Clexane

Clexane

enoxaparin sodium

Manufacturer:

Sanofi

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Enoxaparin Na
Indications/Uses
Prophylaxis of venous thromboembolic disease in moderate & high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery. Prophylaxis of venous thromboembolic disease in medical patients w/ an acute illness (eg, acute heart failure, resp insufficiency, severe infections or rheumatic diseases) & reduced mobility at increased risk of venous thromboembolism. Treatment of DVT & pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. Prevention of thrombus formation in extra corporeal circulation during haemodialysis. Acute coronary syndrome: Treatment of unstable angina & Non ST-segment elevation MI (NSTEMI), in combination w/ oral acetylsalicylic acid. Treatment of acute ST-segment elevation MI (STEMI) including patients to be managed medically or w/ subsequent percutaneous coronary intervention (PCI).
Dosage/Direction for Use
Prophylaxis of venous thromboembolic disease Patients at moderate risk 2,000 IU (20 mg) SC once daily, initiated 2 hr before surgery. Maintain treatment for a min period of 7-10 days. Patients at high risk 4,000 IU (40 mg) SC once daily preferably started 12 hr before surgery. Severe renal impairment 2,000 IU (20 mg) SC once daily. Prophylaxis of venous thromboembolism in medical patients 4,000 IU (40 mg) SC once daily, for at least 6-14 days. Treatment of DVT & PE 150 IU/kg (1.5 mg/kg) SC once daily, or 100 IU/kg (1 mg/kg) SC bd. Duration: Average period of 10 days. Severe renal impairment 100 IU/kg (1 mg/kg) SC once daily. Prevention of thrombus formation during haemodialysis 100 IU/kg (1 mg/kg) introduced into the arterial line of the circuit at the beginning of the dialysis session. Patients w/ high risk of haemorrhage Reduce dose to 50 IU/kg (0.5 mg/kg) for double vascular access or 75 IU/kg (0.75 mg/kg) for single vascular access. Treatment of unstable angina & NSTEMI 100 IU/kg (1 mg/kg) SC every 12 hr in combination w/ antiplatelet therapy. Usual duration of treatment: 2-8 days. Severe renal impairment 100 IU/kg (1 mg/kg) SC once daily. Treatment of acute STEMI 3,000 IU (30 mg) single IV bolus + 100 IU/kg (1 mg/kg) SC followed by 100 IU/kg SC every 12 hr. Max: 10,000 IU (100 mg) for each of the 1st 2 SC doses. Duration of treatment: 8 days or until hospital discharge, whichever comes 1st. Elderly ≥75 yr No initial IV bolus. Initiate w/ 75 IU/kg (0.75 mg/kg) SC every 12 hr. Max: 7,500 IU (75 mg) for each of the 1st 2 SC doses only, followed by 75 IU/kg (0.75 mg/kg) SC dosing for the remaining doses. Severe renal impairment in patients <75 yr 1 x 3,000 IU (30 mg) IV bolus + 100 IU/kg (1 mg/kg) SC then 100 IU/kg (1 mg/kg) SC every 24 hr; >75 yr No initial IV bolus. 100 IU/kg SC, then 100 IU/kg SC every 24 hr.
Contraindications
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 Ab. Active clinically significant bleeding & conditions w/ a high risk of haemorrhage, including 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 or major intraspinal or intracerebral vascular abnormalities. Spinal or epidural anaesth or loco-regional anaesth when enoxaparin Na is used for treatment in the previous 24 hr.
Special Precautions
Enoxaparin Na cannot be used interchangeably w/ other LMWHs. Extreme caution in patients w/ a history (>100 days) of heparin-induced thrombocytopenia (HIT) w/o circulating Abs. Higher risk of HIT in post-op patients. Measure platelet counts before the initiation of therapy, then regularly thereafter during the treatment. Bleeding may occur at any site. Use w/ caution in conditions w/ increased potential for bleeding. Increases in activated partial thromboplastin time (aPTT) & activated clotting time (ACT) may occur at higher doses. Neuraxial haematomas w/ concurrent use of spinal/epidural anaesth or spinal puncture procedures. Skin necrosis & cutaneous vasculitis. Adhere precisely to the recommended intervals between enoxaparin Na doses to minimize the risk of bleeding following vascular instrumentation. Not recommended in patients w/ acute infective endocarditis. Hyperkalemia. Prosthetic heart valve thrombosis especially in pregnant women w/ mechanical prosthetic heart valves. Renal & hepatic impairment. Low-weight. Obese patients. Pregnancy. Elderly.
Adverse Reactions
Hepatic enzyme increases. Haemorrhage, haemorrhagic anaemia, thrombocytopenia, thrombocytosis; allergic reaction; headache; urticaria, pruritus, erythema; inj site haematoma, inj site pain, other inj site reaction.
Drug Interactions
Concomitant use w/ some agents which affect haemostasis (eg, systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, & NSAIDs including ketorolac, other thrombolytics (eg, alteplase, reteplase, streptokinase, tenecteplase, urokinase) & anticoagulants) is not recommended. Use w/ caution when administered concomitantly w/ platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, & glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, Dextran 40, systemic glucocorticoids; medicinal products increasing K levels.
ATC Classification
B01AB05 - enoxaparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
Presentation/Packing
Form
Clexane inj 60 mg/0.6 mL
Packing/Price
2 × 1's
Form
Clexane inj 20 mg/0.2 mL
Packing/Price
2 × 1's
Form
Clexane inj 80 mg/0.8 mL
Packing/Price
2 × 1's
Form
Clexane inj 40 mg/0.4 mL
Packing/Price
2 × 1's
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