Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
RIVAROXABAN (UNII: 9NDF7JZ4M3) (RIVAROXABAN - UNII:9NDF7JZ4M3)
Janssen Pharmaceuticals, Inc.
rivaroxaban
rivaroxaban 10 mg
ORAL
PRESCRIPTION DRUG
XARELTO is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see Clinical Studies (14.1)]. XARELTO is indicated for the treatment of deep vein thrombosis (DVT). XARELTO is indicated for the treatment of pulmonary embolism (PE). XARELTO is indicated for the reduction in the risk of recurrence of DVT and/or PE in adult patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months. XARELTO is indicated for the prophylaxis of DVT, which may lead to PE in adult patients undergoing knee or hip replacement surgery. XARELTO is indicated for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an a
XARELTO ® (rivaroxaban) Tablets are available in the strengths and packages listed below: XARELTO ® (rivaroxaban) for oral suspension is available in the strength and package listed below: Discard reconstituted suspension after "Discard after" date written on the bottle. Storage of tablets, granules and reconstituted suspension: Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze the granules or reconstituted suspension. Keep out of the reach of children.
New Drug Application
XARELTO- RIVAROXABAN TABLET, FILM COATED XARELTO- RIVAROXABAN XARELTO- RIVAROXABAN GRANULE, FOR SUSPENSION Janssen Pharmaceuticals, Inc. ---------- MEDICATION GUIDE XARELTO ® (ZAH-REL-TOE) (RIVAROXABAN) TABLETS XARELTO ® (ZAH-REL-TOE) (RIVAROXABAN) ORAL SUSPENSION This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 02/2023 What is the most important information I should know about XARELTO? XARELTO may cause serious side effects, including: • Increased risk of blood clots if you stop taking XARELTO. People with atrial fibrillation (a type of irregular heart beat) that is not caused by a heart valve problem (non-valvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO, you may have increased risk of forming a clot in your blood. Do not stop taking XARELTO without talking to the doctor who prescribes it for you. Stopping XARELTO increases your risk of having a stroke. If you have to stop taking XARELTO, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming. • Increased risk of bleeding. XARELTO can cause bleeding which can be serious and may lead to death. This is because XARELTO is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with XARELTO you are likely to bruise more easily, and it may take longer for bleeding to stop. You may have a higher risk of bleeding if you take XARELTO and have certain other medical problems. You may have a higher risk of bleeding if you take XARELTO and take other medicines that increase your risk of bleeding, including: • aspirin or aspirin containing products • long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs) • warfarin sodium (Coumadin ®, Jantoven ®) • any medicine that contains heparin • clopidogrel (Plavix ®) • sel Διαβάστε το πλήρες έγγραφο
XARELTO- RIVAROXABAN TABLET, FILM COATED XARELTO- RIVAROXABAN TABLET, FILM COATED XARELTO- RIVAROXABAN XARELTO- RIVAROXABAN GRANULE, FOR SUSPENSION JANSSEN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE XARELTO SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XARELTO. XARELTO (RIVAROXABAN) TABLETS, FOR ORAL USE XARELTO (RIVAROXABAN) FOR ORAL SUSPENSION INITIAL U.S. APPROVAL: 2011 WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS PREMATURE DISCONTINUATION OF ANY ORAL ANTICOAGULANT, INCLUDING XARELTO, INCREASES THE RISK OF THROMBOTIC EVENTS. TO REDUCE THIS RISK, CONSIDER COVERAGE WITH ANOTHER ANTICOAGULANT IF XARELTO IS DISCONTINUED FOR A REASON OTHER THAN PATHOLOGICAL BLEEDING OR COMPLETION OF A COURSE OF THERAPY. ( 2.2, 2.3, 5.1, 14.1) (B) SPINAL/EPIDURAL HEMATOMA EPIDURAL OR SPINAL HEMATOMAS HAVE OCCURRED IN PATIENTS TREATED WITH XARELTO WHO ARE RECEIVING NEURAXIAL ANESTHESIA OR UNDERGOING SPINAL PUNCTURE. THESE HEMATOMAS MAY RESULT IN LONG-TERM OR PERMANENT PARALYSIS. ( 5.2, 5.3, 6.2) MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGICAL IMPAIRMENT AND IF OBSERVED, TREAT URGENTLY. CONSIDER THE BENEFITS AND RISKS BEFORE NEURAXIAL INTERVENTION IN PATIENTS WHO ARE OR WHO NEED TO BE ANTICOAGULATED. ( 5.3) INDICATIONS AND USAGE XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1) for treatment of deep vein thrombosis (DVT) ( 1.2) for treatment of pulmonary embolism (PE) ( 1.3) for reduction in the risk of recurrence of DVT or PE ( 1.4) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical Διαβάστε το πλήρες έγγραφο