DABIGATRAN ETEXILATE capsule, coated pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ascend Laboratories, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dabigatran Etexilate Capsules is indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Dabigatran Etexilate Capsules is 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 is indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated. Dabigatran Etexilate Capsules is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism, in adult patients who have undergone hip replacement surgery.  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 is contraindic

Product summary:

Dabigatran Etexilate Capsules 75 mg capsules have a light cream opaque cap and light cream opaque body imprinted with “DAB” on cap and “75” on body in black ink. The capsules are supplied in the packages listed:  Dabigatran Etexilate Capsules 150 mg capsules have a light navy blue opaque cap and light cream opaque body imprinted with “150” on body and “DAB” on cap in black ink. The capsules are supplied in the packages listed:   Bottles Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Once opened, the product must be used within 4 months. Keep the bottle tightly closed. Store in the original package to protect from moisture.  Keep out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Ascend Laboratories, LLC
----------
MEDICATION GUIDE
Dabigatran Etexilate Capsules
(DA-bi-GAT-ran e-TEX-i-late)
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 it. 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 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 Dabigatran
Etexilate Capsules and:
•
are over 75 years old
•

Summary of Product characteristics

DABIGATRAN ETEXILATE - DABIGATRAN ETEXILATE CAPSULE, COATED PELLETS
ASCEND LABORATORIES, LLC
----------
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
IS 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 is a direct thrombin inhibitor
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