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In patients with a high risk of thrombo-embolism (e.g. orthopedic surgery), the recommended dose of enoxaparin sodium given by subcutaneous injection, is 40 mg once daily, initiated 12 hours prior to surgery or 30 mg twice daily, initiated 12 to 24 hours after surgery.
Enoxaparin sodium treatment is usually prescribed for an average period of 7 to 10 days. Longer treatment duration may be appropriate in some patients and enoxaparin sodium should be continued for as long as there is a risk of venous thrombo-embolism and until the patient is ambulatory. Continued therapy with 40 mg once daily for 3 weeks following the initial therapy has been proven to be beneficial in orthopedic surgery.
For special recommendations concerning dosing intervals for Spinal/Epidural Anesthesia and Percutaneous coronary revascularisation procedures: see Warnings.
Prophylaxis of venous thrombo-embolism in medical patients: The recommended dose of enoxaparin sodium is 40 mg 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 deep vein thrombosis with or without pulmonary embolism: Enoxaparin sodium can be administered subcutaneously either as a single injection of 1.5 mg/kg or as twice daily injections of 1 mg/kg. In patients with complicated thrombo-embolic disorders, a dose of 1 mg/kg administered twice daily is recommended.
Enoxaparin sodium treatment is usually prescribed for an average period of 10 days. Oral anticoagulant therapy should be initiated when appropriate and enoxaparin sodium treatment should be continued until a therapeutic anticoagulant effect has been achieved (International Normalisation Ratio 2 to 3).
Prevention of extra corporeal thrombus during hemodialysis: The recommended dose is 1 mg/kg of enoxaparin sodium.
For patients with a high risk of hemorrhage, the dose should be reduced to 0.5 mg/kg for double vascular access or 0.75 mg/kg for single vascular access. During hemodialysis, enoxaparin sodium 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-hour session; however, if fibrin rings are found, for example after a longer than normal session, a further dose of 0.5 to 1 mg/kg may be given.
Treatment of unstable angina and non-Q-wave myocardial infarction: The recommended dose of enoxaparin sodium is 1 mg/kg every 12 hours by subcutaneous injection, administered concurrently with oral aspirin (100 to 325 mg once daily).
Treatment with enoxaparin sodium 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 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (max 100 mg for each of the first two SC doses only, followed by 1 mg/kg SC dosing for the remaining doses). For dosage in patients ≥75 years of age, see Special Populations Elderly.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific), enoxaparin sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having STEMI and maintained under (75 to 325 mg once daily) unless contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge, whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of enoxaparin sodium should be administered.
SPECIAL POPULATIONS: Children: The safety and efficacy of enoxaparin sodium in children has not been established.
Elderly: For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for each of the first two SC doses only, followed by 0.75 mg/kg SC dosing for the remaining doses).
For other indications, no dose reduction is necessary in the elderly, unless kidney function is impaired (see Pharmacology: Pharmacokinetics: Elderly under Actions, Dosage & Administration, and Precautions).
Hepatic impairment: In the absence of clinical studies, caution should be used in hepatically impaired patients.
Renal impairment: (See Pharmacology: Pharmacokinetics under Actions and Precautions).
Severe renal impairment: A dosage adjustment is required for patients with severe renal impairment (creatinine clearance <30 ml/min), according to the following tables, since enoxaparin sodium exposure is significantly increased in this patient population.
The following dosage adjustments are recommended for therapeutic dosage ranges: (see Table 1.)
Click on icon to see table/diagram/imageThe following dosage adjustments are recommended for prophylactic dosage ranges: (see Table 2.)
Click on icon to see table/diagram/imageThe recommended dosage adjustments do not apply to the hemodialysis indication.
Moderate and mild renal impairment: Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 ml/min) and mild (creatinine clearance 50-80 ml/min) renal impairment, careful clinical monitoring is advised.
Spinal/epidural anesthesia: For patients receiving spinal/epidural anesthesia, see Warnings.
ADMINISTRATION: Subcutaneous injection: Enoxaparin sodium is administered by subcutaneous injection for the prevention of venous thrombo-embolic disease, treatment of deep vein thrombosis, treatment of unstable angina and non-Q-wave myocardial infarction and treatment of acute ST-segment Elevation Myocardial Infarction.
IV bolus injection: For acute ST-segment Elevation Myocardial Infarction, treatment is to be initiated with a single IV bolus injection immediately followed by a subcutaneous injection.
Arterial line injection: It is administered through the arterial line of a dialysis circuit for the prevention of thrombus formation in the extra-corporeal circulation during haemodialysis.
It must not be administered by the intramuscular route.
The pre-filled disposable syringe is ready for immediate use.
Subcutaneous injection technique: Injection should be made preferably when the patient is lying down. Enoxaparin sodium is administered by deep subcutaneous injection. Do not expel the air bubble from the syringe before the injection to avoid the loss of drug when using the 20 and 40 mg pre-filled syringes. The administration should be alternated 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 index finger. The skin fold should not be released until the injection is complete. Do not rub the injection site after administration (see Cautions for Usage).
Intravenous (Bolus) Injection Technique (for acute STEMI indication only): Enoxaparin sodium should be administered through an intravenous line. It should not be mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium with other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the intravenous bolus administration of enoxaparin sodium to clear the port of drug.
Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
Initial 30-mg bolus: For the initial 30-mg bolus, using an enoxaparin sodium graduated pre-filled syringe, expel the excessive volume to retain only 30 mg (0.3 ml in the syringe. The 30-mg dose can then be directly injected into the intravenous line.
Additional bolus for PCI when last SC administration was given more than 8 hours before balloon inflation: For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus of 0.3 mg/kg is to be administered if last SC administration was given more than 8 hours before balloon inflation (see Dosage & Administration).
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 3 mg/ml.
To obtain a 3-mg/ml solution, using a 60-mg enoxaparin sodium pre-filled syringe, it is recommended to use a 50-ml infusion bag (i.e. using either normal saline solution (0.9%) or 5% dextrose in water) as follows: Withdraw 30 ml from the infusion bag with a syringe and discard the liquid. Inject the complete contents of the 60-mg enoxaparin sodium prefilled syringe into the 20 ml remaining in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe for administration into the intravenous line.
After dilution is completed, the volume to be injected can be calculated using the following formula [Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table below. It is recommended to prepare the dilution immediately before use.
Volume to be injected through intravenous line after dilution is completed. (See Table 3.)
Click on icon to see table/diagram/image
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