PRADAXA- dabigatran etexilate mesylate capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

dabigatran etexilate mesylate (UNII: SC7NUW5IIT) (dabigatran etexilate - UNII:2E18WX195X)

Prieinama:

Rebel Distributors Corp

INN (Tarptautinis Pavadinimas):

dabigatran etexilate mesylate

Sudėtis:

dabigatran etexilate 150 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. PRADAXA is contraindicated in patients with: - Active pathological bleeding [see Warnings and Precautions (5.1) 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)] .   There are no adequate and well-controlled studies in pregnant women. Dabigatran has been shown to decrease the number of implantations when male and female rats were treated at a dosage of 70 mg/kg (about 2.6 to 3.0 times the human exposure at maximum recommended human dose [MRHD] of 300 mg/day based on area under the curve [AUC] comparisons) prior to mating and up to implantation (gestation Day 6). Treatment of pregnant rats after implantation with dabigatran at the same dose increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition. Although dabigatran incr

Produkto santrauka:

PRADAXA 75 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted with "R75". The color of the imprinting is black. The capsules are supplied in the packages listed: PRADAXA 150 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted with "R150". The color of the imprinting is black. The capsules are supplied in the packages listed: Bottles Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Once opened, the product must be used within 30 days. Keep the bottle tightly closed. Store in the original package to protect from moisture.  Blisters Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Store in the original package to protect from moisture. Keep out of the reach of children.

Autorizacija statusas:

New Drug Application

Pakuotės lapelis

PRADAXA- DABIGATRAN ETEXILATE MESYLATE CAPSULE
Rebel Distributors Corp
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MEDICATION GUIDE
PRADAXA (pra dax´ a)
(dabigatran etexilate mesylate)
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?
•
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:
Tell your doctor if you
take any of these medicines. Ask your doctor or pharmacist if you are
not sure if your
medicine is one listed above.
•
aspirin or aspirin containing products
•
long-term (chronic) use of non-steroidal anti-inflammatory drugs
(NSAIDs)
•
warfarin sodium (Coumadin®, Jantoven®)
•
a medicine that contains heparin
•
clopidogrel (Plavix®)
•
prasugrel (Effient®)
•
PRADAXA can increase your risk of bleeding because it lessens the
ability of your blood to clot.
While you take PRADAXA:
Call your doctor or get medical help right away if you have any of
these signs or symptoms of
bleeding:
Take PRADAXA exactly as prescribed. Do not stop taking PRADAXA without
first talking to the
doctor who prescribes it for you. Stopping PRADAXA may increase your
risk of a stroke.
PRADAXA may need to be stopped, if possible, for one or more days
before any surgery, or
medical or dental procedure. If you need to stop taking PRADAXA for
any reason, talk to the
doctor who prescribed PRADAXA for you to find out when you should stop
taking it. Your doctor
will

Prekės savybės

PRADAXA- DABIGATRAN ETEXILATE MESYLATE CAPSULE
REBEL DISTRIBUTORS CORP
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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 MESYLATE) CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
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)
DOSAGE AND ADMINISTRATION
For patients with CrCl >30 mL/min: 150 mg orally, twice daily (2.1)
For patients with CrCl 15-30 mL/min: 75 mg orally, twice daily (2.1)
Instruct patients not to chew, break, or open capsules (2.1)
Review recommendations for converting to or from other oral or
parenteral anticoagulants (2.2, 2.3)
Temporarily discontinue PRADAXA before invasive or surgical procedures
when possible, then restart promptly (2.4)
DOSAGE FORMS AND STRENGTHS
Capsules: 75 mg and 150 mg (3)
CONTRAINDICATIONS
Active pathological bleeding (4)
History of serious hypersensitivity reaction to PRADAXA (4)
WARNINGS AND PRECAUTIONS
Risk of bleeding: PRADAXA can cause serious and, sometimes, fatal
bleeding. Promptly evaluate signs and symptoms
of blood loss. (5.1)
Temporary discontinuation: Avoid lapses in therapy to minimize risk of
stroke (5.2)
P-gp inducers and inhibitors: Avoid coadministration of rifampin with
PRADAXA because of effects on dabigatran
exposure (5.3)
ADVERSE REACTIONS
Most common adverse reactions (>15%) are gastritis-like symptoms and
bleeding (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BOEHRINGER INGELHEIM
PHARMACEUTICALS, INC. AT (800)
542-6257 OR [phone] TTY OR FDA AT 1-800-FDA-1088 OR
_WWW.FDA.GOV/MEDWATCH_.
USE IN SPECIFIC POPULATIONS
Geriatric use: Risk of bleeding increases with age (8.5)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 2/2011
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATIO