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Linoac

Linoac

apixaban

Manufacturer:

Stallion Labs

Distributor:

Littman
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 of DVT & 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: 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 micromol/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/ anticoagulant At least 5 doses of 5 mg bid (2.5 mg bid in patient who qualifies for dose reduction) should be given before cardioversion to ensure adequate anticoagulation. If cardioversion is required before 5 doses of Apixaban, give 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.
Contraindications
Hypersensitivity. Clinically active significant bleeding.
Special Precautions
Discontinue use if severe hemorrhage occurs. 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; history of thrombosis who are diagnosed w/ antiphospholipid syndrome. 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. 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. Discontinuing use for active bleeding, elective surgery, or invasive procedures places patients at increased risk of thrombosis. Risk of developing epidural or spinal hematoma when neuraxial anesth (spinal/epidural anesth) or spinal/epidural puncture is employed which can result in long-term or permanent paralysis. Remove indwelling epidural or intrathecal catheters at least 5 hr prior to 1st dose. Frequently monitor for signs & symptoms of neurological impairment. Not recommended in concomitant use w/ other platelet aggregation inhibitors or other antithrombotic agents following surgery. Concomitant use w/ strong CYP3A4 & P-gp inhibitors eg, azole antimycotics (eg, ketoconazole, itraconazole, voriconazole & posaconazole), HIV PIs (eg, ritonavir); strong CYP3A4 & P-gp inducers eg, rifampin, phenytoin, carbamazepine, phenobarb or St. John's wort; NSAIDs, including ASA. Not recommended in patients w/ CrCl <15 mL/min or those undergoing dialysis; severe hepatic impairment. Mild or moderate hepatic impairment (Child Pugh A or B). Not recommended during pregnancy. Discontinue lactation or discontinue/abstain from therapy. Childn <18 yr.
Adverse Reactions
Contusion. Prevention of VTE in elective hip or knee replacement surgery: Anemia, hemorrhage, & nausea. Prevention of stroke & systemic embolism in patients w/ NVAF: Eye hemorrhage (including conjunctive hemorrhage); other hemorrhage, hematoma; GI (including hematemesis & melena) & rectal hemorrhage; hematuria; contusion. Treatment of VTE: Menorrhagia. Prevention of stroke & systemic embolism in patients w/ NVAF & treatment of VTE: Gingival bleeding, epistaxis, hematuria, hematoma.
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. May lead to 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. Concomitant use w/ other 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
Linoac FC tab 2.5 mg
Packing/Price
30's (P720/box)
Form
Linoac FC tab 5 mg
Packing/Price
30's (P1,020/box)
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