to prescribing it is necessary to take an appropriate medical history
and conduct a baseline evaluation of a patient’s cardiovascular
status, including blood pressure and heart rate.
status should be regularly monitored with blood pressure and pulse
recorded after each adjustment of dose and then at least every 6
months. For paediatric patients the use of a centile chart is
recommended. For adults, current reference guidelines for
hypertension should be followed.
should not be used in patients with severe cardiovascular or
cardiovascular disorders may include severe hypertension, heart
failure, arterial occlusive disease, angina, haemodynamically
significant congenital heart disease, cardiomyopathies, myocardial
infarction, potentially life-threatening arrhythmias and
channelopathies (disorders caused by the dysfunction of ion
channels). Severe cerebrovascular disorders may include cerebral
aneurysm or stroke.
should not be used in patients with pheochromocytoma or a history of
death and pre-existing cardiac abnormalities:
death has been reported in patients with structural cardiac
abnormalities who were taking atomoxetine at usual doses. Although
some serious structural cardiac abnormalities alone carry an
increased risk of sudden death, atomoxetine should only be used with
caution in patients with known serious structural cardiac
abnormalities and in consultation with a cardiac specialist.
can affect heart rate and blood pressure. Most patients taking
atomoxetine experience a modest increase in heart rate (mean <10
bpm) and/or increase in blood pressure (mean <5 mm Hg).
combined data from controlled and uncontrolled ADHD clinical trials
show that approximately 8-12% of children and adolescents, and 6-10%
of adults experience more pronounced changes in heart rate (20 beats
per minute or greater) and blood pressure (15-20 mmHg or greater).
Analysis of these clinical trial data showed that approximately
15-26% of children and adolescents, and 27-32% of adults experiencing
such changes in blood pressure and heart rate during atomoxetine
treatment had sustained or progressive increases. Long-term sustained
changes in blood pressure may potentially contribute to clinical
consequences such as myocardial hypertrophy.
a result of these findings, patients who are being considered for
treatment with atomoxetine should have a careful history and physical
exam to assess for the presence of cardiac disease, and should
receive further specialist cardiac evaluation if initial findings
suggest such history or disease.
is recommended that heart rate and blood pressure be measured and
recorded before treatment is started and, during treatment, after
each adjustment of dose and then at least every 6 months to detect
possible clinically important increases. For paediatric patients the
use of a centile chart is recommended.
should not be used in patients with severe cardiovascular or
cerebrovascular disorders. Atomoxetine should be used with caution in
patients whose underlying medical conditions could be worsened by
increases in blood pressure and heart rate, such as patients with
hypertension, tachycardia, or cardiovascular or cerebrovascular
who develop symptoms such as palpitations, exertional chest pain,
unexplained syncope, dyspnoea or other symptoms suggestive of cardiac
disease during atomoxetine treatment should undergo a prompt
addition, atomoxetine should be used with caution in patients with
congenital or acquired long QT or a family history of QT
orthostatic hypotension has also been reported, atomoxetine should be
used with caution in any condition that may predispose patients to
hypotension or conditions associated with abrupt heart rate or blood
with additional risk factors for cerebrovascular conditions (such as
a history of cardiovascular disease, concomitant medications that
elevate blood pressure) should be assessed at every visit for
neurological signs and symptoms after initiating treatment with
of Other Drugs on Atomoxetine
(or other beta2
should be administered with caution to patients treated with high
dose nebulised or systemically administered salbutamol (or other
because cardiovascular effects can be potentiated.
findings regarding this interaction were found. Systemically
administered salbutamol (600 μg i.v. over 2 hrs) in combination
with atomoxetine (60 mg twice daily for 5 days) induced increases in
heart rate and blood pressure. This effect was most marked after the
initial coadministration of salbutamol and atomoxetine but returned
towards baseline at the end of 8 hours. However, in a separate study
the effects on blood pressure and heart rate of a standard inhaled
dose of salbutamol (200 μg) were not increased by the short-term
coadministration of atomoxetine (80 mg once daily for 5 days) in a
study of healthy Asian adults who were extensive atomoxetine
metabolisers. Similarly, heart rate after multiple inhalations of
salbutamol (800 μg) did not differ in the presence or absence of
should be paid to monitoring heart rate and blood pressure, and dose
adjustments may be justified for either atomoxetine or salbutamol (or
agonists) in the
event of significant increases in heart rate and blood pressure
during coadministration of these drugs.
is the potential for an increased risk of QT interval prolongation
when atomoxetine is administered with other QT prolonging drugs (such
as neuroleptics, class IA and III anti-arrhythmics, moxifloxacin,
erythromycin, methadone, mefloquine, tricyclic antidepressants,
lithium, or cisapride), drugs that cause electrolyte imbalance (such
as thiazide diuretics), and drugs that inhibit CYP2D6.
should be used cautiously with anti-hypertensive drugs. Because of a
possible increase in blood pressure, atomoxetine may decrease the
effectiveness of anti-hypertensive drugs / drugs used to treat
hypertension. Attention should be paid to monitoring of blood
pressure and review of treatment of atomoxetine or anti-hypertensive
drugs may be justified in the case of significant changes of blood
agents or drugs that increase blood pressure:
of possible increase in effects on blood pressure, atomoxetine should
be used cautiously with pressor agents or medications that may
increase blood pressure (such as salbutamol). Attention should be
paid to monitoring of blood pressure, and review of treatment for
either atomoxetine or pressor agents may be justified in the case of
significant change in blood pressure.
of the safety profile
both paediatric and adult placebo-controlled trials, patients taking
atomoxetine experienced increases in heart rate, systolic and
diastolic blood pressure.
of its effect on noradrenergic tone, orthostatic hypotension (0.2%)
and syncope (0.8%) have been reported in patients taking atomoxetine.
Atomoxetine should be used with caution in any condition that may
predispose patients to hypotension.
Summary of Product Characteristics