PDxane® is supplied as 4000 IU/0.4 mL, 6000 IU /0.6 mL and 8000 IU /0.8 mL prefilled syringes.
PDxane® contains Enoxaparin sodium belongs to Low Molecular Weight Heparins.
PDxane® has antithrombotic properties that stop blood clot forming and growing existing blood clots.
PDxane® is used both for prophylaxis and treatment of thromboembolic conditions.
PDxane® is used to prevent venous thrombosis and prophylactic treatment for ischemic complications of unstable angina and non-Q wave myocardial infection.
Clinical Pharmacology:
PDxane® is a Low Molecular Weight Heparin (LMWH) and has antithrombotic properties.
Pharmacokinetic:
- Enoxaparin sodium is primarily metabolized in the liver to lower molecular weight species with much reduced biological potency. Renal clearance of active fragments represents about 10% of the administered dose and total renal excretion of active and non-active fragments are about 40% of the dose.
- Elimination half-life based on anti-Factor Xa activity is 4.5 hours after a single SC dose to about 7 hours after repeated dosing.
- Significant anti-Factor Xa activity persists in plasma for about 12 hours following a 40 mg SC injection once a day dose.
Indication:
1) Prophylaxis of Deep Vein Thrombosis (DVT) in:
- Abdominal surgery
- Hip replacement surgery
- Knee replacement surgery
- Medical patients with severely restricted mobility during acute illness
2) Inpatient treatment of acute DVT with or without pulmonary embolism (treat blood clots that are in your blood when you are in hospital)
3) Outpatient treatment of acute DVT without pulmonary embolism (treat blood clots that are in your blood when you are at home)
4) Prophylaxis of ischemic complications of unstable angina (where not enough blood gets to your heart) and non-Q wave myocardial infarction (heart attack).
Dosing:
Prophylaxis of DVT in patients undergoing abdominal surgery:
- 40 mg enoxaparin (4,000 IU anti-Xa activity) once a day administered by SC injection with the initial dose given 2 hours prior to surgery
- The usual duration of administration is 7 to 10 days; up to 12 days in some cases
Prophylaxis of DVT in patients undergoing knee or hip replacement therapy:
- 30 mg enoxaparin (3,000 IU anti-Xa activity) every 12 hours administered by SC injection
- Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery.
- The duration of therapy is 7 to 10 days; up to 14 days in some cases
Alternative dosage for hip replacement surgery:
- 40 mg enoxaparin (4,000 IU anti-Xa activity) once a day administered by SC injection with the initial dose given 9 to 15 hours prior to surgery
- Continued prophylaxis for 3 weeks is recommended
Prophylaxis of DVT in medical Patients during Acute illness:
- 40 mg enoxaparin (4,000 IU anti-Xa activity) once a day administered by SC injection
- The usual duration of administration is 6 to 11 days; up to 14 days in some cases
Treatment of DVT with or without Pulmonary Embolism:
- In outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of PDxane® is 1 mg/kg every 12 hours administered SC.
- In inpatient (hospital) treatment, patients with acute DVT with pulmonary embolism or patients with acute DVT without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of PDxane® is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day.
- The average duration of administration is 7 days; up to 17 days in some cases.
- In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of PDxane®).
- PDxane® should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved.
Unstable Angina and Non-Q-Wave Myocardial Infarction:
- The recommended dose of PDxane® is 1 mg/kg administered by SC injection every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily).
- The usual duration of treatment is 2 to 8 days; up to 12.5 days in some cases
- Treatment should be prescribed for a minimum of 2 days and continued until clinical stabilization
Side effects:
Very common (affects more than 1 in 10 people)
- Bleeding a lot from a wound.
Common (affects 1 to 10 people in a 100)
- A painful rash of dark red spots under the skin which do not go away when you put pressure on them. You may also notice pink patches on your skin. These are more likely to appear in the area you have been injected with PDxane®.
Uncommon (affects 1 to 10 people in a 1,000)
- Sudden severe headache. This could be a sign of bleeding in the brain.
- A feeling of tenderness and swelling in your stomach. You may have bleeding inside your stomach.
Drug interactions:
Heparin, Warfarin, Aspirin, dipyridamole, clopidogrel, Sulfinpyrazone, dextran, ticlopidine, Antithrombin
Non-steroidal anti-inflammatory agents like: Ibuprofen, diclofenac, ketorolac
Selective serotonin reuptake inhibitors like: fluoxetine
Diuretics such as spironolactone, triamterene or amiloride
Monitoring parameters:
- Periodic complete blood cell counts, including platelet counts and hematocrit and hemoglobin
- Stool occult blood test
- Anti-factor Xa level for monitoring the anticoagulant effect in patients with significant renal impairment or abnormal coagulation parameters or bleeding
- Search for a bleeding site if an unexpected drop in hematocrit, hemoglobin or blood pressure occurs.
- When administered at recommended prophylaxis doses, routine coagulation tests such as Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) are relatively insensitive measures of PDxane® activity and, therefore, unsuitable for monitoring.