Argatroban package insert pdf

The coaguchek xs pt test uses only fresh capillary or nonanticoagulated venous whole blood. Insert test strip as far as you can into the meter. No concurrent epidural analgesia, spinal, or lumbar puncture while anticoagulated. Evaluation of bivalirudins effect on international. Argatroban is a direct thrombin inhibitor that reversibly binds to the thrombin active site. It focuses on antithrombotic medications by drug class ex. May 25, 2017 argatroban injection is supplied as a single use vial containing 125 mg argatroban in 125 ml of 0. Argatroban is a formulary drug at our hospital, but obtaining it at some institutions could be challenging. Eligible patients can register for valuable savings offers for nearly 40 brand name medications. Full text update on argatroban for the prophylaxis and treatment of.

Inhibition of platelet aggregation by clopidogrel is achieved through an active metabolite. Argatroban consists of a mixture of r and s stereoisomers at a ratio of approximately 65. Adult argatroban drip protocol draft county of ventura. False elevation of the international normalized ratio inr occurs with these agents making bridging to warfarin challenging. The following pages are intended for viewing by healthcare professionals residing in the uk only. Argatroban fda prescribing information, side effects and. Inr should be measured daily while argatroban and warfarin are coadministered. The main attributes of this synthetic drug are its rapid onset of antithrombin. Argatroban therapy in patients with atrial fibrillation. His past medical history infodmation a cerebrovascular accident with no residual deficit, chronic atrial fibrillation for which he was taking coumadin, a duodenal ulcer, type ii diabetes, benign prostatic hypertrophy, and bilateral cataract and glaucoma surgery.

In general, with doses of argatroban up to 2 gkgmin, argatroban can be discontinued when the inr is 4. Remove the protective cap from the other end of the transfer. Stop all heparin including catheter flushes, enoxaparin or dalteparin, and warfarin obtain baselines labs if none in past 24 hours cbc, ptt, ptinr, basic metabolic profile, lfts. Argatroban suggested guidelines for use university of. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials. The use of argatroban for carotid endarterectomy in.

Connect the syringe plunger to the sterile 10 ml prefilled syringe by screwing the plunger into the rubber stopper. Nov 01, 2018 argatroban consists of a mixture of r and s stereoisomers at a ratio of approximately 65. Undergoing percutaneous coronary intervention pci with provisional use of glycoprotein iibiiia inhibitor gpi. Coaguchek xs pro pt controls package insert and this entire insert. The molecular formula of argatroban is c 23 h 36 n 6 o 5 sh 2 o. Argatroban is used to treat or prevent blood clots in adults who have thrombocytopenia low levels of platelets in the. Argatroban is a small molecule dti that acts by reversibly binding to the catalytic thrombin active site, thus inhibiting activation of factors v, viii and xiii the coagulant factors, as well as preventing fibrin formation and platelet aggregation hursting et al. Use only plastic syringes without anticoagulants or additives. Argatroban does not require the cofactor antithrombin iii for antithrombotic activity. Argatroban side effects, dosage, interactions drugs everyday health search. Argatroban fda prescribing information, side effects and uses. Mcmaster university department of medicine division of.

Study 970034, a randomized, doubleblind, comparative multicenter trial, evaluated the safety of ambisome 3 and 5 mgkgday compared with amphotericin b lipid complex 5 mgkgday in the empirical treatment of 202 adult and 42 pediatric neutropenic patients. The concomitant use of argatroban with warfarin results in prolongation of inr beyond that produced by warfarin alone. At therapeutic concentrations, argatroban has little or no effect on related serine proteases trypsin, factor xa, plasmin, and kallikrein. The drug should be used with caution in patients with coronary. The argatroban package insert recommends an initial i. Thus, although argatroban undergoes hepatic metabolism, with a fourfold decrease in clearance and a threefold increase in elimination halflife eg, from approximately 51 to 181 minutes, package insert recommendations provide guidance on dose reductions eg, reducing the starting dose from 2. Discard product if it contains particulate matter, is cloudy, or discolored do not freeze protect from.

Clinical practice guideline cpg development template uw health. Andexxa coagulation factor xa recombinant, inactivated. The therapeutic range used for thromboprophylaxis and treatment of acute thrombosis is defined by a 1. Nov 09, 2018 argatroban blocks the activity of certain clotting substances in the blood.

