This tablet preparation is indicated for the treatment of major depressive disorder (MDD) in adults.

This is a combined preparation of Dextromethorphan Hydrobromide and Bupropion Hydrochloride. Dextromethorphan acts as an uncompetitive antagonist of the NMDA receptor (an ionotropic glutamate receptor) and also as a sigma-1 receptor agonist. Its exact mechanism in the treatment of MDD is not fully understood. The mechanism of action of Bupropion in MDD is also not clearly established; however, it may be associated with noradrenergic and/or dopaminergic pathways. Bupropion increases plasma levels of Dextromethorphan by competitively inhibiting cytochrome P450 2D6, which is responsible for a major metabolic pathway of Dextromethorphan. It is a relatively weak inhibitor of neuronal reuptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or serotonin reuptake.

Starting dosage: One tablet once daily in the morning. After 3 days, increase to the maximum recommended dosage of one tablet twice daily, separated by at least 8 hours. Do not exceed two doses within the same day.

Use in children & adolescents: The safety and effectiveness of this tablet have not been established. Antidepressants, including bupropion, increase the risk of suicidal thoughts and behaviors in pediatric patients.

Moderate renal impairment: One tablet by mouth once daily in the morning.

Strong CYP2D6 inhibitors – Recommended dose is one tablet once daily in the morning.
Strong CYP2B6 inducers – Avoid concomitant use.
CYP2D6 substrates – May increase exposure of drugs metabolized by CYP2D6.
Digoxin – May reduce plasma digoxin levels; monitor levels regularly.
Drugs that lower seizure threshold – Concomitant use may increase seizure risk.
Dopaminergic drugs – May cause central nervous system (CNS) toxicity when used together.

• Seizure disorder.
• Current or prior diagnosis of bulimia or anorexia nervosa.
• Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs.
• Use with an MAOI or within 14 days of stopping MAOI therapy.
• Known hypersensitivity.

• Dizziness, headache,
• somnolence, diarrhea,
• dry mouth, sexual dysfunction,
• hyperhidrosis.

There are insufficient clinical data on use during pregnancy to determine risk of major birth defects, miscarriage, or adverse outcomes. However, data on bupropion alone have not shown an increased risk of congenital malformations in the first trimester. Untreated depression during pregnancy also poses risks to the mother. Bupropion and its metabolites are present in human milk, but effects on milk production are unknown. Limited data do not show a clear risk of adverse effects in breastfed infants.

• Seizure risk is dose-related; discontinue if seizure occurs.
• May increase blood pressure and cause hypertension; monitor blood pressure before and during treatment.
• Screen patients for bipolar disorder due to risk of mania or hypomania.
• Psychosis and other neuropsychiatric reactions may occur; advise patients to seek medical help if symptoms appear.

There is limited clinical experience with overdose of this combination. Information is based on individual components, dextromethorphan and bupropion. Due to inhibition of dextromethorphan metabolism by bupropion, overdose may be more severe or prolonged compared to dextromethorphan alone.

Combined anxiolytics and antidepressant drugs.

Store at or below 30°C. Protect from light and moisture. Keep out of reach of children. Do not store in a damp place.