Product Information
Olxarin
(Enoxaparin Sodium)
FORMULATION:
Each pre-filled injection contains:
Enoxaparin Sodium….40 mg / 60 mg
PHARMACOKINETICS:
Enoxaparin is rapidly and almost completely absorbed after subcutaneous injection with a bioavailability of about 100%. Peak plasma activity is reached within 1 to 5 hours. The elimination half-life is about 4 to 5 hours but anti-factor Xa activity persists for up to 24 hours after a 40-mg dose. Elimination is prolonged in patients with renal impairment. Enoxaparin is metabolised in the liver and excreted in the urine, as unchanged drug and metabolites.
INDICATION:
Enoxaparin is used in the treatment of prophylaxis of venous thromboembolism and to prevent clotting during extracorporeal circulation. It is also used in the management of unstable angina and in ST-elevation myocardial infarction.
DOSAGE AND ADMINISTRATION:
In the prophylaxis of venous thromboembolism during surgical procedures, enoxaparin sodium is given by subcutaneous injection; treatment is continued for 7 to 10 days or until the patient is ambulant.
Patients at low to moderate risk are given 20 mg (2000 units) once daily with the first dose about 2 hours pre-operatively. In patients at high-risk, such as those undergoing orthopaedic surgery, the dose should be increased to 40 mg (4000units) once daily with the initial dose given about 12 hours before the procedure. Alternatively, a dose of 30 mg (3000 units) may be given subcutaneously twice daily, starting within 12 to 24 hours after operation.
After hip replacement surgery, enoxaparin sodium may be continued in a dose of 40 mg (4000 units) once daily for a further 3 weeks.
For the prophylaxis of thromboembolism in immobilized medical patients, the dose is 40 mg (4000 units) once daily for atleast 6 days; treatment should be continued until the patient is fully ambulant, up to a maximum of 14 days.
For the treatment of deep-vein thrombosis enoxaparin sodium is given subcutaneously in a dose of 1mg/kg (100units/kg) every 12 hours, or 1.5 mg/kg (150units/kg) once daily, for at least 5 days and until oral anticoagulation is established.
For prevention of clotting in the extracorporeal circulation during hemodialysis, enoxaparin sodium 1 mg/kg (100units/kg) is introduced into the arterial line of the circuit at the beginning of the dialysis session. A further dose of 0.5 to 1 mg/kg (50 to 100units/kg) may be given if required. The dose should be reduced in patients at high risk of haemorrhage.
In the management of unstable angina, enoxaparin sodium is given subcutaneously in a dose of 1 mg/kg (100units/kg) every 12 hours. Treatment is usually continued for 2 to 8 days.
In acute ST-elevation myocardial infarction the initial dose of enoxaparin is 30 mg (3000 units), with a subcutaneous dose of 1 mg/kg (100units/kg) given at the same time. Further doses of 1 mg/kg (100units/kg) should be given subcutaneously every 12 hours for 8 days or until hospital discharge. The first 2 subcutaneous doses should not exceed 100mg (10,000units) each.
For patients who undergo a percutaneous coronary intervention, an additional intravenous dose of 300 micrograms/kg (30 units/kg) should be given at the time of the procedure if the last subcutaneous dose was given more than 8 hours previously.
Patients aged 75 years and older with acute myocardial infarction should be given subcutaneous doses only; the recommended dose is 750 mcg/kg (75units/kg) every 12 hours, with a maximum of 75 mg (7500 units) for each of the first 2 doses.
The dose of enoxaparin sodium should be reduced in patients with severe renal impairment.
PRECAUTIONS:
As for Low-molecular-weight Heparins, patients with low-body weight (women below 45kg, men below 57kg) may be at higher risk of bleeding with prophylactic doses of enoxaparin and require careful monitoring. Severe bleeding with enoxaparin may be reduced by the slow intravenous injection of protamine sulfate; 1 mg of protamine sulfate is stated to inhibit the effects of 1 mg (100 units) of enoxaparin sodium.
DRUG INTERACTIONS:
Heparin should be used with care with oral anticoagulants or drugs, such as aspirin and dipyridamole, that affect platelet function. NSAIDs may also increase the risk of haemorrhage. Other drugs that affect the coagulation process and which may therefore increase the risk of haemorrhage include dextrans, thrombolytic enzymes such as streptokinase, high doses of penicillins and some cephalosporins, some contrast media, asparaginase, and epoprostenol; for use of heparin with drotrecogin alfa. Estimations of oral anticoagulant control may be modified by heparin’s action on prothrombin.
CAUTION:
Foods, Drugs, Devices and Cosmetics act prohibits dispensing without prescription.
STORAGE CONDITION:
Store at temperatures not exceeding 30°C
AVAILABILITY:
Box of 1 Pre-filled Injection
Manufactured by:
Hangzhou Jiuyuan Gene Engineering Co., Ltd
East of No. 8th Street, Hangzhou Economic & Technological Development Zone Zhejiang P.R. China
Imported by:
SAHAR INTERNATIONAL TRADING INC.
# 354 Aguirre Avenue, Phase III BF Homes, Paranaque City, Philippines
Distributed by:
Vaxines Trading, Inc.
Blk. 1 lot 33 Uranium St., Pilar Village, Las Pinas City, Philippines 1740