LOVENOX PRESCRIBING INFORMATION PDF

Determine a patient's suggested dosage by entering the appropriate information when the tool prompts you. Select if severe renal impairment is a consideration. You may also need to know the patient's weight. Please input further information to calculate recommended dosage. Usual dose is 40 mg subcutaneously per day, the usual duration of administration is 7 to 10 days. Usual dose is 30 mg subcutaneously every 12 hours, the usual duration of administration is 7 to 10 days.

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Manufacturer: PT. Aventis Pharma. Full Prescribing Info. Each ml of the solution contains anti-Xa IU equivalent to mg enoxaparin sodium. One mg 0. Pharmacotherapeutic Group: Antithrombotic agent. Pharmacology: Pharmacodynamics: Enoxaparin is a low molecular weight heparin in which the antithrombotic and anticoagulant activities of standard heparin have been dissociated.

It is characterized by a higher ratio of anti-Xa activity to anti-IIa or antithrombin activity. The ratio between these two activities is 3. As with standard heparin, the anti-Xa and anti-IIa activity of enoxaparin results from its effect on antithrombin.

When used as prophylactic treatment, it does not significantly affect the activated partial thromboplastin time aPTT. When used as curative treatment, aPTT can be prolonged by 1. This prolongation reflects the residual antithrombin activity. The study medication or placebo were administered once daily for 6 to 14 days to patients who were bedridden due to an acute medical disorder occurring within the previous three days and who were at moderate risk of venous thromboembolism.

Medical patients at high risk of venous thromboembolism complications acute phase of myocardial infarction, heart disease such as arrhythmia or valvular disease requiring anticoagulant therapy, intubated patients or patients who had experienced a stroke within the last three months were not included in the study.

Non-fatal symptomatic pulmonary embolism confirmed by pulmonary angiography or spiral CT; or fatal pulmonary embolism. This was mainly due to the significant decrease in the incidence of total DVT proximal and distal , i.

Most DVTs were asymptomatic only 6 were symptomatic. The observed benefit was maintained after 3 months. Half the patients receiving heparin were administered the drug for less than 48 hours in All the patients were also treated with aspirin for at least 30 days. Enoxaparin significantly reduced the incidence of primary end point events composite end point consisting of myocardial infarction relapse and all-cause mortality within 30 days after inclusion : 9.

The incidence of myocardial infarction relapse was significantly lower in the enoxaparin group 3. The incidence of deaths was lower in the enoxaparin group, with no statistically significant difference between the groups 6.

The benefit of enoxaparin in terms of the primary endpoint was consistent, irrespective of sub-group: age, sex, location of myocardial infarction, history of diabetes of myocardial infarction, type of thrombolytic administered and interval between the first clinical signs and treatment initiation.

Enoxaparin demonstrated a significant benefit versus unfractionated heparin in terms of the primary efficacy criterion, both in patients who had undergone coronary angioplasty within 30 days after inclusion There was a higher incidence of gastrointestinal bleeding in the enoxaparin group 0. Pharmacokinetics: The pharmacokinetic parameters of enoxaparin have been evaluated based on the time course of plasma anti-Xa and anti-IIa activity at the recommended doses validated amidolytic methods following single and repeated SC administration, and following single IV injection.

Peak plasma activity is observed between 3 and 4 hours after administration. This peak activity expressed as Anti-Xa IU is 0. Enoxaparin pharmacokinetics appears to be linear over the recommended dose ranges. Intra- and inter-patient variability is low. Steady-state enoxaparin activity levels are well predicted by single dose pharmacokinetics.

Based on enoxaparin sodium pharmacokinetics, this difference in steady state is expected and is within the therapeutic range. The mean maximum anti-IIa activity is observed approximately hours following SC injection and reaches 0.

Steady state is reached as of the second day of treatment. No pharmacokinetic interaction has been observed between enoxaparin and the thrombolytic agent when co-administered. Distribution: The volume of distribution of enoxaparin anti-Xa activity is about 5 liters and is close to the blood volume. Metabolism: Enoxaparin is primarily metabolized in the liver desulfation, depolymerization. Enoxaparin exhibits a monophasic elimination pattern with a half-life of about 4 hours after a single SC dose to about 7 hours after repeated dosing by SC route.

Enoxaparin and its metabolites are eliminated via the renal route nonsaturable mechanism and by the biliary route. Special Populations: Elderly Subjects: As kidney function is physiologically impaired in this population, elimination is slower. This does not affect doses or the administration schedule in prophylactic treatment as long as the renal function of these patients remains within acceptable limits i.

It is essential to systematically assess renal function in elderly patients aged over 75 years using the Cockcroft formula before initiating treatment with LMWH. The pharmacokinetic parameters remain, in principle, unchanged except in cases of overdose or where the drug passes into the general circulation, causing high anti-Xa activity related to end-stage renal failure. Pregnancy: Low molecular weight heparins are unlikely to cross the placental barrier, but data on the subject remain insufficient.

This heparin is a low molecular weight heparin LMWH. Prevention of clotting in the extracorporeal circulation during hemodialysis generally a session of 4 hours or less. General recommendation: Regular monitoring of the platelet count is essential throughout the treatment due to the risk of heparin-induced thrombocytpenia HIT. See Precautions. Do not inject via the the intramuscular route. One milliliter of solution for injection is equivalent to approximately 10, anti-Xa IU of enoxaparin.

