dextromethorphan hydrobromide and quinidine sulfate
Drug Details
- Generic Name
- dextromethorphan hydrobromide and quinidine sulfate
- Brand Names
- NUEDEXTA, Nuedexta
- Application Number
- NDA021879
- Sponsor
- Avanir Pharmaceuticals, Inc.
- NDC Codes
- 3
- Dosage Forms
- CAPSULE, GELATIN COATED
- Routes
- ORAL
- Active Ingredients
- DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATE
Indications and Usage
1 INDICATIONS AND USAGE Dextromethorphan hydrobromide and quinidine sulfate capsules are indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is 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. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury. Dextromethorphan hydrobromide and quinidine sulfate capsules are a combination product containing dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 agonist) and quinidine sulfate (a CYP450 2D6 inhibitor) indicated for the treatment of pseudobulbar affect (PBA). ( 1 )