Pixab

Pixab

apixaban

Manufacturer:

Intas

Distributor:

Oxpharm

Marketer:

One Dexcel Pharma
Concise Prescribing Info
Contents
Apixaban
Indications/Uses
Prevention of VTE in adults who have undergone elective hip or knee replacement surgery. Reduces the risk of stroke, systemic embolism, & death in patients w/ nonvalvular atrial fibrillation (NVAF) w/ ≥1 risk factors, including patients unsuitable for warfarin. Treatment & prevention of recurrent DVT & pulmonary embolism (PE).
Dosage/Direction for Use
Prevention of VTE in elective hip or knee replacement surgery 2.5 mg bid. Initial dose should be taken 12-24 hr after surgery. Recommended duration of treatment: 32-38 days for hip replacement surgery & 10-14 days for knee replacement surgery. Prevention of stroke & systemic embolism in patient w/ NVAF 5 mg bid. Patient w/ at least 2 of the following characteristics: ≥80 yr, ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 mmol/L) 2.5 mg bid. DVT & PE 10 mg bid for 7 days, followed by 5 mg bid. Prevention of recurrent DVT & PE 2.5 mg bid after at least 6 mth of treatment for DVT or PE. Surgery & invasive procedures for patient not previously treated w/ anticoagulants At least 5 doses of 5 mg bid (2.5 mg bid in patient who qualify for dose reduction) should be given before cardioversion to ensure adequate anticoagulation. If cardioversion is required before 5 doses of Apixaban: 10 mg loading dose, followed by 5 mg bid. Reduce to 5 mg loading dose, followed by 2.5 mg bid if the patient meets the criteria for dose reduction. Loading dose should be given at least 2 hr before cardioversion.
Administration
May be taken with or without food:  For patients w/ difficulty swallowing, crush tab & suspend in water/5% dextrose in water (D5W)/apple juice or mix w/ applesauce & drink immediately. Alternatively, crush tab & suspend in 60 mL water/D5W & administer immediately via nasogastric tube.
Contraindications
Hypersensitivity. Clinically active significant bleeding.
Special Precautions
Conditions w/ increased risk of hemorrhage eg, congenital or acquired bleeding disorders, active ulcerative GI disease, bacterial endocarditis, thrombocytopenia, platelet disorders, history of hemorrhagic stroke, severe uncontrolled HTN, & recent brain, spinal or ophth surgery. Not recommended in patients w/ hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk, undergoing hip fracture surgery; prosthetic heart valves w/ or w/o atrial fibrillation. Temporarily discontinue for active bleeding, elective surgery, or invasive procedures; avoid lapses in therapy & restart as soon as possible. Risk of developing spinal or epidural hematoma during spinal/epidural anesth or puncture which can result in long-term or permanent paralysis. Frequently monitor for signs & symptoms of neurological impairment. Not recommended as an alternative to unfractionated heparin for the initial treatment of patients w/ PE who present w/ hemodynamic instability or who may receive thrombolysis of pulmonary embolectomy; patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome; patients w/ CrCl <15 mL/min or those undergoing dialysis, or w/ severe hepatic impairment. Mild or moderate hepatic impairment (Child Pugh A or B). Carefully assess patients w/ atrial fibrillation & conditions that warrants mono or dual antiplatelet therapy. Not recommended during pregnancy. Discontinue breast-feeding or discontinue/abstain from apixaban therapy. Childn <18 yr.
Adverse Reactions
Haemorrhage, haematoma; contusion. Prevention of VTE in adult who have undergone elective hip or knee replacement surgery (VTEp): Anaemia; nausea. Prevention of stroke & systemic embolism in adult w/ NVAF w/ ≥1 risk factors (NVAF) & treatment of DVT & PE & prevention of recurrent DVT & PE (VTEt): Eye haemorrhage (including conjunctival haemorrhage); epistaxis; GI haemorrhage; rectal haemorrhage, gingival bleeding; haematuria.
Drug Interactions
Increased mean AUC & Cmax w/ strong CYP3A4 & P-pg inhibitors (eg, ketoconazole). Increased plasma conc w/ diltiazem, naproxen, clarithromycin, amiodarone, verapamil, quinidine. Decreased mean AUC & Cmax w/ strong CYP3A4 & P-gp inducers (eg, rifampin). Reduced plasma conc w/ other strong CYP3A4 & P-gp inducers (eg, phenytoin, carbamazepine, phenobarb or St. John's wort). Additive effect on anti-FXa activity w/ enoxaparin. Increased bleeding risk w/ NSAIDs, ASA or P2Y12 inhibitors. Agents associated w/ serious bleeding eg, unfractionated heparins & heparin derivatives (including LMWH), FXa inhibiting oligosaccharides (eg, fondaparinux), direct thrombin II inhibitors (eg, desirudin), thrombolytic agents, GPIIb/IIIa receptor antagonists, dipyridamole, dextran, sulfinpyrazone, vit K antagonists, & other oral anticoagulants.
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
Pixab FC tab 5 mg
Packing/Price
30's (P1,080/box, P36/film-coated tab)
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