Enoxaparin Sodium

Enoxaparin Sodium is a low molecular weight heparin (LMWH) with anticoagulant properties. It is used for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), unstable angina, and myocardial infarction. It is also used for the prevention of venous thromboembolism in surgical patients and medical patients with restricted mobility.

Enoxaparin works by enhancing the inhibition rate of activated clotting factors including thrombin and factor Xa through its action on antithrombin III. It prevents blood clot formation and stops existing clots from growing.

This medicine is administered as a subcutaneous (under the skin) injection. It should not be administered by the intramuscular route. Use under medical supervision as per prescribed dosage and schedule.

• Deep Vein Thrombosis (DVT): Treatment of DVT with or without pulmonary embolism.
• Pulmonary Embolism (PE): Treatment of PE associated with DVT.
• Unstable Angina & Non-Q-Wave Myocardial Infarction: Prevention of ischemic complications when administered concurrently with aspirin.
• Prophylaxis (Prevention): Prevention of venous thromboembolism in patients undergoing abdominal surgery, hip or knee replacement surgery, and medical patients with severely restricted mobility during acute illness.
• Hemodialysis: Prevention of thrombus formation in the extra-corporeal circulation during hemodialysis.

Parenteral anti-coagulants

Low Molecular Weight Heparin (LMWH)

Enoxaparin Sodium is a low molecular weight heparin with a high anti-Xa activity and low anti-IIa or antithrombin activity. At doses required for the various indications, Enoxaparin Sodium does not increase bleeding time. At preventive doses, Enoxaparin Sodium causes no notable modification of activated Partial Thromboplastin Time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. Enoxaparin Sodium is primarily metabolised in the liver.

Enoxaparin is a low molecular weight heparin with anticoagulant properties. It acts by enhancing the inhibition rate of activated clotting factors including thrombin and factor Xa through its action on antithrombin III.

Adult Dose:

• Deep Vein Thrombosis (Treatment - Inpatient): 1 mg/kg SC q12hr OR 1.5 mg/kg SC qDay (in conjunction with warfarin).
• Deep Vein Thrombosis (Treatment - Outpatient): 1 mg/kg SC q12hr (in conjunction with warfarin).
• Unstable Angina & Non-Q-Wave MI: 1 mg/kg SC q12hr + aspirin (100-325 mg/day).
• Acute STEMI (<75 years): 30 mg IV bolus + 1 mg/kg SC, then 1 mg/kg SC q12hr.
• Acute STEMI (>75 years): No IV bolus; 0.75 mg/kg SC q12hr (not to exceed 75 mg/dose for first 2 doses).
• Abdominal Surgery (Prophylaxis): 40 mg SC qDay; initiate 2 hr preoperatively.
• Hip or Knee Replacement (Prophylaxis): 30 mg SC q12hr OR 40 mg SC qDay; initiate 12-24 hr postoperatively.
• Medical Patients with Restricted Mobility (Prophylaxis): 40 mg SC qDay.
• Hemodialysis: 100 anti-Xa IU/kg; high-risk patients: 50-75 anti-Xa IU/kg.

Renal Dose:

• CrCl <30 mL/min: Prophylaxis: 30 mg SC qDay; Treatment: 1 mg/kg SC qDay.
• CrCl 30-50 mL/min: Use with caution; monitor for signs of bleeding.

Injection Preparation & Administration:

• Administer as deep SC injection alternating right and left anterior and posterior abdominal walls.
• Hold skin fold between thumb and forefinger.
• Do not administer by intramuscular route.
• For IV administration, may administer in IV line with 0.9% NaCl or D5W.

Self-Injection Instructions:

• Choose an area on the right or left side of the stomach at least 5 cm away from the belly button.
• Change the injection site each time.
• Wash hands and clean the area with an alcohol swab.
• Remove the needle cap from the syringe (do not press the plunger to remove air bubbles).
• Insert the full length of the needle vertically (90° angle) into the skin fold and inject.
• Do not rub the injection site after injection.

