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  Up And Up Omeprazole | Fresenius Kabi Usa, Llc

  

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  Argatroban injection 250 mg per 2.5 mL (100 mg per mL) must be diluted prior to infusion.  If the solution is cloudy, or if an insoluble precipitate is noted, the vial should be discarded.  Argatroban injection should not be mixed with other drugs prior to dilution.

  2.1 Preparation for Intravenous Administration

  Prior to administration, argatroban injection should be diluted in 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer’s Injection to a final concentration of 1 mg/mL.  The contents of each 2.5 mL vial should be diluted 100-fold by mixing with 250 mL of diluent.  Use 250 mg (2.5 mL) per 250 mL of diluent or 500 mg (5 mL) per 500 mL of diluent.

  
  

  The diluted solution must be mixed by inversion of the diluent bag for 1 minute.  Upon preparation, the solution may show slight but brief haziness due to the formation of microprecipitates that rapidly dissolve upon mixing.  The final diluted solution must be clear before use. Use of diluted solution at room temperature is recommended.  The pH of the intravenous solution prepared as recommended is 3.2 to 7.5.   

  
  

  Solutions prepared are physically, chemically, and microbiologically stable when stored as directed below in Table 1 and protected from light:

  
  

                               Table 1

    Recommended Storage Conditions of Diluted Solution

  Diluent
  Storage Limit
  Storage Temperature
  0.9% Sodium Chloride Injection
  96 hours
  20 to 25°C (68 to 77°F)
  96 hours
  2 to 8°C (36 to 46°F)
  5% Dextrose Injection or
  Lactated Ringer’s Injection
  4 hours
  20 to 25°C (68 to 77°F)
  4 hours
  2 to 8°C (36 to 46°F)
  
  

  Discard unused final product at the completion of these post dilution storage periods. Prepared solutions should not be exposed to direct sunlight.  No significant potency losses have been noted following simulated delivery of the solution through intravenous tubing.

  
  

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  2.2 Dosing in Patients with Heparin-Induced Thrombocytopenia

  Initial Dosage:

  Before administering argatroban injection, discontinue heparin therapy and obtain a baseline aPTT.  The recommended initial dose of argatroban injection for adult patients without hepatic impairment is 2 mcg/kg/min, administered as a continuous infusion (see Table 2).

  
  

                                                 
                                                                                                                                      Table 2
  Recommended Doses and Infusion Rates for 2 mcg/kg/min Dose of Argatroban Injection for Patients with HIT* and Without Hepatic Impairment (1 mg/mL Final Concentration)

  
   Body Weight (kg)
  Dose (mcg/min)
  Infusion Rate (mL/hr)
  50
  100
  6
  60
  120
  7
   70
  140
  8
   80
   160
  10
   90
   180
  11
  100
   200
  12
   110
   220
  13
   120
   240
  14
   130
   260
  16
   140
   280
  17
  

  *with or without thrombosis

  
  

  Monitoring Therapy:
  For use in HIT, therapy with argatroban injection is monitored using the aPTT with a target range of 1.5 to 3 times the initial baseline value (not to exceed 100 seconds).  Tests of anticoagulant effects (including the aPTT) typically attain steady-state levels within 1 to 3 hours following initiation of argatroban injection.  Check the aPTT 2 hours after initiation of therapy and after any dose change to confirm that the patient has attained the desired therapeutic range.

  
  

  Dosage Adjustment:
  After the initiation of argatroban injection, adjust the dose (not to exceed 10 mcg/kg/min) as necessary to obtain a steady-state aPTT in the target range [see Clinical Studies (14.1)].

  2.3 Dosing in Patients Undergoing Percutaneous Coronary Intervention

  Initial Dosage:
  Initiate an infusion of argatroban injection at 25 mcg/kg/min and administer a bolus of 350 mcg/kg via a large bore intravenous line over 3 to 5 minutes (see Table 3).  Check an activated clotting time (ACT) 5 to 10 minutes after the bolus dose is completed.  The PCI procedure may proceed if the ACT is greater than 300 seconds.

