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Uses
Enoxaparin sodium is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
- in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.1)].
- in patients undergoing hip replacement surgery, during and following hospitalization.
- in patients undergoing knee replacement surgery.
- in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.
Enoxaparin sodium is indicated for:
- the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium.
- the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.
Enoxaparin sodium is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
Enoxaparin sodium, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI).
History
There is currently no drug history available for this drug.
Other Information
Enoxaparin sodium injection is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5.
Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains an 1,6 anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is:
<2000 daltons ≤20%
2000 to 8000 daltons ≥68%
>8000 daltons ≤18%
STRUCTURAL FORMULA
* X = Percent of polysaccharide chain containing 1,6 anhydro derivative on the reducing end. | |||
R | X*= 15 to 25% | ![]() |
n= 0 to 20 |
100 - X | H | n =1 to 21 |
Enoxaparin sodium injection 100 mg/mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection.
Enoxaparin sodium injection 150 mg/mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection.
The enoxaparin sodium prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection. The multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative [see Dosage and Administration (2) and How Supplied (16)].
Sources
Enoxaparin Sodium Manufacturers
-
Fresenius Kabi Usa, Llc
Enoxaparin Sodium | Fresenius Kabi Usa, Llc
All patients should be evaluated for a bleeding disorder before administration of enoxaparin sodium, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring enoxaparin activity, routine monitoring of coagulation parameters is not required [see Warnings and Precautions (5.9)].
For subcutaneous use, enoxaparin sodium should not be mixed with other injections or infusions. For intravenous use (i.e., for treatment of acute STEMI), enoxaparin sodium can be mixed with normal saline solution (0.9%) or 5% dextrose in water.
Enoxaparin sodium is not intended for intramuscular administration.
2.1 Adult DosageAbdominal Surgery: In patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of enoxaparin sodium is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials.
Hip or Knee Replacement Surgery: In patients undergoing hip or knee replacement surgery, the recommended dose of enoxaparin sodium is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hours prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, it is recommended that continued prophylaxis with enoxaparin sodium 40 mg once a day be administered by SC injection for 3 weeks. The usual duration of administration is 7 to 10 days; up to 14 days administration has been administered in clinical trials.
Medical Patients During Acute Illness: In medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of enoxaparin sodium is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days; up to 14 days of enoxaparin sodium has been administered in the controlled clinical trial.
Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism: In outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of enoxaparin sodium is 1 mg/kg every 12 hours administered SC. In inpatient (hospital) treatment, patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of enoxaparin sodium is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day. In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of enoxaparin sodium). Enoxaparin sodium should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0). The average duration of administration is 7 days; up to 17 days of enoxaparin sodium administration has been administered in controlled clinical trials.
Unstable Angina and Non-Q-Wave Myocardial Infarction: In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of enoxaparin sodium is 1 mg/kg administered SC every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with enoxaparin sodium should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days; up to 12.5 days of enoxaparin sodium has been administered in clinical trials [see Warnings and Precautions (5.2) and Clinical Studies (14.5)].
Treatment of Acute ST-Segment Elevation Myocardial Infarction: In patients with acute ST-segment elevation myocardial infarction, the recommended dose of enoxaparin sodium is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Dosage adjustments are recommended in patients ≥75 years of age [see Dosage and Administration (2.3)]. All patients should receive aspirin as soon as they are identified as having STEMI and maintained with 75 to 325 mg once daily unless contraindicated. When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), enoxaparin sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. In the pivotal clinical study, the enoxaparin sodium treatment duration was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days.
For patients managed with percutaneous coronary intervention (PCI): If the last enoxaparin sodium SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last enoxaparin sodium SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of enoxaparin sodium should be administered [see Warnings and Precautions (5.2)].
2.2 Renal ImpairmentAlthough no dose adjustment is recommended in patients with moderate (creatinine clearance 30–50 mL/min) and mild (creatinine clearance 50–80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding.
The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance <30 mL/min) are described in Table 1 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Table 1 Dosage Regimens for Patients with Severe Renal Impairment
(creatinine clearance <30mL/minute) Indication Dosage Regimen Prophylaxis in abdominal surgery 30 mg administered SC once daily Prophylaxis in hip or knee replacement surgery 30 mg administered SC once daily Prophylaxis in medical patients during acute illness 30 mg administered SC once daily Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin 1 mg/kg administered SC once daily Treatment of acute ST-segment elevation myocardial infarction in patients <75 years of age, when administered in conjunction with aspirin 30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC once daily. Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, when administered in conjunction with aspirin 1 mg/kg administered SC once daily (no initial bolus) 2.3 Geriatric Patients with Acute ST-Segment Elevation Myocardial InfarctionFor treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses) [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].
No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration (2.2)].
2.4 AdministrationEnoxaparin sodium injection is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.
The use of a tuberculin syringe or equivalent is recommended when using enoxaparin sodium multiple-dose vials to assure withdrawal of the appropriate volume of drug.
Enoxaparin sodium must not be administered by intramuscular injection. Enoxaparin sodium is intended for use under the guidance of a physician.
For subcutaneous administration, patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.
Subcutaneous Injection Technique: Patients should be lying down and enoxaparin sodium administered by deep SC injection. To avoid the loss of drug when using the 30 and 40 mg prefilled syringes, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. 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. To minimize bruising, do not rub the injection site after completion of the injection.
Enoxaparin sodium prefilled syringes and graduated prefilled syringes are for single, one-time use only and are available with a system that shields the needle after injection.
Remove the prefilled syringe from the blister packaging by peeling at the arrow as directed on the blister. Do not remove by pulling on the plunger as this may damage the syringe.
Remove the needle shield by pulling it straight off the syringe (see Figure A). If adjusting the dose is required, the dose adjustment must be done prior to injecting the prescribed dose to the patient.
Figure A
Figure B
Figure C
Figure D
Figure ENOTE:
The safety system can only be activated once the syringe has been emptied. Activation of the safety system must be done only after removing the needle from the patient's skin. Do not replace the needle shield after injection. The safety system should not be sterilized.Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.
