BUPROPION/ DEXTROMETHORPHAN TAB,SA
Clinical Criteria Summary
Indication & Patient Population
- Indicated for the treatment of major depressive disorder (MDD) in adults
- Clinical trial population included patients 18-65 years of age with a primary diagnosis of MDD, Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥25, and Clinician Global Impression-Severity (CGI-S) scale score ≥4
Contraindications
- Seizure disorder
- Current or prior diagnosis of bulimia or anorexia nervosa
- Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs
- Use with a monoamine oxidase inhibitor (MAOI) or within 14 days of stopping treatment with dextromethorphan and/or bupropion; do not use within 14 days of discontinuing an MAOI
- Known hypersensitivity to bupropion, dextromethorphan, or other components
Warnings & Precautions
- Box warning for suicidal thoughts and behaviors in adolescents and young adults
- Seizure risk
- Increased blood pressure and hypertension; assess blood pressure prior to initiation and monitor periodically throughout therapy
- Activation of mania or hypomania; screen for personal or family history of bipolar disorder, mania, or hypomania prior to initiation
- Psychosis and other neuropsychiatric reactions
- Angle-closure glaucoma; avoid use in patients with untreated anatomically narrow angles
- Dizziness
- Serotonin syndrome
- Embryo-fetal toxicity; may cause fetal harm and is not recommended during pregnancy
Formulary Status & Clinical Guidance
- Formulary status: Non-Formulary (NF) for MDD
- Not discussed in current MDD guidelines as the drug was unavailable when guidelines were developed
- Long-term published safety and efficacy data are lacking
- A trial in refractory depression (STRIDE-1) failed
- Potential abuse liability with long-term use in vulnerable patients requires further evaluation
- Represents an antidepressant combination with a unique mechanism of action for MDD management
Alternative Therapeutic Options
- Bupropion, Citalopram, Duloxetine, Escitalopram, Mirtazapine, Sertraline, Venlafaxine, Vilazodone, and Vortioxetine are listed with respective indications (e.g., MDD, GAD, fibromyalgia, musculoskeletal pain, neuropathic pain with DM, OCD, PD, PTSD, PMDD, SAD) and formulary status (predominantly Formulary [F])