ARGATROBAN PACKAGE INSERT PDF

Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. Intravenous, direct thrombin inhibitor Used for thrombosis prophylaxis or treatment in patients with heparin-induced thrombocytopenia HIT and as an anticoagulant in patients with or at risk of HIT undergoing percutaneous coronary intervention PCI Hepatically eliminated, can use in end-stage renal disease without dosage adjustment. Measure INR daily while argatroban and warfarin are coadministered.

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Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. Intravenous, direct thrombin inhibitor Used for thrombosis prophylaxis or treatment in patients with heparin-induced thrombocytopenia HIT and as an anticoagulant in patients with or at risk of HIT undergoing percutaneous coronary intervention PCI Hepatically eliminated, can use in end-stage renal disease without dosage adjustment.

Measure INR daily while argatroban and warfarin are coadministered. After argatroban 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 and repeat the process daily until the desired therapeutic range on warfarin alone is reached. Clinical practice guidelines recommend allowing the platelet count to substantially recover i. Overlap argatroban with warfarin for at least 5 days and until the INR is within the desired range.

Repeat the INR 4 to 6 hours after reduction of the argatroban dose. Clinical practice guidelines recommend 0. Steady-state anticoagulant effects including the aPTT are typically attained within 1 to 3 hours. The steady-state aPTT should be 1. Adjustments in dose were based on maintaining an activated partial thromboplastin time aPTT of 1.

Clinical practice guidelines recommend use of nonheparin anticoagulants, including argatroban, over further use of heparin, low-molecular weight heparin, or vitamin K antagonist.

Argatroban is preferred over other nonheparin anticoagulants in patients with renal insufficiency. Safety and efficacy have not been established. Based on aPTT evaluation every 2 hours, increasing the infusion rate by 0. However, this dosing regimen has not been adequately assessed and did not take into account multiple factors e. Activated clotting time ACT should be measured 5 to 10 minutes later. The procedure may proceed if the ACT is more than seconds.

Once a therapeutic ACT between to seconds has been achieved, this infusion rate should be continued for the duration of the procedure. The ACT should be monitored after each additional bolus, change in infusion rate, and at the end of the procedure.

In addition, during prolonged procedures, monitor ACT every 20 to 30 minutes. Clinical practice guidelines recommend argatroban or bivalirudin over other nonheparin anticoagulants in patients with heparin-induced thrombocytopenia who require percutaneous coronary intervention. Patients continued heparin or argatroban for 48 to 72 hours or until angioplasty, at which point patients receiving argatroban were switched to heparin.

TIMI grade 3 blood flow at 90 minutes trended towards improvement with argatroban; however, these differences were not statistically different.

The maximum dosage is individualized based on aPTT or ACT monitoring and assessment of efficacy and safety parameters. In patients with HIT: Adults with moderate to severe hepatic impairment: decrease the initial dose to 0. In patients undergoing PCI: Carefully titrate to desired level of anticoagulation in patients with hepatic impairment.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Vial may be inverted for use with medical infusion set. Each 2. Use mg 2. Use of diluent at room temperature is recommended. Mix with repeated inversion of the diluent bag for 1 minute. The diluted solution may show slight but brief haziness due to the formation of microprecipitates that rapidly dissolve upon mixing. The final solution must be clear before use. The pH of the diluted solution prepared as recommended is 3.

Storage: Diluted solutions are stable for 24 hours at 25 degrees C 77 degrees F in ambient indoor light. Solutions are physically and chemically stable for up to 96 hours when protected from light and stored at room temperature, 20 to 25 degrees C 68 to 77 degreed F or in the refrigerator, 2 to 8 degrees C 36 to 46 degrees F.

Do not expose prepared solution to direct sunlight. Solutions are physically and chemically stable for up to 96 hours when protected from light and stored at controlled room temperature of 20 to 25 degrees C 68 to 77 degrees F or under refrigeration at 2 to 8 degrees C 36 to 46 degrees F.

Generic: - Discard product if it contains particulate matter, is cloudy, or discolored - Do not freeze - Protect from light - Store at 77 degrees F; excursions permitted to degrees F - Store in original package until time of use Argatroban: - Discard product if it contains particulate matter, is cloudy, or discolored - Discard unused portion. Do not store for later use. Start with a lower dose and carefully titrate argatroban in patients with hepatic disease.

Achievement of steady-state aPTT concentrations may take longer and require more dosage adjustments in patients with hepatic impairment compared to patients with normal hepatic function. Upon argatroban discontinuation, full reversal of anticoagulant effects may require longer than 4 hours due to decreased clearance and increased elimination half-life. Bleeding can be a major risk associated with use of argatroban; therefore, argatroban is contraindicated in patients with overt major bleeding.

Coagulopathy should be ruled out before initiation of therapy. Blood coagulation tests should be performed before and regularly during therapy. Argatroban should not be initiated in patients with a baseline aPTT ratio of 2. For patients at increased risk of bleeding, a careful assessment must be made weighing the risk of argatroban administration versus its anticipated benefit. Conditions which increase the risk of bleeding include: a recent stroke; severe uncontrolled hypertension; infective endocarditis; advanced renal disease; dissecting aortic aneurysm; peptic ulcer disease; diverticulitis; inflammatory bowel disease; hemophilia; menstruation; recent major surgery or trauma, including eye, brain, or spinal cord surgery; lumbar puncture; spinal anesthesia; recent puncture of large vessels or organ biopsy; an anomaly of vessels or organs; or recent major bleeding including intracranial bleeding, GI bleeding, intraocular bleeding, retroperitoneal bleeding, or pulmonary bleeding.