Intravenous (Bolus) Injection Technique: For intravenous injection, the multiple-dose vial should be used. Enoxaparin sodium should be administered through an intravenous line. Enoxaparin sodium should not be mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium 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 enoxaparin sodium to clear the port of drug. Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
-
Sandoz Inc
Enoxaparin Sodium | Sandoz Inc
All patients should be evaluated for a bleeding disorder before administration of enoxaparin sodium injection, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring enoxaparin sodium injection activity, routine monitoring of coagulation parameters is not required [see Warnings and Precautions (5.9)].
For subcutaneous use, enoxaparin sodium injection should not be mixed with other injections or infusions. For intravenous use (i.e., for treatment of acute STEMI), enoxaparin sodium injection can be mixed with normal saline solution (0.9%) or 5% dextrose in water.
Enoxaparin sodium injection is not intended for intramuscular administration.
2.1 Adult Dosage Abdominal SurgeryIn patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of enoxaparin sodium injection is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials.
Hip or Knee Replacement SurgeryIn patients undergoing hip or knee replacement surgery, the recommended dose of enoxaparin sodium injection is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hours prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, it is recommended that continued prophylaxis with enoxaparin sodium injection 40 mg once a day be administered by SC injection for 3 weeks. The usual duration of administration is 7 to 10 days; up to 14 days administration has been administered in clinical trials.
Medical Patients During Acute IllnessIn medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of enoxaparin sodium injection is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days; up to 14 days of enoxaparin sodium injection has been administered in the controlled clinical trial.
Treatment of Deep Vein Thrombosis With or Without Pulmonary EmbolismIn outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of enoxaparin sodium injection is 1 mg/kg every 12 hours administered SC. In inpatient (hospital) treatment, patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of enoxaparin sodium injection is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day. In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of enoxaparin sodium injection). Enoxaparin sodium injection should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0). The average duration of administration is 7 days; up to 17 days of enoxaparin sodium injection administration has been administered in controlled clinical trials.
Unstable Angina and Non-Q-Wave Myocardial InfarctionIn patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of enoxaparin sodium injection is 1 mg/kg administered SC every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with enoxaparin sodium injection should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days; up to 12.5 days of enoxaparin sodium injection has been administered in clinical trials. [See Warnings and Precautions (5.2) and Clinical Studies (14.5)].
Treatment of Acute ST-Segment Elevation Myocardial Infarction:In patients with acute ST-segment elevation myocardial infarction, the recommended dose of enoxaparin sodium injection is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Dosage adjustments are recommended in patients ≥75 years of age [see Dosage and Administration (2.3)]. All patients should receive aspirin as soon as they are identified as having STEMI and maintained with 75 to 325 mg once daily unless contraindicated.
When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), enoxaparin sodium injection should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. In the pivotal clinical study, the enoxaparin sodium injection treatment duration was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days.
For patients managed with percutaneous coronary intervention (PCI): If the last enoxaparin sodium injection SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last enoxaparin sodium injection SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of enoxaparin sodium injection should be administered [see Warnings and Precautions (5.2)].
2.2 Renal ImpairmentAlthough no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding.
The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance <30 mL/min) are described in Table 1 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Table 1 Dosage Regimens for Patients with Severe Renal Impairment
(creatinine clearance <30mL/minute) Indication Dosage Regimen Prophylaxis in abdominal surgery 30 mg administered SC once daily Prophylaxis in hip or knee replacement surgery 30 mg administered SC once daily Prophylaxis in medical patients during acute illness 30 mg administered SC once daily Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin 1 mg/kg administered SC once daily Treatment of acute ST-segment elevation myocardial infarction in patients <75 years of age, when administered in conjunction with aspirin 30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC once daily. Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, when administered in conjunction with aspirin 1 mg/kg administered SC once daily (no initial bolus) 2.3 Geriatric Patients with Acute ST-Segment Elevation Myocardial InfarctionFor treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses) [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].
No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration (2.2)].
2.4 AdministrationEnoxaparin sodium injection is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.
The use of a tuberculin syringe or equivalent is recommended when using enoxaparin sodium injection multiple-dose vials to assure withdrawal of the appropriate volume of drug.
Enoxaparin sodium injection must not be administered by intramuscular injection. Enoxaparin sodium injection is intended for use under the guidance of a physician.
For subcutaneous administration, patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.
Subcutaneous Injection TechniquePatients should be lying down and enoxaparin sodium injection administered by deep SC injection. To avoid the loss of drug when using the 30 and 40 mg prefilled syringes, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. 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. To minimize bruising, do not rub the injection site after completion of the injection.
Enoxaparin sodium injection prefilled syringes and graduated prefilled syringes are for single, one-time use only and are available with a system that shields the needle after injection.
Remove the needle shield by pulling it straight off the syringe (see Figure A). If adjusting the dose is required, the dose adjustment must be done prior to injecting the prescribed dose to the patient.
Figure A
Figure B
Figure C
Figure D
Figure ENOTE:
The safety system can only be activated once the syringe has been emptied. Activation of the safety system must be done only after removing the needle from the patient's skin. Do not replace the needle shield after injection. The safety system should not be sterilized.Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.
Intravenous (Bolus) Injection TechniqueFor intravenous injection, the multiple-dose vial should be used. Enoxaparin sodium injection should be administered through an intravenous line. Enoxaparin sodium injection should not be mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium injection 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 enoxaparin sodium injection to clear the port of drug. Enoxaparin sodium injection may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
-
Cardinal Health
Enoxaparin Sodium | Cardinal Health
All patients should be evaluated for a bleeding disorder before administration of enoxaparin sodium injection, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring enoxaparin sodium injection activity, routine monitoring of coagulation parameters is not required [see Warnings and Precautions (5.9)].
For subcutaneous use, enoxaparin sodium injection should not be mixed with other injections or infusions. For intravenous use (i.e., for treatment of acute STEMI), enoxaparin sodium injection can be mixed with normal saline solution (0.9%) or 5% dextrose in water.
Enoxaparin sodium injection is not intended for intramuscular administration.
