Ovenox SC Injection

Introduction

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml is a low molecular weight heparin (LMWH) used as an anticoagulant to prevent and treat thromboembolic disorders. It is commonly prescribed for the prevention of deep vein thrombosis (DVT), pulmonary embolism (PE), and other clot-related conditions, particularly after surgery or during hospitalization. Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml is favored due to its more predictable pharmacokinetics compared to unfractionated heparin and its ease of administration through subcutaneous injections.

Uses

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml is used to:

Prevent deep vein thrombosis (DVT), especially in patients undergoing surgery or those who are immobile.
Treat DVT and pulmonary embolism (PE).
Prevent ischemic complications in patients with unstable angina and non-ST elevation myocardial infarction (NSTEMI).
Treat acute ST-elevation myocardial infarction (STEMI) in conjunction with other agents.

Brand Name	Ovenox
Type	SC Injection
Weight	4000 Anti-Xa IU/0.4 ml
Generic	Enoxaparin Sodium
Manufacturer	Synovia Pharma PLC.
Available in	English বাংলা

Mechanism of Action

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml exerts its anticoagulant effect by inhibiting Factor Xa and thrombin (Factor IIa) in the coagulation cascade. Its primary effect is on Factor Xa, which prevents the formation of thrombin and, subsequently, the development of fibrin clots. The inhibition of thrombin formation helps prevent the extension of existing clots and the formation of new ones.

How Long Does It Take to Work?

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml begins to act within 2 to 4 hours after subcutaneous injection. Peak plasma concentrations of anti-Factor Xa activity are achieved within 3 to 5 hours post-administration. Its anticoagulant effects persist for up to 12 to 24 hours depending on the dose and the patient's renal function.

Absorption

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml is rapidly and almost completely absorbed after subcutaneous injection, with a bioavailability of around 90%. The absorption rate is dose-dependent, and the drug reaches its maximum plasma concentration within 3 to 5 hours after injection.

Route of Elimination

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml is primarily eliminated via the kidneys. Renal excretion accounts for about 40% of the administered dose, with both the parent drug and its metabolites being excreted. Reduced renal function can significantly prolong the elimination half-life.

Dosage

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

Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin: Subcutaneously 100 anti-Xa lU/kg twice daily for 2- 8 days. Should be administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with Enoxaparin Sodium in these patients should be prescribed fora minimum of 2 days and continued until clinical stabilization.

Prevention of thrombus formation in extra corporeal circulation during hemodialysis: Recommended dose is 100 anti-Xa lU/kg. For patients with a high risk of hemorrhage, the dose should be reduced to 50 anti-Xa lU/kg for double vascular access or 75 anti-Xa lU/kg for single vascular access. During hemodialysis, Enoxaparin Sodium should be introduced into the arterial line of the circuit at the beqinninq of the dialysis session.

Prophylaxis of venous thromboembolic disease in surgical patients:

Patients undergoing general surgery with a moderate risk of thromboembolism (e.g. abdominal surgery): Subcutaneously 2000 anti-Xa IU (0.2 ml) or 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 2 hours before the surgical procedure.
Patients undergoing orthopedic surgery with a high risk of thromboembolism: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 12 hours before the surgical procedure. Longer treatment duration may be appropriate in some patients like continued therapy with 4000 anti-Xa IU once daily for 3 weeks following the initial therapy has been proven to be beneficial in orthopaedic surqery.

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

The dosing of Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml depends on the indication:

For DVT prevention: 40 mg once daily, typically for 7 to 10 days post-surgery. In high-risk patients, such as those undergoing hip replacement, dosing may extend to 30 mg twice daily.
For DVT and PE treatment: 1 mg/kg body weight every 12 hours or 1.5 mg/kg once daily.
For unstable angina and NSTEMI: 1 mg/kg every 12 hours, administered along with aspirin.
For STEMI treatment: A single IV bolus of 30 mg followed by 1 mg/kg subcutaneously every 12 hours.

