Nuedexta

Nuedexta

Generic Name: dextromethorphan hydrobromide and quinidine sulfate

Company: Avanir Pharmaceuticals, Inc.

Treatment for: Pseudobulbar Affect

The U.S. Food and Drug Administration (FDA) has approved Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect (PBA). Pseudobulbar affect occurs secondary to a variety of otherwise unrelated neurological 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 patient's underlying emotional state.

Highlights of Nuedexta Prescribing Information

These highlights do not include all the information needed to use Nuedexta safely and effectively. See full prescribing information for Nuedexta.

Indications and Usage

Nuedexta is 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). Studies to support the effectiveness of Nuedexta were performed in patients with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). Nuedexta has not been shown to be safe or effective in other types of emotional lability that can commonly occur, for example, in Alzheimer’s disease and other dementias.

Dosage and Administration

Starting dose: one capsule daily by mouth for 7 days.

Maintenance dose: After 7 days, 1 capsule every 12 hours.

Dosage Forms and Strengths

Nuedexta Capsules:

Dextromethorphan 20 mg/Quinidine 10 mg

Contraindications

Concomitant use with quinidine, quinine, or mefloquine.

Patients with a history of quinidine, quinine or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions.

Patients with known hypersensitivity to dextromethorphan

Use with an MAOI or within 14 days of stopping an MAOI. Allow 14 days after stopping Nuedexta before starting an MAOI.

Prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure.

Complete atrioventricular (AV) block without implanted pacemaker, or patients at high risk of complete AV block.

Concomitant use with drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine or pimozide).

Warnings and Precautions

Thrombocytopenia or other hypersensitivity reactions: Discontinue if occurs.

Hepatitis: Discontinue if occurs.

QT Prolongation: Monitor ECG if concomitant use of drugs that prolong QT interval cannot be avoided or if concomitant CYP3A4 inhibitors used.

Left ventricular hypertrophy (LVH) or left ventricular dysfunction (LVD): Monitor ECG in patients with LVH or LVD.

CYP2D6 substrate: Nuedexta inhibits CYP2D6. Accumulation of parent drug and/or failure of metabolite formation may decrease safety and/or efficacy of concomitant CYP2D6 metabolized drugs. Adjust dose of CYP2D6 substrate or use alternative treatment when clinically indicated.

Dizziness: Take precautions to reduce falls.

Serotonin syndrome: Use of Nuedexta with selective serotonin reuptake inhibitor (SSRI)'s or tricyclic antidepressants increases the risk. Discontinue if occurs.

Anticholinergic effects of quinidine: Monitor for worsening in myasthenia gravis and other sensitive conditions.

Nuedexta side effects

The most common adverse reactions (incidence of ? 3% and two-fold greater than placebo) in patients taking Nuedexta are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence.

To report SUSPECTED ADVERSE REACTIONS, contact Avanir Pharmaceuticals at (1-866-388-5041) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Desipramine: Exposure increases 8-fold. Reduce desipramine dose and adjust based on clinical response.

Paroxetine: Exposure increases 2-fold. Reduce paroxetine dose and adjust based on clinical response.

Digoxin: Increased digoxin substrate plasma concentration may occur.

Use In Specific Populations

Pregnancy: Based on animal data, may cause fetal harm.

Pediatric Use: Safety and effectiveness have not been established.

See also: Nuedexta side effects (in more detail)

Patient Counseling Information

Physicians are advised to discuss the following topics with patients for whom they prescribe Nuedexta:

Hypersensitivity Patients should be advised a hypersensitivity reaction to Nuedexta could occur. Patients should be instructed to seek medical attention immediately if they experience symptoms indicative of hypersensitivity after taking Nuedexta

Cardiac effects Patients should be advised to consult their healthcare provider immediately if they feel faint or lose consciousness. Patients should be counseled to inform their healthcare provider if they have any personal or family history of QTc prolongation.

Dizziness Patients should be advised that Nuedexta may cause dizziness. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.

Drug Interactions Inform patients that Nuedexta increases the risk of adverse drug interactions, Instruct patients to inform their healthcare provider about all the medications that they are taking before taking Nuedexta. Before taking any new medications, patients should tell their healthcare provider that they are taking Nuedexta>

Benefits and Risks Summarize for patients the risks of treatment with Nuedexta. Advise patients to tell their healthcare provider if they have side effects that bother them or do not go away.

Dosing Instructions Instruct patients to take Nuedexta exactly as prescribed. Instruct patients not to take more than 2 capsules in a 24-hour period and to make sure that there is an approximate 12-hour interval between doses, and not to take a double dose after they miss a dose.

General Patients should not share or give Nuedexta to others, even if they have the same symptoms, because it may harm them.

Advise patients to contact their healthcare provider if their PBA symptoms persist or worsen.

Advise patients to keep this and all medications out of reach of children and pets.