DABIGATRAN ETEXILATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Dabigatran etexilate capsules are indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days. Dabigatran etexilate capsules are indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated. Pediatric use information is approved for Boehringer Ingelheim Pharmaceuticals, Inc.’s Pradaxa (dabigatran etexilate) capsules. However, due to Boehringer Ingelheim Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Dabigatran etexilate capsules are contraindicated in patients with: - Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] - History of a serious hypersensitivity

Product summary:

Dabigatran etexilate 75 mg capsules are cream opaque cap / cream opaque body size '2' HPMC capsules imprinted with 'H' on cap and 'D10' on body with black ink, filled with mixture of off white to yellowish white pellets. The capsules are supplied in the packages listed: Unit dose packages of 30 (3 x 10) NDC 60687-744-21 Dabigatran etexilate 150 mg capsules are cream opaque cap / cream opaque body size '0' HPMC capsules imprinted with 'H' on cap and 'D11' on body with black ink, filled with mixture of off white to yellowish white pellets. The capsules are supplied in the packages listed: Unit dose packages of 20 (5 x 4) NDC 60687-752-32 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. If the capsules are taken out of the blister, the product must be used within 4 months. Store in the original blister to protect from moisture. Keep out of the reach of children. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

American Health Packaging
----------
MEDICATION GUIDE
8474421/0323F
Dabigatran Etexilate
(DA-bi-GAT-ran e-TEX-i-late) Capsules
This Medication Guide is for dabigatran etexilate capsules.
Read this Medication Guide before you start taking dabigatran
etexilate capsules and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking with your
healthcare provider about your medical condition or your treatment.
What is the most important information I should know about dabigatran
etexilate capsules?
•
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.
Dabigatran etexilate capsules lowers your chance of having a stroke by
helping to prevent clots
from forming. If you stop taking dabigatran etexilate capsules, you
may have increased risk of
forming a clot in your blood.
Do not stop taking dabigatran etexilate capsules without talking to
the healthcare provider who
prescribes it for you. Stopping dabigatran etexilate capsules
increases your risk of having a stroke.
Dabigatran etexilate capsules may need to be stopped, if possible,
before surgery or a medical or
dental procedure. Ask the healthcare provider who prescribed
dabigatran etexilate capsules for you
when you should stop taking them. Your healthcare provider will tell
you when you may start
taking dabigatran etexilate capsules again after your surgery or
procedure. If you have to stop
taking dabigatran etexilate capsules, your healthcare provider may
prescribe another medicine to
help prevent a blood clot from forming.
•
Dabigatran etexilate capsules can cause bleeding which can be serious,
and sometimes lead to
death. This is because dabigatran etexilate capsules are 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 dabigatran
etexilate capsules and:
•
are over

Summary of Product characteristics

DABIGATRAN ETEXILATE- DABIGATRAN ETEXILATE CAPSULE
AMERICAN HEALTH PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DABIGATRAN ETEXILATE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DABIGATRAN
ETEXILATE CAPSULES.
DABIGATRAN ETEXILATE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
WARNING: (A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE
CAPSULES
INCREASES THE RISK OF THROMBOTIC EVENTS, AND (B) SPINAL/EPIDURAL
HEMATOMA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
(A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES
INCREASES
THE RISK OF THROMBOTIC EVENTS: PREMATURE DISCONTINUATION OF ANY ORAL
ANTICOAGULANT, INCLUDING DABIGATRAN ETEXILATE CAPSULES, INCREASES THE
RISK OF
THROMBOTIC EVENTS. TO REDUCE THIS RISK, CONSIDER COVERAGE WITH ANOTHER
ANTICOAGULANT IF
DABIGATRAN ETEXILATE CAPSULES ARE DISCONTINUED FOR A REASON OTHER THAN
PATHOLOGICAL
BLEEDING OR COMPLETION OF A COURSE OF THERAPY (2.6, 2.7, 2.8, 5.1).
(B) SPINAL/EPIDURAL HEMATOMA: EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR
IN PATIENTS
TREATED WITH DABIGATRAN ETEXILATE CAPSULES 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
Dabigatran etexilate capsules are a direct thrombin inhibitors
indicated:
To reduce the risk of stroke and systemic embolism in adult patients
with non-valvular atrial fibrillation
(1.1)
For the treatment of deep venous thrombosis (DVT) and pulmonary
embolism (PE) in adult patients
who have been treated with a parenteral anticoagulant for 5 to 10 days
(1.2)
To reduce the risk of recurrence of DVT and PE in adult patients who
have been previously treated (1.3)
DOSAGE AND