Elimbosis

Composition

Each Elimbosis 2.5mg , 5mg Film tablet contains: 

apixaban ........................................................ 2.5mg , 5mg                                                          

Therapeutic Indications                 

• Stroke Prophylaxis with Atrial Fibrillation
• Postoperative Prophylaxis of DVT/PE       
•  DVT or PE Treatment                                              

Dosage and Administration   

• To prevent stroke and systemic embolism in nonvalvular atrial fibrillation
  • 5 mg PO BID
• Indicated following hip or knee replacement surgery
  • Initial: Give 2.5 mg PO 12-24 hr after surgery
  • Duration of therapy (hip replacement): 2.5 mg PO BID for 35 days
  • Duration of therapy (knee replacement): 2.5 mg PO BID for 12 days
• Indicated for treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)
  • 10 mg PO BID x 7 days, then 5 mg BID
  • Reduce risk for recurrent DVT or PE
• Indicated to reduce the risk of recurrent DVT and PE following initial 6 months treatment for DVT and/or PE
  • 2.5 mg PO BID

Contraindications         

• Severe hypersensitivity (ie, anaphylactic reactions)
• Active pathological bleeding.                                                         

Warnings and precautions            

• Discontinuing apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events (see Black Box Warnings)
• Risk of epidural or spinal hematoma when used with neuraxial anesthesia (see Black Box Warnings)
• Safety and efficacy has not been studied in patients with prosthetic heart valves; therefore, use of is not recommended in these patients
• Not recommended as an alternative to unfractionated heparin for the initial treatment of PE in patients who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy
• Coadministration with strong dual inhibitors of CYP3A4 and P-gp (see Dosage Modifications)
• Avoid coadministration with strong dual inducers of CYP3A4 and P-gp; such drugs decrease apixaban’s systemic exposure
• Increases the risk of bleeding and can cause serious, potentially fatal, bleeding; advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room; discontinue therapy in patients with active pathological hemorrhage
• Coadministration with other drugs that affect hemostasis increases bleeding risk (eg, aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, NSAIDs)
• Prolongs PT and aPTT; however, changes are small and highly variable and are not useful for monitoring anticoagulation effect of apixaban
• Direct-acting oral anticoagulants (DOACs), are not recommended for use in patients with triple-positive antiphospholipid syndrome (APS); for patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti–beta 2- glycoprotein I antibodies]), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy                                                      

Undesirable Effects        

• Bleeding                                                                 

Pharmacological Properties        

    Apixaban is an oral, direct, and highly selective factor Xa (FXa) inhibitor of both free and bound FXa, as well as prothrombinase, independent of antithrombin III for the prevention and treatment of thromboembolic diseases belong to the proton pump inhibitor group is a medication which reduces stomach acid                                                              

Packaging                

   Elimbosis 2.5mg Tablet: Box containing 3 blisters of 10 tablets each                                                                

Composition

Each Elimbosis 5 mg Film tablet contains: 

apixaban ........................................................ 5 mg                                                           

Therapeutic Indications                 

• Stroke Prophylaxis with Atrial Fibrillation
• Postoperative Prophylaxis of DVT/PE       
•  DVT or PE Treatment                                              

Dosage and Administration   

• To prevent stroke and systemic embolism in nonvalvular atrial fibrillation
  • 5 mg PO BID
• Indicated following hip or knee replacement surgery
  • Initial: Give 2.5 mg PO 12-24 hr after surgery
  • Duration of therapy (hip replacement): 2.5 mg PO BID for 35 days
  • Duration of therapy (knee replacement): 2.5 mg PO BID for 12 days
• Indicated for treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)
  • 10 mg PO BID x 7 days, then 5 mg BID
  • Reduce risk for recurrent DVT or PE
• Indicated to reduce the risk of recurrent DVT and PE following initial 6 months treatment for DVT and/or PE
  • 2.5 mg PO BID

Contraindications         

• Severe hypersensitivity (ie, anaphylactic reactions)
• Active pathological bleeding.                                                         

Warnings and precautions            

• Discontinuing apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events (see Black Box Warnings)
• Risk of epidural or spinal hematoma when used with neuraxial anesthesia (see Black Box Warnings)
• Safety and efficacy has not been studied in patients with prosthetic heart valves; therefore, use of is not recommended in these patients
• Not recommended as an alternative to unfractionated heparin for the initial treatment of PE in patients who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy
• Coadministration with strong dual inhibitors of CYP3A4 and P-gp (see Dosage Modifications)
• Avoid coadministration with strong dual inducers of CYP3A4 and P-gp; such drugs decrease apixaban’s systemic exposure
• Increases the risk of bleeding and can cause serious, potentially fatal, bleeding; advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room; discontinue therapy in patients with active pathological hemorrhage
• Coadministration with other drugs that affect hemostasis increases bleeding risk (eg, aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, NSAIDs)
• Prolongs PT and aPTT; however, changes are small and highly variable and are not useful for monitoring anticoagulation effect of apixaban
• Direct-acting oral anticoagulants (DOACs), are not recommended for use in patients with triple-positive antiphospholipid syndrome (APS); for patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti–beta 2- glycoprotein I antibodies]), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy                                                      

Undesirable Effects        

• Bleeding                                                                 

Pharmacological Properties        

    Apixaban is an oral, direct, and highly selective factor Xa (FXa) inhibitor of both free and bound FXa, as well as prothrombinase, independent of antithrombin III for the prevention and treatment of thromboembolic diseases belong to the proton pump inhibitor group is a medication which reduces stomach acid                                                              

Packaging                

   Elimbosis 5mg Tablet: Box containing 3 blisters of 10 tablets each