enoxaparin sodium
enoxaparin sodium is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including Enoxaparin Sodium, Lovenox, Enoxaparin sodium. Available dosage form: injection.
Drug Details
- Generic Name
- enoxaparin sodium
- Brand Names
- Enoxaparin Sodium, Lovenox, Enoxaparin sodium, enoxaparin sodium
- Application Number
- ANDA208600
- Sponsor
- Amphastar Pharmaceuticals, Inc.
- NDC Codes
- 50
- Dosage Forms
- INJECTION
- Routes
- INTRAVENOUS, SUBCUTANEOUS
- Active Ingredients
- ENOXAPARIN SODIUM
Indications and Usage
1 INDICATIONS AND USAGE Enoxaparin sodium injection, USP is a low molecular weight heparin (LMWH) indicated for: • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness ( 1.1 ) • Inpatient treatment of acute DVT with or without pulmonary embolism ( 1.2 ) • Outpatient treatment of acute DVT without pulmonary embolism ( 1.2 ) • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) ( 1.3 ) • Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) ( 1.4 ) 1.1 Prophylaxis of Deep Vein Thrombosis Enoxaparin sodium injection, USP is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): • in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies ( 14.1 ) ] • in patients undergoing hip replacement surgery, during and following hospitalization • in patients undergoing knee replacement surgery • in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness 1.2 Treatment of Acute Deep Vein Thrombosis Enoxaparin sodium injection, USP is indicated for: • the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium • the outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium 1.3 Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction Enoxaparin sodium injection, USP is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin. 1.4 Treatment of Acute ST-Segment Elevation Myocardial Infarction Enoxaparin sodium injection, USP, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI).