Enoxaparin

• Treatment of deep vein thrombosis • Unstable angina, myocardial infarction • Prophylaxis of venous thromboembolic disease

Low Molecular Weight Heparin

Enoxaparin Sodium is a low molecular weight heparin with a high anti-Xa activity and low anti-lla 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.

Dose in Elderly patients: No dosage adjustment is necessary, unless kidney function is impaired. Dose in Renal Impairment: No dosage adjustment is recommended in patients with moderate & mild renal impairment. For patients with severe (creatinine clearance <30 ml/min) renal impairment, following dosage adjustments are recommended: Prophylactic dose ranges: 2000 anti-Xa IU once daily; Therapeutic dose ranges: 100 anti-Xa IU/kg once daily. Dose in Hepatic Impairment: Caution should be used in hepatically impaired patients.

It is recommended that agents which affect hemostasis should be discontinued prior to Enoxaparin Sodium therapy unless strictly indicated. These agents include medications such as: acetylsalicylic acid (and derivatives), NSAIDs (including ketorolac), ticlopidine,clopidogrel,dextran 40,glucocorticoids, thrombolytics and anticoagulants, other antiplatelet aggregation agents including glycoprotein llb/llla antagonists. If the combination is indicated, should be used with careful clinical and laboratory monitoring.

Contraindication: Patients with known hypersensitivity to Enoxaparin Sodium, heparin or other low molecular weight heparins. Patients with active major bleeding & conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke. Precaution: Enoxaparin Sodium should be injected by deep subcutaneous route in prophylactic & curative treatment & by intravascular route during hemodialysis. Do not administer by the intramuscular route. Enoxaparin Sodium should be used with caution in conditions with increased potential for bleeding. It is recommended that the platelet counts be measured before the initiation of the treatment & regularly thereafter during treatment.

Hemorrhage (bleeding), thrombocytopenia, elevations of serum amino transferase, pain, bluish marks at injection site, skin rash at injection site, cases of neuraxial hematomas with concurrent use of enoxaparin & spinal/ epidural anesthesia or spinal puncture have resulted in varying degrees of neurological injuries.

Pregnancy category B. It should be used during pregnancy & lactation only if clearly needed.

Accidental overdosage following administration 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.

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

P© L© Lab *

Each 0.2 ml pre-filled syringe contains Enoxaparin Sodium BP 20 mg equivalent to 2000 anti-Xa III. Each 0.4 ml pre-filled syringe contains Enoxaparin Sodium BP 40 mg equivalent to 4000 anti-Xa III. 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.