Dextromethorphan hydrobromide/quinidine sulfate
(Redirected from Nuedexta)
What is Dextromethorphan hydrobromide/quinidine sulfate?[edit | edit source]
- Dextromethorphan hydrobromide/quinidine sulfate (NUEDEXTA) is a combination product containing dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 agonist) and quinidine sulfate (a CYP450 2D6 inhibitor) used for the treatment of pseudobulbar affect (PBA).
What are the uses of this medicine?[edit | edit source]
NUEDEXTA is used 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.
How does this medicine work?[edit | edit source]
- Dextromethorphan (DM) is a sigma-1 receptor agonist and an uncompetitive NMDA receptor antagonist.
- Quinidine increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6, which catalyzes a major biotransformation pathway for dextromethorphan.
- The mechanism by which dextromethorphan exerts therapeutic effects in patients with pseudobulbar affect is unknown.
Who Should Not Use this medicine ?[edit | edit source]
This medicine cannot be used:
- with quinidine, quinine, or mefloquine.
- In patients with a history of quinidine, quinine or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions.
- In patients with known hypersensitivity to dextromethorphan.
- with an MAOI or within 14 days of stopping an MAOI. Allow 14 days after stopping NUEDEXTA before starting an MAOI.
- In patients with Prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure.
- In patients with Complete atrioventricular (AV) block without implanted pacemaker, or patients at high risk of complete AV block.
- with drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine or pimozide).
What drug interactions can this medicine cause?[edit | edit source]
- Do not use NUEDEXTA with monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days.
- Do not use with drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine or pimozide).
- Recommend ECG in patients taking drugs with NUEDEXTA that prolong the QT interval and in patients taking concomitant moderate or strong CYP3A4 inhibitors.
- Use of NUEDEXTA with SSRIs or tricyclic antidepressants increases the risk of ‘serotonin syndrome’.
- Plasma digoxin concentrations should be closely monitored in patients taking NUEDEXTA concomitantly, and the digoxin dose reduced, as necessary.
- As with any other CNS drug, caution should be used when NUEDEXTA is taken in combination with other centrally acting drugs and alcohol.
- 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.
Is this medicine FDA approved?[edit | edit source]
- Dextromethorphan/quinidine was approved for medical use in the United States in October 2010, and is marketed by Avanir Pharmaceuticals.
How should this medicine be used?[edit | edit source]
Recommended dosage: Starting dose:
- one capsule daily by mouth for 7 days.
Maintenance dose:
- After 7 days, 1 capsule every 12 hours.
Administration:
- NUEDEXTA must be taken 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.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- As Capsules: Dextromethorphan hydrobromide 20 mg/quinidine sulfate 10 mg.
This medicine is available in fallowing brand namesː
- NUEDEXTA
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
- diarrhea
- dizziness
- cough
- vomiting
- asthenia
- peripheral edema
- urinary tract infection
- influenza
- increased gamma-glutamyltransferase
- flatulence
What special precautions should I follow?[edit | edit source]
- NUEDEXTA should be discontinued immediately if thrombocytopenia occurs, unless the thrombocytopenia is clearly not drug-related, as continued use increases the risk for fatal hemorrhage.
- Hepatitis, including granulomatous hepatitis, has been reported in patients receiving quinidine, generally during the first few weeks of therapy. Discontinue if occurs.
- NUEDEXTA causes dose-dependent QTc 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) may occur. Monitor ECG in patients with LVH or LVD.
- The quinidine in 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.
- NUEDEXTA may cause dizziness.
- Take precautions to reduce falls.
- Use of NUEDEXTA with selective serotonin reuptake inhibitor (SSRIs) or tricyclic antidepressants increases the risk of Serotonin syndrome. Discontinue if occurs.
- Monitor for worsening clinical condition in myasthenia gravis and other conditions that may be adversely affected by anticholinergic effects.
What to do in case of emergency/overdose?[edit | edit source]
Symptoms of overdosage may include: Quinidine overdose:
- ventricular arrhythmias
- hypotension
- vomiting
- diarrhea
- tinnitus
- high-frequency hearing loss
- vertigo
- blurred vision
- diplopia
- photophobia
- headache
- confusion
- delirium
Dextromethorphan overdose:
- nausea
- vomiting
- stupor
- coma
- respiratory depression
- seizures
- tachycardia
- hyperexcitability
- toxic psychosis
- ataxia
- nystagmus
- dystonia
- blurred vision
- changes in muscle reflexes
- serotonin syndrome
Treatment of overdosage:
- Treatment of dextromethorphan overdosage should be directed at symptomatic and supportive measures.
- Quinidine-induced hypotension that is not due to an arrhythmia is likely to be a consequence of quinidine-related α-blockade and vasorelaxation. Treatment of hypotension should be directed at symptomatic and supportive measures.
Can this medicine be used in pregnancy?[edit | edit source]
- There are no adequate data on the developmental risk associated with the use of NUEDEXTA in pregnant women.
Can this medicine be used in children?[edit | edit source]
- The safety and effectiveness in pediatric patients below the age of 18 have not been established.
What are the active and inactive ingredients in this medicine?[edit | edit source]
Active ingredient:
- DEXTROMETHORPHAN HYDROBROMIDE
- QUINIDINE SULFATE
Inactive ingredients:
- CROSCARMELLOSE SODIUM
- CELLULOSE, MICROCRYSTALLINE
- SILICON DIOXIDE
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
Who manufactures and distributes this medicine?[edit | edit source]
Marketed by:
- Avanir Pharmaceuticals, Inc.
- Aliso Viejo, CA
- AVANIR and NUEDEXTA are trademarks or registered trademarks of Avanir Pharmaceuticals.
What should I know about storage and disposal of this medication?[edit | edit source]
- Store NUEDEXTA capsules at controlled room temperature, 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F).
- Dailymed label info on Dextromethorphan hydrobromide/quinidine sulfate
- FDA Dextromethorphan hydrobromide/quinidine sulfate
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