Drug - Nuedexta (dextromethorphan hydrobromide/quinidine) [Avanir Pharmaceuticals]
Criteria for initial coverage
Patient has pseudobulbar affect (PBA) and none of the exclusion criteria listed below. A six month initial PA will be given.
Criteria for continued coverage
Prescriber must provide documentation of benefit, which should include at least a measure of the PBA episodes showing a reduction over time.
Exclusion criteria (all are contraindications)
- Patients with a prolonged QT interval
- Patients with a congenital long QT syndrome or a history suggestive of torsades de pointes
- Patients with heart failure as well as patients with, or at risk of, complete atrioventricular (AV) block, unless the patient has an implanted pacemaker
- Patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide)
- Patients who are using the following concomitant medications: quinidine, quinine, or mefloquine as well as monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days
FDA approved indication
Nuedexta is FDA approved for the treatment of pseudobulbar affect (PBA), a condition characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state.
Dosage forms and strengths
Capsules of dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg.
Starting dose: One capsule daily by mouth for 7 days.
Maintenance dose: After 7 days, 1 capsule every 12 hours.
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