Argatroban should not be used in patients with uncontrollable bleeding. If possible, intramuscular injections should be avoided in patients receiving argatroban. Patients with unstable angina have been reported to have a recurrence of rest angina following abrupt discontinuation of infusions of argatroban.

Angina appears to occur after administration of higher doses of argatroban and is associated with greater prolongations of aPTT and evidence of rebound thrombin generation. Significant increases in thrombin-antithrombin III complex concentrations were observed within a few hours following infusion.

Infusions of argatroban should be gradually tapered in patients with unstable angina following initiation of aspirin or other antiplatelet agents. If argatroban is used during pregnancy, monitor neonates for bleeding and pregnant women for evidence of excessive bleeding or unexpected changes in coagulation parameters during labor or obstetric delivery.

The use of argatroban during pregnancy may increase the risk of bleeding. Limited data from postmarketing reports and published literature do not suggest an association between the use of argatroban and adverse fetal developmental outcomes. In animal reproduction studies with argatroban doses up to 0.

It is not known if argatroban is excreted in human milk; however, it is present in the milk of lactating rats. There are no data on the effects of argatroban on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for argatroban and any potential adverse effects on the breast-fed infant from argatroban or the underlying maternal condition.

If pharmacotherapy is necessary in the nursing mother, previous American Academy of Pediatrics AAP recommendations considered warfarin to be usually compatible with breast-feeding. During the study period, thrombotic events occurred during argatroban infusion in 2 patients and after argatroban discontinuation in 3 other patients. Major bleeding occurred in 2 patients; 1 patient with sepsis and thrombocytopenia experienced an intracranial hemorrhage after 4 days of argatroban therapy and another experienced intracranial hemorrhage after receiving argatroban for more than 14 days.

All patients had serious underlying conditions and were receiving multiple concomitant medications. Abciximab: Moderate An additive risk of bleeding may be seen in patients receiving platelet inhibitors e. Nonsteroidal antiinflammatory drugs NSAIDs may also increase bleeding risk when given with argatroban because of their potential to cause GI bleeding or inhibit platelet aggregation.

Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine: Moderate An additive risk of bleeding may be seen in patients receiving salicylates e. Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide: Moderate An additive risk of bleeding may be seen in patients receiving salicylates e.

Ado-Trastuzumab emtansine: Moderate Use caution if coadministration of anticoagulants with ado-trastuzumab emtansine is necessary due to reports of severe and sometimes fatal hemorrhage, including intracranial bleeding, with ado-trastuzumab emtansine therapy. Consider additional monitoring when concomitant use is medically necessary.

While some patients who experienced bleeding during ado-trastuzumab therapy were also receiving anticoagulation therapy, others had no known additional risk factors. Altretamine: Moderate Due to the thrombocytopenic effects of altretamine, an additive risk of bleeding may be seen in patients receiving concomitant anticoagulants. Aminosalicylate sodium, Aminosalicylic acid: Moderate An additive risk of bleeding may be seen in patients receiving salicylates e.

Anagrelide: Moderate An additive risk of bleeding may be seen in patients receiving platelet inhibitors e. In addition, the half-life of AT III may be altered during concomitant administration with anticoagulants. Coagulation tests aPTT and anti-Factor Xa, when appropriate should be performed regularly and especially in the first hours following the start or withdrawal of AT III therapy to ensure appropriate anticoagulation.

Antithymocyte Globulin: Moderate Drugs that can cause thrombocytopenia, such as antithymocyte globulin, may lead to an increased risk of bleeding when given concurrently with anticoagulants. Apixaban: Major Monitor patients closely and promptly evaluate any signs or symptoms of bleeding if apixaban and other anticoagulants are used concomitantly. If switching from apixaban to another anticoagulant, discontinue apixaban and start the other anticoagulant at the usual time of the next dose of apixaban.

If switching from another anticoagulant to apixaban, discontinue the other anticoagulant and start apixaban at the usual time of the next dose of the other anticoagulant. Coadministration of apixaban and other anticoagulants may increase the risk of bleeding. Arsenic Trioxide: Moderate An additive risk of bleeding may be seen in thrombocytopenic patients receiving antineoplastic agents and anticoagulants concomitantly.

Aspirin, ASA; Dipyridamole: Moderate An additive risk of bleeding may be seen in patients receiving platelet inhibitors e. Moderate An additive risk of bleeding may be seen in patients receiving salicylates e. Azelastine; Fluticasone: Moderate Concomitant use of systemic sodium chloride, especially at high doses, and corticosteroids may result in sodium and fluid retention.

Assess sodium chloride intake from all sources, including intake from sodium-containing intravenous fluids and antibiotic admixtures. Carefully monitor sodium concentrations and fluid status if sodium-containing drugs and corticosteroids must be used together. Beclomethasone: Moderate Concomitant use of systemic sodium chloride, especially at high doses, and corticosteroids may result in sodium and fluid retention.

Betamethasone: Moderate Concomitant use of systemic sodium chloride, especially at high doses, and corticosteroids may result in sodium and fluid retention. Betrixaban: Major Avoid concurrent use of betrixaban with thrombin inhibitors due to the increased bleeding risk.

Monitor patients closely and promptly evaluate any signs or symptoms of bleeding if betrixaban and other anticoagulants are used concomitantly.

Coadministration of betrixaban and other anticoagulants may increase the risk of bleeding.

ACHARTENGINE TUTORIAL PDF

Argatroban

Argatroban in Sodium Chloride injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia HIT. Argatroban in Sodium Chloride injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention PCI. Dilution is not required. Argatroban in Sodium Chloride injection is a clear, colorless to pale yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

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