Bupropion Hydrochloride is indicated for the treatment of depressive disorders. It is also used as an aid in smoking cessation.

Bupropion acts as a selective inhibitor of neuronal reuptake of catecholamines, specifically norepinephrine and dopamine. It has minimal effect on serotonin reuptake and does not inhibit monoamine oxidase. Although the exact mechanism of action is not fully understood, its antidepressant effect is believed to be related to its influence on noradrenergic and dopaminergic pathways.

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.

Child and adolescent: Not recommended for child and adolescent under 18 years of age.

Bupropion should not be used together with, or within 14 days of discontinuing, monoamine oxidase inhibitors (MAOIs).
Alcohol consumption should be limited or avoided, as it may lower the seizure threshold. Caution is required when used with other medications that reduce seizure threshold, such as antidepressants, antimalarials, antipsychotics, sedating antihistamines, quinolones, tramadol, theophylline, or systemic corticosteroids. Drugs like carbamazepine, phenobarbital, and phenytoin may increase the metabolism of bupropion, while cimetidine and ritonavir may decrease its metabolism. Potential interactions may also occur with orphenadrine, cyclophosphamide, and ifosfamide. Use caution when combining with antidepressants, antipsychotics, beta-blockers, and type 1C antiarrhythmic agents.

Bupropion Hydrochloride is contraindicated in patients with seizure disorders. It should not be used in patients receiving other bupropion-containing products due to the dose-related risk of seizures. It is also contraindicated in patients with a history of bulimia or anorexia nervosa due to increased seizure risk. Concurrent use with MAO inhibitors is contraindicated, and at least 14 days should pass between stopping MAOI therapy and starting bupropion. It is also contraindicated in patients with known hypersensitivity to bupropion or any of its components.

During the initial phase of therapy, agitation, anxiety, and insomnia are commonly observed. Other frequent adverse effects include fever, dry mouth, headache or migraine, dizziness, nausea, vomiting, constipation, tremor, sweating, and skin rash. Hypersensitivity reactions may occur, including itching, urticaria, and less commonly angioedema, dyspnea, or anaphylactoid reactions.

Pregnancy Category C. Adequate and well-controlled studies in pregnant women are not available. This drug should be used during pregnancy only if clearly needed. Bupropion and its metabolites are excreted in human milk. A decision should be made whether to discontinue breastfeeding or discontinue the drug, considering the importance of the treatment to the mother.

Use with extreme caution in patients with a history of seizures or risk factors such as severe hepatic cirrhosis or CNS tumors. Caution is also needed during abrupt withdrawal from alcohol or benzodiazepines. Patients with additional seizure risk factors (e.g., alcohol abuse, head trauma, diabetes, or use of seizure-threshold-lowering drugs) should only be treated when clearly necessary. Use carefully in patients with bipolar disorder, psychosis, recent myocardial infarction, unstable heart disease, or hepatic/renal impairment.

Atypical antidepressant drugs

Store below 30°C, protected from light and moisture. Keep out of reach of children.