2.1 Adult Dosage Abdominal SurgeryIn patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of enoxaparin sodium injection is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials.
Hip or Knee Replacement SurgeryIn patients undergoing hip or knee replacement surgery, the recommended dose of enoxaparin sodium injection is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hours prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, it is recommended that continued prophylaxis with enoxaparin sodium injection 40 mg once a day be administered by SC injection for 3 weeks. The usual duration of administration is 7 to 10 days; up to 14 days administration has been administered in clinical trials.
Medical Patients During Acute IllnessIn medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of enoxaparin sodium injection is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days; up to 14 days of enoxaparin sodium injection has been administered in the controlled clinical trial.
Treatment of Deep Vein Thrombosis With or Without Pulmonary EmbolismIn outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of enoxaparin sodium injection is 1 mg/kg every 12 hours administered SC. In inpatient (hospital) treatment, patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of enoxaparin sodium injection is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day. In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of enoxaparin sodium injection). Enoxaparin sodium injection should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0). The average duration of administration is 7 days; up to 17 days of enoxaparin sodium injection administration has been administered in controlled clinical trials.
Unstable Angina and Non-Q-Wave Myocardial InfarctionIn patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of enoxaparin sodium injection is 1 mg/kg administered SC every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with enoxaparin sodium injection should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days; up to 12.5 days of enoxaparin sodium injection has been administered in clinical trials. [See Warnings and Precautions (5.2) and Clinical Studies (14.5)].
Treatment of Acute ST-Segment Elevation Myocardial Infarction:In patients with acute ST-segment elevation myocardial infarction, the recommended dose of enoxaparin sodium injection is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Dosage adjustments are recommended in patients ≥75 years of age [see Dosage and Administration (2.3)]. All patients should receive aspirin as soon as they are identified as having STEMI and maintained with 75 to 325 mg once daily unless contraindicated.
When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), enoxaparin sodium injection should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. In the pivotal clinical study, the enoxaparin sodium injection treatment duration was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days.
For patients managed with percutaneous coronary intervention (PCI): If the last enoxaparin sodium injection SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last enoxaparin sodium injection SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of enoxaparin sodium injection should be administered [see Warnings and Precautions (5.2)].
2.2 Renal ImpairmentAlthough no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding.
The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance <30 mL/min) are described in Table 1 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Table 1 Dosage Regimens for Patients with Severe Renal Impairment
(creatinine clearance <30mL/minute) Indication Dosage Regimen Prophylaxis in abdominal surgery 30 mg administered SC once daily Prophylaxis in hip or knee replacement surgery 30 mg administered SC once daily Prophylaxis in medical patients during acute illness 30 mg administered SC once daily Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin 1 mg/kg administered SC once daily Treatment of acute ST-segment elevation myocardial infarction in patients <75 years of age, when administered in conjunction with aspirin 30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC once daily. Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, when administered in conjunction with aspirin 1 mg/kg administered SC once daily (no initial bolus) 2.3 Geriatric Patients with Acute ST-Segment Elevation Myocardial InfarctionFor treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses) [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].
No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration (2.2)].
2.4 AdministrationEnoxaparin sodium injection is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.
The use of a tuberculin syringe or equivalent is recommended when using enoxaparin sodium injection multiple-dose vials to assure withdrawal of the appropriate volume of drug.
Enoxaparin sodium injection must not be administered by intramuscular injection. Enoxaparin sodium injection is intended for use under the guidance of a physician.
For subcutaneous administration, patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.
Subcutaneous Injection TechniquePatients should be lying down and enoxaparin sodium injection administered by deep SC injection. To avoid the loss of drug when using the 30 and 40 mg prefilled syringes, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. 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. To minimize bruising, do not rub the injection site after completion of the injection.
Enoxaparin sodium injection prefilled syringes and graduated prefilled syringes are for single, one-time use only and are available with a system that shields the needle after injection.
Remove the needle shield by pulling it straight off the syringe (see Figure A). If adjusting the dose is required, the dose adjustment must be done prior to injecting the prescribed dose to the patient.
Figure A
Figure B
Figure C
Figure D
Figure ENOTE:
The safety system can only be activated once the syringe has been emptied. Activation of the safety system must be done only after removing the needle from the patient's skin. Do not replace the needle shield after injection. The safety system should not be sterilized.Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.
Intravenous (Bolus) Injection TechniqueFor intravenous injection, the multiple-dose vial should be used. Enoxaparin sodium injection should be administered through an intravenous line. Enoxaparin sodium injection should not be mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium injection 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 enoxaparin sodium injection to clear the port of drug. Enoxaparin sodium injection may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
-
Watson Pharma, Inc.
Enoxaparin Sodium | Watson Pharma, Inc.
All patients should be evaluated for a bleeding disorder before administration of Enoxaparin Sodium Injection, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring Enoxaparin Sodium Injection activity, routine monitoring of coagulation parameters is not required [see Warnings and Precautions (5.9)].
For subcutaneous use, Enoxaparin Sodium Injection should not be mixed with other injections or infusions.
For intravenous use (i.e., for treatment of acute STEMI), Enoxaparin Sodium Injection can be mixed with normal saline solution (0.9%) or 5% dextrose in water.
Enoxaparin Sodium Injection is not intended for intramuscular administration.
2.1 Adult DosageAbdominal Surgery: In patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of Enoxaparin Sodium Injection is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials.
Hip or Knee Replacement Surgery: In patients undergoing hip or knee replacement surgery, the recommended dose of Enoxaparin Sodium Injection is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hours prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, it is recommended that continued prophylaxis with Enoxaparin Sodium Injection 40 mg once a day be administered by SC injection for 3 weeks. The usual duration of administration is 7 to 10 days; up to 14 days administration has been administered in clinical trials.
Medical Patients During Acute Illness: In medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of Enoxaparin Sodium Injection is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days; up to 14 days of Enoxaparin Sodium Injection has been administered in the controlled clinical trial.
Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism: In outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of Enoxaparin Sodium Injection is 1 mg/kg every 12 hours administered SC. In inpatient (hospital) treatment, patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of Enoxaparin Sodium Injection is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day. In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of Enoxaparin Sodium Injection). Enoxaparin Sodium Injection should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0). The average duration of administration is 7 days; up to 17 days of Enoxaparin Sodium Injection administration has been administered in controlled clinical trials.
Unstable Angina and Non-Q-Wave Myocardial Infarction: In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of Enoxaparin Sodium Injection is 1 mg/kg administered SC every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with Enoxaparin Sodium Injection should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days; up to 12.5 days of Enoxaparin Sodium Injection has been administered in clinical trials. [See Warnings and Precautions (5.2) and Clinical Studies (14.5)].
Treatment of Acute ST-Segment Elevation Myocardial Infarction:
In patients with acute ST-segment elevation myocardial infarction, the recommended dose of Enoxaparin Sodium Injection is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Dosage adjustments are recommended in patients ≥75 years of age [see Dosage and Administration (2.3)]. All patients should receive aspirin as soon as they are identified as having STEMI and maintained with 75 to 325 mg once daily unless contraindicated.When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), Enoxaparin Sodium Injection should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. In the pivotal clinical study, the Enoxaparin Sodium Injection treatment duration was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days.
For patients managed with percutaneous coronary intervention (PCI): If the last Enoxaparin Sodium Injection SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last Enoxaparin Sodium Injection SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of Enoxaparin Sodium Injection should be administered [see Warnings and Precautions (5.2)].
2.2 Renal ImpairmentAlthough no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding.
The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance <30 mL/min) are described in Table 1 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Table 1: Dosage Regimens for Patients with Severe Renal Impairment (creatinine clearance < 30 mL/minute)Indication
Dosage Regimen
Prophylaxis in abdominal surgery
30 mg administered SC once daily
Prophylaxis in hip or knee replacement
surgery30 mg administered SC once daily
Prophylaxis in medical patients during acute illness
30 mg administered SC once daily
Inpatient treatment of acute deep vein
thrombosis with or without pulmonary
embolism, when administered in
conjunction with warfarin sodium1 mg/kg administered SC once daily
Outpatient treatment of acute deep vein
thrombosis without pulmonary embolism,
when administered in conjunction with
warfarin sodium1 mg/kg administered SC once daily
Prophylaxis of ischemic complications
of unstable angina and non-Q-wave
myocardial infarction, when concurrently
administered with aspirin1 mg/kg administered SC once daily
Treatment of acute ST-segment
elevation myocardial infarction in
patients < 75 years of age, when
administered in conjunction with aspirin30 mg single IV bolus plus a 1 mg/kg SC
dose followed by 1 mg/kg administered SC
once dailyTreatment of acute ST-segment
elevation myocardial infarction in
geriatric patients ≥ 75 years of age, when
administered in conjunction with aspirin1 mg/kg administered SC once daily (no
2.3 Geriatric Patients with Acute ST-Segment Elevation Myocardial Infarction
initial bolus)For treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses) [see Use in Specific Populations (8.5) and Clinical Phamacology (12.3)].
No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration (2.2)].
2.4 AdministrationEnoxaparin Sodium Injection is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.
Enoxaparin Sodium Injection must not be administered by intramuscular injection. Enoxaparin Sodium Injection is intended for use under the guidance of a physician.
For subcutaneous administration, patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.
Subcutaneous Injection Technique: Patients should be lying down and Enoxaparin Sodium Injection administered by deep SC injection. To avoid the loss of drug when using the 30 and 40 mg prefilled syringes, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. 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. To minimize bruising, do not rub the injection site after completion of the injection.
Enoxaparin Sodium Injection prefilled syringes and graduated prefilled syringes are for single, one-time use only and are available with a system that shields the needle after injection.
Remove the prefilled syringe from the blister packaging by peeling at the arrow as directed on the blister. Do not remove by pulling on the plunger as this may damage the syringe.
Remove needle cover by pulling straight off of needle (see Figure 1). If adjusting the dose is required, the adjustment must be done prior to injecting the prescribed dose into the patient.
See Administration: Subcutaneous Injection Technique for a description of the Standard Protocol for administration.
Depress the plunger while grasping the finger flange until the entire dose has been given.The Passive needle guard will NOT activate unless the ENTIRE dose has been given.
Remove needle from patient, then let go of the plunger and allow syringe to move up until the entire needle is guarded.
Dispose of syringe/needle guard assembly in approved sharps container.
NOTE:
The safety system can only be activated once the syringe has been emptied. Activation of the safety system must be done only after removing the needle from the patient’s skin. Do not replace the needle shield after injection. The safety system should not be sterilized.Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.
Intravenous (Bolus) Injection Technique
For intravenous injection, the multiple-dose vial should be used. Enoxaparin Sodium Injection should be administered through an intravenous line. Enoxaparin Sodium Injection should not be mixed or co-administered with other medications. To avoid the possible mixture of Enoxaparin Sodium Injection 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 Enoxaparin Sodium Injection to clear the port of drug. Enoxaparin Sodium Injection may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
-
Winthrop U.s.
Enoxaparin Sodium | Winthrop U.s.
All patients should be evaluated for a bleeding disorder before administration of enoxaparin sodium, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring enoxaparin activity, routine monitoring of coagulation parameters is not required [see Warnings and Precautions (5.9)].
For subcutaneous use, enoxaparin sodium should not be mixed with other injections or infusions. For intravenous use (i.e., for treatment of acute STEMI), enoxaparin sodium can be mixed with normal saline solution (0.9%) or 5% dextrose in water.
Enoxaparin sodium is not intended for intramuscular administration.
2.1 Adult DosageAbdominal Surgery: In patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of enoxaparin sodium is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials.
Hip or Knee Replacement Surgery: In patients undergoing hip or knee replacement surgery, the recommended dose of enoxaparin sodium is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hours prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, it is recommended that continued prophylaxis with enoxaparin sodium 40 mg once a day be administered by SC injection for 3 weeks. The usual duration of administration is 7 to 10 days; up to 14 days administration has been administered in clinical trials.
