Vistarin^®

Vistarin® is a preparation of Enoxaparin Sodium which is a low molecular weight heparin with a high anti-Xa activity and with a low anti-lla or anti-thrombin activity. At doses required for the various indications, Enoxaparin 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 metabolized in the liver

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Vistarin is indicated for-

• Treatment of venous thromboembolic disease presenting with deep vein thrombosis, pulmonary embolism or both.

• Treatment of unstable angina and non-Q-wave myocardial infarction, administered
concurrently with aspirin.

• Treatment of acute ST-Segment Elevation Myocardial Infarction (STEMI) including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI) in
conjunction with thrombolytic drugs (fibrin or non-fibrin specific).

•Prophylaxis of thromboembolic disorders of venous origin, in particular those which may be associated with orthopaedic or general surgery.

•Prophylaxis of venous thromboembolism in medical patients bedridden due to acute illness.

•Prevention of thrombus formation in the extracorporeal circulation during hemodialysis.

Route of administration: 1mg (0.01ml) of enoxaparin corresponds approximately to 100 anti-Xa IU. Vistarin® should be injected by deep subcutaneous route in prophylactic and curative treatment and by intravascular route during haemodialysis. It should not be administered by intramuscular route.

Prophylaxis of venous thromboembolism: In patients with a low to moderate risk of venous thromboembolism the recommended dosage is 20 mg (2,000 IU) once daily by subcutaneous injection for 7 to 10 days or until the risk of thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given approximately 2 hours pre-operatively. In patients with a higher risk, such as in orthopaedic surgery, the dosage should be 40 mg (4,000 IU) daily by subcutaneous injection with the initial dose  dministered approximately 12 hours before surgery.

Prophylaxis of venous thromboembolism in medical patients: The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by subcutaneous injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued until the return to full ambulation, for a maximum of 14 days.

Treatment of venous thromboembolism: Enoxaparin should be administered subcutaneously as a single daily injection of 1.5 mg/kg (150 IU/kg). Enoxaparin treatment is usually prescribed for at least 5 days and until adequate oral anticoagulation is established.

Treatment of unstable angina and non-Q-wave myocardial infarction: The recommended dose is 1 mg/kg enoxaparin every 12 hours by subcutaneous injection, administered
concurrently with oral aspirin (100 to 325 mg once daily). Treatment with enoxaparin in these patients should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days.

Treatment of acute ST-Segment Elevation Myocardial Infarction: The recommended dose of enoxaparin sodium is a single IV bolus of 30 mg plus a 1mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (max. 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Prevention of extracorporeal thrombus formation during haemodialysis: A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis session is usually sufficient for a 4 hour session. If fibrin rings are found, such as after a longer than normal session, a further dose of 0.5 to 1 mg/kg (50 to 100 IU/kg) may be given. For patients at a high risk of haemorrhage the dose should be reduced to 0.5 mg/kg (50 IU/kg) for double vascular access or 0.75 mg/kg (75 IU/kg) for single vascular access.

Elderly: No dosage adjustment is necessary in preventive therapy.

Patients with renal impairment: No dosage adjustment is required in patients with moderate (creatinine clearance 30-50 ml/min) and mild (creatinine clearance 50-80 ml/min) renal impairment. But, all such patients should be observed carefully for signs and symptoms of bleeding. For patients with severe (creatinine clearance < 30 ml/min) renal impairment, the dosage adjustment for prophylactic dose is 2000 IU once daily and therapeutic dose is 100 IU/kg once daily.

Pregnancy: Pregnancy category B. In humans, there is no evidence that enoxaparin crosses the placental barrier. Enoxaparin should be used during pregnancy only if the physician has established a clear need. Enoxaparin is not recommended for use in pregnant women with prosthetic heart valves.

Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when enoxaparin injection is
administered to nursing women.

Use in children and adolescents
Safety and effectiveness of enoxaparin in pediatric patients have not been established.

Enoxaparin injection should not be administered by intramuscular route. Enoxaparin should be used with caution in conditions with increased potential for bleeding such as impaired haemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy, recent neuro or ophthalmologic surgery and low weight
patients (women <45 kg and men <57 kg). It is recommended that the platelet count be measured before the initiation of the treatment and regularly thereafter during treatment.

Most common side effects of enoxaparin are haemorrhage (bleeding), thrombocytopenia, elevations of serum aminotransferase, pain, hepatic enzymes increase (mainly transaminases), urticaria, pruritus, erythema, bluish marks at injection sites to skin rash at injection sites. Cases of neuraxial hematomas with the concurrent use of enoxaparin and spinal or epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries.

Hypersensitivity to either enoxaparin, heparin or other low molecular weight heparins, major clotting disorders like history of thrombocytopenia, active gastro-intestinal ulcer or organic lesion likely to bleed, recent hemorrhagic vascular cerebral stroke. Although rare, cutaneous or systemic allergic reactions may occur

Drug interaction with medication: It is recommended that agents which affect hemostasis should be discontinued prior to enoxaparin therapy unless their use is essential, such as: systemic salicylates, acetylsalicylic acid, clopidogrel, systemic glucocorticoids, thrombolytics and anticoagulants. If the combination cannot be avoided, enoxaparin should be used with careful clinical and laboratory monitoring.

Drug interaction with food and others: Not applicable.

Accidental overdosage following administration of enoxaparin may lead to haemorrhagic complications. Injected enoxaparin may be largely neutralized by the slow IV 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

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Vistarin® 2000 IU/0.2 ml: Each pre-filled syringe (0.2 ml) contains 2000 anti-Xa IU equivalent to 20 mg Enoxaparin Sodium BP.
Vistarin® 4000 IU/0.4 ml: Each pre-filled syringe (0.4 ml) contains 4000 anti-Xa IU equivalent to 40 mg Enoxaparin Sodium BP.
Vistarin® 6000 IU/0.6 ml: Each pre-filled syringe (0.6 ml) contains 6000 anti-Xa IU equivalent to 60 mg Enoxaparin Sodium BP.
Vistarin® 8000 IU/0.8 ml: Each pre-filled syringe (0.8 ml) contains 8000 anti-Xa IU equivalent to 80 mg Enoxaparin Sodium BP.

Storage
Store in a cool (below 25°C) and dry place protected from light. Do not freeze. Keep away from the reach of children

Packing

Vistarin® 2000 IU/0.2 ml: Each box contains 1 pre-filled syringe (0.2 ml), an alcohol pad and a first aid bandage.

Vistarin® 4000 IU/0.4 ml: Each box contains 1 pre-filled syringe (0.4 ml), an alcohol pad and a first aid bandage.

Vistarin® 6000 IU/0.6 ml: Each box contains 1 pre-filled syringe (0.6 ml), an alcohol pad and a first aid bandage.

Vistarin® 8000 IU/0.8 ml: Each box contains 1 pre-filled syringe (0.8 ml), an alcohol pad and a first aid bandage.