Apiban 5

Introduction
Apiban 5 is a medicine known as an anticoagulant or blood thinner. It helps prevent and treat blood clots. It is used to reduce the risk of stroke and heart attack. It prevents and treats clot formation in the veins of your legs, lungs, brain and heart. Apiban 5 is commonly used in patients with irregular heart rhythm (atrial fibrillation) to prevent clot formation. It also reduces the risk of getting clots in people who have undergone knee or hip replacement surgeries. It can be taken with or without food and it is best to take them at the same time each day. You may need to take this medicine for many years, even for life in some cases. Do not stop taking it or change the dose without guidance from your doctor. It could quickly put you more at risk of having a heart attack, stroke or thrombosis (formation of a blood clot within a blood vessel). You can reduce your risk of having a blood clot by making changes to your lifestyle, such as not smoking, eating a healthy diet, getting regular exercise and losing weight if you need to. The most common side effect of Apiban 5 is bleeding more easily than normal, for example, having nosebleeds or bruising. If you experience any symptoms, tell your doctor immediately. Other side effects include low blood pressure, nausea, and skin rash. Do not take this medicine if you have severe kidney or liver problems, if you are currently bleeding or if you are taking other medicines to reduce blood clotting. You should not breastfeed while using this medicine. Unlike other anticoagulants, a regular blood test (PT-INR) is not required while taking this medicine.

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Uses of Apiban 5
Deep vein thrombosis
Pulmonary embolism
Stroke prevention
How to use Apiban 5
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Apiban 5 may be taken with or without food, but it is better to take it at a fixed time.
How Apiban 5 works
Apiban 5 is a novel oral anticoagulant (NOAC). It works by preventing the formation of blood clots in the body.
What if you forget to take Apiban 5?
If you miss a dose of Apiban 5, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Quick Tips
For best results, take Apiban 5 at the same time every day. It is better to take at night with meals
It interacts less with food or other medicines. Hence, frequent dose changes are not required.
It increases your risk of bleeding. Be careful while shaving, cutting fingernails or toenails, using sharp objects or engaging in contact sports (e.g. football, wrestling).
Inform your doctor if you see blood in your vomit, urine or stool (black, tarry stools or bright red blood).
If you are going to have a surgery or dental treatment, you may be asked to stop taking Apiban 5 temporarily.
Notify your doctor if you have any kidney problem.
Inform your doctor if you are pregnant, planning pregnancy or breastfeeding.
Do not stop taking medication without talking to your doctor.
Brief Description
Indication
Indicated to reduce risk of stroke and systemic embolism associated with nonvalvular atrial fibrillation, Postoperative Prophylaxis of DVT/PE following hip or knee replacement surgery, Deep venous thrombosis (DVT), Pulmonary embolism (PE),
Administration
May be taken with or without food.
Adult Dose
Oral Adult Prevention of VTE: Elective hip or knee replacement surgery Tablet 2.5 mg twice daily. Initial dose should be taken 12-24 hr post-op. Recommended duration of treatment: Patient undergoing hip replacement surgery 32-38 days. Patient undergoing knee replacement surgery 10-14 days. Prevention of stroke and systemic embolism in non-valvular atrial fibrillation Adult: 5 mg bid. Decrease dose to 2.5 mg PO BID in patients with any 2 of the following characteristics: Age ?80 years Weight ?60 kg Serum creatinine ?1.5 mg/dL Oral Deep vein thrombosis, Pulmonary embolism Adult: 10 mg bid for 7 days, followed by 5 mg bid. Prevention of recurrence: 2.5 mg bid after at least 6 mth of treatment. Hepatic impairment Mild: No dosage adjustment required Moderate: Patients may have intrinsic coagulation abnormalities; data are limited and no recommendations are available Severe: Not recommended

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Renal Dose
Renal impairment, including with ESRD on dialysis Deep Vein Thrombosis: No dose adjustment recommended; clinical efficacy and safety studies did not enroll patients with ESRD on dialysis or patients with a CrCl <15 mL/min; dosing recommendations are based on pharmacokinetic and pharmacodynamic (anti-FXa activity) data in study subjects with ESRD maintained on dialysis Renal impairment (nonvalvular atrial fibrillation) Mild-to-moderate: No dosage adjustment required Serum creatinine ?1.5 mg/dL: Decrease dose to 2.5 mg BID if patient has 1 additional characteristic of age ?80 years or weight ?60 kg ESRD maintained on hemodialysis: 5 mg BID; decrease dose to 2.5 mg BID if 1 additional characteristic of age ?80 years or weight ?60 kg is present _ Contraindication Hypersensitivity. Clinically significant active bleeding. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk. Lesion or condition at significant risk of major bleeding. Concomitant treatment w/ other anticoagulant agent. _ Mode of Action Apixaban is an anticoagulant that inhibits platelet activation and fibrin clot formation via direct, selective and reversible inhibition of free and clot-bound factor Xa in both intrinsic and extrinsic coagulation pathways. Inhibition of coagulation factor Xa prevents conversion of thrombin and subsequent thrombus formation. Precaution Increased risk of hemorrhage eg, congenital or acquired bleeding disorders; active ulcerative GI disease; bacterial endocarditis; thrombocytopenia; platelet disorders; history of haemorrhagic stroke; severe uncontrolled HTN; recent brain, spinal or ophthalmological surgery. Discontinue use if severe haemorrhage occurs. Renal impairment (CrCl <15 mL/min). Contraindicated in patients w/ hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk. Not recommended in patients w/ severe hepatic impairment. Patients w/ mild or moderate hepatic impairment (Child Pugh A or B). Low body wt (<60 kg). Patients receiving concomitant systemic treatment w/ strong inhibitors of both CYP3A4 & P-gp 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). Patients receiving concomitant systemic treatment w/ strong inducers of both CYP3A4 & P-gp for the prevention of VTE in elective hip or knee replacement surgery, stroke in patients w/ NVAF. Patients treated concomitantly w/ medicinal products affecting haemostasis eg, NSAIDs, acetylsalicylic acid, platelet aggregation inhibitors or other antithrombotic agents. Spinal/epidural anaesth or puncture. Hip fracture surgery. Patients w/ prosthetic heart valves w/ or w/o atrial fibrillation. Patients w/ rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation. Childn <18 yr. Elderly. Lactation: Unknown whether distributed in human breast milk; rats excreted apixaban in milk (12% of the maternal dose) Women should be instructed either to discontinue breastfeeding or to discontinue apixaban therapy, taking into account the importance of the drug to the mother _ Side Effect Epistaxis, haematoma, anaemia, haematuria, contusion, nausea; GI, rectal or gingival haemorrhage. Potentially Fatal: Epidural or spinal haematoma, fatal bleeding. _ Pregnancy Category Note Pregnancy There are no adequate and well-controlled studies in pregnant women Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery Use of anticoagulants, during pregnancy, may increase risk of bleeding in fetus and neonate Pregnancy confers an increased risk of thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions Published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy Therapy should be administered during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus Animal studies Treatment of pregnant rats, rabbits, and mice after implantation until the end of gestation resulted in fetal exposure to apixaban, but was not associated with increased risk for fetal malformations or toxicity Labor and delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding; use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas; consider use of a shorter acting anticoagulant as delivery approaches Consider the risks of bleeding and of stroke in this setting Lactation There are no data on presence of drug metabolites in human milk, effects on breastfed child, or the effects on milk production; the drug and/or its metabolites were present in milk of rats Rats excrete apixaban in milk (12% of the maternal dose) Because human exposure through milk is unknown, instruct women to either discontinue breastfeeding or to discontinue apixaban therapy, taking into account the importance of the drug to the mother _ Interaction Increased exposure w/ strong dual CYP3A4 and P-glycoprotein (P-gp) inhibitors (e.g. clarithromycin, itraconazole, ketoconazole, ritonavir). Increased risk of bleeding w/ drugs affecting haemostasis (e.g. aspirin, heparin, fibrinolytics, SSRIs, NSAIDs, serotonin norepinephrine reuptake inhibitors). Increased risk of stroke w/ strong dual CYP3A4 and P-gp inducers (e.g. rifampicin, phenytoin, carbamazepine).