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Enoxar

Enoxar

enoxaparin

Manufacturer:

Brawn Labs

Distributor:

Uni-Pharma

Marketer:

Ambica
Concise Prescribing Info
Contents
Enoxaparin Na
Indications/Uses
2,000 IU/0.2 mL soln for inj: Treatment & prophylaxis of acute DVT. Treatment of acute ST-segment elevation MI (STEMI). Ischaemic complications of unstable angina & non-Q-wave MI. 4,000 IU/0.4 mL soln for inj: Prophylaxis VTE disease in moderate & high-risk surgical patients particularly those undergoing orthopedic or general surgery including cancer surgery; in medical patients w/ an acute illness (eg, heart failure, resp insufficiency, severe infections or rheumatic disease) & reduced mobility at increased risk of VTE. Prevention of thrombus formation in extracorporeal circulation during hemodialysis. Acute coronary syndrome. Treatment of unstable angina & non-STEMI in combination w/ oral ASA. Treatment of STEMI including patients to be managed medically or w/ subsequent percutaneous coronary intervention (PCI). 6,000 IU/0.6 mL soln for inj: Treatment & prophylaxis of acute DVT. Prophylaxis of ischaemic complications of unstable angina & non-Q-wave MI.
Dosage/Direction for Use
2,000 IU/0.2 mL & 6,000 IU/0.6 mL soln for inj Abdominal surgery 40 mg once daily w/ initial dose given 2 hr prior to surgery for 7-10 days, up to 12 days. Hip or knee replacement surgery 30 mg every 12 hr given 12-24 hr after surgery for 7-10 days, up to 14 days. For hip replacement surgery, 40 mg once daily given initially 12 hr prior to surgery may be considered & continue prophylaxis for 3 wk. Medical patient during acute illness 40 mg once daily for 6-11 days up to 14 days. 4,000 IU/0.4 mL soln for inj Prophylaxis of VTE disease in moderate & high-risk surgical patients 2,000 IU (20 mg) once daily initiated 2 hr before surgery. Maintain for a min of 7-10 days. Patient at high risk of thromboembolism 4,000 IU (40 mg) preferably started 12 hr before surgery. If there is a need for earlier than 12 hr of pre-op prophylactic initiation, the last inj should be administered no later than 12 hr prior to surgery & resumed 12 hr after surgery. Patient who undergoes major orthopedic surgery Extended thromboprophylaxis for up to 5 wk. Patient w/ high VTE risk who undergoes abdominal or pelvic surgery for cancer Extended prophylaxis for up to 4 wk. Prophylaxis of VTE in medical patient 4,000 IU (40 mg) once daily for 6-14 days. DVT & PE 150 IU/kg (1.5 mg/kg) once daily for uncomplicated patients w/ a low risk of VTE recurrence & 100 IU/kg (1 mg/kg) bid for all other patients eg, those w/ obesity, symptomatic PE, cancer, recurrent VTE or proximal thrombosis). Prevention of thrombus formation during hemodialysis 100 IU/kg (1 mg/kg). Patient w/ high risk of hemorrhage Reduce dose to 50 IU/kg for double vascular access or 75 IU/kg for single vascular access. Unstable angina & NSTEMI 100 IU/kg every 12 hr + antiplatelet therapy for 2-8 days. Acute STEMI 3,000 IU as single IV bolus + 100 IU/kg SC dose followed by 100 IU/kg as SC every 12 hr (max: 10,000 IU for each of the 1st 2 SC doses). Administer concomitantly w/ antiplatelet therapy eg, ASA 75 mg-325 mg once daily. Duration of treatment: 8 days or until hospital discharge. Elderly ≥75 yr Acute STEMI Initially 75 IU/kg SC every 12 hr. Max: 7,500 IU for each of the 1st 2 SC doses only, followed by 75 IU/kg SC dosing for the remaining doses.
Contraindications
2,000 IU/0.2 mL & 6,000 IU/0.6 mL soln for inj: Hypersensitivity to enoxaparin Na, heparin or its derivatives including LMWH. Patients w/ active major bleeding, thrombocytopenia associated w/ +ve in vitro test for antiplatelet Ab in the presence of Enoxaparin Na. 4,000 IU/0.4 mL soln for inj: History of immune-mediated heparin-induced thrombocytopenia w/in the past 100 days or in the presence of circulating Abs. Active clinically significant bleeding & conditions w/ a high risk of hemorrhage, including recent hemorrhagic stroke, GI ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophth surgery, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; spinal or epidural anesth or loco-regional anesth when enoxaparin Na is used for treatment in the previous 24 hr.
