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Nuedexta

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Nuedexta Capsules

Nuedexta Capsules

INDICATIONS

NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) is 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.

Studies to support the effectiveness of NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias.

DOSAGE AND ADMINISTRATION

Recommended Dose

The recommended starting dose of NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) is one capsule daily by mouth for the initial seven days of therapy. On the eighth day of therapy and thereafter, the daily dose should be a total of two capsules a day, given as one capsule every 12 hours.

The need for continued treatment should be reassessed periodically, as spontaneous improvement of PBA occurs in some patients.

HOW SUPPLIED

Dosage Forms And Strengths

NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) capsules contain 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate in a brick red gelatin capsule with "DMQ/20-10" printed in white ink on the capsule.

NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) is supplied as brick red gelatin capsules imprinted with "DMQ / 20-10". NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) is supplied in the following package configurations:

Package Configuration Capsule Strength (mg) NDC Code
Bottles of 13 (sample) dextromethorphan 20 mg/ quinidine 10 mg 64597-011-13
Bottles of 60 (30 day supply) dextromethorphan 20 mg/ quinidine 10 mg 64597-011-60

Storage

Store NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) capsules at controlled room temperature, 25°C (77°F); excursions permitted to 15° - 30 °C (59° - 86°F) [See USP Controlled Room Temperature].

Marketed by: Avanir Pharmaceuticals, Inc. Aliso Viejo, CA 92656. Revised: 10/2010

Last reviewed on RxList: 12/10/2010
This monograph has been modified to include the generic and brand name in many instances.

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Nuedexta Capsules - User Reviews

Nuedexta Capsules User Reviews

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Report Problems to the Food and Drug Administration

 

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