Open the package containing the reconstitution spike. Argatroban exerts its anticoagulant effects by inhibiting thrombincatalyzed or. The metabolism of clopidogrel to its active metabolite can be impaired by genetic variations in cyp2c19 see boxed warning. Argatroban injection must be diluted 100fold prior to infusion. Argatroban anticoagulation in patients with heparininduced. It is not a substitute for appropriate clinical evaluation and does not supersede clinical judgment.

Discard product if it contains particulate matter, is cloudy, or. Argatroban, a synthetic direct thrombin inhibitor, is indicated for the treatment and. Argatroban glaxosmithkine and lepirudin berlex laboratories are both direct thrombin inhibitors dtis approved for the treatment of patients with heparininduced thrombocytopenia. Although not all of these side effects may occur, if they do occur they may need medical attention. Argatroban in sodium chloride injection is a sterile, nonpyrogenic, clear, colorless to pale yellow solution. The vial is sealed with a gray rubber stopper and a red aluminum flipoff seal. Argatroban argatroban injection, solution this product information is intended only for residents of the united states. Argatroban is a synthetic direct thrombin inhibitor derived from l arginine. Angiomax bivalirudin for injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients.

Note that argatroban is a nonformulary drug at uw medicine. Highlights of prescribing information these highlights do not include all the information needed to use ubrelvy safely and effectively. Demographic subgroup information coagulation factor xa recombinant, inactivatedzhzo andexxa refer to section 1. Argatroban side effects, dosage, interactions drugs. We compared aptt, thrombin time tt, and prothrombin time pt to drug levels obtained by the ecarin chromogenic assay. This product information is intended only for residents of the united states. Argatroban package insert pdf store in original package until time of use. Argatroban argatroban for injection product monograph. Argatroban in sodium chloride injection is a sterile, nonpyrogenic, clear, colorless to pale yellow, aqueous solution.

Highlights of prescribing information these highlights do not include all the information needed to use coumadin safely and effectively. Apr 04, 2019 argatroban injection is supplied as a singledose vial containing 125 mg argatroban in 125 ml of aqueous sodium chloride solution 1 mgml. Argatroban is dosed by pharmacists in accordance to an institutional argatroban dosing guideline. Aug, 2014 thus, although argatroban undergoes hepatic metabolism, with a fourfold decrease in clearance and a threefold increase in elimination halflife eg, from approximately 51 to 181 minutes, package insert recommendations provide guidance on dose reductions eg, reducing the starting dose from 2. We suggest that it should be available as a nonformulary alternative to lepirudin or bivalirudin if the physician emphasizes the need for a direct thrombin inhibitor not requiring renal adjustment in the setting of hit with renal.

The use of antixa assay to monitor intravenous unfractionated. For those with active clot or high risk for clotting, there must be a five day overlap of both drugs and 2. Highlights of prescribing information acute ischemic stroke. On day 9, venous thrombosis was detected, and a filter was inserted into the. Child pugh classification for severity of liver disease. Argatroban injection should not be mixed with other drugs prior to dilution. Argatroban injection is supplied as a singledose vial containing 125 mg argatroban in 125 ml of aqueous sodium chloride solution 1 mgml. No anticoagulation within 24 hours of therapeutic tpa for ischemic stroke. The recommended rate for argatroban administration through a continuous infusion is 0. Pdf weightbased argatroban dosing nomogram for treatment of. Aug 11, 2019 argatroban package insert pdf store in original package until time of use.

This leaflet is part iii of a threepart product monograph published. Guidelines for the use of argatroban in hit anticoagulation. Argatroban package insert pdf posted on february 18, 2019 by admin store in original package until time of use. Jul 30, 2019 argatroban package insert pdf store in original package until time of use. Highdose argatroban for treatment of heparininduced. A premature discontinuation of pradaxa increases the risk of thrombotic events, and b spinalepidural hematoma 1 indications and usage 1. The vial is sealed with a gray rubber stopper and a green aluminum flipoff seal. Based on steady state correlation studies, argatroban levels between 0. Argatroban injection is indicated as an anticoagulant in adult patients with or at risk for hit undergoing percutaneous coronary intervention pci. The coaguchek xs pt test uses only fresh capillary or non. The metabolism of clopidogrel can also be impaired by drugs that inhibit cyp2c19, such.