  
  

  Dosage Adjustment:
  If the ACT is less than 300 seconds, an additional intravenous bolus dose of 150 mcg/kg should be administered, the infusion dose increased to 30 mcg/kg/min, and the ACT checked 5 to 10 minutes later (see Table 3).

  
  

  If the ACT is greater than 450 seconds, decrease the infusion rate to 15 mcg/kg/min, and check the ACT 5 to 10 minutes later (see Table 4).

  
  

  Continue titrating the dose until a therapeutic ACT (between 300 and 450 seconds) has been achieved; continue the same infusion rate for the duration of the PCI procedure.

  
  

  In case of dissection, impending abrupt closure, thrombus formation during the procedure, or inability to achieve or maintain an ACT over 300 seconds, additional bolus doses of 150 mcg/kg may be administered and the infusion dose increased to 40 mcg/kg/min.  Check the ACT after each additional bolus or change in the rate of infusion.

  
  

                                                                                                                                          Table 3
  Recommended Starting and Maintenance Doses (Within the Target ACT Range) of Argatroban Injection in Patients Undergoing PCI Without Hepatic Impairment 
                                                                                                                      (1 mg/mL Final Concentration) 

   
  Body
   
  Weight
  
  (kg) 
   Starting Bolus Dose
   
  (350 mcg/kg)
  Starting and Maintenance Continuous Infusion Dosing For ACT 300 to 450 seconds
   
  25 mcg/kg/min
  Bolus
   
  Dose
  
  (mcg)
   Bolus Volume (mL)
  Continuous Infusion Dose (mg/min)
   Continuous Infusion
   
  Rate
  
  (mL/hr)
  50
  17,500
  18
  1,250
  75
   60
   21,000
   21
  1,500
  90
   70
   24,500
   25
  1,750
  105
   80
   28,000
   28
  2,000
  120
   90
   31,500
   32
  2,250
   135
   100
   35,000
   35
  2,500
   150
   110
   38,500
   39
   2,750
  165
   120
  42,000
   42 
  3,000
  180
   130
   45,500
   46
  3,250
  195
   140
    49,000
   49
  3,500
  210
  

  NOTE: 1 mg = 1,000 mcg; 1 kg = 2.2 lbs
  
  

  
  

                                                            Table 4
  Recommended Dose Adjustments of Argatroban Injection for Patients
  Outside of ACT Target Range Undergoing PCI Without Hepatic Impairment
                                           (1 mg/mL Final Concentration) 

   Body
   
  Weight
  
  (kg)
  If ACT Less than 300 seconds Dosage Adjustment†
  30 mcg/kg/min
  If ACT Greater than
   
  450 seconds
  
  Dosage Adjustment*
  
  15 mcg/kg/min
   Additional Bolus
   
  Dose
  
  (mcg)
   Bolus Volume
   
  (mL)
   Continuous Infusion
   
  Dose
  
  (mcg/min)
   Continuous Infusion
   
  Rate
  
  (mL/hr)
   Continuous Infusion
   
  Dose
  
  (mcg/min)
  Continuous Infusion
   
  Rate
  
  (mL/hr)
   50
   7,500
   8
  1,500
  90
  750
  45
   60
   9,000
   9
   1,800
   108
   900
  54
   70
   10,500
   11
   2,100
  126
   1,050
  63
   80 
   12,000 
  12
   2,400
  144
   1,200
  72
   90
  13,500
   14
   2,700
   162
   1,350
  81
   100
   15,000
   15
   3,000
  180
   1,500
  90
   110
   16,500
  17
   3,300
  198
   1,650
  99
   120
   18,000
  18
   3,600
   216
   1,800
   108
   130
   19,500
   20
   3,900
  234
   1,950
  117
  140
   21,000
  21
   4,200
   252
   2,100
   126
  

  NOTE: 1 mg = 1,000 mcg; 1 kg = 2.2 lbs

  
  

  † Additional intravenous bolus dose of 150 mcg/kg should be administered if ACT less than 300 seconds.

