Lovenox

Lovenox

enoxaparin

Manufacturer:

Kalventis Sinergi Farma
Concise Prescribing Info
Contents
Enoxaparin Na
Indications/Uses
2,000 & 4,000 anti-Xa IU: Prophylactic treatment of venous thromboembolic disease in moderate or high risk surgery. Prevention of clotting in extracorporeal circulation during hemodialysis (≤4 hr session). 4,000 anti-Xa IU: Prophylactic treatment of DVT in bedridden patient due to acute medical condition eg, heart failure (NYHA class III or IV), acute resp failure, acute infection or acute rheumatic disorder associated w/ at least 1 other VTE risk factor. 6,000 anti-Xa IU: Treatment of acute ST-segment elevation MI as an adjunct to thrombolytic & in combination w/ anti-aggregation treatment, including patients to be managed medically or w/ subsequent percutaneous coronary intervention (PCI).
Dosage/Direction for Use
SC Prophylactic treatment of venous thromboembolic disease in surgery Patient w/ moderate thrombogenic risk 2,000 anti-Xa IU (0.2 mL) daily, 1st inj administered 2 hr pre-op. Patient w/ high thrombogenic risk (eg, hip & knee surgery, cancer surgery) 4,000 anti-Xa IU (0.4 mL) once daily, 1st inj administered either 4,000 anti-Xa IU 12 hr pre-op or 2,000 anti-Xa IU 2 hr pre-op. Duration of treatment: General surgery <10 days. Prophylaxis after hip surgery 4,000 anti-Xa IU/day for 4-5 wk. Prophylactic treatment of DVT in bedridden patient due to acute medical condition 4,000 anti-Xa IU/0.4 mL once daily for 6-14 days. Prevention of clotting in extracorporeal circulation/hemodialysis Initially 100 anti-Xa IU/kg into arterial line of dialysis circuit at beginning of session as single intravascular bolus inj for a ≤4-hr session, an additional dose of 50-100 anti-Xa IU/kg may be injected if fibrin rings are found. Hemodialysis patient w/ high risk or w/ active hemorrhage 50 anti-Xa IU/kg (double vascular access) or 75 anti-Xa IU/kg (single vascular access). Acute ST-segment elevation MI & in combination w/ thrombolytic agent in patient eligible or not for subsequent coronary angioplasty Initially 3,000 anti-Xa IU IV bolus inj followed by 100 anti-Xa IU/kg SC w/in 15 min then every 12 hr. Max: 10,000 anti-Xa IU for the 1st 2 SC doses. 1st dose should be administered between 15 min before & 30 min after start of thrombolytic treatment. Max duration: 8 days. In combination w/ aspirin: 75-325 mg daily for at least 30 days. Patient treated by coronary angioplasty 30 anti-Xa IU/kg IV bolus if last SC inj was performed >8 hr before balloon inflation. Elderly ≥75 yr 75 anti-Xa IU/kg SC every 12 hr. Max dose: 7,500 anti-Xa IU for the 1st 2 SC inj. DVT w/ or w/o pulmonary embolism, w/o signs of clinical severity 2 inj daily at 12-hr intervals w/ a dose of 100 anti-Xa IU/kg for patient 40-100 kg for 10 days. Oral anticoagulant therapy should be quickly initiated. Unstable angina/non-Q-wave MI 100 anti-Xa IU/kg SC twice daily at 12-hr intervals w/ aspirin 75-325 mg orally, following min loading dose of 160 mg for 2-8 days until clinically stable.
Contraindications
Hypersensitivity to enoxaparin, heparin or heparin derivatives or other LMWH. History of serious type II heparin-induced thrombocytopenia or immune mediated heparin-induced thrombocytopenia (HIT) w/in the past 100 days or in the presence of circulating Abs. Bleeding or tendency to bleed related to impaired hemostasis; organic lesion w/ tendency to bleed; clinically significant active bleeding; intracerebral hemorrhage; severe renal failure. Spinal/epidural anesth. Not recommended in cases of acute extensive ischemic stroke w/ or w/o impaired consciousness; acute infectious endocarditis, in combination w/ ASA at analgesic, antipyretic & anti-inflammatory doses, NSAIDs (systemic use), dextran 40 (parenteral use), ticlopidine; mild to moderate renal failure (CrCl >30 & <60 mL/min). Severe renal failure (CrCl <30 mL/min).
Special Precautions
Not for IM administration. Spinal/epidural anesth. Risk of hemorrhage in elderly, patient w/ renal failure, wt <40 kg, treatment duration of >10 days, non-compliance w/ therapeutic recommendations & co-administration w/ drugs increasing risk of hemorrhage. Risk of heparin-induced thrombocytopenia. Patient w/ mechanical prosthetic heart valves. Obese patients (BMI >30 kg/m2). Patients w/ hepatic insufficiency, history of GI ulcers or any other organic lesion likely to bleed, vascular chorioretinal disease, following cerebral or spinal cord injury post-op, lumbar puncture, combination w/ drugs affecting hemostasis. Perform platelet count before administration or w/in 24 hr of treatment, then twice a wk for duration of treatment. Discontinue treatment if significant drop (30-50% vs baseline) or increase is confirmed. Monitor anti-factor Xa activity in patients w/ mild to moderate renal insufficiency (CrCl 30-60 mL/min), extreme body wt, unexplained bleeding. Not to be administered during the 1st trimester of pregnancy. Childn. Patient >75 yr & <40 kg. 4,000 anti-Xa IU: Acute episode of infection or bone-joint disease; cancer; history of VTE; obesity; hormone therapy; heart failure; chronic resp failure.
Adverse Reactions
Hemorrhage; thrombocytosis, thrombocytopenia; increased hepatic enzymes. Allergic reaction; urticaria, pruritus, erythema; inj site hematoma, inj site pain/reactions (eg, edema, hemorrhage, allergic reaction, inflammation, nodules).
Drug Interactions
Potentiated risk of hyperkalemia w/ K salts, K-sparing diuretics, ACE & AIIA inhibitors, NSAIDs, LMW or unfractionated heparin, ciclosporin, tacrolimus, trimethoprim. Increased risk of hemorrhage w/ ASA at analgesic, anti-pyretic & anti-inflammatory doses, NSAIDs (systemic use), dextran 40 (parenteral use), ticlopidine, platelet aggregation inhibitors (eg, abciximab, ASA at antiaggregant doses in cardiological & neurological indications, baraprost, clopidogrel, eptifibatide, iloprost, ticlopidine, tirofiban).
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
Lovenox inj 20 mg/0.2 mL
Packing/Price
(pre-filled syringe) (2,000 anti-Xa) 2 × 1's (Rp243,482/boks)
Form
Lovenox inj 40 mg/0.4 mL
Packing/Price
(pre-filled syringe) (4,000 anti-Xa) 2 × 1's (Rp542,471/boks)
Form
Lovenox inj 60 mg/0.6 mL
Packing/Price
(pre-filled syringe) (6,000 anti-Xa) 2 × 1's (Rp673,406/boks)
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