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Overview

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This medicine contains an important and useful components, as it consists of
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Name

Enoxaparin Sodium

Precaution

Before starting treatment with **Enoxaparin Sodium**, patients should consult their healthcare provider to ensure it is appropriate for their condition. Several precautions need to be considered: - **Bleeding Disorders**: Enoxaparin is an anticoagulant (blood thinner), and it increases the risk of **bleeding**. Patients with a history of **bleeding disorders**, such as **hemophilia**, **thrombocytopenia**, or **active bleeding**, should use this medication with caution. - **Renal Impairment**: Enoxaparin is primarily excreted through the kidneys. Patients with **renal impairment** (such as **creatinine clearance** <30 mL/min) require **dose adjustments**, as decreased renal function may increase the risk of bleeding due to accumulation of the drug in the body. - **Spinal Anesthesia or Puncture**: Patients who are undergoing **spinal anesthesia** or have a **spinal puncture** should be cautious when using Enoxaparin, as it may increase the risk of **epidural or spinal hematoma** leading to long-term or permanent paralysis. - **Pregnancy**: Enoxaparin is often used during pregnancy to prevent or treat conditions like deep vein thrombosis (DVT) or pulmonary embolism (PE), but it should be used only when necessary and under careful supervision. **Unfractionated heparin** might be considered in some cases. - **Liver Disease**: Enoxaparin should be used with caution in patients with severe **liver disease**, as liver dysfunction may influence the drug's anticoagulant effect. - **Surgical Procedures**: Enoxaparin should be discontinued several hours before surgery to minimize bleeding risks, and it should be resumed only after the patient’s bleeding risk has been properly assessed.

Indication

Enoxaparin Sodium is a **low molecular weight heparin** used primarily as an **anticoagulant** to prevent and treat various thromboembolic disorders. Its key indications include: - **Prevention of Deep Vein Thrombosis (DVT)**: Enoxaparin is used in surgical patients (e.g., orthopedic or abdominal surgery) or those with **immobility** to prevent the formation of DVT, which could lead to **pulmonary embolism**. - **Treatment of DVT and Pulmonary Embolism (PE)**: Enoxaparin is used to treat **acute DVT** and **PE**, particularly in patients who are not suitable candidates for **oral anticoagulants**. - **Unstable Angina and Non-ST Elevation Myocardial Infarction (NSTEMI)**: It is used as part of the treatment regimen in patients with **unstable angina** or **NSTEMI**, often in combination with other drugs like **aspirin** and **clopidogrel**. - **ST Elevation Myocardial Infarction (STEMI)**: Enoxaparin is used in the treatment of STEMI, particularly in patients undergoing **fibrinolytic therapy**. - **Prophylaxis in Acute Coronary Syndrome (ACS)**: It is used to reduce the risk of thromboembolic events in patients with ACS.

Contra indication

Enoxaparin Sodium should be avoided in certain situations, as it may lead to severe or potentially life-threatening complications: - **Hypersensitivity**: Contraindicated in patients with known hypersensitivity to **enoxaparin** or **heparin**, or any component of the formulation. - **Active Bleeding**: Enoxaparin should not be used in patients with **active bleeding** disorders or conditions such as **gastrointestinal bleeding**, **intracranial hemorrhage**, or **trauma** involving the eye or brain, where anticoagulation would exacerbate bleeding. - **Severe Thrombocytopenia**: Enoxaparin is contraindicated in patients with a **history of heparin-induced thrombocytopenia (HIT)** or those with **severe thrombocytopenia** (platelet count <100,000/mm³). - **Epidural or Spinal Anesthesia**: Contraindicated in patients who will undergo procedures that involve the **spinal cord** or **epidural space**, due to an increased risk of **spinal hematoma** and paralysis. - **Severe Renal Impairment**: In patients with severe **renal failure** (creatinine clearance <15 mL/min), enoxaparin may accumulate and increase bleeding risks, making it contraindicated in these patients unless absolutely necessary.

Side Effect

Enoxaparin Sodium can cause a range of side effects, from mild to severe: - **Common Side Effects**: - **Injection site reactions**: Pain, redness, or swelling at the site of injection - **Elevated liver enzymes**: Asymptomatic increase in liver function tests - **Nausea** or **vomiting** - **Low blood pressure** or dizziness - **Mild thrombocytopenia**: Decrease in platelet count without serious symptoms - **Serious Side Effects** (require immediate medical attention): - **Severe bleeding**: Symptoms include **unexplained bruising**, **nosebleeds**, **gums bleeding**, or blood in urine or stool - **Heparin-induced thrombocytopenia (HIT)**: A rare but serious condition causing severe platelet count drop and thrombosis - **Spinal or epidural hematoma**: Resulting from accidental injury during spinal or epidural procedures, potentially leading to **paralysis**. - **Allergic reactions**: Rash, itching, swelling (especially around the face or throat), **difficulty breathing**, which may indicate an **anaphylactic reaction**. Patients should seek immediate medical attention if they experience any signs of severe side effects, especially bleeding.

