Dextromethorphan hydrobromide/quinidine sulfate

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(Redirected from Nuedexta)

What is Dextromethorphan hydrobromide/quinidine sulfate?[edit | edit source]

Dextromethorphan skeletal
Dextromethorphan3Dan
Quinidine structure
Quinidine-3d-balls



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:

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:

Dextromethorphan overdose:

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).
Dextromethorphan hydrobromide/quinidine sulfate Resources
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