  
  

  * No bolus dose is given if ACT greater than 450 seconds

  
  
  

  Monitoring Therapy:
  For use in PCI, therapy with argatroban injection is monitored using ACT.  Obtain ACTs before dosing, 5 to 10 minutes after bolus dosing, following adjustments in the infusion rate, and at the end of the PCI procedure.  Obtain additional ACTs every 20 to 30 minutes during a prolonged procedure.

  
  

  Continued Anticoagulation after PCI:
  If a patient requires anticoagulation after the procedure, argatroban injection may be continued, but at a rate of 2 mcg/kg/min and adjusted as needed to maintain the aPTT in the desired range [see  Dosage and Administration (2.1)].                                                                                               

  2.4 Dosing in Patients with Hepatic Impairment

  Initial Dosage:

  For adult patients with HIT and moderate or severe hepatic impairment (based on Child-Pugh classification), an initial dose of 0.5 mcg/kg/min is recommended, based on the approximately 4-fold decrease in argatroban injection clearance relative to those with normal hepatic function.  Monitor the aPTT closely, and adjust the dosage as clinically indicated.

  
  

  Monitoring Therapy:

  Achievement of steady-state aPTT levels may take longer and require more dose adjustments in patients with hepatic impairment compared to patients with normal hepatic function.

  For patients with hepatic impairment undergoing PCI and who have HIT or are at risk for HIT, carefully titrate argatroban until the desired level of anticoagulation is achieved.  Use of argatroban in PCI patients with clinically significant hepatic disease or AST/ALT levels greater than or equal to 3 times the upper limit of normal should be avoided [see Warnings and Precautions (5.2)]. 

  2.5 Dosing in Pediatric Patients with Heparin-Induced Thrombocytopenia/Heparin-Induced Thrombocytopenia and Thrombosis Syndrome

  Initial Dosage:

  Initial argatroban injection infusion doses are lower for seriously ill pediatric patients compared to adults with normal hepatic function [see Use in Specific Populations (8.4)].

  Monitoring Therapy:

  In general, therapy with argatroban injection is monitored using the aPTT.  Tests of anticoagulant effects (including the aPTT) typically attain steady-state levels within one to three hours following initiation of argatroban injection in patients without hepatic impairment [see Warnings and Precautions  (5.2)].   Dose adjustment may be required to attain the target aPTT.  Check the aPTT two hours after initiation of therapy and after any dose change to confirm that the patient has attained the desired therapeutic range.

  Dosage Adjustment:

  [see Use in Specific Populations (8.4)].

  2.6 Conversion to Oral Anticoagulant Therapy

  Initiating Oral Anticoagulant Therapy:

  When converting patients from argatroban injection to oral anticoagulant therapy, consider the potential for combined effects on INR with co-administration of argatroban and warfarin.  A loading dose of warfarin should not be used.  Initiate therapy using the expected daily dose of warfarin.  To avoid prothrombotic effects and to ensure continuous anticoagulation when initiating warfarin, it is suggested that argatroban and warfarin therapy be overlapped.  There are insufficient data available to recommend the duration of the overlap.

  Co-Administration of Warfarin and Argatroban Injection at Doses up to 2 mcg/kg/min:

  Measure INR daily while argatroban injection and warfarin are co-administered. In general, with doses of argatroban injection up to 2 mcg/kg/min, argatroban injection can be discontinued when the INR is greater than 4 on combined therapy. After argatroban injection is discontinued, repeat the INR measurement in 4 to 6 hours. If the repeat INR is below the desired therapeutic range, resume the infusion of argatroban injection and repeat the procedure daily until the desired therapeutic range on warfarin alone is reached.

  Co-Administration of Warfarin and Argatroban Injection at Doses Greater than 2 mcg/kg/min:

  For doses of argatroban injection greater than 2 mcg/kg/min, the relationship of INR between warfarin alone to the INR on warfarin plus argatroban injection is less predictable.  In this case, in order to predict the INR on warfarin alone, temporarily reduce the dose of argatroban injection to a dose of 2 mcg/kg/min.  Repeat the INR on argatroban injection and warfarin 4 to 6 hours after reduction of the argatroban injection dose and follow the process outlined above for administering argatroban injection at doses up to 2 mcg/kg/min.