Pregnancy Category ID

2

Mode of Action

Enoxaparin Sodium is an **anticoagulant** that primarily works by inhibiting **factor Xa** and **thrombin** in the blood clotting cascade: - **Inhibition of Factor Xa**: Enoxaparin binds to **antithrombin III**, a protein that inactivates clotting factors, particularly **factor Xa**. This prevents the conversion of prothrombin to thrombin, which is necessary for the formation of fibrin and the subsequent formation of blood clots. - **Inhibition of Thrombin**: Although its primary action is on **factor Xa**, enoxaparin also exerts some inhibitory effect on **thrombin**, further reducing clot formation. This dual action on **factor Xa** and **thrombin** makes enoxaparin effective in preventing and treating thromboembolic disorders, such as **deep vein thrombosis (DVT)**, **pulmonary embolism (PE)**, and in the prevention of clot formation in certain types of heart disease.

Interaction

Enoxaparin Sodium may interact with various medications and substances, increasing or decreasing its effectiveness or leading to harmful effects: - **Other Anticoagulants**: Co-administration with other anticoagulants, such as **warfarin**, **aspirin**, or **clopidogrel**, increases the risk of bleeding. - **NSAIDs**: Nonsteroidal anti-inflammatory drugs (e.g., **ibuprofen**, **naproxen**) may enhance the bleeding risk when used in combination with enoxaparin. - **Antiplatelet Agents**: Drugs like **aspirin** or **clopidogrel** can increase the bleeding risk when used concurrently with enoxaparin. - **Thrombolytics**: Combining enoxaparin with **thrombolytic agents** (e.g., **alteplase**, **streptokinase**) may increase the risk of serious bleeding events. - **Protease Inhibitors**: Some **HIV medications** (such as **ritonavir** and **saquinavir**) can increase the anticoagulant effects of enoxaparin, necessitating careful monitoring. - **Selective Serotonin Reuptake Inhibitors (SSRIs)**: SSRIs such as **fluoxetine** or **sertraline** can also increase the risk of bleeding due to platelet dysfunction. Patients should inform their healthcare provider of all medications, including over-the-counter drugs, to minimize the risk of dangerous drug interactions.

Pregnancy Category Note

Information not available

Adult Dose

The typical adult dosage of **Enoxaparin Sodium** depends on the clinical condition being treated: - **Deep Vein Thrombosis (DVT) Prevention**: - 40 mg subcutaneously once daily, usually starting 2 hours before surgery and continuing for up to 7-10 days. - **Treatment of DVT**: - 1 mg/kg subcutaneously every 12 hours or 1.5 mg/kg once daily. - **Pulmonary Embolism (PE)**: - 1 mg/kg subcutaneously every 12 hours or 1.5 mg/kg once daily. - **Unstable Angina or Non-ST Elevation Myocardial Infarction (NSTEMI)**: - 1 mg/kg subcutaneously every 12 hours. - **ST Elevation Myocardial Infarction (STEMI)**: - **1 mg/kg** subcutaneously, administered every 12 hours, typically for 8 days or until hospital discharge.

Child Dose

Enoxaparin is generally used in children for the prevention and treatment of **venous thromboembolism**, but dosing should be individualized based on weight: - The typical **pediatric dose** is **1 mg/kg** subcutaneously every 12 hours for both DVT and PE treatment. Due to limited data on long-term safety and dosing in children, a healthcare provider’s guidance is essential before starting therapy. As always, patients should consult their healthcare provider before using **Enoxaparin Sodium** to ensure safe and appropriate use tailored to their specific health needs.

Renal Dose

For patients with **renal impairment** (creatinine clearance <30 mL/min), Enoxaparin requires **dose adjustments**: - In cases of **severe renal impairment**, the dose may need to be reduced or the drug may be substituted with an alternative anticoagulant, depending on the clinical scenario. - Monitoring of **anti-Xa levels** is recommended in these patients to ensure therapeutic anticoagulation without increasing the risk of bleeding.

Administration

Information not available