APLENZIN is indicated for the treatment of major depressive disorder in adults aged
18 years and older. Aplenzin is also indicated for the prevention of seasonal major
depressive episodes in adult patients with a diagnosis of seasonal affective disorder
APLENZIN is contraindicated in patients with seizure disorder or conditions that
increase the risk of seizures, known hypersensitivity to bupropion (anaphylactoid/anaphylactic
reactions and Stevens-Johnson syndrome have been reported) and the concurrent use
of monoamine oxidase (MAO) inhibitors.
APLENZIN can cause seizure. The risk of seizure is dose-related. The dose should
not exceed 522 mg once daily. Increase the dose gradually. Discontinue APLENZIN
and do not restart treatment if the patient experiences a seizure (see Warnings and
Precaution in Full Prescribing Information)
Families and caregivers of patients being treated with antidepressants for major
depressive disorder or other indications, both psychiatric and nonpsychiatric, should
be alerted about the need to monitor patients for the emergence of agitation, irritability,
unusual changes in behavior, and the other symptoms described above, as well as
the emergence of suicidality, and to report such symptoms immediately to health
care providers. Such monitoring should include daily observation by families and
caregivers. Prescriptions for APLENZIN should be written for the smallest quantity
of tablets consistent with good patient management, in order to reduce the risk
of overdose. Families and caregivers of adults being treated for depression should
be similarly advised.
APLENZIN is not approved for smoking cessation treatment; however, bupropion HCl
sustained-release is approved for this use. Serious neuropsychiatric symptoms have
been reported in patients taking bupropion for smoking cessation. These have included
changes in mood (including depression and mania), psychosis, hallucinations, paranoia,
delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic,
as well as suicidal ideation, suicide attempt, and completed suicide [see Boxed
Warning and Adverse Reactions in Full Prescribing Information]. Observe patients
for the occurrence of neuropsychiatric reactions. Instruct patients to contact a
healthcare professional if such reactions occur.
Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode.
The risk appears to be increased in patients with bipolar disorder or who have risk
factors for bipolar disorder. Prior to initiating APLENZIN, screen patients for
a history of bipolar disorder and the presence of risk factors for bipolar disorder
(e.g., family history of bipolar disorder, suicide, or depression). APLENZIN is
not approved for the treatment of bipolar depression.
For patients with severe hepatic impairment, the maximum APLENZIN dose is 174 mg
every other day. In patients with mild to moderate impairment, consideration should
be given to reducing the dose and/or frequency of dosing. Depressed patients treated
with bupropion have had a variety of neuropsychiatric signs and symptoms, including
delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion.
Some of these patients had a diagnosis of bipolar disorder. In some cases, these
symptoms abated upon dose reduction and/or withdrawal of treatment. Discontinue
APLENZIN if these reactions occur. Anaphylactoid reactions characterized by symptoms
such as pruritus, urticaria, angioedema, and dyspnea requiring medical treatment
have been reported in clinical trials with bupropion. Treatment with APLENZIN can
result in elevated blood pressure and hypertension. Assess blood pressure before
initiating treatment with APLENZIN, and monitor periodically during treatment.
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 in clinical trails were anorexia, dry
mouth, rash, sweating, tinnitus, tremor, abdominal pain, agitation, anxiety, dizziness,
insomnia, myalgia, nausea, palpitation, pharyngitis and urinary frequency.
Click here for full Prescribing Information, including boxed WARNING.