LOVENOX PI PDF
LOVENOX® is indicated to help reduce the risk of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE). Read full important safety. /83/EC for Lovenox and associated names, in order to resolve divergences The PI was split as follows according to the indications the. Save money on your Lovenox® Injection prescription by switching to Teva’s FDA- approved generic version, Enoxaparin Sodium Injection, USP.
| Author: | Arazil Negrel |
| Country: | Sierra Leone |
| Language: | English (Spanish) |
| Genre: | Career |
| Published (Last): | 24 August 2006 |
| Pages: | 222 |
| PDF File Size: | 15.63 Mb |
| ePub File Size: | 11.69 Mb |
| ISBN: | 268-7-83490-302-4 |
| Downloads: | 32567 |
| Price: | Free* [*Free Regsitration Required] |
| Uploader: | Shakticage |
Cases of headache, hemorrhagic anemia, eosinophilia, alopecia, hepatocellular and cholestatic liver injury have been reported Osteoporosis has also been reported following long-term therapy.
Enoxaparin Sodium Injection, USP
If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs, platelet inhibitors, or other anticoagulants, advise them to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness especially in the lower limbs and muscular weakness. Prophylaxis of ischemic complications of unstable angina and non—Q-wave myocardial infarction, when concurrently administered with aspirin. A retrospective study reviewed the records of women who used enoxaparin during pregnancy.
Retroperitoneal and intracranial hemorrhages were always considered major. If the pharmacy doesn’t regularly stock a certain medication from Teva, ask if it can be ordered for you at no additional cost. In a clinical trial in patients with acute ST-segment elevation myocardial infarction, thrombocytopenia occurred at a rate of 1.
TGA eBS – Product and Consumer Medicine Information
The molecular weight distribution is: Activation of the safety system must be done only after removing the needle from the patient’s skin. A total of patients were randomized in the study and patients were treatedof which 99 had total knee replacement and 32 had either unicompartmental knee replacement or tibial osteotomy.
Use of indwelling epidural catheters Concomitant use of other drugs that affect hemostasis, lovwnox as non-steroidal anti-inflammatory drugs NSAIDsplatelet inhibitors, other anticoagulants A history of traumatic or repeated epidural or spinal punctures A history of spinal deformity or spinal surgery Optimal timing between the administration of Lovenox and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment.
For patients at least 75 years of age, the intravenous bolus was not given and the subcutaneous dose was reduced to 0. In a multicenter, double-blind, double-dummy, parallel-group study, patients with acute ST-segment elevation myocardial infarction STEMI who were to be hospitalized within 6 hours of onset and were eligible to receive fibrinolytic therapy were randomized in a 1: Increased risk of hemorrhage: The mean treatment duration of unfractionated heparin was 54 hours.
Data Human Data There are no adequate and well-controlled studies in pregnant women. The usual duration of treatment is 2 to 8 days; up to Lovenox 40 mg subcutaneously, administered once a ip, beginning 2 hours prior to surgery and continuing for a maximum of 12 days after surgery, was comparable to heparin U every 8 hours subcutaneously in reducing the risk of DVT.
All patients also received warfarin sodium as described in the previous study. There was no evidence of teratogenic effects or fetotoxicity due to enoxaparin. A total of patients were randomized in the study and all were treated. All patients should receive lovnox as soon as they are identified as having STEMI and maintained with 75 to mg pk daily unless contraindicated. The use of Lovenox for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves has not been adequately studied.
If coadministration is essential, conduct close clinical and laboratory monitoring [see Warnings and Precautions 5. Use with caution in patients at risk 5.
Because benzyl alcohol may cross the placenta, if anticoagulation with Lovenox is needed during pregnancy, use the preservative-free formulations where possible [see Use in Specific Populations 8. Lovenox versus heparin Not adequately studied 8. In a second double-blind, parallel group study, Lovenox 40 mg subcutaneously once a day was compared to heparin U every 8 hours subcutaneously in patients undergoing colorectal surgery one-third with cancer.
Therapy continued for up to 8 days median duration of 2. Renal Impairment A linear relationship between anti-Factor Xa plasma clearance and creatinine clearance at steady state has been observed, which indicates decreased clearance of enoxaparin sodium in patients with reduced renal function. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection.
When given at a dose of 40 mg once a day lovennox, Lovenox significantly reduced the incidence of DVT as compared to placebo. A total of patients were randomized in the study and all patients were treated.
All patients were also treated with aspirin to mg per day.
Studies with enoxaparin in patients with hepatic impairment have not been conducted and the impact of hepatic impairment on the exposure to enoxaparin is unknown [see Use in Specific Populations 8. Mean peak anti-Factor Xa activity was 0.
Mild local irritation, pain, hematoma, ecchymosis, and erythema may follow subcutaneous injection of Lovenox. Apparent clearance and A max derived from anti-Factor Xa values following single and multiple subcutaneous dosing in geriatric subjects were close to those observed in young subjects.