  2.1 Preparation for Intravenous Administration

  Prior to administration, argatroban injection should be diluted in 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer’s Injection to a final concentration of 1 mg/mL.  The contents of each 2.5 mL vial should be diluted 100-fold by mixing with 250 mL of diluent.  Use 250 mg (2.5 mL) per 250 mL of diluent or 500 mg (5 mL) per 500 mL of diluent.

  
  

  The diluted solution must be mixed by inversion of the diluent bag for 1 minute.  Upon preparation, the solution may show slight but brief haziness due to the formation of microprecipitates that rapidly dissolve upon mixing.  The final diluted solution must be clear before use. Use of diluted solution at room temperature is recommended.  The pH of the intravenous solution prepared as recommended is 3.2 to 7.5.   

  
  

  Solutions prepared are physically, chemically, and microbiologically stable when stored as directed below in Table 1 and protected from light:

  
  

                               Table 1

    Recommended Storage Conditions of Diluted Solution

  Diluent
  Storage Limit
  Storage Temperature
  0.9% Sodium Chloride Injection
  96 hours
  20 to 25°C (68 to 77°F)
  96 hours
  2 to 8°C (36 to 46°F)
  5% Dextrose Injection or
  Lactated Ringer’s Injection
  4 hours
  20 to 25°C (68 to 77°F)
  4 hours
  2 to 8°C (36 to 46°F)
  
  

  Discard unused final product at the completion of these post dilution storage periods. Prepared solutions should not be exposed to direct sunlight.  No significant potency losses have been noted following simulated delivery of the solution through intravenous tubing.

  
  

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  2.2 Dosing in Patients with Heparin-Induced Thrombocytopenia

  Initial Dosage:

  Before administering argatroban injection, discontinue heparin therapy and obtain a baseline aPTT.  The recommended initial dose of argatroban injection for adult patients without hepatic impairment is 2 mcg/kg/min, administered as a continuous infusion (see Table 2).

  
  

                                                 
                                                                                                                                      Table 2
  Recommended Doses and Infusion Rates for 2 mcg/kg/min Dose of Argatroban Injection for Patients with HIT* and Without Hepatic Impairment (1 mg/mL Final Concentration)

  
   Body Weight (kg)
  Dose (mcg/min)
  Infusion Rate (mL/hr)
  50
  100
  6
  60
  120
  7
   70
  140
  8
   80
   160
  10
   90
   180
  11
  100
   200
  12
   110
   220
  13
   120
   240
  14
   130
   260
  16
   140
   280
  17
  

  *with or without thrombosis

  
  

  Monitoring Therapy:
  For use in HIT, therapy with argatroban injection is monitored using the aPTT with a target range of 1.5 to 3 times the initial baseline value (not to exceed 100 seconds).  Tests of anticoagulant effects (including the aPTT) typically attain steady-state levels within 1 to 3 hours following initiation of argatroban injection.  Check the aPTT 2 hours after initiation of therapy and after any dose change to confirm that the patient has attained the desired therapeutic range.

  
  

  Dosage Adjustment:
  After the initiation of argatroban injection, adjust the dose (not to exceed 10 mcg/kg/min) as necessary to obtain a steady-state aPTT in the target range [see Clinical Studies (14.1)].

  2.3 Dosing in Patients Undergoing Percutaneous Coronary Intervention

  Initial Dosage:
  Initiate an infusion of argatroban injection at 25 mcg/kg/min and administer a bolus of 350 mcg/kg via a large bore intravenous line over 3 to 5 minutes (see Table 3).  Check an activated clotting time (ACT) 5 to 10 minutes after the bolus dose is completed.  The PCI procedure may proceed if the ACT is greater than 300 seconds.

  
  

  Dosage Adjustment:
  If the ACT is less than 300 seconds, an additional intravenous bolus dose of 150 mcg/kg should be administered, the infusion dose increased to 30 mcg/kg/min, and the ACT checked 5 to 10 minutes later (see Table 3).

