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Maximum anti- Factor Xa and anti- thrombin (anti- Factor IIa). SC injection of enoxaparin. Mean peak. anti- Factor Xa activity was 0. IU/m. L (1. 5. 8 mcg/m. L) and 0. 3. 8 IU/m. L (3. 8. 3. mcg/m. L) after the 2. 0 mg and the 4. SC doses, respectively. Steady state. is achieved on the second day of treatment. Enoxaparin pharmacokinetics appear to be linear over the. After. repeated subcutaneous administration of 4. After repeated subcutaneous administration of the 1 mg/kg. IU/m. L, respectively. Based on enoxaparin sodium. Although not studied clinically, the 1. L. concentration of enoxaparin sodium is projected to result in anticoagulant. L and 2. 00 mg/m. L concentrations at the. When a daily 1. 5 mg/kg SC injection of enoxaparin sodium. L or a 2. 00. mg/m. L concentration the following pharmacokinetic profiles were obtained . After IV dosing of. Tc, 4. 0% of. radioactivity and 8 to 2. Factor Xa activity were recovered in urine. Elimination half- life based on anti- Factor Xa activity was 4. SC dose to about 7 hours after repeated dosing. Renal clearance of active fragments represents. Special Populations. Gender: Apparent clearance and Amax derived from. Factor Xa values following single SC dosing (4. The source of the gender difference. Geriatric: Apparent clearance and Amax derived. Factor Xa values following single and multiple SC dosing in geriatric. Following once a day. SC dosing of 4. 0 mg enoxaparin, the Day 1. Factor Xa. activity versus time curve (AUC) was approximately 1. Day 1 AUC value . Anti- Factor Xa exposure represented by. AUC, at steady state, is marginally increased in mild (creatinine clearance. L/min) and moderate (creatinine clearance 3. L/min) renal impairment. In patients with severe. L/min), the AUC at steady state. The symptoms of acute toxicity were ataxia, decreased motility, dyspnea. Reproductive and Developmental Toxicology. Teratology studies have been conducted in pregnant rats. SC doses of enoxaparin up to 3. There was no evidence of teratogenic effects or fetotoxicity due. Clinical Studies. Prophylaxis of Deep Vein Thrombosis Following Abdominal. Surgery in Patients at Risk for Thromboembolic Complications. Abdominal surgery patients at risk include those who are. DVT) or pulmonary embolism. PE). In a double- blind, parallel group study of patients. Patients ranged in age from 3. Patients were 9. 8% Caucasian, 1. Black, 0. 4% Asian and 0. Lovenox 4. 0 mg SC, administered once a day. U every 8 hours SC in reducing. DVT. The efficacy data are provided below . SC n (%) Heparin 5. U q. 8h SCn (%) All Treated Abdominal Surgery Patients 5. Treatment Failures Total VTE1 (%)5. CI2: 8 to 1. 3) 6. CI: 9 to 1. 4) DVT Only (%) 5. CI: 7 to 1. 2) 6. CI: 8 to 1. 3) 1 VTE = Venous thromboembolic events which included DVT, PE. CI = Confidence Interval. In a second double- blind. Lovenox 4. 0 mg SC once a day was compared to heparin 5. U every 8 hours SC in patients undergoing colorectal surgery (one- third with. A total of 1. 34. Patients ranged in age from 1. Treatment was initiated approximately 2 hours. SCn (%) Heparin 5. U q. 8h SC n (%) All Treated Colorectal Surgery Patients 6. Treatment Failures Total VTE1 (%) 4. CI2: 5 to 9) 4. 5 (6. CI: 5 to 9) DVT Only (%) 4. CI: 5 to 9) 4. 4 (6. CI: 5 to 8) 1 VTE = Venous thromboembolic events which. DVT, PE, and death considered to be thromboembolic in origin 2 CI = Confidence Interval. Prophylaxis of Deep Vein. Thrombosis Following Hip or Knee Replacement Surgery. Lovenox has been shown to. DVT) following hip or. In a double- blind study. Lovenox 3. 0 mg every 1. SC was compared to placebo in patients with hip. A total of 1. 00 patients were randomized in the study and all. Patients ranged in age from 4. After hemostasis was established. The efficacy data are provided below . A total of 5. 72 patients were randomized in the study and 5. Patients ranged in age from 3. Patients were 9. 3% Caucasian, 6% Black. Asian, and 1% others. Treatment was initiated within two days after. The efficacy data are. SCn (%) 3. 0 mg q. SC n (%) 4. 0 mg q. SC n (%) All Treated Hip Replacement Patients 1. Treatment Failures Total DVT (%) 4. Proximal DVT (%) 1. Lovenox 1. 0 mg once a day = 0. Lovenox 1. 0 mg once a day = 0. There was no significant. In a. double- blind study, Lovenox 3. SC was compared to placebo in. A total of 1. 32 patients were. The 9. 9 patients with total knee replacement ranged in age from 4. After hemostasis. The incidence of proximal and total DVT. Lovenox compared to placebo. The. efficacy data are provided below . A total of 4. 53 patients were randomized in the study. Patients ranged in age from 3. Patients were 9. 2. Caucasian, 5. 3%. Black, and 0. 