T H E R A P E U T I C I N D E X

Zybex SR
Tablet

Description
Zybex SR is a preparation of Bupropion Hydrochloride, an
antidepressant of the aminoketone class. It is chemically unrelated to
tricyclic, tetracyclic, or other known antidepressants. Its structure closely
resembles that of diethylpropion; it is related to phenylethylamines.

Indications
Bupropion Hydrochloride is indicated in the treatment of depression.
Bupropion is also indicated in smoking cessation.

Dosage and Administration

The usual adult target dose for Bupropion is 300 mg/day, given as 150
mg, twice daily. Dosing should begin at 150 mg/day given as a single daily
dose in the morning. If the 150 mg initial dose is adequately tolerated, an
increase to the 300 mg/day target dose, given as 150 mg twice daily, may
be made as early as day 4 of dosing. There should be an interval of at least
8 hours between successive doses.

Increasing the dosage above 300 mg/day : As with other antidepressants, the full
antidepressant effect of Bupropion Hydrochloride may not be evident
until 4 weeks of treatment or longer. An increase in dosage to the
maximum of 400 mg/day, given as 200 mg twice daily, may be considered
for patients in whom no clinical improvement is noted after several weeks
of treatment at 300 mg/day. Bupropion Hydrochloride should be
discontinued in patients who do not demonstrate an adequate response
after an appropriate period of treatment at 450 mg/day.

Maintenance : The lowest dose that maintains remission is recommended.

Although it is not known how long the patient should remain on
Bupropion Hydrochloride, it is generally recognised that acute episodes
of depression require several months or longer of antidepressant drug
treatment.

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Contraindications
It is contraindicated in patients with a seizure disorder. Bupropion
Hydrochloride is contraindicated in patients treated with other
medications that contain Bupropion because the incidence of seizure is
dose dependent. Bupropion may induce seizure and consequently its use
is contraindicated in patients with epilepsy. The drug is also
contraindicated in patients with a current or prior diagnosis of bulimia or
anorexia nervosa because of a higher incidence of seizures noted in such
patients treated for bulimia with Bupropion Hydrochloride. The
concurrent administration of Bupropion Hydrochloride and a
monoamine oxidase (MAO) inhibitor is contraindicated. At least 14 days
should elapse between discontinuation of MAO inhibitor and initiation of
treatment with Bupropion Hydrochloride. Bupropion Hydrochloride is
contraindicated in patients who have shown an allergic response to
Bupropion or the other ingredients that make up Bupropion
Hydrochloride.

Precautions
It should be used with extreme caution, in patients with history of seizure
disorders or in patients with other predisposing factors such as severe
hepatic cirrhosis or a CNS tumour, and in those undergoing abrupt
withdrawal from alcohol or Benzodiazepines. The use of Bupropion in
patients with other risk factors for seizures (for example, alcohol abuse, a
history of head trauma, diabetes, and drugs known to lower the seizure
threshold) should only be undertaken when there are compelling clinical
reasons. Bupropion should be used with caution in patients with bipolar
depression or psychoses and in patients with a recent history of
myocardial infarction or unstable heart disease and in hepatic or renal
impairment.

Drug Interactions
Bupropion should not be given concurrently with or within 14 days of
stopping an MAOI. The use of alcohol should be minimised or avoided
completely because it may alter the seizure threshold. Similarly, other
drugs that lower the seizure threshold, such as other antidepressants,
antimalarials, antipsychotics, sedating antihistamines, Quinolones,
Tramadol, Theophylline, or systemic corticosteroids, should be used with
extreme caution together with Bupropion. Carbamazepine,

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Phenobarbital, or Phenytoin may induce the metabolism of Bupropion
while other drugs such as Cimetidine or Ritonavir may inhibit its
metabolism. Interaction may occur between Bupropion and
Orphenadrine, Cyclophosphamide, and Ifosfamide. Caution should be
exercised when it is given with drugs such as some antidepressants,
antipsychotics, blockers, and type 1C antiarrhythmics.

Side Effects
Agitation, anxiety, and insomnia often occur during the initial stages of
Bupropion therapy. Other relatively common side effects reported with
Bupropion include fever, dry mouth, headache or migraine, dizziness,
nausea and vomiting, constipation, tremor, sweating, and skin rashes.
Hypersensitivity reactions, ranging from pruritus and urticaria, less
commonly, angio-oedema, dyspnoea, and anaphylactoid reactions have
been reported.

Use in Special Populations

Pregnancy : There are no adequate and well controlled studies in pregnant
women. This drug should be used during pregnancy only if clearly
needed.

Lactation : Bupropion and its metabolites are secreted in human milk.

Because Bupropion is excreted in human milk, a decision should be made
whether to discontinue breast feeding or to discontinue the drug.

Child and adolescent under 18 years : Not recommended.

Commercial Pack
Zybex SR Tablet : Box containing 3 x 10s Alu-Alu form pack. Each
sustained release tablet contains Bupropion Hydrochloride USP 150 mg

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