  
  

  If the ACT is greater than 450 seconds, decrease the infusion rate to 15 mcg/kg/min, and check the ACT 5 to 10 minutes later (see Table 4).

  
  

  Continue titrating the dose until a therapeutic ACT (between 300 and 450 seconds) has been achieved; continue the same infusion rate for the duration of the PCI procedure.

  
  

  In case of dissection, impending abrupt closure, thrombus formation during the procedure, or inability to achieve or maintain an ACT over 300 seconds, additional bolus doses of 150 mcg/kg may be administered and the infusion dose increased to 40 mcg/kg/min.  Check the ACT after each additional bolus or change in the rate of infusion.

  
  

                                                                                                                                          Table 3
  Recommended Starting and Maintenance Doses (Within the Target ACT Range) of Argatroban Injection in Patients Undergoing PCI Without Hepatic Impairment 
                                                                                                                      (1 mg/mL Final Concentration) 

   
  Body
   
  Weight
  
  (kg) 
   Starting Bolus Dose
   
  (350 mcg/kg)
  Starting and Maintenance Continuous Infusion Dosing For ACT 300 to 450 seconds
   
  25 mcg/kg/min
  Bolus
   
  Dose
  
  (mcg)
   Bolus Volume (mL)
  Continuous Infusion Dose (mg/min)
   Continuous Infusion
   
  Rate
  
  (mL/hr)
  50
  17,500
  18
  1,250
  75
   60
   21,000
   21
  1,500
  90
   70
   24,500
   25
  1,750
  105
   80
   28,000
   28
  2,000
  120
   90
   31,500
   32
  2,250
   135
   100
   35,000
   35
  2,500
   150
   110
   38,500
   39
   2,750
  165
   120
  42,000
   42 
  3,000
  180
   130
   45,500
   46
  3,250
  195
   140
    49,000
   49
  3,500
  210
  

  NOTE: 1 mg = 1,000 mcg; 1 kg = 2.2 lbs
  
  

  
  

                                                            Table 4
  Recommended Dose Adjustments of Argatroban Injection for Patients
  Outside of ACT Target Range Undergoing PCI Without Hepatic Impairment
                                           (1 mg/mL Final Concentration) 

   Body
   
  Weight
  
  (kg)
  If ACT Less than 300 seconds Dosage Adjustment†
  30 mcg/kg/min
  If ACT Greater than
   
  450 seconds
  
  Dosage Adjustment*
  
  15 mcg/kg/min
   Additional Bolus
   
  Dose
  
  (mcg)
   Bolus Volume
   
  (mL)
   Continuous Infusion
   
  Dose
  
  (mcg/min)
   Continuous Infusion
   
  Rate
  
  (mL/hr)
   Continuous Infusion
   
  Dose
  
  (mcg/min)
  Continuous Infusion
   
  Rate
  
  (mL/hr)
   50
   7,500
   8
  1,500
  90
  750
  45
   60
   9,000
   9
   1,800
   108
   900
  54
   70
   10,500
   11
   2,100
  126
   1,050
  63
   80 
   12,000 
  12
   2,400
  144
   1,200
  72
   90
  13,500
   14
   2,700
   162
   1,350
  81
   100
   15,000
   15
   3,000
  180
   1,500
  90
   110
   16,500
  17
   3,300
  198
   1,650
  99
   120
   18,000
  18
   3,600
   216
   1,800
   108
   130
   19,500
   20
   3,900
  234
   1,950
  117
  140
   21,000
  21
   4,200
   252
   2,100
   126
  

  NOTE: 1 mg = 1,000 mcg; 1 kg = 2.2 lbs

  
  

  † Additional intravenous bolus dose of 150 mcg/kg should be administered if ACT less than 300 seconds.

  
  

  * No bolus dose is given if ACT greater than 450 seconds

  
  
  

  Monitoring Therapy:
  For use in PCI, therapy with argatroban injection is monitored using ACT.  Obtain ACTs before dosing, 5 to 10 minutes after bolus dosing, following adjustments in the infusion rate, and at the end of the PCI procedure.  Obtain additional ACTs every 20 to 30 minutes during a prolonged procedure.