Medical Patients During Acute Illness: In medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of enoxaparin sodium is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days; up to 14 days of enoxaparin sodium has been administered in the controlled clinical trial.
Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism: In outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of enoxaparin sodium is 1 mg/kg every 12 hours administered SC. In inpatient (hospital) treatment, patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of enoxaparin sodium is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day. In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of enoxaparin sodium). Enoxaparin sodium should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0). The average duration of administration is 7 days; up to 17 days of enoxaparin sodium administration has been administered in controlled clinical trials.
Unstable Angina and Non-Q-Wave Myocardial Infarction: In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of enoxaparin sodium is 1 mg/kg administered SC every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with enoxaparin sodium should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days; up to 12.5 days of enoxaparin sodium has been administered in clinical trials [see Warnings and Precautions (5.2) and Clinical Studies (14.5)].
Treatment of Acute ST-Segment Elevation Myocardial Infarction: In patients with acute ST-segment elevation myocardial infarction, the recommended dose of enoxaparin sodium is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Dosage adjustments are recommended in patients ≥75 years of age [see Dosage and Administration (2.3)]. All patients should receive aspirin as soon as they are identified as having STEMI and maintained with 75 to 325 mg once daily unless contraindicated.
When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), enoxaparin sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. In the pivotal clinical study, the enoxaparin sodium treatment duration was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days.
For patients managed with percutaneous coronary intervention (PCI): If the last enoxaparin sodium SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last enoxaparin sodium SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of enoxaparin sodium should be administered [see Warnings and Precautions (5.2)].
2.2 Renal ImpairmentAlthough no dose adjustment is recommended in patients with moderate (creatinine clearance 30–50 mL/min) and mild (creatinine clearance 50–80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding.
The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance <30 mL/min) are described in Table 1 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Table 1 Dosage Regimens for Patients with Severe Renal Impairment
(creatinine clearance <30mL/minute) Indication Dosage Regimen Prophylaxis in abdominal surgery 30 mg administered SC once daily Prophylaxis in hip or knee replacement surgery 30 mg administered SC once daily Prophylaxis in medical patients during acute illness 30 mg administered SC once daily Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin 1 mg/kg administered SC once daily Treatment of acute ST-segment elevation myocardial infarction in patients <75 years of age, when administered in conjunction with aspirin 30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC once daily. Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, when administered in conjunction with aspirin 1 mg/kg administered SC once daily (no initial bolus) 2.3 Geriatric Patients with Acute ST-Segment Elevation Myocardial InfarctionFor treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses) [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].
No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration (2.2)].
2.4 AdministrationEnoxaparin sodium injection is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.
The use of a tuberculin syringe or equivalent is recommended when using enoxaparin sodium multiple-dose vials to assure withdrawal of the appropriate volume of drug.
Enoxaparin sodium must not be administered by intramuscular injection. Enoxaparin sodium is intended for use under the guidance of a physician.
For subcutaneous administration, patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.
Subcutaneous Injection Technique: Patients should be lying down and enoxaparin sodium administered by deep SC injection. To avoid the loss of drug when using the 30 and 40 mg prefilled syringes, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. 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. To minimize bruising, do not rub the injection site after completion of the injection.
Enoxaparin sodium prefilled syringes and graduated prefilled syringes are for single, one-time use only and are available with a system that shields the needle after injection.
Remove the prefilled syringe from the blister packaging by peeling at the arrow as directed on the blister. Do not remove by pulling on the plunger as this may damage the syringe.
Remove the needle shield by pulling it straight off the syringe (see Figure A). If adjusting the dose is required, the dose adjustment must be done prior to injecting the prescribed dose to the patient.
Figure A
Figure B
Figure C
Figure D
Figure ENOTE:
The safety system can only be activated once the syringe has been emptied. Activation of the safety system must be done only after removing the needle from the patient's skin. Do not replace the needle shield after injection. The safety system should not be sterilized.Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.
Intravenous (Bolus) Injection Technique: For intravenous injection, the multiple-dose vial should be used. Enoxaparin sodium should be administered through an intravenous line. Enoxaparin sodium should not be mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium 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 enoxaparin sodium to clear the port of drug. Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
-
Sandoz Inc
Enoxaparin Sodium | Sandoz Inc
All patients should be evaluated for a bleeding disorder before administration of enoxaparin sodium injection, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring enoxaparin sodium injection activity, routine monitoring of coagulation parameters is not required [see Warnings and Precautions (5.9)].
For subcutaneous use, enoxaparin sodium injection should not be mixed with other injections or infusions. For intravenous use (i.e., for treatment of acute STEMI), enoxaparin sodium injection can be mixed with normal saline solution (0.9%) or 5% dextrose in water.
Enoxaparin sodium injection is not intended for intramuscular administration.
2.1 Adult Dosage Abdominal SurgeryIn patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of enoxaparin sodium injection is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials.
Hip or Knee Replacement SurgeryIn patients undergoing hip or knee replacement surgery, the recommended dose of enoxaparin sodium injection is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hours prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, it is recommended that continued prophylaxis with enoxaparin sodium injection 40 mg once a day be administered by SC injection for 3 weeks. The usual duration of administration is 7 to 10 days; up to 14 days administration has been administered in clinical trials.
Medical Patients During Acute IllnessIn medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of enoxaparin sodium injection is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days; up to 14 days of enoxaparin sodium injection has been administered in the controlled clinical trial.
Treatment of Deep Vein Thrombosis With or Without Pulmonary EmbolismIn outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of enoxaparin sodium injection is 1 mg/kg every 12 hours administered SC. In inpatient (hospital) treatment, patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of enoxaparin sodium injection is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day. In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of enoxaparin sodium injection). Enoxaparin sodium injection should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0). The average duration of administration is 7 days; up to 17 days of enoxaparin sodium injection administration has been administered in controlled clinical trials.
Unstable Angina and Non-Q-Wave Myocardial InfarctionIn patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of enoxaparin sodium injection is 1 mg/kg administered SC every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with enoxaparin sodium injection should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days; up to 12.5 days of enoxaparin sodium injection has been administered in clinical trials. [see Warnings and Precautions (5.2) and Clinical Studies (14.5)].
