Enomax

Enomax

enoxaparin

Manufacturer:

Nanjing King-Friend

Distributor:

Goodfellow
Concise Prescribing Info
Contents
Enoxaparin Na
Indications/Uses
Prophylaxis of VTE in moderate & high risk surgical patients & in medical patients w/ acute illness (eg, acute heart failure, resp insufficiency, severe infections or rheumatic diseases) & reduced mobility at increased risk of VTE. Prevention of thrombus formation in extracorporeal circulation during haemodialysis. DVT & pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery. In combination w/ oral ASA for unstable angina & non-ST-segment elevation MI (NSTEMI). Acute ST-segment elevation MI (STEMI) including patients to be managed medically or w/ subsequent percutaneous coronary intervention (PCI).
Dosage/Direction for Use
Surgical prophylaxis of VTE Patient w/ moderate thromboembolism risk 2,000 IU (20 mg) SC once daily given 2 hr pre-op. Maintain treatment for min period of 7-10 days until patient no longer has significantly reduced mobility. Patient w/ high thromboembolism risk 4,000 IU (40 mg) SC once daily given ≤12 hr pre-op. Extend thromboprophylaxis up to 5 wk for patient who undergoes major orthopaedic surgery; up to 4 wk for high-risk patient who undergoes abdominal or pelvic surgery for cancer. Prophylaxis of VTE Medical patient 4,000 IU SC once daily for 6-14 days. Patient w/ severe renal impairment (CrCl 15-30 mL/min) 2,000 IU SC once daily. DVT & PE Uncomplicated patient w/ low risk of VTE recurrence 150 IU/kg (1.5 mg/kg) SC once daily for ave period of 10 days. Patient w/ obesity, symptomatic PE, cancer, recurrent VTE or proximal (vena iliaca) thrombosis 100 IU/kg (1 mg/kg) bd for ave period of 10 days. Patient w/ severe renal impairment (CrCl 15-30 mL/min) 100 IU/kg SC once daily. Prevention of thrombus formation during haemodialysis 100 IU/kg. Patient w/ high risk of haemorrhage Reduce to 50 IU/kg (0.5 mg/kg) for double vascular access or 75 IU/kg (0.75 mg/kg) for single vascular access. Unstable angina & NSTEMI 100 IU/kg SC every 12 hr in combination w/ antiplatelet therapy. Usual treatment duration: 2-8 days. Patient w/ severe renal impairment (CrCl 15-30 mL/min) 100 IU/kg SC once daily. Acute STEMI 3,000 IU (30 mg) single IV bolus followed by 100 IU/kg SC every 12 hr [max 10,000 IU (100 mg) for each of the 1st 2 SC doses] for 8 days or until hospital discharge. Administer between 15 min before & 30 min after start of fibrinolytic therapy when administered in conjunction w/ a thrombolytic (fibrin or non-fibrin specific). Patient managed by PCI 30 IU/kg (0.3 mg/kg) IV bolus if last SC inj was given >8 hr before balloon inflation. Elderly ≥75 yr 75 IU/kg SC every 12 hr. Max: 7,500 IU for 1st 2 SC doses. Patient >75 yr w/ severe renal impairment (CrCl 15-30 mL/min) 100 IU/kg SC then 100 IU/kg SC every 24 hr, <75 yr w/ severe renal impairment (CrCl 15-30 mL/min) 3,000 IU IV bolus + 100 IU/kg SC then 100 IU/kg SC every 24 hr.
Contraindications
Hypersensitivity to enoxaparin, heparin or its derivatives, including 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 or major intraspinal or intracerebral vascular abnormalities. Spinal, epidural or locoregional anaesth when enoxaparin Na is used for treatment in the previous 24 hr.
Special Precautions
Not for IM administration. Not to be used interchangeably w/ other LMWH. Discontinue use in case of confirmed significant decreased platelet count (30-50% of the initial value); & if skin necrosis & cutaneous vasculitis occur. Measure platelet count prior to treatment initiation, regularly thereafter, & if there are clinical symptoms suggestive of HIT. Increases in aPTT & activated clotting time may occur at higher doses w/ no linear correlation w/ increasing antithrombotic activity. Reports of neuraxial haematomas w/ spinal/epidural anaesth or spinal puncture procedures resulting in long-term or permanent paralysis. Spinal/epidural anaesth or lumbar puncture must not be performed w/in 24 hr of administration of enoxaparin at therapeutic doses. Observe site of PCI procedure for signs of bleeding or hematoma formation. Can suppress adrenal secretion of aldosterone leading to hyperkalaemia; regularly monitor plasma K especially in patients at risk. Patients w/ history of HIT w/o circulating Ab (>100 days); increased bleeding potential eg, impaired haemostasis, history of peptic ulcer, recent ischemic stroke, severe arterial HTN, recent diabetic retinopathy, neuro- or ophth surgery, concomitant medications affecting haemostasis; mechanical prosthetic heart valves, especially in pregnant women; hepatic or renal impairment. Low wt women (<45 kg) & men (<57 kg); obese patients (BMI >30 kg/m2). Not recommended in patients w/ acute infective endocarditis; ESRD (CrCl <15 mL/min); liver cirrhosis. Pregnancy. Safety & efficacy in paed population have not been established. Elderly ≥75 yr.
Adverse Reactions
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).
Drug Interactions
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. Caution when concomitantly used 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.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AB05 - enoxaparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
Presentation/Packing
Form
Enomax soln for inj 40 mg/0.4 mL
Packing/Price
2 × 1's
Form
Enomax soln for inj 60 mg/0.6 mL
Packing/Price
2 × 1's