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Nuedexta

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Nuedexta Capsules




Indications
Dosage
How Supplied

INDICATIONS

NUEDEXTA 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. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.

DOSAGE AND ADMINISTRATION

Recommended Dose

The recommended starting dose of NUEDEXTA 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 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.

Storage And Handling

NUEDEXTA is supplied as brick red gelatin capsules imprinted with “DMQ / 20-10”. NUEDEXTA is supplied in the following package configuration:

Package Configuration Capsule Strength (mg) NDC Code
Bottles of 60 (30 day supply) dextromethorphan 20 mg/ quinidine 10 mg 64597-301-60

Storage

Store NUEDEXTA 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. 1-949-389-6700. Revised January 2015

Last reviewed on RxList: 1/30/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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