APLENZIN is contraindicated in patients who have a seizure disorder, patients being
treated with ZYBAN
® (bupropion HCl) Sustained-Release Tablets, WELLBUTRIN
®
(bupropion HCl), WELLBUTRIN SR
® (bupropion HCl) Sustained-Release
Tablets, or any other medications that contain bupropion, patients who have or had
bulimia or anorexia nervosa, patients undergoing abrupt discontinuation of alcohol
or sedatives (including benzodiazepines), patients who have shown an allergic response
to bupropion and patients taking MAO inhibitors. At least 14 days should elapse
between discontinuation of an MAO inhibitor and initiation of APLENZIN.
Physicians should be aware that bupropion is associated with a risk of seizure,
which is dose related. The incidence of seizure may be similar to that of the sustained-release
formulations of bupropion, since APLENZIN has demonstrated bioequivalence. To reduce
the risk of seizures, please see WARNINGS and PRECAUTIONS in the Prescribing Information
for patient selection considerations, including concomitant medications and dosing
recommendations.
Physicians, families, and caregivers should monitor patients for suicidality as
well as anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness,
impulsivity, akathisia (psychomotor restlessness), hypomania, mania, and other unusual
changes in behavior. All patients should be closely monitored for these symptoms,
especially at the beginning of therapy, or with changes in dose and reported immediately
to the patient’s healthcare provider. Please consult prescribing information for
APLENZIN for additional monitoring recommendations. There is concern that such symptoms
may be precursors to suicidality, although a causal link has not been proven. If
such symptoms occur, prescribers should consider changing or discontinuing treatment.
Patients should be screened for bipolar disorder prior to initiating treatment with
an antidepressant.
APLENZIN is not approved for smoking cessation treatment, but bupropion under the
name ZYBAN is approved for this use. Serious neuropsychiatric symptoms have been
reported in patients taking bupropion for smoking cessation. Some reported cases
may have been complicated by the symptoms of nicotine withdrawal in patients who
stopped smoking. These events have occurred in patients with and without pre-existing
psychiatric disease; some have experienced worsening of their psychiatric illnesses.
All patients being treated with bupropion as part of smoking cessation treatment
should be observed for neuropsychiatric symptoms or worsening of pre-existing psychiatric
illness.
Advise patients and caregivers that the patient using bupropion for smoking
cessation should stop taking bupropion and contact a healthcare provider immediately
if agitation, hostility, depressed mood, or changes in thinking or behavior that
are not typical for the patient are observed, or if the patient develops suicidal
ideation or suicidal behavior. In many post-marketing cases, resolution
of symptoms after discontinuation of ZYBAN was reported, although in some cases
the symptoms persisted; therefore, ongoing monitoring and supportive care should
be provided until symptoms resolve.
Antidepressants can precipitate manic episodes in bipolar disorder patients during
the depressed phase of their illness and may activate latent psychosis in other
susceptible patients. APLENZIN is expected to pose similar risks.
When treating patients with severe hepatic cirrhosis, extreme caution should be
exercised, and a reduced dosage and/or frequency is required to avoid accumulation.
Increased restlessness, agitation, anxiety, and insomnia, especially shortly after
initiation of treatment, have been associated with treatment with bupropion. Neuropsychiatric
signs and symptoms, including delusions, hallucinations, psychosis, concentration
disturbance, paranoia, and confusion have been reported with bupropion. Anaphylactoid
reactions characterized by symptoms such as pruritus, urticaria, angioedema, and
dyspnea requiring medical treatment have been reported in clinical trials with bupropion.
There have been reports of hypertension, in some cases severe, in patients receiving
bupropion alone and in combination with nicotine replacement therapy.
Co-administration with drugs that are metabolized by CYP2B6 or CYP2D6 isoenzymes
should be approached with caution. Please see the DRUG INTERACTIONS section in the
Prescribing Information for further information.
The most common adverse reactions reported are anorexia, dry mouth, rash, sweating,
tinnitus, tremor, abdominal pain, agitation, anxiety, dizziness, insomnia, myalgia,
nausea, palpitation, pharyngitis, and urinary frequency.
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