FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
Up And Up Omeprazole Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Argatroban injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT).
Argatroban injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).
Argatroban injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT).
1.2 Percutaneous Coronary InterventionArgatroban injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).
History
There is currently no drug history available for this drug.
Other Information
Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35.
The molecular formula of argatroban is C23H36N6O5S•H2O. Its molecular weight is 526.66 g/mol. The structural formula is:
Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether.
Argatroban injection is a sterile clear, colorless to pale yellow, slightly viscous solution in a single dose amber vial containing 250 mg per 2.5 mL of argatroban. It is supplied as a solution intended for dilution prior to intravenous use. Each mL of sterile, nonpyrogenic solution contains 100 mg argatroban and 954 mg propylene glycol.
Sources
Up And Up Omeprazole Manufacturers
-
Target Corporation
Up And Up Omeprazole | Fresenius Kabi Usa, Llc
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 AdministrationPrior 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 ThrombocytopeniaInitial 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:
2.3 Dosing in Patients Undergoing Percutaneous Coronary Intervention
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)].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
Body
Recommended Dose Adjustments of Argatroban Injection for Patients
Outside of ACT Target Range Undergoing PCI Without Hepatic Impairment
(1 mg/mL Final Concentration)
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:
2.4 Dosing in Patients with Hepatic Impairment
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)].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 SyndromeInitial 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 TherapyInitiating 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 AdministrationPrior 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 ThrombocytopeniaInitial 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:
2.3 Dosing in Patients Undergoing Percutaneous Coronary Intervention
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)].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
Body
Recommended Dose Adjustments of Argatroban Injection for Patients
Outside of ACT Target Range Undergoing PCI Without Hepatic Impairment
(1 mg/mL Final Concentration)
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:
2.4 Dosing in Patients with Hepatic Impairment
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)].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 SyndromeInitial 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 TherapyInitiating 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.
-
Target Corporation
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 hours14-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 tabletsRepeated 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.
Login To Your Free Account