Intravas

Intravas

enoxaparin sodium

Manufacturer:

Aristopharma

Distributor:

KTZ
Full Prescribing Info
Contents
Enoxaparin sodium.
Description
Each 0.4 mL, 0.6 mL and 0.8 mL pre-filled syringe contains 4000-, 6000- and 8000 anti-Xa IU equivalent to enoxaparin sodium 40 mg, 60 mg and 80 mg, respectively.
Each mL of the solution contains 10,000 anti-Xa IU equivalent to enoxaparin sodium 100 mg.
Action
Pharmacology: Enoxaparin 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 causes no notable modification of activated partial thromboplastin time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. Enoxaparin is primarily metabolized in the liver.
Indications/Uses
Treatment of deep vein thrombosis, with or without pulmonary embolism.
Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.
Prevention of thrombus formation in the extra-corporal circulation during haemodialysis.
Prophylaxis of venous thromboembolic disease (prevention of blood clot formation in the veins), in particular those which may be associated with orthopedic or general, major colorectal or cancer surgery.
Prophylaxis of venous thromboembolic disease in medical patients bedridden due to acute illness including acute heart failure, respiratory failure, severe infections and rheumatic diseases.
Dosage/Direction for Use
Prophylaxis of Deep Vein Thrombosis Especially in Surgical Patients: By SC injection, moderate risk, 20 mg (2000 units) approximately 2 hrs before surgery then 20 mg (2000 units) every 24 hrs for 7–10 days.
High Risk (eg, Orthopaedic Surgery): 40 mg (4000 units) 12 hrs before surgery then 40 mg (4000 units) every 24 hrs for 7–10 days.
Prophylaxis of Deep Vein Thrombosis in Medical Patients: By SC injection, 40 mg (4000 units) every 24 hrs for at least 6 days and continued until patient ambulant (Max: 14 days).
Treatment of Deep Vein Thrombosis or Pulmonary Embolism: By SC injection, 1.5 mg/kg (150 units/kg) every 24 hrs, usually for at least 5 days (and until adequate oral anticoagulation established).
Treatment of Acute ST-Segment Elevation Myocardial Infarction: Adults <75 years: By IV injection, 30 mg (3000 units) followed by SC injection, 1 mg/kg (100 units/kg), then by SC injection, 1 mg/kg every 12 hrs for up to 8 days. Max dose: 100 mg (10,000 units) for first 2 SC doses only.
Elderly >75 years: By SC injection only, 750 mcg/kg (75 units/kg) every 12 hrs. Max dose: 75 mg (7500 units) for first 2 doses only.
Patients Undergoing Percutaneous Coronary Intervention: Additional dose, by IV injection, 300 mcg/kg (30 units/kg) at time of procedure if last SC dose given more than 8 hrs previously.
Note: When administered in conjunction with a thrombolytic, enoxaparin should be given between 15 min before and 30 min after the start of thrombolytic therapy.
Unstable Angina and Non-ST-Segment-Elevation Myocardial Infarction: By SC injection, 1 mg/kg (100 units/kg) every 12 hrs usually for 2–8 days (minimum 2 days).
Prevention of Clotting in Extracorporeal Circuits: Recommended Dose: 1 mg/kg. For patients with a high risk of haemorrhage the dose should be reduced to 0.5 mg/kg for double vascular access or 0.75 mg/kg for singular vascular access. During haemodialysis, enoxaparin should be introduced into the arterial line of the circuit at the beginning of the dialysis session. The effect of this dose is usually sufficient for a 4-hr session however, if fibrin rings are found eg, after a longer than normal session, a further dose of 0.5 to 1 mg/kg may be given.
Treatment of Venous Thromboembolism in Pregnancy: by SC injection, early pregnancy body-weight under 50 kg, 40 mg (4000 units) twice daily; body-weight 50–70 kg, 60 mg (6000 units) twice daily; body-weight 70–90 kg, 80 mg (8000 units) twice daily; body-weight over 90 kg, 100 mg (10 000 units) twice daily.
Administration: Intravas pre-filled disposable syringe is ready for immediate use. Intravas contains no antimicrobial agent and should be used only once and then discarded. Intravas should be injected by deep SC route in prophylactic and curative treatment and by IV route during hemodialysis. Do not administer by the IM route. The air bubble from the syringe should not be expelled before the injection. The SC injection should preferably be made when the patient is lying down. Intravas is administered alternatively between the left and right anterolateral or posterolateral abdominal wall. The whole length of the needle should be introduced vertically into a skin fold gently held between the thumb and forefinger. The skin fold should not be released until the injection is complete.
Contraindications
Hypersensitivity to either enoxaparin, heparin or other low molecular weight heparins; major clotting disorders like history of thrombocytopenia, active gastrointestinal ulcer or organic lesion likely to bleed, recent haemorrhagic vascular cerebral stroke. Although rare, cutaneous or systemic allergic reactions may occur.
Special Precautions
Enoxaparin injection should not be administered by IM route. Enoxaparin should be used with caution in conditions with increased potential for bleeding eg, impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy, recent neuro or ophthalmologic surgery and low weight patients. It is recommended that the platelet count should be measured before the initiation of the treatment and regularly thereafter during treatment.
Use in 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.
Use in lactation: It is not known whether this drug is excreted in human milk. However, as a precaution, lactating mothers receiving enoxaparin sodium should be advised to avoid breastfeeding.
Use in children: The safety and efficacy of enoxaparin sodium in children have not been established.
Use in the elderly: No dose reduction is necessary in the elderly, unless kidney function is impaired.
Use In Pregnancy & Lactation
Use in 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.
Use in lactation: It is not known whether this drug is excreted in human milk. However, as a precaution, lactating mothers receiving enoxaparin sodium should be advised to avoid breastfeeding.
Adverse Reactions
Haemorrhage (bleeding), thrombocytopenia, local reactions (pain, haematoma and mild local irritation) may follow the SC injection of enoxaparin. There have been reports of neuraxial haematomas with the concurrent use of enoxaparin sodium and spinal/epidural anaesthesia or spinal puncture resulting in varying degrees of neurologic injuries.
Drug Interactions
There have been reports of neuraxial haematomas with the concurrent use of enoxaparin sodium and spinal/epidural anaesthesia or spinal puncture resulting in varying degrees of neurologic injuries.
ATC Classification
B01AB05 - enoxaparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
Presentation/Packing
Soln for inj (pre-filled syringe) 40 mg/0.4 mL x 1's. 60 mg/0.6 mL x 1's.
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