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Cymbalta ® (duloxetine)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information:
Cymbalta Summary of Product Characteristics (SmPC)
Cymbalta (duloxetine): Cardiovascular
Duloxetine has been associated with an increase in blood pressure, and clinically significant hypertension in some patients.
initiation of treatment with Cymbalta is contraindicated in patients
with uncontrolled hypertension that could expose patients to a
potential risk of hypertensive crisis.
Pressure and Heart Rate
has been associated with an increase in blood pressure, and
clinically significant hypertension in some patients. This may be due
to the noradrenergic effect of duloxetine. Cases of hypertensive
crisis have been reported with duloxetine, especially in patients
with pre-existing hypertension. Therefore, in patients with known
hypertension and/or other cardiac disease, blood pressure monitoring
is recommended, especially during the first month of treatment.
Duloxetine should be used with caution in patients whose conditions
could be compromised by an increased heart rate or by an increase in
blood pressure. Caution should also be exercised when duloxetine is
used with medicinal products that may impair its metabolism. For
patients who experience a sustained increase in blood pressure while
receiving duloxetine, either dose reduction or gradual
discontinuation should be considered. In patients with uncontrolled
hypertension, duloxetine should not be initiated.
have been reports of bleeding abnormalities, such as ecchymoses,
purpura, and gastrointestinal haemorrhage, with selective serotonin
reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake
inhibitors (SNRIs), including duloxetine. Caution is advised in
patients taking anticoagulants and/or medicinal products known to
affect platelet function (e.g., NSAIDs or acetylsalicylic acid
(ASA)), and in patients with known bleeding tendencies.
and antiplatelet agents: Caution should be exercised when
duloxetine is combined with oral anticoagulants or antiplatelet
agents due to a potential increased risk of bleeding attributable to
a pharmacodynamic interaction. Furthermore, increases in INR values
have been reported when duloxetine was co-administered to patients
treated with warfarin. However, concomitant administration of
duloxetine with warfarin under steady-state conditions, in healthy
volunteers, as part of a clinical pharmacology study, did not result
in a clinically significant change in INR from baseline or in the
pharmacokinetics of R- or S-warfarin.
heart rate-corrected QT interval in duloxetine-treated patients did
not differ from that seen in placebo-treated patients. No clinically
significant differences were observed for QT, PR, QRS, or QTcB
measurements between duloxetine-treated and placebo-treated patients.
[Summary of Product Characteristics]. Utrecht, The Netherlands: Eli
Lilly Nederland B.V.
Date of Last Review:November 15, 2018
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