Integrilin

Integrilin Manufacturers

• Merck Sharp & Dohme Corp.
  

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  Integrilin | Merck Sharp & Dohme Corp.

  

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  Before infusion of INTEGRILIN, the following laboratory tests should be performed to identify pre-existing hemostatic abnormalities: hematocrit or hemoglobin, platelet count, serum creatinine, and PT/aPTT. In patients undergoing PCI, the activated clotting time (ACT) should also be measured.

  The activated partial thromboplastin time (aPTT) should be maintained between 50 and 70 seconds unless PCI is to be performed. In patients treated with heparin, bleeding can be minimized by close monitoring of the aPTT and ACT.

  2.1 Dosage in Acute Coronary Syndrome (ACS) Indication Normal Renal Function Creatinine Clearance less than 50 mL/min Patients with ACS 180 mcg/kg intravenous (IV) bolus as soon as possible after diagnosis, followed by continuous infusion of 2 mcg/kg/min 180 mcg/kg IV bolus as soon as possible after diagnosis, followed by continuous infusion of 1 mcg/kg/min Infusion should continue until hospital discharge or initiation of coronary artery bypass graft surgery (CABG), up to 72 hours If a patient is to undergo PCI, the infusion should be continued until hospital discharge or for up to 18 to 24 hours after the procedure, whichever comes first, allowing for up to 96 hours of therapy Aspirin, 160 to 325 mg, should be given daily

  INTEGRILIN should be given concomitantly with heparin dosed to achieve the following parameters:

    During Medical Management: Target aPTT 50 to 70 seconds If weight greater than or equal to 70 kg, 5000-unit bolus followed by infusion of 1000 units/h. If weight less than 70 kg, 60-units/kg bolus followed by infusion of 12 units/kg/h.   During PCI: Target ACT 200 to 300 seconds If heparin is initiated prior to PCI, additional boluses during PCI to maintain an ACT target of 200 to 300 seconds. Heparin infusion after the PCI is discouraged. 2.2 Dosage in Percutaneous Coronary Intervention (PCI) Indication Normal Renal Function Creatinine Clearance less than 50 mL/min Patients with PCI 180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 2 mcg/kg/min and a second bolus of 180 mcg/kg (given 10 minutes after the first bolus) 180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 1 mcg/kg/min and a second bolus of 180 mcg/kg (given 10 minutes after the first bolus) Infusion should be continued until hospital discharge, or for up to 18 to 24 hours, whichever comes first. A minimum of 12 hours of infusion is recommended. In patients who undergo CABG surgery, INTEGRILIN infusion should be discontinued prior to surgery. Aspirin, 160 to 325 mg, should be given 1 to 24 hours prior to PCI and daily thereafter INTEGRILIN should be given concomitantly with heparin to achieve a target ACT of 200 to 300 seconds. Administer 60-units/kg bolus initially in patients not treated with heparin within 6 hours prior to PCI. Additional boluses during PCI to maintain ACT within target. Heparin infusion after the PCI is strongly discouraged.

  Patients requiring thrombolytic therapy should discontinue INTEGRILIN.

  2.3 Important Administration Instructions Inspect INTEGRILIN for particulate matter and discoloration prior to administration, whenever solution and container permit. May administer INTEGRILIN in the same intravenous line as alteplase, atropine, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, or verapamil. Do not administer INTEGRILIN through the same intravenous line as furosemide. May administer INTEGRILIN in the same IV line with 0.9% NaCl or 0.9% NaCl/5% dextrose. With either vehicle, the infusion may also contain up to 60 mEq/L of potassium chloride. Withdraw the bolus dose(s) of INTEGRILIN from the 10-mL vial into a syringe. Administer the bolus dose(s) by IV push. Immediately following the bolus dose administration, initiate a continuous infusion of INTEGRILIN. When using an intravenous infusion pump, administer INTEGRILIN undiluted directly from the 100-mL vial. Spike the 100-mL vial with a vented infusion set. Center the spike within the circle on the stopper top. Discard any unused portion left in the vial.

  Administer INTEGRILIN by volume according to patient weight (see Table 1).

