Apixan 5

Apixan 5

apixaban

Manufacturer:

Intas Pharmaceuticals

Distributor:

Berlin Pharm

Marketer:

Berlin Pharm
Concise Prescribing Info
Contents
Apixaban
Indications/Uses
DVT & pulmonary embolism (PE). Prevention of venous thromboembolic events in adults who have undergone elective hip or knee replacement surgery; stroke & systemic embolism in adults w/ non-valvular atrial fibrillation (NVAF) w/ ≥1 risk factors including patients unsuitable for warfarin; recurrent DVT & PE.
Dosage/Direction for Use
DVT & PE 10 mg bid for 7 days, followed by 5 mg bid. Prevention of venous thromboembolic events in elective hip or knee replacement surgery 2.5 mg bid. Take initial dose 12-24 hr after surgery. Recommended treatment duration: 32-38 days in hip replacement surgery & 10-14 days in knee replacement surgery. Prevention of stroke & systemic embolism in NVAF 5 mg bid. Patient w/ 2 of the following: ≥80 yr, ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L) 2.5 mg bid. Prevention of recurrent DVT & PE 2.5 mg bid after at least 6 mth of DVT or PE treatment.
Administration
May be taken with or without food: Swallow whole w/ water. For patients w/ swallowing difficulties, crush tab & suspend in water/5% dextrose in water (D5W)/apple juice or mixed w/ applesauce & taken immediately. Alternatively, crush tab & suspend in 60 mL water/D5W & administer via nasogastric tube.
Contraindications
Hypersensitivity. Clinically significant active bleeding. Lesion or condition considered as significant risk factor for major bleeding. Concomitant treatment w/ anticoagulants eg, unfractionated heparin (except for doses used to maintain open central venous or arterial catheter), LMWH, heparin derivatives (fondaparinux), oral anticoagulants (warfarin, rivaroxaban, dabigatran) except when switching anticoagulant therapy to or from apixaban therapy; strong CYP3A4 & P-gp inhibitors. Patients w/ CrCl <15 mL/min or receiving dialysis. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk.
Special Precautions
Discontinue use in patients w/ active pathological hemorrhage. Not to double dose to make up for missed dose. Not recommended in hemodynamically unstable patients w/ acute PE or PE requiring thrombolysis or pulmonary embolectomy; patients w/ prosthetic heart valves or significant rheumatic heart disease. Increased risk of serious, potentially fatal bleeding; thrombotic events w/ premature discontinuation in absence of alternative anticoagulants. Patients may bruise &/or bleed easily & take longer than normal to stop bleeding. Delay administration for at least 48 hr if traumatic puncture occurs. Avoid removal of epidural or intrathecal catheter for at least 24 hr following last dose & treatment administration for at least 5 hr following catheter removal in patients receiving both apixaban & neuraxial anesth. Monitor patients who have had neuraxial anesth (spinal/epidural) or spinal/epidural puncture, especially when receiving concomitant NSAIDs, platelet-aggregation inhibitors or other anticoagulants, for manifestations of epidural or spinal hematoma (eg, numbness or weakness of legs, bowel, or bladder dysfunction). Consider alternative anticoagulants if needed to discontinue treatment. Not recommended in patients w/ CrCl <15 mL/min, or undergoing dialysis; severe hepatic impairment. Mild or moderate hepatic impairment (Child Pugh A or B). Pregnancy & lactation. Childn & adolescents <18 yr. Not recommended in elderly ≥65 yr w/ CrCl <25 mL/min.
Adverse Reactions
Increased γ-glutamyltransferase; gingival hemorrhage, nausea; hematuria, hypermenorrhea; anemia, bruise, hematoma, hemorrhage, post-procedural & rectal hemorrhage; increased serum transaminase; epistaxis, hemoptysis.
Drug Interactions
Increased exposure & risk of bleeding w/ strong CYP3A4 & P-gp inhibitors eg, ketoconazole, itraconazole, ritonavir, or clarithromycin. Decreased exposure, & increased risk of stroke & other thromboembolic events w/ CYP3A4 & P-gp inducers eg, rifampin, carbamazepine, phenytoin, St. John's wort. Increased risk of bleeding w/ aspirin & other antiplatelet agents, fibrinolytics, heparin or other anticoagulants, SSRIs, SNRIs, & NSAIDs.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AF02 - apixaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.
Presentation/Packing
Form
Apixan 5 FC tab 5 mg
Packing/Price
6 × 10's
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