DABIGATRAN ETEXILATE- 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:

Camber Pharmaceuticals, Inc.

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 seri

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 of use bottle of 60 capsules                  NDC 31722-621-60 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 of use bottle of 60 capsules                   NDC 31722-622-60 Bottles Store at 20°C to 25°C (68°F to 77°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

Camber Pharmaceuticals, Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
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:
o are

Summary of Product characteristics

DABIGATRAN ETEXILATE - DABIGATRAN ETEXILATE CAPSULE
CAMBER PHARMACEUTICALS, INC.
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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 WITHDABIGATRAN 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 t