Treatment of Acute ST-Segment Elevation Myocardial InfarctionIn patients with acute ST-segment elevation myocardial infarction, the recommended dose of enoxaparin sodium injection is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Dosage adjustments are recommended in patients ≥75 years of age [see Dosage and Administration (2.3)]. All patients should receive aspirin as soon as they are identified as having STEMI and maintained with 75 to 325 mg once daily unless contraindicated.
When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), enoxaparin sodium injection should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. In the pivotal clinical study, the enoxaparin sodium injection treatment duration was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days.
For patients managed with percutaneous coronary intervention (PCI): If the last enoxaparin sodium injection SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last enoxaparin sodium injection SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of enoxaparin sodium injection should be administered [see Warnings and Precautions (5.2)].
2.2 Renal ImpairmentAlthough no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding.
The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance <30 mL/min) are described in Table 1 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Table 1 Dosage Regimens for Patients with Severe Renal Impairment
(creatinine clearance <30mL/minute) Indication Dosage RegimenProphylaxis in abdominal surgery
30 mg administered SC once daily
Prophylaxis in hip or knee replacement surgery
30 mg administered SC once daily
Prophylaxis in medical patients during acute illness
30 mg administered SC once daily
Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium
1 mg/kg administered SC once daily
Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium
1 mg/kg administered SC once daily
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin
1 mg/kg administered SC once daily
Treatment of acute ST-segment elevation myocardial infarction in patients <75 years of age, when administered in conjunction with aspirin
30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC once daily.
Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, when administered in conjunction with aspirin
1 mg/kg administered SC once daily (no initial bolus)
2.3 Geriatric Patients with Acute ST-Segment Elevation Myocardial InfarctionFor treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses) [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].
No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration (2.2)].
2.4 AdministrationEnoxaparin sodium injection is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.
The use of a tuberculin syringe or equivalent is recommended when using enoxaparin sodium injection multiple-dose vials to assure withdrawal of the appropriate volume of drug.
Enoxaparin sodium injection must not be administered by intramuscular injection. Enoxaparin sodium injection is intended for use under the guidance of a physician.
For subcutaneous administration, patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.
Subcutaneous Injection TechniquePatients should be lying down and enoxaparin sodium injection administered by deep SC injection. To avoid the loss of drug when using the 30 and 40 mg prefilled syringes, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. 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. To minimize bruising, do not rub the injection site after completion of the injection.
Enoxaparin sodium injection prefilled syringes and graduated prefilled syringes are for single, one-time use only and are available with a system that shields the needle after injection.
Remove the prefilled syringe from the blister packaging by peeling at the arrow as directed on the blister. Do not remove by pulling on the plunger as this may damage the syringe.
1. Remove the needle shield by pulling it straight off the syringe (see Figure A). If adjusting the dose is required, the dose adjustment must be done prior to injecting the prescribed dose to the patient.
Figure A
2. Inject using standard technique, pushing the plunger to the bottom of the syringe (see Figure B).
Figure B
3. Remove the syringe from the injection site keeping your finger on the plunger rod (see Figure C).
Figure C
4. Orient the needle away from you and others, and activate the safety system by firmly pushing the plunger rod. The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation (see Figure D).
Figure D
5. Immediately dispose of the syringe in the nearest sharps container (see Figure E).
Figure E
NOTE:
• The safety system can only be activated once the syringe has been emptied. • Activation of the safety system must be done only after removing the needle from the patient’s skin. • Do not replace the needle shield after injection. • The safety system should not be sterilized.Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.
Intravenous (Bolus) Injection TechniqueFor intravenous injection, the multiple-dose vial should be used. Enoxaparin sodium injection should be administered through an intravenous line. Enoxaparin sodium injection should not be mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium injection 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 enoxaparin sodium injection to clear the port of drug. Enoxaparin sodium injection may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
-
Cardinal Health
Enoxaparin Sodium | Cardinal Health
All patients should be evaluated for a bleeding disorder before administration of enoxaparin sodium injection, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring enoxaparin sodium injection activity, routine monitoring of coagulation parameters is not required [see Warnings and Precautions (5.9)].
For subcutaneous use, enoxaparin sodium injection should not be mixed with other injections or infusions. For intravenous use (i.e., for treatment of acute STEMI), enoxaparin sodium injection can be mixed with normal saline solution (0.9%) or 5% dextrose in water.
Enoxaparin sodium injection is not intended for intramuscular administration.
2.1 Adult Dosage Abdominal SurgeryIn patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of enoxaparin sodium injection is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials.
Hip or Knee Replacement SurgeryIn patients undergoing hip or knee replacement surgery, the recommended dose of enoxaparin sodium injection is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hours prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, it is recommended that continued prophylaxis with enoxaparin sodium injection 40 mg once a day be administered by SC injection for 3 weeks. The usual duration of administration is 7 to 10 days; up to 14 days administration has been administered in clinical trials.
Medical Patients During Acute IllnessIn medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of enoxaparin sodium injection is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days; up to 14 days of enoxaparin sodium injection has been administered in the controlled clinical trial.
Treatment of Deep Vein Thrombosis With or Without Pulmonary EmbolismIn outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of enoxaparin sodium injection is 1 mg/kg every 12 hours administered SC. In inpatient (hospital) treatment, patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of enoxaparin sodium injection is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day. In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of enoxaparin sodium injection). Enoxaparin sodium injection should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0). The average duration of administration is 7 days; up to 17 days of enoxaparin sodium injection administration has been administered in controlled clinical trials.
Unstable Angina and Non-Q-Wave Myocardial InfarctionIn patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of enoxaparin sodium injection is 1 mg/kg administered SC every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with enoxaparin sodium injection should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days; up to 12.5 days of enoxaparin sodium injection has been administered in clinical trials. [see Warnings and Precautions (5.2) and Clinical Studies (14.5)].
