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.

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Safety and effectiveness of Lovenox in pediatric patients have not been established. Patients ranged in age from 47 to 87 years mean age At no time point were the 40 mg once a day pre-operative and the 30 mg every 12 hours postoperative hip replacement surgery prophylactic regimens compared in clinical trials.

Enoxaparin Sodium Injection, USP

In a study of extended prophylaxis for patients undergoing hip replacement surgery, patients were treated, while hospitalized, with Lovenox 40 mg subcutaneously, initiated up to 12 hours prior to surgery for the prophylaxis of postoperative DVT. Treatment continued for a maximum of 14 days median duration 7 days. Significant anti-Factor Xa activity persists in plasma for about 12 hours following a 40 mg subcutaneous once a day dose.

Lovenox cannot be loevnox interchangeably unit for unit with heparin or other low molecular weight heparins as they differ in manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage.

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The combined incidence of death or myocardial infarction at all time points was lower for Lovenox compared to standard heparin therapy, but did not achieve llovenox significance.

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In patients with renal failure, treatment with enoxaparin has been associated with lovdnox development of hyperkalemia [see Adverse Reactions 6. Observe for signs of bleeding 8. The site of the procedure should be observed for signs of bleeding or hematoma formation [see Dosage and Administration 2.

Major congenital anomalies in live births occurred at rates 2. Administration of lovenx sulfate can cause severe hypotensive and anaphylactoid reactions. An optimal duration of treatment is not known, but it is likely to be longer than 8 days. If the last Lovenox subcutaneous administration was given more than 8 hours oovenox balloon inflation, an intravenous bolus of 0. There was no evidence of teratogenic effects or fetotoxicity due to enoxaparin.

Obese patients are at higher risk for thromboembolism.

Teva’s generic of Lovenox® Injection: Enoxaparin Sodium Injection, USP

Obtain hemostasis at the puncture site before lovenxo removal 5. Local Reactions Mild local irritation, pain, hematoma, ecchymosis, and erythema may follow subcutaneous injection of Lovenox.

The safety system can only be activated once the syringe has been emptied. A retrospective study reviewed the records of women who used enoxaparin during pregnancy. A total of patients were randomized in the study and all patients were treated. Lovenox has been shown to reduce the risk of postoperative deep vein thrombosis DVT following hip or knee replacement surgery.

Whenever possible, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of Lovenox therapy. There is a trend in favor of enoxaparin during the first 48 hours, but most of the treatment difference is attributed to a step increase in the event rate in the UFH group at 48 hours seen in Figure 2an effect that is more striking when comparing the event rates just prior to and just subsequent to actual times of discontinuation.

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Teva Product Catalog The product catalog provides you with a full listing of Teva’s brand and generic product lines.

Observe for thromboembolism 8. The symptoms of acute toxicity were ataxia, decreased motility, dyspnea, cyanosis, and coma.

Maximum anti-Factor Xa and anti-thrombin anti-Factor IIa activities occur 3 to 5 hours after subcutaneous injection of enoxaparin. Consideration for use of a shorter acting anticoagulant should be specifically addressed as delivery approaches [see Boxed Warning ].

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Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Because Olvenox may still occur in these circumstances, the decision to use Lovenox in such a case must be made only after a careful benefit-risk assessment and after non-heparin alternative treatments are considered.

All such patients should be observed carefully for signs and symptoms of bleeding [see Clinical Pharmacology Monitor for increased risk of bleeding 8. In the knee replacement surgery trials, intraocular hemorrhages were also considered major hemorrhages. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions 5.

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