. Patient undergoing surgery Give initial dose approx 2 hr pre-op. Patient w/ a higher risk eg, orthopedic surgery 40 mg (4,000 IU) SC daily w/ the initial dose administered approx 12 hr before surgery. Patient w/ a high-risk of venous thromboembolism who undergo abdominal or pelvic surgery for cancer & are not otherwise at risk for major bleeding complications 40 mg (4,000 IU) SC once daily for 4 wk w/ the initial dose administered approx 12 hr before surgery. Prophylaxis of venous thromboembolism in medical patients 40 mg (4,000 IU) SC once daily for a min of 6 days & continued until return to full ambulation. Max: 14 days. Treatment of venous thromboembolism 1.5 mg/kg (150 IU/kg) SC as a single daily inj for at least 5 days & until adequate oral anticoagulation is established. Treatment of acute STEMI 30 mg singe IV bolus + 1 mg/kg SC followed by 1 mg/kg SC every 12 hr. Max 100 mg for the 1st 2 doses only, followed by 1 mg/kg dosing for the remaining dose. Patient managed w/ PCI 0.3 mg/kg IV bolus if last SC administration was given >8 hr before balloon inflation. Prevention of extracorporeal thrombus formation during hemodialysis 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis session, sufficient for 4 hr session. Further dose of 0.5-1 mg/kg (50-100 IU/kg) may be given if fibrin rings are found eg, after longer sessions. Patient at a high risk of hemorrhage Reduced dose to 0.5 mg/kg (50 IU/kg) for double vascular access or 0.75 mg/kg (75 IU/kg) for single vascular access. Elderly ≥75 yr Treatment of acute STEMI Initially 0.75 mg/kg SC every 12 hr. Max: 75 mg for 1st 2 doses only, followed by 0.75 mg/kg SC for the remaining doses. Severe renal impairment 1 mg/kg SC once daily. Acute STEMI in patient ≥75 yr 1 mg/kg SC once daily w/o initial bolus. Max: 100 mg for 1st SC dose. Acute STEMI in patient <75 yr 30 mg single IV bolus + 1 mg/kg SC, followed by 1 mg/kg SC once daily. Max: 100 mg for 1st SC dose. Prophylaxis 20 mg SC once daily.
Contraindications
Hypersensitivity to enoxaparin Na, heparin or its derivatives including other LMWH. Patients w/ acute bacterial endocarditis, active major bleeding & conditions w/ a high risk of uncontrolled hemorrhage, including recent hemorrhagic stroke, thrombocytopenia in patients w/ +ve in vitro aggregation test in the presence of enoxaparin; active gastric or duodenal ulceration. Patients receiving heparin for treatment rather than prophylaxis, locoregional anesth in elective surgical procedures.
Special Precautions
Patients w/ history of heparin-induced thrombocytopenia w/ or w/o thrombosis. Discontinue use immediately & switch to another therapy if confirmed significant decrease of the platelet count is observed (30-50% of the initial values). 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. Hyperkalemia, particularly in patients w/ DM, chronic renal failure, preexisting metabolic acidosis, raised plasma K or taking K-sparing drugs. Regular monitoring of platelet counts prior to & during therapy; plasma K if prolonged therapy beyond 7 days. Concurrent use w/ spinal/epidural anesth or spinal puncture; post-op indwelling catheters or additional drugs affecting hemostasis eg, NSAIDs; traumatic or repeated neuraxial puncture or w/ history of spinal surgery or deformity. Puncture site after PCI should be observed for signs of bleeding or hematoma formation. Not recommended in patients w/ prosthetic heart valves. Pregnancy & lactation. Not recommended in childn. Elderly ≥80 yr. Low-wt women (<45 kg) & low-wt men (<57 kg); obese patients.
Adverse Reactions
Hemorrhage; thrombocytopenia & thrombocytosis. Increased hepatic enzymes (mainly transaminases). Allergic reaction; urticaria, pruritus, erythema; inj site hematoma, inj site pain, other inj site reaction.
Drug Interactions
Discontinue use w/ agents that affect hemostasis eg, systemic salicylates, acetylsalicylic acid & NSAIDs including ketorolac, dextran, clopidogrel, systemic glucocorticoids, thrombolytics & anticoagulants.
ATC Classification
B01AB05 - enoxaparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
Presentation/Packing
Form
Enoxane soln for inj 6000 anti-Xa IU/0.6 mL
Packing/Price
2 × 1's
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