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Check Drug InteractionsEnoxaparin Sodium Prescribing Information
Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
- Use of indwelling epidural catheters
- Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, and other anticoagulants
- A history of traumatic or repeated epidural or spinal punctures
- A history of spinal deformity or spinal surgery
- Optimal timing between the administration of enoxaparin sodium and neuraxial procedures is not known
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis
[see
Warnings and Precautions (5.1) and
Drug Interactions (7)]
.Warnings and Precautions (5.1) and
Drug Interactions (7)]
Enoxaparin sodium 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)
See full prescribing information for dosing and administration information. (
2)
Enoxaparin sodium injection is a clear, colorless to pale-yellow solution available in two concentrations.
100 mg/mL Concentration | |
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150 mg/mL Concentration | |
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- Severe Renal Impairment: Adjust dose for patients with creatinine clearance <30 mL/min. (
2.3,
8.7) - Geriatric Patients: Monitor for increased risk of bleeding. (
8.5) - Low-Weight Patients: Observe for signs of bleeding. (
8.8)
Enoxaparin sodium is contraindicated in patients with:
- Active major bleeding
- History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies [see
Warnings and Precautions (5.4)] - Known hypersensitivity to enoxaparin sodium (e.g., pruritus, urticaria, anaphylactic/anaphylactoid reactions) [see
Adverse Reactions (6.2)] - Known hypersensitivity to heparin or pork products
- Known hypersensitivity to benzyl alcohol (which is in only the multiple-dose formulation of enoxaparin sodium) [see
Warnings and Precautions (5.8)]
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available