DESCRIPTION
Elmood™ is a combined preparation of Dextromethorphan Hydrobromide and Bupropion Hydrochloride. Dextromethorphan is an uncompetitive antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. The mechanism of Dextromethorphan in the treatment of MDD is unclear. The mechanism of action of bupropion in the treatment of MDD is unclear; however, it may be related to noradrenergic and/or dopaminergic mechanisms. Bupropion increases plasma levels of Dextromethorphan by competitively inhibiting cytochrome P450 2D6, which catalyzes a major biotransformation pathway for Dextromethorphan. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.

INDICATIONS
Major depressive disorder (MDD) in adults.

DOSAGE AND ADMINISTRATION
Starting dosage is 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.
Moderate renal impairment: One tablet by mouth once daily in the morning.

CONTRAINDICATIONS
• Seizure disorder.
• Current or prior diagnosis of bulimia or anorexia nervosa.
• Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs.
• Use with an MAOI or within 14 days of stopping treatment with this combination. Do not use Elmood™ within 14 days of discontinuing an MAOI.
• Known hypersensitivity.

WARNING AND PRECAUTION
• Seizure: Risk is dose-related. Discontinue if seizure occurs.
• Increased Blood Pressure and Hypertension: this combination can increase blood pressure and cause hypertension. Assess blood pressure before
initiating treatment and monitor periodically during treatment.
• Activation of Mania or Hypomania: Screen patients for bipolar disorder.
• Psychosis and Other Neuropsychiatric Reactions: Instruct patients to contact a healthcare provider if such reactions occur.

SIDE EFFECTS
• Dizziness, headache, somnolence • Diarrhea, dry mouth
• Sexual dysfunction • Hyperhidrosis

STORAGE
Store at or below 30˚C temperature. Keep away from light and wet place. Keep out of reach of children.

PHARMACEUTICAL PRECAUTION
Do not store in wet place. Keep away from light. Keep out of reach of children.

PACKAGING
Elmood™ Tablet: Each Extended Release tablet contains 45 mg/105 mg dextromethorphan hydrobromide/ bupropion hydrochloride.