  Table 1: INTEGRILIN Dosing Charts by Weight Patient Weight 180-mcg/kg
  Bolus Volume 2-mcg/kg/min
  Infusion Volume
  (CrCl greater than or equal to 50 mL/min) 1-mcg/kg/min
  Infusion Volume
  (CrCl less than 50 mL/min) (kg) (lb) (from 2-mg/mL vial) (from 2-mg/mL 100-mL vial) (from 0.75-mg/mL 100-mL vial) (from 2-mg/mL 100-mL vial) (from 0.75-mg/mL 100-mL vial) 37-41 81-91 3.4 mL 2 mL/h 6 mL/h 1 mL/h 3 mL/h 42-46 92-102 4 mL 2.5 mL/h 7 mL/h 1.3 mL/h 3.5 mL/h 47-53 103-117 4.5 mL 3 mL/h 8 mL/h 1.5 mL/h 4 mL/h 54-59 118-130 5 mL 3.5 mL/h 9 mL/h 1.8 mL/h 4.5 mL/h 60-65 131-143 5.6 mL 3.8 mL/h 10 mL/h 1.9 mL/h 5 mL/h 66-71 144-157 6.2 mL 4 mL/h 11 mL/h 2 mL/h 5.5 mL/h 72-78 158-172 6.8 mL 4.5 mL/h 12 mL/h 2.3 mL/h 6 mL/h 79-84 173-185 7.3 mL 5 mL/h 13 mL/h 2.5 mL/h 6.5 mL/h 85-90 186-198 7.9 mL 5.3 mL/h 14 mL/h 2.7 mL/h 7 mL/h 91-96 199-212 8.5 mL 5.6 mL/h 15 mL/h 2.8 mL/h 7.5 mL/h 97-103 213-227 9 mL 6 mL/h 16 mL/h 3.0 mL/h 8 mL/h 104-109 228-240 9.5 mL 6.4 mL/h 17 mL/h 3.2 mL/h 8.5 mL/h 110-115 241-253 10.2 mL 6.8 mL/h 18 mL/h 3.4 mL/h 9 mL/h 116-121 254-267 10.7 mL 7 mL/h 19 mL/h 3.5 mL/h 9.5 mL/h >121 >267 11.3 mL 7.5 mL/h 20 mL/h 3.7 mL/h 10 mL/h

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• Merck Sharp & Dohme Corp.
  

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  Integrilin | Merck Sharp & Dohme Corp.

  

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  Before infusion of INTEGRILIN, the following laboratory tests should be performed to identify pre-existing hemostatic abnormalities: hematocrit or hemoglobin, platelet count, serum creatinine, and PT/aPTT. In patients undergoing PCI, the activated clotting time (ACT) should also be measured.

  The activated partial thromboplastin time (aPTT) should be maintained between 50 and 70 seconds unless PCI is to be performed. In patients treated with heparin, bleeding can be minimized by close monitoring of the aPTT and ACT.

  2.1 Dosage in Acute Coronary Syndrome (ACS) Indication Normal Renal Function Creatinine Clearance less than 50 mL/min Patients with ACS 180 mcg/kg intravenous (IV) bolus as soon as possible after diagnosis, followed by continuous infusion of 2 mcg/kg/min 180 mcg/kg IV bolus as soon as possible after diagnosis, followed by continuous infusion of 1 mcg/kg/min Infusion should continue until hospital discharge or initiation of coronary artery bypass graft surgery (CABG), up to 72 hours If a patient is to undergo PCI, the infusion should be continued until hospital discharge or for up to 18 to 24 hours after the procedure, whichever comes first, allowing for up to 96 hours of therapy Aspirin, 160 to 325 mg, should be given daily

  INTEGRILIN should be given concomitantly with heparin dosed to achieve the following parameters:

    During Medical Management: Target aPTT 50 to 70 seconds If weight greater than or equal to 70 kg, 5000-unit bolus followed by infusion of 1000 units/h. If weight less than 70 kg, 60-units/kg bolus followed by infusion of 12 units/kg/h.   During PCI: Target ACT 200 to 300 seconds If heparin is initiated prior to PCI, additional boluses during PCI to maintain an ACT target of 200 to 300 seconds. Heparin infusion after the PCI is discouraged. 2.2 Dosage in Percutaneous Coronary Intervention (PCI) Indication Normal Renal Function Creatinine Clearance less than 50 mL/min Patients with PCI 180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 2 mcg/kg/min and a second bolus of 180 mcg/kg (given 10 minutes after the first bolus) 180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 1 mcg/kg/min and a second bolus of 180 mcg/kg (given 10 minutes after the first bolus) Infusion should be continued until hospital discharge, or for up to 18 to 24 hours, whichever comes first. A minimum of 12 hours of infusion is recommended. In patients who undergo CABG surgery, INTEGRILIN infusion should be discontinued prior to surgery. Aspirin, 160 to 325 mg, should be given 1 to 24 hours prior to PCI and daily thereafter INTEGRILIN should be given concomitantly with heparin to achieve a target ACT of 200 to 300 seconds. Administer 60-units/kg bolus initially in patients not treated with heparin within 6 hours prior to PCI. Additional boluses during PCI to maintain ACT within target. Heparin infusion after the PCI is strongly discouraged.

