PRADAXA- dabigatran etexilate mesylate capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

DABIGATRAN ETEXILATE MESYLATE (UNII: SC7NUW5IIT) (DABIGATRAN - UNII:I0VM4M70GC)

Διαθέσιμο από:

A-S Medication Solutions

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. PRADAXA is indicated for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days. PRADAXA is indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated. PRADAXA is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism, in patients who have undergone hip replacement surgery. PRADAXA is contraindicated in patients with: - Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] . - History of a serious hypersensitivity reaction to PRADAXA (e.g., anaphylactic reaction or anaphylactic shock) [see Adverse Reactions (6.1)] . - Mechanical prosthetic heart valve [see Warnings and Precautions (5.4)]. Risk Summary The limited available data on PRADAXA use in pregnant wo

Περίληψη προϊόντος:

Product: 50090-3617 NDC: 50090-3617-0 60 CAPSULE in a BOTTLE / 1 in a CARTON

Καθεστώς αδειοδότησης:

New Drug Application

Φύλλο οδηγιών χρήσης

A-S Medication Solutions
----------
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Revised: April 2021
MEDICATION GUIDE
PRADAXA (pra dax a)
(dabigatran etexilate)
capsules
Read this Medication Guide before you start taking PRADAXA and each
time you get a refill. There may be
new information. This Medication Guide does not take the place of
talking with your doctor about your
medical condition or your treatment.
What is the most important information I should know about PRADAXA?
•
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.
PRADAXA lowers your chance of having a stroke by helping to prevent
clots from forming. If you
stop taking PRADAXA, you may have increased risk of forming a clot in
your blood.
Do not stop taking PRADAXA without talking to the doctor who
prescribes it for you. Stopping
PRADAXA increases your risk of having a stroke.
PRADAXA may need to be stopped, if possible, prior to surgery or a
medical or dental procedure.
Ask the doctor who prescribed PRADAXA for you when you should stop
taking it. Your doctor will
tell you when you may start taking PRADAXA again after your surgery or
procedure. If you have to
stop taking PRADAXA, your doctor may prescribe another medicine to
help prevent a blood clot
from forming.
•
PRADAXA can cause bleeding which can be serious, and sometimes lead to
death. This is because
PRADAXA is a blood thinner medicine that lowers the chance of blood
clots forming in your body.
•
You may have a higher risk of bleeding if you take PRADAXA and:
•
are over 75 years old
•
have kidney problems
•
have stomach or intestine bleeding that is recent or keeps coming
back, or you have a stomach
ulcer
•
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
(NSA

Αρχείο Π.Χ.Π.

PRADAXA- DABIGATRAN ETEXILATE MESYLATE CAPSULE
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRADAXA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRADAXA.
PRADAXA® (DABIGATRAN ETEXILATE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK
OF
THROMBOTIC EVENTS, AND (B) SPINAL/EPIDURAL HEMATOMA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF
THROMBOTIC
EVENTS: PREMATURE DISCONTINUATION OF ANY ORAL ANTICOAGULANT, INCLUDING
PRADAXA,
INCREASES THE RISK OF THROMBOTIC EVENTS. TO REDUCE THIS RISK, CONSIDER
COVERAGE WITH
ANOTHER ANTICOAGULANT IF PRADAXA IS DISCONTINUED FOR A REASON OTHER
THAN PATHOLOGICAL
BLEEDING OR COMPLETION OF A COURSE OF THERAPY (2.4, 2.5, 2.6, 5.1).
(B) SPINAL/EPIDURAL HEMATOMA: EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR
IN PATIENTS
TREATED WITH PRADAXA WHO ARE RECEIVING NEURAXIAL ANESTHESIA OR
UNDERGOING SPINAL
PUNCTURE. THESE HEMATOMAS MAY RESULT IN LONG-TERM OR PERMANENT
PARALYSIS (5.3).
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
PRADAXA is a direct thrombin inhibitor indicated:
To reduce the risk of stroke and systemic embolism in patients with
non-valvular atrial fibrillation (1.1)
For the treatment of deep venous thrombosis (DVT) and pulmonary
embolism (PE) in patients who
have been treated with a parenteral anticoagulant for 5-10 days (1.2)
To reduce the risk of recurrence of DVT and PE in patients who have
been previously treated (1.3)
For the prophylaxis of DVT and PE in patients who have undergone hip
replacement surgery (1.4)
DOSAGE AND ADMINISTRATION
Non-valvular Atrial Fibrillation:
For patients with CrCl >30 mL/min: 150 mg orally,