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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Intraocularretroperitoneal, and intracranial hemorrhages were always considered major. Hemodialysis In a single study, elimination rate appeared similar but AUC was two-fold higher than control population, after a single 0.

Since aminotransferase determinations are important in the differential diagnosis of myocardial infarction, liver disease, and pulmonary emboli, elevations that might be caused by drugs like Lovenox should be interpreted with caution.

Local reactions at the injection site e. Mean absolute bioavailability of enoxaparin, after 1. Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and low birth weight infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative.

Hip Replacement Surgery with Extended Prophylaxis. Indication Dose DVT prophylaxis in abdominal surgery. All pregnancies have a background risk of birth loenox, loss, or other adverse outcome regardless of drug exposure.

Treatment was initiated after surgery and continued up to 14 days. CI denotes confidence intervals. After repeated subcutaneous administration of 40 mg once daily and 1. The primary efficacy endpoint was the composite of death from any cause or myocardial re-infarction in the first 30 days after randomization.

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Enoxaparin Sodium Injection, USP

Urgent revascularization procedures were performed less frequently in the Lovenox group as compared to the heparin group, 6.

Steady state is achieved on the second day lovfnox treatment. Cases of headache, hemorrhagic anemia, eosinophilia, alopecia, hepatocellular and cholestatic liver injury have been reported Osteoporosis has also been reported following long-term therapy.

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Treatment was initiated within two days after surgery and was continued for 7 to 11 days after surgery. If coadministration is po, conduct close clinical and laboratory monitoring [see Warnings and Precautions 5. Urgent revascularization denotes episodes of recurrent myocardial ischemia without infarction leading to the clinical decision to perform coronary revascularization during the same hospitalization.

Lovenox does not cross the placenta, and is not expected to result in fetal exposure to the drug. The overall treatment effect of enoxaparin as compared to the unfractionated heparin is shown at the bottom of the figure. In a double-blind study, Lovenox 30 mg every 12 hours subcutaneously was compared to placebo in patients with hip replacement.

Because HIT may still lovwnox 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. To minimize bruising, do not rub the injection site after completion of the injection.

Patients ranged in age from 18 to 92 years mean age A clinical study using enoxaparin in pregnant women with mechanical prosthetic heart valves has been conducted [see Warnings and Precautions 5. The 99 patients with total knee replacement ranged in age from 42 to 85 years mean age Pregnant women should be apprised of the potential hazard to the fetus and the mother if enoxaparin is administered during pregnancy.

Monitor patients frequently for signs and symptoms of neurological impairment. Geriatric 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.

The site of the procedure should be observed for signs of bleeding or hematoma formation [see Dosage and Administration 2. For subcutaneous use, Lovenox should not be mixed with other injections or infusions.

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 Lovenox activity and, therefore, unsuitable for monitoring. Based on animal data, enoxaparin is not predicted to increase the risk of major developmental abnormalities [see Data ]. All patients were also treated with aspirin to mg per day.

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All patients receiving anticoagulants, including pregnant women, are at risk for bleeding. Lovenox 40 mg subcutaneously, administered once a day, 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.

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

Use of Lovenox in patients with a history of immune-mediated HIT within the past days or in the presence of circulating antibodies is contraindicated [see Contraindications 4 ]. Bleeding can occur at any site during therapy with Lovenox. Activation of the safety system must be done only after removing the needle from the patient’s skin. The multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative [see Dosage and Administration 2 and How Supplied 16 ]. 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.

Clinical Considerations Pregnancy alone confers an increased risk for thromboembolism that is even higher for women with thromboembolic disease and certain high risk pregnancy conditions.

In a double-blind, parallel group study of patients undergoing elective cancer surgery of the gastrointestinal, urological, or gynecological tract, a total of patients were enrolled in the study, and patients were treated.

If the last Lovenox subcutaneous administration was given more than 8 hours before balloon inflation, an intravenous bolus of 0.

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