The dose may need to be adjusted in patients with renal impairment.

Administration

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml is administered subcutaneously, typically in the abdomen or thigh. The injection site should be rotated to prevent irritation. In certain cases, an intravenous bolus may be administered, especially in the treatment of myocardial infarction.

Side Effects

Common side effects include:

Bleeding or bruising at the injection site
Anemia
Thrombocytopenia (low platelet count)
Elevated liver enzymes
Hematoma

Serious side effects include:

Major bleeding (e.g., gastrointestinal, intracranial)
Severe thrombocytopenia
Allergic reactions, including anaphylaxis

Toxicity

In cases of overdose, Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml can cause excessive bleeding. Protamine sulfate can be administered to partially neutralize its anticoagulant effects. Severe cases may require blood transfusion or other supportive measures. Monitoring for signs of bleeding, particularly in high-risk patients, is essential.

Precautions

Precautions should be taken in patients with:

Renal impairment, as it can prolong drug clearance
Recent history of stroke or active bleeding
Spinal or epidural anesthesia, due to an increased risk of spinal/epidural hematoma
Heparin-induced thrombocytopenia (HIT), as cross-reactivity may occur

Patients should be monitored for signs of bleeding, and caution should be exercised in those taking other anticoagulants or antiplatelet agents.

Interaction

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml can interact with:

Anticoagulants: such as warfarin, increasing the risk of bleeding.
Antiplatelet agents: such as aspirin or clopidogrel, also increasing the bleeding risk.
Nonsteroidal anti-inflammatory drugs (NSAIDs): These can enhance the risk of gastrointestinal bleeding.

Disease Interaction

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml should be used with caution in patients with:

Severe renal impairment
Active bleeding disorders
Uncontrolled hypertension
Severe liver disease
History of heparin-induced thrombocytopenia

Drug Interaction

Drug interactions with Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml may occur with:

Oral anticoagulants: Co-administration may increase the risk of bleeding.
Thrombolytics: Concomitant use can elevate the risk of major bleeding events.
NSAIDs: Concurrent use can increase the likelihood of gastrointestinal bleeding.

Food Interactions

No significant food interactions have been reported with Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml. However, patients should avoid excessive alcohol consumption, as it may increase the risk of gastrointestinal bleeding.

Pregnancy Use

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml is classified as pregnancy category B. Animal studies have not demonstrated fetal harm, and limited data in human pregnancies suggest that it can be safely used, particularly in preventing thromboembolic complications in pregnant women. However, monitoring for bleeding risks is essential.

Lactation Use

It is not known whether Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml is excreted in human breast milk. Although its use is considered relatively safe during lactation, caution is advised, and breastfeeding mothers should be monitored for potential adverse effects.

Acute Overdose

Symptoms of overdose include excessive bleeding or hemorrhage. Treatment involves the use of protamine sulfate, which can partially neutralize the anticoagulant effects of Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml. Supportive care, such as fluid replacement or blood transfusions, may be required depending on the severity of the bleeding.

Contraindication

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml is contraindicated in patients with:

Active major bleeding
Heparin-induced thrombocytopenia (HIT)
Hypersensitivity to enoxaparin, heparin, or pork products
History of bleeding disorders

Use Direction

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml should be administered as an injection subcutaneously. The patient should be instructed on the proper injection technique, and the injection site should be rotated regularly. Patients should avoid intramuscular injections while on enoxaparin therapy due to the risk of hematoma formation.

Storage Conditions

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml should be stored at room temperature, between 20°C and 25°C (68°F and 77°F). It should be protected from light and moisture, and kept out of reach of children. Pre-filled syringes should not be frozen.

Volume of Distribution

Ovenox SC Injection 4000 Anti-Xa IU/0.4 ml has a low volume of distribution, primarily confined to the plasma and extracellular fluid compartments. It exhibits limited penetration into other tissues due to its molecular weight and polarity.

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