Treatment of Acute ST-Segment Elevation Myocardial InfarctionIn patients with acute ST-segment elevation myocardial infarction, the recommended dose of enoxaparin sodium injection is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Dosage adjustments are recommended in patients ≥75 years of age [see Dosage and Administration (2.3)]. All patients should receive aspirin as soon as they are identified as having STEMI and maintained with 75 to 325 mg once daily unless contraindicated.
When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), enoxaparin sodium injection should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. In the pivotal clinical study, the enoxaparin sodium injection treatment duration was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days.
For patients managed with percutaneous coronary intervention (PCI): If the last enoxaparin sodium injection SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last enoxaparin sodium injection SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of enoxaparin sodium injection should be administered [see Warnings and Precautions (5.2)].
2.2 Renal ImpairmentAlthough no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding.
The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance <30 mL/min) are described in Table 1 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Table 1 Dosage Regimens for Patients with Severe Renal Impairment
(creatinine clearance <30mL/minute) Indication Dosage RegimenProphylaxis in abdominal surgery
30 mg administered SC once daily
Prophylaxis in hip or knee replacement surgery
30 mg administered SC once daily
Prophylaxis in medical patients during acute illness
30 mg administered SC once daily
Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium
1 mg/kg administered SC once daily
Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium
1 mg/kg administered SC once daily
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin
1 mg/kg administered SC once daily
Treatment of acute ST-segment elevation myocardial infarction in patients <75 years of age, when administered in conjunction with aspirin
30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC once daily.
Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, when administered in conjunction with aspirin
1 mg/kg administered SC once daily (no initial bolus)
2.3 Geriatric Patients with Acute ST-Segment Elevation Myocardial InfarctionFor treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses) [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].
No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration (2.2)].
2.4 AdministrationEnoxaparin sodium injection is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.
The use of a tuberculin syringe or equivalent is recommended when using enoxaparin sodium injection multiple-dose vials to assure withdrawal of the appropriate volume of drug.
Enoxaparin sodium injection must not be administered by intramuscular injection. Enoxaparin sodium injection is intended for use under the guidance of a physician.
For subcutaneous administration, patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.
Subcutaneous Injection TechniquePatients should be lying down and enoxaparin sodium injection administered by deep SC injection. To avoid the loss of drug when using the 30 and 40 mg prefilled syringes, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. 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. To minimize bruising, do not rub the injection site after completion of the injection.
Enoxaparin sodium injection prefilled syringes and graduated prefilled syringes are for single, one-time use only and are available with a system that shields the needle after injection.
Remove the prefilled syringe from the blister packaging by peeling at the arrow as directed on the blister. Do not remove by pulling on the plunger as this may damage the syringe.
1. Remove the needle shield by pulling it straight off the syringe (see Figure A). If adjusting the dose is required, the dose adjustment must be done prior to injecting the prescribed dose to the patient.
Figure A
2. Inject using standard technique, pushing the plunger to the bottom of the syringe (see Figure B).
Figure B
3. Remove the syringe from the injection site keeping your finger on the plunger rod (see Figure C).
Figure C
4. Orient the needle away from you and others, and activate the safety system by firmly pushing the plunger rod. The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation (see Figure D).
Figure D
5. Immediately dispose of the syringe in the nearest sharps container (see Figure E).
Figure E
NOTE:
• The safety system can only be activated once the syringe has been emptied. • Activation of the safety system must be done only after removing the needle from the patient’s skin. • Do not replace the needle shield after injection. • The safety system should not be sterilized.Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.
Intravenous (Bolus) Injection TechniqueFor intravenous injection, the multiple-dose vial should be used. Enoxaparin sodium injection should be administered through an intravenous line. Enoxaparin sodium injection should not be mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium injection 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 enoxaparin sodium injection to clear the port of drug. Enoxaparin sodium injection may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
-
Amphastar Pharmaceuticals, Inc.
Enoxaparin Sodium | Lupin Pharmaceuticals, Inc.
The recommended dosage is one drop in the affected eye(s) once daily in the evening.
Bimatoprost ophthalmic solution, 0.03% should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect.
Reduction of the intraocular pressure starts approximately 4 hours after the first administration with maximum effect reached within approximately 8 to 12 hours.
Bimatoprost ophthalmic solution, 0.03% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.
-
Amphastar Pharmaceuticals, Inc.
Enoxaparin Sodium | Endo Pharmaceuticals Solutions Inc.
Prior to initiating DELATESTRYL, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.
Dosage and duration of therapy with DELATESTRYL® (Testosterone Enanthate Injection, USP) will depend on age, sex, diagnosis, patient’s response to treatment, and appearance of adverse effects. When properly given, injections of DELATESTRYL are well tolerated. Care should be taken to slowly inject the preparation deeply into the gluteal muscle, being sure to follow the usual precautions for intramuscular administration, such as the avoidance of intravascular injection (see PRECAUTIONS).
In general, total doses above 400 mg per month are not required because of the prolonged action of the preparation. Injections more frequently than every two weeks are rarely indicated. NOTE: Use of a wet needle or wet syringe may cause the solution to become cloudy; however this does not affect the potency of the material. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. DELATESTRYL is a clear, colorless to pale yellow solution.
Male hypogonadism: As replacement therapy, i.e., for eunuchism, the suggested dosage is 50 to 400 mg every 2 to 4 weeks.
In males with delayed puberty: Various dosage regimens have been used; some call for lower dosages initially with gradual increases as puberty progresses, with or without a decrease to maintenance levels. Other regimens call for higher dosage to induce pubertal changes and lower dosage for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. Dosage is within the range of 50 to 200 mg every 2 to 4 weeks for a limited duration, for example, 4 to 6 months. X-rays should be taken at appropriate intervals to determine the amount of bone maturation and skeletal development (see INDICATIONS AND USAGE, and WARNINGS).
Palliation of inoperable mammary cancer in women: A dosage of 200 to 400 mg every 2 to 4 weeks is recommended. Women with metastatic breast carcinoma must be followed closely because androgen therapy occasionally appears to accelerate the disease.
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Teva Parenteral Medicines, Inc.
