ARIXTRA PI PDF


PI Trade Names and Active Ingredients containing Arixtra. 1 Documents available. Need more information on a product? Search the Australian Register of. Mylan manufactures ARIXTRA®* (fondaparinux sodium) Injection, Solution ( Arixtra) in strengths of 25 mg05 mL 5 mgmL5 mg04 mL mgmL75 mg06 mL injection of Arixtra mg in young healthy subjects are provided in Table 1 below: . Arixtra mg once daily following hip fracture surgery, patients were.

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Moderate Because of the potential effects of certain dextran formulations on bleeding time, use with caution in patients on anticoagulants concurrently. Occurrences of major bleeding in patients fondaparinux for treatment of DVT and PE with normal renal function, mild renal arixtda, moderate renal impairment, and severe renal impairment have been found to be 0.

One month later, the patient’s INR was 1.

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Furthermore, a significantly reduced incidence of major bleeding 2. Moderate Patients should be instructed to monitor for signs and symptoms of bleeding while taking trazodone concurrently with anticoagulants and to promptly report any bleeding events to the practitioner.

Theoretically, fondaparinux should not cause HIT because it does not bind to platelet factor 4. See Dosage section for specific information on timing of subcutaneous administration.

Patients, especially those with dental disease, should be instructed in proper oral hygiene, including caution in pj of regular toothbrushes, dental floss, and toothpicks. Monitor INR levels when venlafaxine is added to or discontinued from warfarin therapy.

Administration before 6 hours after surgery has been associated an increased risk of major bleeding. Your email has been sent.

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Neutralization of factor Xa interrupts the blood coagulation cascade that leads to thrombin ;i and thrombus development. For example, concurrent use of oxandrolone and warfarin may result in unexpectedly large increases in the INR or prothrombin time PT.

If epidural anesthesia, lumbar puncture, or spinal anesthesia is employed, patients should be frequently monitored for symptoms arixtta neurological impairment, such as midline back pain, sensory and motor deficits numbness, tingling, or weakness in lower limbsand bowel or bladder dysfunction; fondaparinux should be discontinued and appropriate therapy initiated if needed.

Because of the potential effects arixhra coagulation, patients receiving prasterone or DHEA concurrently with preventative anticoagulants e. Fondaparinux should be used with caution in patients receiving other anticoagulant therapy e. An in vivo interaction study in humans demonstrated that a single 1 mg dose of anagrelide administered concomitantly with a single dose of aspirin mg was well tolerated; there was no effect on bleeding time, PT, or PTT.

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However, an additive risk of bleeding may be seen in patients receiving platelet inhibitors.

Arixtra (fondaparinux sodium) dose, indications, adverse effects, interactions from

Moderate lthough anagrelide inhibits platelet aggregation at high doses, there is a arixtrz additive risk for bleeding if anagrelide is given in combination with other agents that effect hemostasis such as other anticoagulants. One episode of ecchymosis was reported, but no major bleeding episodes occurred. Moderate Drugs that can cause thrombocytopenia, such as antithymocyte globulin, may lead to an increased risk of bleeding when given concurrently with anticoagulants.

Per the manufacturer of ticlopidine, if a patient is switched from an anticoagulant or a thrombolytic agent to ticlopidine, the former drug should be discontinued prior to the administration of ticlopidine.

Moderate Telavancin has no effect on coagulation or platelet aggregation; however, caution is advised when administering telavancin concurrently with anticoagulants as telavancin agixtra interfere with laboratory tests used in monitoring these medications. In the DVT and PE treatment clinical trials, the risk of fondaparinux-associated major bleeding increased with age: In patients treated with fondaparinux for DVT and PE prophylaxis after abdominal surgery, major bleeding occurred in 2.

However, an increase in INR from 2. The optimal timing between the administration of fondaparinux and neuraxial procedures is not known. Bleeding, endocarditis, epidural anesthesia, GI bleeding, lumbar puncture, spinal anesthesia, stroke, surgery. Clinical practice guidelines recommend arixttra molecular weight heparin for the prevention and treatment of venous thromboembolism during pregnancy. When mifepristone Korlym is used, concurrent use of some anticoagulants should be approached with caution.

Fondaparinux should be administered by deep subcutaneous injection. Discontinue betrixaban before starting fondaparinux, unless these agents are essential. Moderate Concomitant use of vorinostat with anticoagulants may result in an additive risk of bleeding due to vorinostat-induced thrombocytopenia; monitor patients closely.

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Fondaparinux is a copy of the antithrombin III binding area of heparin. Inhibition of vitamin K synthesis due to alterations in the intestinal flora may be a mechanism; however, concurrent infection is also a potential risk factor for elevated INR. Sulfinpyrazone is also known to markedly potentiate the effect of warfarin. As with other antithrombotic agents, fondaparinux should be used with extreme caution in patients with an increased risk of hemorrhage.

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The presence of active major bleeding, e. Additionally, increased monitoring of the INR, especially during initiation and upon discontinuation of the antibiotic, may be necessary in patients receiving warfarin.

Fondaparinux exhibits dose-dependent, linear pharmacokinetics. An increase in plasminogen-activator activity, and serum concentrations of plasminogen, protein C, and antithrombin III have occurred with several alpha-alkylated androgens.

Therapy should be continued for at least 5 days and until a therapeutic warfarin response is established INR 2. Concomitant anticoagulants may increase the risk of hemorrhage. Moderate An additive risk of bleeding may be seen in patients receiving platelet inhibitors e. Because vorapaxar inhibits platelet aggregation, a potential additive risk for bleeding exists if vorapaxar is given in combination with other agents that affect hemostasis such as anticoagulants. If therapy with defibrotide is necessary, discontinue systemic antithrombotic agents not including use for routine maintenance or reopening of central venous catheters prior to initiation of defibrotide therapy.

Monitor patients with hepatic impairment closely for signs and symptoms of bleeding as they may be at higher risk for bleeding during treatment.

International standards of heparin or LMWH are not calibrators to measure anti-factor Xa activity of fondaparinux. Patients receiving warfarin that initiate concomitant fish oil therapy should have their INR monitored more closely and the dose of warfarin adjusted accordingly. Subgroup aeixtra indicate that fondaparinux therapy was beneficial in patients receiving thrombolytics and in those that did not receive any type of reperfusion treatment; however, in those patients undergoing primary PCI, a benefit with fondaparinux was not seen.

Serotonergic agents may increase the risk of bleeding when combined with anticoagulants via inhibition of serotonin uptake by platelets; however, the absolute risk is not known. Aritxra of apixaban and other anticoagulants may increase the risk of bleeding.