For spinal and epidural anesthesia techniques, the benefit of a preoperative injection of enoxaparin should be weighed against the theoretically increased risk of spinal hematoma see Precautions. Administration schedule: One injection per day. Dosage: The dose must be determined based on the risk related to the patient and the type of surgery. Surgery involving moderate thrombogenic risk: In surgery involving moderate thrombogenic risk and in patients who are not at high risk of thromboembolism, effective prevention is achieved by daily injection of 2 anti-Xa IU 0.

The studied dosage regimen involves administration of the first injection approximately 2 hours before surgery. The studied dosage regimen involves either administration of the first injection of 4 anti-Xa IU total dose 12 hours before surgery, or a first injection of 2 anti-Xa IU half dose 2 hours before surgery.

Duration of treatment: Treatment with LMWH should be maintained, along with the usual methods of elastic support for the legs, until the patient is fully and actively ambulatory.

In general surgery, the duration of LMWH treatment must be less than 10 days, unless there is a patient-specific risk of venous thromboembolism see Precautions. However, the clinical benefit of long-term treatment with low molecular weight heparins or oral anticoagulants has not yet been evaluated. This dose, administered as a single intravascular bolus injection, is only suitable for hemodialysis sessions of 4 hours or less.

Duration of treatment: It has been demonstrated that treatment is beneficial for between 6 to 14 days. To date, no efficacy and safety data are available concerning prophylaxis for more than 14 days. If the risk of venous thromboembolism persists, prolonged prophylactic treatment, particularly with oral anticoagulants, must be considered. Administration schedule: Two injections daily at hour intervals. LMWH dosage has not been evaluated in terms of body weight in patients weighing more than kg or less than 40 kg.

The efficacy of LMWH treatment may be slightly lower in patients weighing more than kg, and the risk of hemorrhage may be higher in patients weighing less than 40 kg. Specific clinical monitoring must be carried out in these patients. DVT treatment duration: Treatment with low molecular weight heparins should be quickly replaced by oral anticoagulant therapy, unless contraindicated. Treatment duration with LMWH should not exceed 10 days, including the time needed to reach the required oral anticoagulant effect, except when this is difficult to achieve see Laboratory Tests: Platelet Monitoring under Precautions.

Oral anticoagulant treatment should, therefore, be initiated as soon as possible. The recommended duration of treatment is about days, until the patient is clinically stable. The first dose of enoxaparin should be administered at any time between 15 minutes before and 30 minutes after the start of thrombolytic treatment whether fibrin-specific or not.

The recommended duration of treatment is 8 days, or until the patient is discharged from hospital if the hospitalization period is less than 8 days. Concomitant treatment: administration of aspirin must be instituted as soon as possible after symptoms appear and maintained at a dosage between 75 mg and mg daily for at least 30 days, unless otherwise indicated. Patient treated by coronary angioplasty: if the last SC injection of enoxaparin was performed less than 8 hours before balloon inflation, no additional administration is necessary.

Administration: Subcutaneous injection technique: Enoxaparin should be administered by injection into the subcutaneous tissue preferably with the patient supine. Administration should be alternated between the left and right anterolateral or posterolateral abdominal wall. The whole length of the needle should be inserted perpendicularly, not from the side, into a skin fold held between the thumb and index finger. The skin fold should be held throughout the injection.

When there is no excess volume, the air should not be expelled from the syringe before the injection. The multidose vial should be used to allow the initial dose of 3 IU, i.

This dose of enoxaparin should be injected into a venous line, and must not be mixed or administered with other medicinal products. To avoid any traces of other medicinal products and therefore to prevent them from mixing with enoxaparin, the injection line must be rinsed with a sufficient quantity of normal saline or glucose solution before and after IV bolus injection of enoxaparin. Enoxaparin can be safely administered with 0.

Accidental overdose following subcutaneous administration of massive doses of low molecular weight heparin may result in hemorrhagic complications. Neutralization is performed by slow intravenous injection of protamine sulfate or hydrochloride. The protamine dose required depends on: The heparin dose injected anti-heparin units of protamine neutralizes the activity of anti-Xa IU of low molecular weight heparin , if the enoxaparin sodium was administered within the last 8 hours.

The time since the heparin injection: An infusion of 50 anti-heparin units of protamine per anti-Xa IU of enoxaparin sodium can be administered if the enoxaparin sodium was given more than 8 hours earlier, or if a second dose of protamine appears necessary; administration of protamine is not necessary if the enoxaparin injection was given more than 12 hours earlier.

The above recommendations are intended for patients with normal renal function receiving repeated doses. Nevertheless, the anti-Xa activity of enoxaparin cannot be completely neutralized. Furthermore, the neutralization may only be transient due to the absorption pharmacokinetics of low molecular weight heparin.

This may require dividing the total calculated dose of protamine into several injections 2 to 4 given over 24 hours. Serious consequences are likely after ingestion of low molecular weight heparin, even in massive quantities no cases reported , due to the low gastric and intestinal absorption of the drug.

This medical product must not be used in the following situations: Hypersensitivity to enoxaparin, heparin or heparin derivatives, including other LMWHs; Organic lesion likely to bleed; Clinically significant active bleeding. History of immune mediated heparin-induced thrombocytopenia HIT within the past days or in the presence of circulating antibodies.

In patients with severe renal failure, unfractionated heparin should be used. For the calculation using the Cockroft formula, a recent bodyweight measurement is necessary see Precautions.

CITOLOGIA ASCUS PDF

Lovenox is a proven choice in anticoagulant therapy.

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins LMWH or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. 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:. Monitor patients frequently for signs and symptoms of neurological impairment.

LLMC 1996 PDF

Lovenox dosing

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