XARELTO rivaroxaban tablet film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

rivaroxaban (UNII: 9NDF7JZ4M3) (rivaroxaban - UNII:9NDF7JZ4M3)

Disponibil de la:

Avera McKennan Hospital

INN (nume internaţional):

rivaroxaban

Compoziție:

rivaroxaban 15 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

XARELTO- RIVAROXABAN TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XARELTO (RIVAROXABAN) SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XARELTO.
XARELTO (RIVAROXABAN) TABLETS, FOR ORAL USE
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, 2.6,
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).
RECENT MAJOR CHANGES
Dosage and Administration (2.8)
01/2015
INDICATIONS AND USAGE
XARELTO is a factor Xa inhibitor indicated:
to reduce the risk of stroke and systemic embolism in patients with
nonvalvular atrial fibrillation (1.1)
for the treatment of deep vein thrombosis (DVT), pulmonary embolism
(PE), and for the reduction in the risk of
recurrence of DVT and of PE (1.2, 1.3, 1.4)
for the prophylaxis of DVT, which may lead to PE in patients
undergoing knee or hip replacement surgery (1.5)
DOSAGE AND ADMINISTRATION
Take 15 mg and 20 mg tablets with food; take 10 mg tablets with or
without food (2.1)
Nonvalvular Atrial Fibrillation