Allerfed Cold And Allergy

Allerfed Cold And Allergy Manufacturers

• Great Lakes Wholesale, Marketing, & Sales, Inc.
  

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  Allerfed Cold And Allergy | 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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• Chain Drug Marketing Association Inc
  

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  Allerfed Cold And Allergy | Sun Pharma Global Fze

  

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  2.1 General Dosing Considerations

  The chronic daily dose of tetrabenazine tablets used to treat chorea associated with Huntington's disease (HD) is determined individually for each patient. When first prescribed, tetrabenazine tablets therapy should be titrated slowly over several weeks to identify a dose of tetrabenazine tablets that reduces chorea and is tolerated. Tetrabenazine tablets can be administered without regard to food [see Clinical Pharmacology (12.3)].

  2.2 Individualization of Dose

  The dose of tetrabenazine tablets should be individualized.
  
  Dosing Recommendations Up to 50 mg per day
  The starting dose should be 12.5 mg per day given once in the morning. After one week, the dose should be increased to 25 mg per day given as 12.5 mg twice a day. Tetrabenazine tablets should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. If a dose of 37.5 to 50 mg per day is needed, it should be given in a three times a day regimen. The maximum recommended single dose is 25 mg. If adverse reactions such as akathisia, restlessness, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing tetrabenazine tablets treatment or initiating other specific treatment (e.g., antidepressants) [see Adverse Reactions (6.1)].
  
  Dosing Recommendations Above 50 mg per day
  Patients who require doses of tetrabenazine tablets greater than 50 mg per day should be first tested and genotyped to determine if they are poor metabolizers (PMs) or extensive metabolizers (EMs) by their ability to express the drug metabolizing enzyme, CYP2D6. The dose of tetrabenazine tablets should then be individualized accordingly to their status as PMs or EMs [see Warnings and Precautions (5.3), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
  
  Extensive and Intermediate CYP2D6 Metabolizers

  
  

  Genotyped patients who are identified as extensive (EMs) or intermediate metabolizers (IMs) of CYP2D6, who need doses of tetrabenazine tablets above 50 mg per day, should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. Doses above 50 mg per day should be given in a three times a day regimen. The maximum recommended daily dose is 100 mg and the maximum recommended single dose is 37.5 mg. If adverse reactions such as akathisia, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing tetrabenazine tablets treatment or initiating other specific treatment (e.g., antidepressants) [see Warnings and Precautions (5.3), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
  
  Poor CYP2D6 Metabolizers
  In PMs, the initial dose and titration is similar to EMs except that the recommended maximum single dose is 25 mg, and the recommended daily dose should not exceed a maximum of 50 mg [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

  2.3 Dosage Adjustments with CYP2D6 Inhibitors

  Strong CYP2D6 Inhibitors
  Medications that are strong CYP2D6 inhibitors such as quinidine or antidepressants (e.g., fluoxetine, paroxetine) significantly increase the exposure to α-HTBZ and β-HTBZ, therefore, the total dose of tetrabenazine tablets should not exceed a maximum of 50 mg and the maximum single dose should not exceed 25 mg [see Warnings and Precautions (5.3), Drug Interactions (7.1), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

  2.4 Discontinuation of Treatment

  Treatment with tetrabenazine tablets can be discontinued without tapering. Re-emergence of chorea may occur within 12 to 18 hours after the last dose of tetrabenazine tablets [see Drug Abuse and Dependence (9.2)].

  2.5 Resumption of Treatment

  Following treatment interruption of greater than five (5) days, tetrabenazine tablets therapy should be re-titrated when resumed. For short-term treatment interruption of less than five (5) days, treatment can be resumed at the previous maintenance dose without titration.

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