  Patients requiring thrombolytic therapy should discontinue INTEGRILIN.

  2.3 Important Administration Instructions Inspect INTEGRILIN for particulate matter and discoloration prior to administration, whenever solution and container permit. May administer INTEGRILIN in the same intravenous line as alteplase, atropine, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, or verapamil. Do not administer INTEGRILIN through the same intravenous line as furosemide. May administer INTEGRILIN in the same IV line with 0.9% NaCl or 0.9% NaCl/5% dextrose. With either vehicle, the infusion may also contain up to 60 mEq/L of potassium chloride. Withdraw the bolus dose(s) of INTEGRILIN from the 10-mL vial into a syringe. Administer the bolus dose(s) by IV push. Immediately following the bolus dose administration, initiate a continuous infusion of INTEGRILIN. When using an intravenous infusion pump, administer INTEGRILIN undiluted directly from the 100-mL vial. Spike the 100-mL vial with a vented infusion set. Center the spike within the circle on the stopper top. Discard any unused portion left in the vial.

  Administer INTEGRILIN by volume according to patient weight (see Table 1).

  Table 1: INTEGRILIN Dosing Charts by Weight Patient Weight 180-mcg/kg
  Bolus Volume 2-mcg/kg/min
  Infusion Volume
  (CrCl greater than or equal to 50 mL/min) 1-mcg/kg/min
  Infusion Volume
  (CrCl less than 50 mL/min) (kg) (lb) (from 2-mg/mL vial) (from 2-mg/mL 100-mL vial) (from 0.75-mg/mL 100-mL vial) (from 2-mg/mL 100-mL vial) (from 0.75-mg/mL 100-mL vial) 37-41 81-91 3.4 mL 2 mL/h 6 mL/h 1 mL/h 3 mL/h 42-46 92-102 4 mL 2.5 mL/h 7 mL/h 1.3 mL/h 3.5 mL/h 47-53 103-117 4.5 mL 3 mL/h 8 mL/h 1.5 mL/h 4 mL/h 54-59 118-130 5 mL 3.5 mL/h 9 mL/h 1.8 mL/h 4.5 mL/h 60-65 131-143 5.6 mL 3.8 mL/h 10 mL/h 1.9 mL/h 5 mL/h 66-71 144-157 6.2 mL 4 mL/h 11 mL/h 2 mL/h 5.5 mL/h 72-78 158-172 6.8 mL 4.5 mL/h 12 mL/h 2.3 mL/h 6 mL/h 79-84 173-185 7.3 mL 5 mL/h 13 mL/h 2.5 mL/h 6.5 mL/h 85-90 186-198 7.9 mL 5.3 mL/h 14 mL/h 2.7 mL/h 7 mL/h 91-96 199-212 8.5 mL 5.6 mL/h 15 mL/h 2.8 mL/h 7.5 mL/h 97-103 213-227 9 mL 6 mL/h 16 mL/h 3.0 mL/h 8 mL/h 104-109 228-240 9.5 mL 6.4 mL/h 17 mL/h 3.2 mL/h 8.5 mL/h 110-115 241-253 10.2 mL 6.8 mL/h 18 mL/h 3.4 mL/h 9 mL/h 116-121 254-267 10.7 mL 7 mL/h 19 mL/h 3.5 mL/h 9.5 mL/h >121 >267 11.3 mL 7.5 mL/h 20 mL/h 3.7 mL/h 10 mL/h

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  Integrilin | Direct Rx

  

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  Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.

  2.1 Adults

  The usual adult dose is one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet.

  Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should not be substituted for one amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg.

  The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium tablet 250 mg/125 mg contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.

  2.2 Pediatric Patients

  
  

  Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:

  Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium tablets is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.

  Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics. 

  Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
  b Duration of therapy studied and recommended for acute otitis media is 10 days. INFECTION DOSING REGIMEN Every 12 hours Every 8 hours 200 mg/28.5 mg per 5 mL or
  400 mg/57 mg per 5 mL oral suspensiona 125 mg/31.25 mg per 5 mL or
  250 mg/62.5 mg per 5 mL oral suspensiona Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hours

  Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.

  The amoxicillin and clavulanate potassium tablet 250 mg/125 mg should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium tablet 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable tablet 250 mg/62.5 mg.

  2.3 Patients with Renal Impairment

  Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the amoxicillin and clavulanate potassium tablets 875 mg/125 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.

  Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

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