Enoxaparin is indicated for:

• Treatment of deep vein thrombosis (DVT), with or without pulmonary embolism
• Treatment of unstable angina and non–Q-wave myocardial infarction, in combination with aspirin
• Prevention of clot formation in extracorporeal circulation during hemodialysis
• Prophylaxis of venous thromboembolic disease, especially in patients undergoing orthopedic or general surgery
• Prophylaxis of venous thromboembolism in medical patients who are immobilized due to acute illnesses such as heart failure, respiratory failure, severe infections, or rheumatic disorders

• Each 0.2 mL pre-filled syringe contains Enoxaparin Sodium BP 20 mg equivalent to 2000 anti-Xa IU
• Each 0.4 mL pre-filled syringe contains Enoxaparin Sodium BP 40 mg equivalent to 4000 anti-Xa IU
• Each 0.6 mL pre-filled syringe contains Enoxaparin Sodium BP 60 mg equivalent to 6000 anti-Xa IU
• Each 0.8 mL pre-filled syringe contains Enoxaparin Sodium BP 80 mg equivalent to 8000 anti-Xa IU

Enoxaparin Sodium is a low molecular weight heparin with strong anti-factor Xa activity and relatively low anti-IIa (antithrombin) activity. At therapeutic doses, it does not significantly prolong bleeding time. At prophylactic doses, it produces minimal changes in activated partial thromboplastin time (aPTT). It does not affect platelet aggregation or the binding of fibrinogen to platelets. Enoxaparin Sodium is mainly metabolized in the liver.

Treatment of deep vein thrombosis, with or without pulmonary embolism: Subcutaneously 100 anti-Xa IU/kg twice daily for 10 days or 150 anti-Xa IU/kg once daily for 10 days. Oral anticoagulant therapy should be started when appropriate, and Enoxaparin Sodium should be continued until a therapeutic anticoagulant effect is achieved.

Treatment of unstable angina and non–Q-wave myocardial infarction, administered concurrently with aspirin: Subcutaneously 100 anti-Xa IU/kg twice daily for 2–8 days, with oral aspirin (100–325 mg once daily). Treatment should be continued for at least 2 days and until clinical stabilization.

Prevention of thrombus formation in extracorporeal circulation during hemodialysis: Recommended dose is 100 anti-Xa IU/kg. For patients at high risk of bleeding, reduce to 50 IU/kg (double access) or 75 IU/kg (single access). Administer into the arterial line at the beginning of dialysis.

Prophylaxis of venous thromboembolic disease in surgical patients:

• Patients undergoing general surgery (moderate risk): 2000 anti-Xa IU (0.2 mL) or 4000 anti-Xa IU (0.4 mL) once daily for 7–10 days. First dose 2 hours before surgery.
• Patients undergoing orthopedic surgery (high risk): 4000 anti-Xa IU (0.4 mL) once daily for 7–10 days. First dose 12 hours before surgery. Extended therapy up to 3 weeks may be beneficial.

Prophylaxis of venous thromboembolic disease in medical patients: Subcutaneously 4000 anti-Xa IU (0.4 mL) once daily for 6–14 days.

Instructions on injecting yourself with Enoxaparin Sodium Syringes: Preparing the injection site

• Choose an injection site on the right or left side of the abdomen, at least 5 cm away from the navel
• Avoid injecting near scars or bruises
• Rotate injection sites between left and right sides
• Clean the area with alcohol or soap and water; do not rub
• Sit or lie in a comfortable position

Selecting dose:

• Remove needle cap and discard
• Do not press plunger before the injection
• Keep needle sterile
• Ensure correct dose in syringe
• Remove air bubble if present

njecting:

• Hold syringe like a pencil
• Pinch skin to form a fold
• Insert needle vertically (90°)
• Press plunger fully

After injection:

• Do not rub the site
• Dispose of the syringe safely
• Keep out of reach of children

It is recommended to discontinue drugs that affect hemostasis before starting Enoxaparin Sodium therapy unless absolutely necessary. These include acetylsalicylic acid (and its derivatives), NSAIDs (such as ketorolac), ticlopidine, clopidogrel, dextran 40, glucocorticoids, thrombolytics, anticoagulants, and other antiplatelet agents including glycoprotein IIb/IIIa inhibitors. If combination therapy is required, careful clinical and laboratory monitoring is essential.

Patients with known hypersensitivity to Enoxaparin Sodium, heparin, or other low molecular weight heparins. Also contraindicated in patients with active major bleeding or conditions with a high risk of uncontrolled hemorrhage, including recent hemorrhagic stroke.

Bleeding (hemorrhage), thrombocytopenia, increased liver enzymes, pain and bruising at the injection site, skin rash at the injection site. Cases of neuraxial hematoma associated with spinal/epidural anesthesia or spinal puncture have been reported, which may result in varying degrees of neurological impairment.

 Pregnancy Category B. There is no evidence in humans that Enoxaparin Sodium crosses the placental barrier. However, due to the lack of adequate and well-controlled studies in pregnant women, it should be used during pregnancy only when clearly needed. Pregnant women with mechanical prosthetic heart valves may have a higher risk of thromboembolism.

It is not known whether Enoxaparin is excreted in human milk. As many drugs are excreted in breast milk and may cause adverse effects in infants, a decision should be made whether to discontinue breastfeeding or discontinue Enoxaparin, considering the importance of the drug to the mother.

Enoxaparin Sodium should be administered by deep subcutaneous injection for prophylaxis and treatment, and intravenously during hemodialysis. It should not be given by the intramuscular route. Use with caution in patients with increased bleeding risk, such as impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe hypertension, diabetic retinopathy, recent neuro- or ophthalmic surgery, and in those receiving medications affecting hemostasis. Platelet counts should be checked before and regularly during treatment.

Dose in Elderly Patients: No dose adjustment is required unless renal function is impaired.

Dose in Renal Impairment: No adjustment is needed in mild to moderate renal impairment (CrCl 30–80 mL/min), but patients should be monitored for bleeding. In severe renal impairment (CrCl <30 mL/min), dose adjustment is required. Prophylaxis dose: 2000 anti-Xa IU once daily; Treatment dose: 100 anti-Xa IU/kg once daily.

Dose in Hepatic Impairment: Use with caution in patients with liver impairment.

Accidental overdose may lead to bleeding complications. Enoxaparin can be partially neutralized by slow IV injection of protamine sulfate (1% solution). The dose of protamine should be equal to the dose of Enoxaparin administered (1 mg protamine neutralizes 1 mg Enoxaparin).

Parenteral anticoagulants

Store in a cool and dry place. Protect from light and moisture. Do not store above 25°C. Do not refrigerate or freeze. Keep out of the reach of children.