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Apixan

Apixan Special Precautions

apixaban

Manufacturer:

Intas Pharmaceuticals

Distributor:

Berlin Pharm

Marketer:

Berlin Pharm
Full Prescribing Info
Special Precautions
Apixaban increases the risk of bleeding and can cause serious, potentially fatal, bleeding.
Concomitant use of drugs affecting hemostasis increases the risk of bleeding. Discontinue apixaban in patients with active pathological hemorrhage.
A specific antidote for apixaban is not available, the symptomatic and supportive treatments are depended on the bleeding severity. If ingestion occurred within 1 or 2 hours of presentation, activated oral charcoal should be considered for decreasing the plasma concentrations because of the high plasma protein binding of apixaban and it is not expected to be dialyzable. The following alternative options, 4-factor unactivated prothrombin concentrate (PCC) or 4-factor activated prothrombin concentrate (aPCC) or recombinant factor VIIa, may also be considered depending specific clinical scenario.
Premature discontinuation of apixaban in absence of any alternative anticoagulants will increase the risk of thrombotic events.
If it is needed to discontinue apixaban because of the other reasons other than the pathologic bleeding or completion of a course of the therapy, anticoagulant coverage with the alternative anticoagulants should be considered.
The dose should not be doubled to make up for a missed dose.
It is not recommended in patients with severe hepatic impairment.
It should be used with caution in patients with mild or moderate hepatic impairment (Child Pugh A or B).
Patients may bruise and/or bleed more easily and that longer than normal time may be required to stop bleeding.
Patients should be advised on how to recognize signs and symptoms of bleeding and to inform clinicians immediately.
Advice patients who have had neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture, especially when they are receiving concomitant nonsteroidal anti-inflammatory agents (NSAIDs), platelet-aggregation inhibitors or other anticoagulants, to monitor for manifestations of epidural or spinal hematoma (e.g., numbness or weakness of the legs, bowel, or bladder dysfunction) and report them to clinicians immediately.
In patients who receive both apixaban and neuraxial anesthesia, avoid removal of epidural or intrathecal catheter for at least 24 hours following last apixaban dose; avoid apixaban administration for at least 5 hours following catheter removal. If traumatic puncture occurs, delay apixaban administration for at least 48 hours.
Hemodynamically unstable patients with acute PE or patients with PE who require thrombolysis or pulmonary embolectomy, the use of apixaban is not recommended.
The safety and efficacy of apixaban have not been studied in patients with prosthetic heart valves or significant rheumatic heart disease, the use of apixaban is not recommended in these patients.
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