6% others. Treatment was initiated after surgery and continued up. The incidence of deep vein thrombosis was significantly lower for. Lovenox compared to heparin. Extended Prophylaxis of Deep Vein Thrombosis Following. Hip Replacement Surgery: In a study of extended prophylaxis for patients. Lovenox 4. 0 mg SC, initiated up to 1. DVT. At the end of the peri- operative period, all. In a double- blind design, those. Lovenox 4. 0 mg (n = 9. SC or to. placebo (n = 8. A total of 1. 79 patients were randomized in the. Patients ranged. in age from 4. In. this population of patients, the incidence of DVT during extended prophylaxis. Lovenox compared to placebo. The efficacy data are. SC n (%) Placebo q. SCn (%) All Treated Extended Prophylaxis Patients 9. Treatment Failures Total DVT (%) 6 (7)1(9. CI2: 3 to 1. 4) 1. CI: 1. 2 to 3. 0) Proximal DVT (%) 5 (6)3(9. CI: 2 to 1. 3) 7 (8) (9. CI: 3 to 1. 6) 1 p value versus placebo = 0. CI= Confidence Interval 3 p value versus placebo = 0. In a second study, patients. Lovenox 4. 0 mg SC, initiated up to 1. All patients were. VTE). disease. In a double- blind design, patients without clinical signs and symptoms. VTE disease were randomized to a post- discharge regimen of either Lovenox 4. SC or to placebo (n = 1. A total of 2. 62. Patients ranged in age from 4. Similar to the first study the incidence of DVT. Lovenox compared to. DVT (Lovenox. 2. 1 . This study included patients with heart failure (NYHA Class. III or IV); acute respiratory failure or complicated chronic respiratory. A total of 1. 10. Patients ranged in age from 4. Treatment. continued for a maximum of 1. When given at a. dose of 4. SC, Lovenox significantly reduced the incidence of DVT. The efficacy data are provided below . SCn (%) Lovenox 4. SCn (%) Placebon (%) All Treated Medical Patients During Acute Illness 3. Treatment Failure. Total VTE2 (%) 4. Total DVT (%) 4. 3 (1. CI3 8. 8 to 1. 5. CI3 2. 3 to 6. 6) 4. CI3 8. 1 to 1. 4. Proximal DVT (%)1. Treatment failures during therapy, between Days 1 and 1. VTE = Venous thromboembolic events which included DVT, PE, and. CI = Confidence Interval. At approximately 3 months. Lovenox 4. 0 mg treatment group versus the placebo. Treatment of Deep Vein. Thrombosis with or without Pulmonary Embolism. In a multicenter, parallel group. DVT) with. or without pulmonary embolism (PE) were randomized to an inpatient (hospital). Lovenox 1. 5 mg/kg once a day SC, (ii) Lovenox 1 mg/kg. SC, or (iii) heparin IV bolus (5. IU) followed by a. PTT of 5. 5 to 8. A. total of 9. 00 patients were randomized in the study and all patients were. Patients ranged in age from 1. All patients also received warfarin sodium (dose. PT to achieve an International Normalization Ratio . Lovenox or standard heparin. INR was achieved. Both Lovenox regimens were equivalent to standard. DVT. and/or PE). The efficacy data are provided below . SCn (%) Lovenox 1 mg/kg q. SC n (%) Heparin a. PTT Adjusted IV Therapy n (%) All Treated DVT Patients with or without PE 2. Patient Outcome Total VTE2 (%)1. DVT Only (%)1. 1 (3. Proximal DVT (%)9 (3. PE (%) 2 (0. 7) 2 (0. All patients were also treated with warfarin sodium. Lovenox or standard heparin therapy. VTE = venous thromboembolic event (DVT and/or PE) 3 The 9. Confidence Intervals for the treatment differences for. VTE were: Lovenox once a day versus heparin (- 3. Lovenox every 1. 2 hours versus heparin (- 4. Similarly, in a multicenter. DVT were. randomized to Lovenox or heparin. Patients who could not receive outpatient. Outpatient exclusion criteria. Eligible patients could be treated in the hospital, but ONLY. Lovenox patients were permitted to go home on therapy (7. A total of 5. 01. Patients. ranged in age from 1. Patients were randomized to either Lovenox 1 mg/kg every 1. SC or heparin IV bolus (5. IU) followed by a continuous infusion administered. PTT of 6. 0 to 8. All patients. also received warfarin sodium as described in the previous study. Lovenox or. standard heparin therapy was administered for a minimum of 5 days. Lovenox was. equivalent to standard heparin therapy in reducing the risk of recurrent venous. The efficacy data are provided below . VTE = venous thromboembolic event (deep vein thrombosis . The 9. 5% Confidence Intervals for the treatment difference for. VTE was: Lovenox versus heparin (- 5. Prophylaxis of Ischemic. Complications in Unstable Angina and Non- Q- Wave Myocardial Infarction. In a multicenter, double- blind. Q- wave myocardial infarction were randomized to either Lovenox 1 mg/kg. SC or heparin IV bolus (5. U) followed by a continuous. PTT of 5. 5 to 8. A total of 3. 17. Patients. ranged in age from 2. Download Adobe Illustrator CS5 For Free. Secure download of Adobe Illustrator CS5 100% virus free. Download Adobe Illustrator CS5 last version for free. Install the leading image editor for Mac or Windows - Adobe Photoshop CS5 and CS6 free online download. 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