Zuellig Pharma
Concise Prescribing Info
DVT & pulmonary embolism (PE). Prevention of stroke & systemic embolism in adult patients w/ non-valvular atrial fibrillation (NVAF), w/ ≥1 risk factors [eg, prior stroke or transient ischaemic attack, age ≥75 yr, HTN, DM, symptomatic heart failure (NYHA class ≥II)]. Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of recurrent DVT & PE in haemodynamically unstable PE adult patients.
Dosage/Direction for Use
Acute DVT & PE 10 mg bd for 1st 7 days followed by 5 mg bd. Prevention of stroke & systemic embolism in patient w/ NVAF 5 mg bd. In patient w/ at least 2 of the following characteristics: Age ≥80 yr, ≤60 kg or serum creatinine ≥1.5 mg/dL Dose may be reduced to 2.5 mg bd. Prevention of VTE 2.5 mg bd. Initial dose should be taken 12-24 hr post-op. Recommended duration of treatment: Hip replacement surgery 32-38 days. Knee replacement surgery 10-14 days. Prevention of recurrent DVT & PE Initially 2.5 mg bd, following 6-mth treatment completion w/ 5 mg bd or w/ another anticoagulant. Severe renal impairment (CrCl 15-29 mL/min) 2.5 mg bd.
May be taken with or without food: May be crushed & suspended in water/D5W/apple juice or mixed w/ apple puree. Take mixt immediately or w/in 4 hr.
Hypersensitivity. Clinically significant active bleeding. Lesion or condition at significant risk of major bleeding eg, current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding; recent brain/spinal injury, brain/spinal/ophth surgery, recent intracranial haemorrhage; known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. Concomitant treatment w/ any other anticoagulant eg, unfractionated heparin (UFH), LMWH, heparin derivatives, oral anticoagulants except under the circumstances of switching therapy to or from apixaban, or when UFH is given at doses necessary to maintain an open central venous or arterial catheter or given during catheter ablation for atrial fibrillation. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk.
Special Precautions
Discontinue use if severe haemorrhage occurs. Not recommended in patients w/ prosthetic heart valves, undergoing hip fracture surgery & patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome. Active cancer; spinal/epidural anaesth or puncture. Frequently monitor signs & symptoms of neurological impairment. Not to interrupt treatment in patients undergoing catheter ablation for atrial ablation. Discontinue use at least 48 hr prior to elective surgery or invasive procedures w/ moderate or high risk of bleeding & at least 24 hr prior to elective surgery or invasive procedures w/ low risk of bleeding. Temporary discontinuation may increase risk of thrombosis. Remove indwelling epidural or intrathecal catheters at least 5 hr prior to 1st dose. Concomitant use w/ antiplatelets, NSAIDs including acetylsalicylic acid (ASA), other platelet aggregation inhibitors (following surgery) or thrombolytic agents for acute ischemic stroke. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Mild or moderate (Child-Pugh A or B) & severe hepatic impairment; elevated liver enzymes ALT/AST >2 x ULN or total bilirubin ≥1.5 x ULN. Severe renal impairment (CrCl 15-29 mL/min) or undergoing dialysis. Not recommended during pregnancy. Lactation. Childn & adolescent <18 yr. Elderly (co-administration w/ ASA).
Adverse Reactions
Epistaxis, anaemia, nausea, contusion, haematuria, haemorrhage, haematoma; eye, GI & rectal haemorrhage, gingival bleeding.
Drug Interactions
Increased plasma conc w/ azole antimycotics (eg, ketoconazole, itraconazole, voriconazole, posaconazole), HIV-PIs (eg, ritonavir), diltiazem, naproxen, amiodarone, verapamil, quinidine. Decreased plasma conc w/ rifampicin, phenytoin, carbamazepine, phenobarb or St. John's wort. Increased bleeding risk w/ other anticoagulants, platelet aggregation inhibitors, SSRIs/SNRIs, NSAIDs including ASA. Serious bleeding risk w/ thrombolytic agents, GPIIb/IIIa receptor antagonists, thienopyridines (eg, clopidogrel), dipyridamole, dextran, sulfinpyrazone. Reduced exposure w/ activated charcoal.
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.
Eliquis FC tab 2.5 mg
Eliquis FC tab 5 mg
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