Crusia

Crusia

enoxaparin sodium

Manufacturer:

Rovi

Distributor:

Unimed
Concise Prescribing Info
Contents
Enoxaparin Na
Indications/Uses
Prophylaxis of venous thromboembolic (VTE) disease in moderate & high-risk surgical patients particularly those undergoing orthopaedic or general surgery including cancer surgery; in medical patients w/ acute illness eg, acute heart failure, resp insufficiency, severe infection or rheumatic diseases & reduced mobility at increased risk of venous thromboembolism. Prevention of thrombus formation in extracorporeal circulation during haemodialysis. DVT & pulmonary embolism (PE) excluding PE likely requiring thrombolytic therapy or surgery. Unstable angina & non-ST-segment elevation MI (NSTEMI) in combination w/ PO acetylsalicylic acid; 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 VTE disease in surgery Patient w/ moderate thromboembolism risk 2,000 IU SC once daily. 1st inj given 2 hr pre-op. Maintained for min: 7-10 days. Patient w/ high thromboembolism risk 4,000 IU SC once daily w/ initial dose given 12 hr pre-op. Last inj to be given not >12 hr pre-op & resumed 12 hr post-op. Patient who undergoes major orthopaedic surgery May extend for up to 5 wk. Patient w/ high VTE risk who undergoes abdominal or pelvic cancer surgery May extend for up to 4 wk. Prophylaxis of VTE in medical patient 4,000 IU SC once daily for at least 6-14 days. DVT & PE 150 IU/kg SC once daily or 100 IU/kg SC bd. Prevention of thrombus formation during haemodialysis 100 IU/kg introduced into arterial circuit line prior to 4-hr haemodialysis. Patient w/ high-risk of haemorrhage Reduce dose to 50 IU/kg for double vascular access or 75 IU/kg for single vascular access. Unstable angina & NSTEMI 100 IU/kg SC every 12 hr in combination w/ antiplatelet therapy for min: 2 days until clinical stabilization. Usual duration: 2-8 days. Acute STEMI 3,000 IU single IV bolus + 100 IU/kg SC followed by 100 IU/kg SC every 12 hr. Max: 10,000 IU each for 1st 2 SC doses. Recommended duration: 8 days or until hospital discharge. Elderly ≥75 yr Initially 75 IU/kg SC every 12 hr. Max: 7,500 IU each for 1st 2 SC doses, followed by 75 IU/kg SC for the remaining doses. Patient managed w/ PCI 30 IU/kg IV bolus if last SC inj was given >8 hr before balloon inflation.
Contraindications
Hypersensitivity to enoxaparin Na, heparin or its derivatives, other LMWH. History of immune-mediated heparin-induced thrombocytopenia (HIT) w/in past 100 days or in presence of circulating Ab; clinically significant active bleeding & conditions w/ 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 or loco-regional anaesth.
Special Precautions
Not for IM administration. Discontinue use if skin necrosis & cutaneous vasculitis occur. Not recommended in patients w/ acute infective endocarditis, liver cirrhosis. History of HIT w/o circulating Ab; conditions w/ increased bleeding potential eg, impaired haemostasis, history of peptic ulcer, recent ischemic stroke & diabetic retinopathy, severe arterial HTN, neuro- or ophth surgery; hyperkalaemia, DM, chronic renal failure, preexisting metabolic acidosis. Low wt & obese patients. Spinal/epidural anaesth or lumbar puncture must not be performed w/in 24 hr of administration. Percutaneous coronary revascularization procedures; mechanical prosthetic heart valves. Monitor platelet counts prior to therapy & regularly thereafter. Not to be used interchangeably w/ other LMWHs. Concomitant use w/ medications affecting haemostasis; medicinal products increasing K. Not recommended in end-stage renal disease (CrCl <15 mL/min). Hepatic & severe renal impairment. Pregnant women w/ mechanical prosthetic heart valves. Paed. Elderly ≥75 yr.
Adverse Reactions
Increased hepatic enzymes. Haemorrhage, haemorrhagic anaemia, thrombocytopenia, thrombocytosis; allergic reaction; headache; urticaria, pruritus, erythema; inj site hematoma & pain, other inj site reaction eg, oedema, haemorrhage, hypersensitivity, inflammation, mass.
Drug Interactions
Medicinal products affecting haemostasis eg, systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, NSAIDS, other thrombolytics (eg, alteplase, reteplase, streptokinase, tenecteplase, urokinase), anticoagulants. Platelet aggregation inhibitors eg, acetylsalicylic acid at antiaggregrant doses, clopidogrel, ticlopidine, glycoprotein IIb/IIIa antagonists, Dextran 40, systemic glucocorticoids, medicinal products increasing serum K levels.
ATC Classification
B01AB05 - enoxaparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
Presentation/Packing
Form
Crusia soln for inj 6,000 IU/0.6 mL
Packing/Price
10 × 1's
Form
Crusia soln for inj 8,000 IU/0.8 mL
Packing/Price
10 × 1's
Form
Crusia soln for inj 2,000 IU/0.2 mL
Packing/Price
10 × 1's
Form
Crusia soln for inj 4,000 IU/0.4 mL
Packing/Price
10 × 1's
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