LOVENOX PI PDF

Postmarketing Experience The following adverse reactions have been identified during postapproval use of Lovenox. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The majority of patients had a postoperative indwelling epidural catheter placed for analgesia or received additional drugs affecting hemostasis such as NSAIDs. Many of the epidural or spinal hematomas caused neurologic injury, including long-term or permanent paralysis. Local reactions at the injection site e. Cases of hyperkalemia have been reported.

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Fenrigrel Active major bleeding 4 History of heparin-induced thrombocytopenia HIT within the past days or in the presence of lovenoxx antibodies 4 Hypersensitivity to enoxaparin sodium 4 Hypersensitivity to heparin or pork products 4 Hypersensitivity to benzyl alcohol for multidose formulation only 4. All patients receiving anticoagulants, including pregnant women, are at risk for bleeding. Bleeding can occur at any site during therapy with Lovenox.

Do not remove by pulling on the plunger as this may damage the syringe. Discontinue agents which may enhance hemorrhage risk prior to initiation of Lovenox or conduct close clinical and laboratory monitoring 5. Lovenox should not be mixed or coadministered with other medications.

Enoxaparin pharmacokinetics appears to be linear over the recommended dosage ranges [see Dosage and Administration 2 ]. Patients pj in age from 41 to 84 years mean age While not adequately studied, pregnant women with mechanical prosthetic heart valves may be at even higher risk for thrombosis [see Warnings and Precautions 5.

CI denotes confidence intervals. Subcutaneous Ppi Technique Patients should be lovenoz down and Lovenox administered by deep subcutaneous injection. All patients were treated with aspirin for a minimum of 30 days. Lovenox should be used with care in lovfnox with a bleeding diathesis, uncontrolled arterial hypertension or a history of recent gastrointestinal ulceration, diabetic retinopathy, renal dysfunction and hemorrhage. Weight After repeated subcutaneous 1.

To minimize the risk of bleeding following the vascular instrumentation during the treatment of unstable angina, non—Q-wave myocardial infarction and acute ST-segment elevation myocardial infarction, adhere precisely to the intervals recommended between Lovenox doses. Cases of heparin-induced thrombocytopenia with thrombosis have also been observed in clinical practice.

The usual duration of administration is 6 to 11 days; up to 14 days of Lovenox has been administered in the controlled clinical trial. Outpatient exclusion criteria included the following: The primary efficacy endpoint was the composite of death from any cause or myocardial re-infarction in the first 30 days after randomization. If neurological compromise is noted, urgent treatment is necessary. Lovenox does not cross the placenta, and is not expected to result in fetal exposure to the drug.

All such patients should be observed carefully for signs and symptoms of bleeding [see Clinical Pharmacology A single subcutaneous dose of All patients should be evaluated for a bleeding disorder before administration of Lovenox, unless the medication is needed urgently.

Patients ranged in age from 25 to 94 years median age 64 yearswith The maximum human dose in clinical trials was 2. Lovenox is a clear, colorless to pale yellow oovenox solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration. A retrospective study reviewed the records of women who used enoxaparin during pregnancy.

Livenox of the safety system may cause minimal splatter of fluid. In patients with renal failure, treatment with enoxaparin has been associated with the development of hyperkalemia [see Adverse Reactions 6. These patients should be observed carefully for signs and symptoms of thromboembolism.

The risk of Lovenox-associated bleeding increased with age. At the end of the peri-operative period, all patients underwent bilateral venography. In patients with renal impairment, there is an increase in exposure of enoxaparin sodium. Obese patients are at higher risk for thromboembolism. Whenever possible, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of Lovenox therapy. Where can I find Teva medications? Monitor for increased risk of bleeding 8.

Lovenoox these risks when scheduling patients for spinal procedures. In a multicenter, parallel group study, patients with acute lower extremity deep vein thrombosis DVT with or without pulmonary embolism PE were randomized to an inpatient hospital treatment of either i Lovenox 1. There are no adequate and well-controlled studies in pregnant lovenos. Fetal Risk Summary Lovenox does not cross the placenta, and is not expected to result in fetal exposure to the drug.

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Fenrigrel Active major bleeding 4 History of heparin-induced thrombocytopenia HIT within the past days or in the presence of lovenoxx antibodies 4 Hypersensitivity to enoxaparin sodium 4 Hypersensitivity to heparin or pork products 4 Hypersensitivity to benzyl alcohol for multidose formulation only 4. All patients receiving anticoagulants, including pregnant women, are at risk for bleeding. Bleeding can occur at any site during therapy with Lovenox. Do not remove by pulling on the plunger as this may damage the syringe. Discontinue agents which may enhance hemorrhage risk prior to initiation of Lovenox or conduct close clinical and laboratory monitoring 5. Lovenox should not be mixed or coadministered with other medications. Enoxaparin pharmacokinetics appears to be linear over the recommended dosage ranges [see Dosage and Administration 2 ].

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Lovenox dosing

These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: Use of indwelling epidural catheters Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs NSAIDs , platelet inhibitors, and 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. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

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Lovenox is a proven choice in anticoagulant therapy.

Votaxe The subcutaneous injections of enoxaparin were given until hospital discharge or for a maximum of eight days whichever came first. Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium. To avoid the possible mixture of Lovenox with other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the intravenous bolus administration of Lovenox to clear the port of drug. Pii has been shown to reduce the risk of postoperative deep vein thrombosis DVT following hip or knee replacement surgery.

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LOVENOX PI PDF

Mazugul Therapy continued for up to 8 days median duration of 2. Increased risk of hemorrhage: Each of these medicines has its own instructions for use. Lovenox may be safely administered with normal saline solution 0. An infusion of 0. In a second study, patients undergoing hip replacement surgery were treated, while hospitalized, with Lovenox 40 mg subcutaneously, initiated up to 12 hours prior to surgery.

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