Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
apixaban (UNII: 3Z9Y7UWC1J) (apixaban - UNII:3Z9Y7UWC1J)
Cardinal Health 107, LLC
apixaban
apixaban 2.5 mg
ORAL
PRESCRIPTION DRUG
ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. ELIQUIS is indicated for the treatment of DVT. ELIQUIS is indicated for the treatment of PE. ELIQUIS is indicated to reduce the risk of recurrent DVT and PE following initial therapy. ELIQUIS is contraindicated in patients with the following conditions: The limited available data on ELIQUIS use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes. Treatment may increase the risk of bleeding during pregnancy and delivery. In animal reproduction studies, no adverse developmental effects were seen when apixaban was administered to rats (orally), rabbits (intravenously) and mice (orally) during organogenesis at unbound apixaban exposu
ELIQUIS (apixaban) tablets are available as listed in the table below. Tablet Strength Tablet Color/Shape Tablet Markings Package Size NDC Code 2.5 mg Yellow, round, Debossed with “893” on Overbagged with 10 Tablets per bag 55154-0612-0 biconvex one side and “2½” on the other side 2.5 mg Yellow, round, biconvex Debossed with “893” on one side and “2½” on the other side Bottles of approximately 4140 Tablets 55154-0612-8 5 mg Pink, oval, biconvex Debossed with “894” on Overbagged with 10 Tablets 55154-0613-0 one side and “5” on the per bag other side 5 mg Pink, oval, biconvex Debossed with “894” on Bottles of approximately 55154-0613-8 one side and “5” on the 2040 Tablets other side Store at 20°C to 25°C (68°F-77°F); excursions permitted between 15°C and 30°C (59°F-86°F) [see USP Controlled Room Temperature].
New Drug Application
ELIQUIS- APIXABAN TABLET, FILM COATED Cardinal Health 107, LLC ---------- MEDICATION GUIDE ELIQUIS® (ELL eh kwiss) (apixaban) tablets What is the most important information I should know about ELIQUIS? • For people taking ELIQUIS for atrial fibrillation: People with atrial fibrillation (a type of irregular heartbeat) 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. ELIQUIS lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking ELIQUIS, you may have increased risk of forming a clot in your blood. Do not stop taking ELIQUIS without talking to the doctor who prescribes it for you. Stopping ELIQUIS increases your risk of having a stroke. ELIQUIS may need to be stopped, if possible, prior to surgery or a medical or dental procedure. Ask the doctor who prescribed ELIQUIS for you when you should stop taking it. Your doctor will tell you when you may start taking ELIQUIS again after your surgery or procedure. If you have to stop taking ELIQUIS, your doctor may prescribe another medicine to help prevent a blood clot from forming. • ELIQUIS can cause bleeding which can be serious and rarely may lead to death. This is because ELIQUIS is a blood thinner medicine that reduces blood clotting. You may have a higher risk of bleeding if you take ELIQUIS and take other medicines that increase your risk of bleeding, including: • aspirin or aspirin-containing products • long-term (chronic) use of nonsteroidal anti-inflammatory drugs (NSAIDs) • warfarin sodium (COUMADIN®, JANTOVEN®) • any medicine that contains heparin • selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) • other medicines to help prevent or treat blood clots Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. While taking ELIQUIS: • you may bruise more easily • it may t read_full_document
ELIQUIS- APIXABAN TABLET, FILM COATED CARDINAL HEALTH 107, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ELIQUIS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ELIQUIS. ELIQUIS (APIXABAN) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2012 WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS: PREMATURE DISCONTINUATION OF ANY ORAL ANTICOAGULANT, INCLUDING ELIQUIS, INCREASES THE RISK OF THROMBOTIC EVENTS. TO REDUCE THIS RISK, CONSIDER COVERAGE WITH ANOTHER ANTICOAGULANT IF ELIQUIS IS DISCONTINUED FOR A REASON OTHER THAN PATHOLOGICAL BLEEDING OR COMPLETION OF A COURSE OF THERAPY. (2.4, 5.1, 14.1) (B) SPINAL/EPIDURAL HEMATOMA: EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN PATIENTS TREATED WITH ELIQUIS WHO ARE RECEIVING NEURAXIAL ANESTHESIA OR UNDERGOING SPINAL PUNCTURE. THESE HEMATOMAS MAY RESULT IN LONG-TERM OR PERMANENT PARALYSIS. CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS FOR SPINAL PROCEDURES. (5.3) INDICATIONS AND USAGE ELIQUIS is a factor Xa inhibitor indicated: • • • DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS ® to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2) for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3, 1.4, 1.5) Reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation: • • The recommended dose is 5 mg orally twice daily. (2.1) In patients with at least 2 of the following characteristics: age greater than or equal to 80 years, body weight le read_full_document