Argatroban anticoagulation in patients with heparin. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. Pdf manufacturer recommendations for argatroban use in the setting of heparin induced. Direct thrombin inhibitors are recommended in confirmed or suspected heparininduced thrombocytopenia. Clinical monitoring of direct thrombin inhibitors using. Highlights of prescribing information these highlights do not include all the information needed to use angiomax safely and effectively. Argatroban is the preferred parenteral anticoagulant for patients with a contraindication to ufh at the study site. Apr 25, 2019 argatroban package insert pdf store in original package until time of use. Aug 19, 2019 argatroban package insert pdf store in original package until time of use. Adult argatroban drip protocol this protocol reflects current evidence based clinical practice. Verzenioabemaciclib tablets, for oral use initial u. Pdf update on argatroban for the prophylaxis and treatment of. This faq is provided for informational purposes only and is not intended as medical advice.

Ddavp injection desmopressin acetate 4 mcgml has infrequently produced changes in blood pressure causing either a slight elev ation in blood pressure or a transient fall in blood pressure and a compensatory increase in heart rate. Argatroban is a synthetic, smallmolecule dti derived from arginine 527 da. Discard product if it contains particulate matter, is cloudy, or discolored do not freeze. Highlights of prescribing information these highlights do not. Pdf heparininduced thrombocytopenia hit is a rare but potentially severe. In a prospective study 17 of argatroban use in patients with hit argatroban 911, argatroban therapy significantly reduced the primary composite end point of death, amputation, or new thrombosis in patients with isolated hit. Argatroban is not for use in patients with moderate to severe hepatic insufficiency. Argatroban dosing requirements in extracorporeal life. The argatroban package insert states that a plasma argatroban concentration of 0. Argatroban therapy in patients with atrial fibrillation and heparininduced. Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone see drug interactions 7. Check with your doctor or nurse immediately if any of the following side effects occur while taking argatroban.

Argatroban suggested guidelines for use university of washington medical center dept of pharmacy for physician use only this is not intended as a nursemanaged protocol september 2008 background. Argatroban is a a small molecule, synthetic direct thrombin inhibitor. Turn the package over and insert the clear plastic spike through the diluent stopper by pressing straight down fig. This is lower than heparin anticoagulation goals and approximately 2 x uhs normal range. Highlights of prescribing information these highlights do. For detailed prescription information, refer to the manufacturers package insert for each medication. Monitoring of argatroban and lepirudin sage journals. Along with its needed effects, argatroban may cause some unwanted effects. 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 singleuse amber vial containing 250 mg2.

Comparison of a predefined dose increment nomogram with a. Argatroban is a synthetic direct thrombin inhibitor derived from larginine. Place the diluents vial on a flat and solid surface. Argatroban is highly selective for thrombin with an inhibitory constant k. Ndc 07828512 one package containing two vials of argatroban injection each vial contains 125 mg of argatroban. In this article, we describe, to our knowledge, the largest prospective study of patients with hit reported to date. Find patient medical information for argatroban intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Update on argatroban for the prophylaxis and treatment of. Remove the protective cap from one end of the transfer device and keeping the vial of swfi upright, insert the piercing pin vertically into the center of the stopper of the vial of swfi. The package insert states that the effectiveness of this device for this use has not been demonstrated. A clinicians test selection and interpretation, diagnosis, and patient management decisions should be based on hisher education, clinical expertise, and assessment of the. Open the package containing the transfer device by peeling the paper label off the package. Wait 3 hours after discontinuation of heparin infusion to start ar gatroban infusion.

Argatroban is capable of inhibiting the action of both free and clotassociated thrombin. Argatroban is an anticoagulant thrombin inhibitor that helps prevent the formation of blood clots. The use of argatroban in patients with hit and hitts is associated with. Argatroban injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparininduced thrombocytopenia hit. It reversibly binds to the active site pocket of thrombin alone and thus is a univalent dti. Argatroban exerts its anticoagulant effects by inhibiting thrombincatalyzed or induced. Healthcare professionals argatroban injection in % sodium chloride mg ml 1 mg1 ml. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic.