Xarelto Tablets / Film-coated
Rivaroxaban
15mg
BAYER SCHERING PHARMA AG
| Pack size | 28's (14's Blister x 2) |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | AL ITTIHAD DRUG STORE |
| Retail Price | 491.50 AED |
Available as:
Indications
Xarelto Tablets / Film-coated is used for:
Atrial fibrillation, Strokes, Deep venous thrombosis
Adult Dose
DVT Prophylaxis (Orthopedic Surgery)
Indicated for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery
Knee replacement: 10 mg PO qDay for 12 days; may take with or without food
Hip replacement: 10 mg PO qDay for 35 days; may take with or without food
Administer initial dose at least 6-10 hr after surgery once hemostasis has been established
Nonvalvular Atrial Fibrillation
Indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
20 mg/day PO with the evening meal
DVT or PE Treatment
Indicated for treatment of DVT and PE
15 mg PO q12hr for 21 days with food, THEN 20 mg PO qDay for 6 months
Reduce risk for recurrent DVT or PE
Indicated to reduce the risk of recurrence of DVT and PE following initial 6 months treatment for DVT and/or PE
20 mg PO qDay following initial 6 months of treatment for DVT and/or PE
Hepatic impairment
Moderate impairment: Not studied
Avoid use in patients with moderate-to-severe impairment (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment or with any hepatic disease associated with coagulopathy
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment (nonvalvular AF)
CrCl 30-50 mL/min: 20 mg/day
CrCl 15-50 mL/min: 15 mg/day
ESRD on intermittent renal dialysis: 15 mg/day
Renal impairment (postoperative thromboprophylaxis)
CrCl >50 mL/min: Dose adjustment not necessary
CrCl 30-50 mL/min: Use with caution; dose adjustment not necessary
CrCl <30 mL/min: Avoid use
Administration
10-Mg Tab: May be taken with or without food.
15- & 20-Mg Tab: Should be taken with food.
Contra Indications
Patient w/ active pathologic bleeding, significant risk of major bleeding (e.g. recent GI ulcer, oesophageal varices, recent brain, spine, or ophth surgery, recent intracranial haemorrhage, malignant neoplasms, vascular aneurysm).
Precautions
Patient w/ hepatic disease associated w/ coagulopathy, severe HTN, prosthetic heart valve, vascular retinopathy, bronchiectasis. Anaesth w/ post-op indwelling epidural catheter. Hepatic and renal impairment. Pregnancy and lactation.
Lactation: Unknown whether distributed in human breast milk; not recommended; a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
Pregnancy-Lactation
Pregnancy
Limited available data in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes
Use with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery; anticoagulant effect cannot be reliably monitored with standard laboratory testing
Consider benefits and risks for the mother and possible risks to the fetus when prescribing to a pregnant woman
Females of reproductive potential requiring anticoagulation should discuss pregnancy planning
Clinical considerations
Pregnancy is a risk factor for VTE and risk increases in women with inherited or acquired thrombophilias; pregnant women with thromboembolic disease have an increased risk of maternal complications (eg, pre-eclampsia); maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption, and early and late pregnancy loss
Based on pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate
All patients receiving anticoagulants, including pregnant women, are at risk for bleeding and this risk may be increased during labor or delivery; risk of bleeding should be balanced with the risk of thrombotic events when considering the use in this setting
Lactation
Drug detected in human milk
Insufficient data available to determine effects on breastfed child or on milk production; drug and/or its metabolites were present in milk of rats
Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Interactions
Reduced hepatic & renal clearance w/ strong CYP3A4 inhibitors (clarithromycin, erythromycin, fluconazole). Increased bleeding risk w/ azole antimycotics (eg ketoconazole, itraconazole, voriconazole, posaconazole) or HIV-PIs (eg ritonavir); other anticoagulants; NSAIDs (including acetylsalicylic acid) & platelet aggregation inhibitors. Reduced plasma conc w/ CYP3A4 inducers (eg rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort). 20-mg FC tab: Increased prothrombin time/INR of warfarin.
Adverse Effects
Side effects of Rivaroxaban :
1-10%
Abdominal pain (<2%), Back pain (<4%), Blister (1%), Bruising (3%), Constipation (<3%), Diarrhea (<5%), Dizziness (<6%), Dyspepsia (<2%), Epistaxis (4-10%), Fatigue (<3%), Headache (3-5%), Nausea (1-3%), Hematuria (<4%), Muscle spasm (1%), Oropharyngeal pain (<1%), Osteoarthritis (<2%), Peripheral edema (<6%), Pruritus (<2%), Pyrexia (1-3%), Rash (2%), Syncope (<2%), Toothache (<1%), Urinary tract infection (<1%), Vomiting (<2%), Wound secretion (<3%)
Bleeding
Atrial fibrillation (21%; major bleeding 6%)
DVT prophylaxis (5-6%; major bleeding <1%)
DVT treatment (6-10%; major bleeding 1%)
Hematoma (<3%)
<1%
Agranulocytosis, Hepatitis, Dysuria, Fatal bleeding, Hematoma, Hemiparesis, Hemorrhage, Hypotension, Increased amylase, Increased BUN, Jaundice, Menorrhagia, Retroperitoneal bleeding, Stevens-Johnson syndrome, Thrombocytopenia, Urticaria, Xerostomia
Mechanism of Action
Factor Xa inhibitor that inhibits platelet activation by selectively blocking the active site of factor Xa without requiring a cofactor (eg, antithrombin III) for activity.
Blood coagulation cascade is dependent on the activation of factor X to factor Xa via the intrinsic and extrinsic pathways plays a central role in the blood coagulation cascade.
Dose-dependent inhibition of factor Xa activity observed; antifactor Xa activity is also influenced by rivaroxaban; prolongs PT and aPTT and HepTest .
Note
Xarelto 15mg Tablets / Film-coated manufactured by BAYER SCHERING PHARMA AG. Its generic name is Rivaroxaban. Xarelto is availble in United Arab Emirates.
Farmaco UAE drug index information on Xarelto Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.