Special Precautions
Higher risk of bleeding in low wt (<45 kg) women & men (<57 kg). Hepatic & severe renal impairment. Pregnancy. Elderly. 2,000 IU/0.2 mL & 6,000 IU/0.6 mL soln for inj: Not to be mixed w/ other inj or infusions. Patients w/ bleeding diathesis, uncontrolled arterial HTN, or a history of recent GI ulceration, diabetic retinopathy, & hemorrhage. Patients w/ history of heparin-induced thrombocytopenia. Conditions w/ increased risk of hemorrhage, eg, as bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative & angiodysplastic GI disease, hemorrhagic stroke, or shortly after brain, spinal, or ophth surgery, or in patients treated concomitantly w/ platelet inhibitors. Cases of epidural or spinal hematomas & spinal/epidural anesth or spinal puncture resulting in long-term or permanent paralysis. 4,000 IU/0.4 mL soln for inj: Risk of Ab-mediated HIT. Measure platelet counts before the initiation of therapy & regularly thereafter during the treatment. Immediately discontinue treatment if a significant decrease of the platelet count is observed. Impaired hemostasis, history of peptic ulcer, recent ischemic stroke, severe arterial HTN, recent diabetic retinopathy, neuro- or ophthalmologic surgery. Spinal/epidural anesth or lumbar puncture must not be performed w/in 24 hr of administration of enoxaparin Na at therapeutic doses. Skin necrosis & cutaneous vasculitis. To minimize the risk of bleeding following the vascular instrumentation during the treatment of unstable angina, NSTEMI & acute STEMI, adhere precisely to the intervals recommended between enoxaparin Na inj doses. Not recommended in patients w/ acute infective endocarditis due to the risk of cerebral hemorrhage. Patients w/ mechanical prosthetic heart valves. Pregnant women w/ mechanical prosthetic heart valves may be at higher risk for thromboembolism. Obese patients. Hyperkalemia; regularly monitor plasma K. This medicine contains >24 mg Na in each dose.
Adverse Reactions
2,000 IU/0.2 mL & 6,000 IU/0.6 mL soln for inj: Mild to moderate thrombocytopenia. Mild local irritation, pain, hematoma, ecchymosis, & erythema. Patients w/ unstable angina or non-Q-wave MI: Non-major hemorrhagic, primarily inj site ecchymoses & hematoma. 4,000 IU/0.4 mL soln for inj: Increased hepatic enzyme increases (mainly transaminases >3x ULN). Hemorrhage, hemorrhagic anemia, thrombocytopenia, thrombocytosis; allergic reaction; headache; urticaria, pruritus, erythema; inj site hematoma, pain, other inj site reaction (eg, oedema, hemorrhage, hypersensitivity, inflammation, mass, pain, or reaction).
Drug Interactions
2,000 IU/0.2 mL & 6,000 IU/0.6 mL soln for inj: Agents which may enhance the risk of hemorrhage eg, anticoagulants, platelet inhibitors including ASA, salicylates, NSAIDS (including ketorolac tromethamine), dipyridamole, or sulfinpyrazone should be discontinued prior to initiation of therapy. 4,000 IU/0.4 mL soln for inj: Concomitant use of medications affecting hemostasis eg, systemic salicylates, ASA at anti-inflammatory doses, & NSAIDs including ketorolac, other thrombolytics (eg, alteplase, reteplase, streptokinase, tenecteplase, urokinase) & anticoagulants. Risk of bleeding w/ platelet aggregation inhibitors including ASA used at antiaggregant dose (cardio protection), clopidogrel, ticlopidine, & glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome. Increased serum K levels w/ medicinal products increasing K levels. Concomitant use w/ dextran 40.
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
Enoxar soln for inj 2,000 IU/0.2 mL
Packing/Price
1's
Form
Enoxar soln for inj 4,000 IU/0.4 mL
Packing/Price
1's
Form
Enoxar soln for inj 6,000 IU/0.6 mL
Packing/Price
1's
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