If you miss a dose of Enoxaparin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not double the dose. Skipping doses increases the risk of treatment failure.

Common Side Effects (1-10%):

• Hemorrhage/Bleeding (1-4%)
• Elevation of serum aminotransferases (6%)
• Fever (5-8%)
• Local site reactions (2-5%)
• Thrombocytopenia (3%)
• Nausea (3%)
• Anemia (2%)
• Ecchymosis/Bruising (3%)

Rare Side Effects (<1%):

• Atrial fibrillation
• Heart failure
• Pulmonary edema
• Pneumonia

Potentially Fatal: Hemorrhagic complications.

Other: Neuraxial hematomas (with concurrent use of spinal/epidural anesthesia).

Precautions:

• Do not administer by intramuscular route.
• Increased risk of bleeding; carefully monitor for signs/symptoms of bleeding.
• Low body weight (<45 kg for women, <57 kg for men): Increased exposure with prophylactic dosage; monitor carefully.
• Platelet count should be measured before initiation and regularly during treatment.
• Caution with spinal/epidural anesthesia; risk of neuraxial hematoma.
• Caution in patients with history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy, recent neuro or ophthalmologic surgery.
• Use with caution during pregnancy.

Contraindications:

• Hypersensitivity to enoxaparin, heparin or other low molecular weight heparins.
• History of thrombocytopenia.
• Active gastrointestinal ulcer or organic lesion likely to bleed.
• Recent hemorrhagic vascular cerebral stroke.
• Active major bleeding and conditions with high risk of uncontrolled hemorrhage.

Drug Interactions:

• Anticoagulants, platelet aggregation inhibitors (dipyridamole, salicylates, NSAIDs, sulfinpyrazone): Increased risk of bleeding.
• Acetylsalicylic acid (aspirin) and derivatives: Increased risk of bleeding.
• Ticlopidine, clopidogrel: Increased risk of bleeding.
• Dextran 40, glucocorticoids, thrombolytics: Increased risk of bleeding.
• Glycoprotein IIb/IIIa antagonists: Increased risk of bleeding.
• Vitamin E: May increase bleeding.

Food Interactions: No significant food interactions with Enoxaparin. However, alcohol consumption may increase bleeding risk, so avoid alcohol.

Use in Pregnancy: Pregnancy Category B. In humans, there is no evidence that Enoxaparin Sodium crosses the placental barrier. As there are no adequate and well-controlled studies in pregnant women, Enoxaparin Sodium should be used during pregnancy only if clearly needed. Pregnant women with mechanical prosthetic heart valves may be at a higher risk for thromboembolism.

Use in Lactation: It is not known whether Enoxaparin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue Enoxaparin, taking into account the importance of Enoxaparin to the mother and the known benefits of nursing.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Use under medical supervision.

Geriatric Use: No dosage adjustment is necessary unless kidney function is impaired. Elderly patients should have renal function monitored.

Renal Impairment:

• Severe renal impairment (CrCl <30 mL/min): Prophylaxis: 30 mg SC qDay; Treatment: 1 mg/kg SC qDay.
• Moderate renal impairment (CrCl 30-50 mL/min): No dosage adjustment recommended, but monitor for signs of bleeding.
• Mild renal impairment (CrCl 50-80 mL/min): No dosage adjustment needed.

Hepatic Impairment: Caution should be used in hepatically impaired patients.

Overdose: Accidental overdosage of Enoxaparin may lead to hemorrhagic complications. Injected Enoxaparin may be largely neutralized by the slow i.v. injection of protamine sulfate (1% solution). The dose of protamine sulfate should be equal to the dose of Enoxaparin injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Enoxaparin.

Storage: Store in a cool and dry place, protect from light and moisture. Do not store above 25°C. Do not store in a refrigerator or freezer. Keep out of the reach of children.

Enoxaparin Sodium