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Apiklot

Apiklot Special Precautions

apixaban

Manufacturer:

Unison Pharmaceutical

Distributor:

Cathay YSS
Full Prescribing Info
Special Precautions
Increased Risk of Stroke with Discontinuation of Apixaban: Discontinuing Apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Apixaban to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If Apixaban must be discontinued for a reason other than pathological bleeding consider coverage with another anticoagulant.
Bleeding: Apixaban increases the risk of bleeding and can cause serious, potentially fatal, bleeding. Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitor, and nonsteroidal anti-inflammatory drugs (NSAIDs).
Patients should be made aware of signs and symptoms of blood loss and instructed to report them immediately or go to an emergency room. Apixaban should be discontinued in patients with active pathological hemorrhage.
There is no established way to reverse the anticoagulant effect of apixaban, which can be expected to persist for about 24 hours after the last dose, i.e., for about two half-lives. A specific antidote for Apixaban is not available. Because of high plasma protein binding, apixaban is not expected to be dialyzable. Protamine sulfate and vitamin K would not be expected to affect the anticoagulant activity of apixaban. There is no experience with antifibrinolytic agents (tranexamic acid, aminocaproic acid) in individuals receiving apixaban.
There is neither scientific rationale for reversal nor experience with systemic hemostatics (desmopressin and aprotinin) in individuals receiving apixaban. Use of procoagulant reversal agents such as prothrombin complex concentrate, activated prothrombin complex concentrate, or recombinant factor VIIa may be considered but has been evaluated in clinical studies. Activated oral charcoal reduces absorption of apixaban, thereby lowering apixaban plasma concentration.
Patients with Prosthetic Heart Valves: The safety and efficacy of Apixaban has not been studied in patients with prosthetic heart valves. Therefore, use of Apixaban is not recommended in these patients.
Effects on ability to drive and use machines: Apixaban has no or negligible influence on the ability to drive and use machines.
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