  
  

  Continued Anticoagulation after PCI:
  If a patient requires anticoagulation after the procedure, argatroban injection may be continued, but at a rate of 2 mcg/kg/min and adjusted as needed to maintain the aPTT in the desired range [see  Dosage and Administration (2.1)].                                                                                               

  2.4 Dosing in Patients with Hepatic Impairment

  Initial Dosage:

  For adult patients with HIT and moderate or severe hepatic impairment (based on Child-Pugh classification), an initial dose of 0.5 mcg/kg/min is recommended, based on the approximately 4-fold decrease in argatroban injection clearance relative to those with normal hepatic function.  Monitor the aPTT closely, and adjust the dosage as clinically indicated.

  
  

  Monitoring Therapy:

  Achievement of steady-state aPTT levels may take longer and require more dose adjustments in patients with hepatic impairment compared to patients with normal hepatic function.

  For patients with hepatic impairment undergoing PCI and who have HIT or are at risk for HIT, carefully titrate argatroban until the desired level of anticoagulation is achieved.  Use of argatroban in PCI patients with clinically significant hepatic disease or AST/ALT levels greater than or equal to 3 times the upper limit of normal should be avoided [see Warnings and Precautions (5.2)]. 

  2.5 Dosing in Pediatric Patients with Heparin-Induced Thrombocytopenia/Heparin-Induced Thrombocytopenia and Thrombosis Syndrome

  Initial Dosage:

  Initial argatroban injection infusion doses are lower for seriously ill pediatric patients compared to adults with normal hepatic function [see Use in Specific Populations (8.4)].

  Monitoring Therapy:

  In general, therapy with argatroban injection is monitored using the aPTT.  Tests of anticoagulant effects (including the aPTT) typically attain steady-state levels within one to three hours following initiation of argatroban injection in patients without hepatic impairment [see Warnings and Precautions  (5.2)].   Dose adjustment may be required to attain the target aPTT.  Check the aPTT two hours after initiation of therapy and after any dose change to confirm that the patient has attained the desired therapeutic range.

  Dosage Adjustment:

  [see Use in Specific Populations (8.4)].

  2.6 Conversion to Oral Anticoagulant Therapy

  Initiating Oral Anticoagulant Therapy:

  When converting patients from argatroban injection to oral anticoagulant therapy, consider the potential for combined effects on INR with co-administration of argatroban and warfarin.  A loading dose of warfarin should not be used.  Initiate therapy using the expected daily dose of warfarin.  To avoid prothrombotic effects and to ensure continuous anticoagulation when initiating warfarin, it is suggested that argatroban and warfarin therapy be overlapped.  There are insufficient data available to recommend the duration of the overlap.

  Co-Administration of Warfarin and Argatroban Injection at Doses up to 2 mcg/kg/min:

  Measure INR daily while argatroban injection and warfarin are co-administered. In general, with doses of argatroban injection up to 2 mcg/kg/min, argatroban injection can be discontinued when the INR is greater than 4 on combined therapy. After argatroban injection is discontinued, repeat the INR measurement in 4 to 6 hours. If the repeat INR is below the desired therapeutic range, resume the infusion of argatroban injection and repeat the procedure daily until the desired therapeutic range on warfarin alone is reached.

  Co-Administration of Warfarin and Argatroban Injection at Doses Greater than 2 mcg/kg/min:

  For doses of argatroban injection greater than 2 mcg/kg/min, the relationship of INR between warfarin alone to the INR on warfarin plus argatroban injection is less predictable.  In this case, in order to predict the INR on warfarin alone, temporarily reduce the dose of argatroban injection to a dose of 2 mcg/kg/min.  Repeat the INR on argatroban injection and warfarin 4 to 6 hours after reduction of the argatroban injection dose and follow the process outlined above for administering argatroban injection at doses up to 2 mcg/kg/min.

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• Target Corporation
  

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  Up And Up Omeprazole | Target Corporation

  

  ---

  • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

  14-Day Course of Treatment

  • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush tablets

  Repeated 14-Day Courses (if needed)

  • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

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