Enoxaparin Sodium | Teva Parenteral Medicines, Inc.
All patients should be evaluated for a bleeding disorder before administration of enoxaparin sodium injection USP, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring enoxaparin sodium injection USP activity, routine monitoring of coagulation parameters is not required [see Warnings and Precautions (5.9)].
For subcutaneous use, enoxaparin sodium injection USP should not be mixed with other injections or infusions. For intravenous use (i.e., for treatment of acute STEMI), enoxaparin sodium injection USP can be mixed with normal saline solution (0.9%) or 5% dextrose in water.
Enoxaparin sodium injection USP is not intended for intramuscular administration.
2.1 Adult DosageAbdominal Surgery: In patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of enoxaparin sodium injection USP is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials.
Hip or Knee Replacement Surgery: In patients undergoing hip or knee replacement surgery, the recommended dose of enoxaparin sodium injection USP is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hours prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, it is recommended that continued prophylaxis with enoxaparin sodium injection USP 40 mg once a day be administered by SC injection for 3 weeks. The usual duration of administration is 7 to 10 days; up to 14 days administration has been administered in clinical trials.
Medical Patients During Acute Illness: In medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of enoxaparin sodium injection USP is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days; up to 14 days of enoxaparin sodium injection USP has been administered in the controlled clinical trial.
Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism: In outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of enoxaparin sodium injection USP is 1 mg/kg every 12 hours administered SC. In inpatient (hospital) treatment, patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of enoxaparin sodium injection USP is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day. In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of enoxaparin sodium injection USP). Enoxaparin sodium injection USP should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0). The average duration of administration is 7 days; up to 17 days of enoxaparin sodium injection USP administration has been administered in controlled clinical trials.
Unstable Angina and Non-Q-Wave Myocardial Infarction: In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of enoxaparin sodium injection USP is 1 mg/kg administered SC every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with enoxaparin sodium injection USP should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days; up to 12.5 days of enoxaparin sodium injection USP has been administered in clinical trials [see Warnings and Precautions (5.2) and Clinical Studies (14.5)].
Treatment of Acute ST-Segment Elevation Myocardial Infarction:In patients with acute ST-segment elevation myocardial infarction, the recommended dose of enoxaparin sodium injection USP is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Dosage adjustments are recommended in patients ≥ 75 years of age [see Dosage and Administration (2.3)]. All patients should receive aspirin as soon as they are identified as having STEMI and maintained with 75 to 325 mg once daily unless contraindicated.
When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), enoxaparin sodium injection USP should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. In the pivotal clinical study, the enoxaparin sodium injection USP treatment duration was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days.
For patients managed with percutaneous coronary intervention (PCI): If the last enoxaparin sodium injection USP SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last enoxaparin sodium injection USP SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of enoxaparin sodium injection USP should be administered [see Warnings and Precautions (5.2)].
2.2 Renal ImpairmentAlthough no dose adjustment is recommended in patients with moderate (creatinine clearance 30 to 50 mL/min) and mild (creatinine clearance 50 to 80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding.
The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance < 30 mL/min) are described in Table 1 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Table 1: Dosage Regimens for Patients With Severe Renal Impairment (Creatinine Clearance < 30 mL/Minute)Indication
Dosage Regimen
Prophylaxis in abdominal surgery
30 mg administered SC once daily
Prophylaxis in hip or knee replacement surgery
30 mg administered SC once daily
Prophylaxis in medical patients during acute illness
30 mg administered SC once daily
Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium
1 mg/kg administered SC once daily
Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium
1 mg/kg administered SC once daily
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin
1 mg/kg administered SC once daily
Treatment of acute ST-segment elevation myocardial infarction in patients < 75 years of age, when administered in conjunction with aspirin
30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC once daily.
Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥ 75 years of age, when administered in conjunction with aspirin
1 mg/kg administered SC once daily (no initial bolus)
2.3 Geriatric Patients With Acute ST-Segment Elevation Myocardial InfarctionFor treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥ 75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses) [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].
No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration (2.2)].
2.4 AdministrationEnoxaparin sodium injection USP is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.
Enoxaparin sodium injection USP must not be administered by intramuscular injection. Enoxaparin sodium injection USP is intended for use under the guidance of a physician.
For subcutaneous administration, patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.
Subcutaneous Injection Technique: Patients should be lying down and enoxaparin sodium injection USP administered by deep SC injection. To avoid the loss of drug when using the 30 and 40 mg prefilled syringes, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. 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. To minimize bruising, do not rub the injection site after completion of the injection.
Enoxaparin sodium injection USP prefilled syringes and graduated prefilled syringes are for single, one-time use only and are available with a system that shields the needle after injection.
Remove the prefilled syringe from the blister packaging by peeling at the arrow as directed on the blister. Do not remove by pulling on the plunger as this may damage the syringe.
1. Remove the needle shield by pulling it straight off the syringe (see Figure A). If adjusting the dose is required, the dose adjustment must be done prior to injecting the prescribed dose to the patient.
Figure A
Figure A
2. Inject using standard technique, pushing the plunger to the bottom of the syringe (see Figure B).
Figure B
Figure B
3. Remove the syringe from the injection site keeping your finger on the plunger rod (see Figure C).
Figure C
Figure C
4. Orient the needle away from you and others, and activate the safety system by firmly pushing the plunger rod. The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation (see Figure D).
Figure D
Figure D
5. Immediately dispose of the syringe in the nearest sharps container (see Figure E).
Figure E
Figure E
NOTE:
• The safety system can only be activated once the syringe has been emptied. • Activation of the safety system must be done only after removing the needle from the patient’s skin. • Do not replace the needle shield after injection. • The safety system should not be sterilized.Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.
Intravenous (Bolus) Injection Technique: For intravenous injection, the multiple-dose vial should be used. Enoxaparin sodium injection USP should be administered through an intravenous line. Enoxaparin sodium injection USP should not be mixed or coadministered with other medications. To avoid the possible mixture of enoxaparin sodium injection USP 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 enoxaparin sodium injection USP to clear the port of drug. Enoxaparin sodium injection USP may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
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