Alexa 60

• 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.

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.

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.

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).

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.

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.

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.