See Supplemental Patient Information
- Therapy may cause immune-mediated thrombocytopenia or other hypersensitivity reactions that can be severe or fatal. Suspend therapy immediately if such reactions occur
- Therapy may be associated with a lupus-like syndrome involving polyarthritis, occasionally with a positive antinuclear antibody test
- During the first few weeks of therapy, quinidine may cause hepatitis, including granulomatous hepatitis
- Dose-dependent QTc prolongation leading to torsades de pointes-type ventricular tachycardia may occur with the use of therapy; this risk increases as the degree of prolongation increases. When considering therapy in patients at risk of QT prolongation and torsades de pointes, conduct ECG evaluation of QT interval at baseline and 3-4 hrs following the first dose
- Closely monitor ECG during concomitant use of drugs that prolong QT interval or that are strong or moderate CYP3A4 inhibitors, and patients with left ventricular hypertrophy or left ventricular dysfunction
- Reevaluate ECG if risk factors for arrhythmia change during the course of therapy. These include concomitant use of drugs associated with QT prolongation, bradycardia, electrolyte abnormality, and family history of QT abnormality
- Hypokalemia and hypomagnesemia, if present, should be corrected prior to therapy initiation, and should be regularly monitored during treatment
- Discontinue therapy and consider further evaluation if patients receiving therapy experience symptoms indicative of cardiac arrhthmia such as syncope or palpitations
- Caution should be exercised to reduce the risk of falls in patients with motor impairment affecting gait or a history of falls as therapy may cause dizziness
- Therapy may inhibit CYP2D6 in patients in whom CYP2D6 is not otherwise genetically absent. Accumulation of parent drug and/or failure of active metabolite formation may decrease the safety and/or efficacy of drugs administered concomitantly that are metabolized by CYP2D6. Adjust dose of CYP2D6 substrate or use alternative treatment when clinically indicated
- Serotonin syndrome with changes including altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor may occur when used with SSRIs or tricyclic antidepressants
- Monitor for worsening clinical condition in myasthenia gravis and other conditions that may be adversely affected by anticholinergic effects
Cautions: Use cautiously in
- Left ventricular hypertrophy
- Left ventricular dysfunction
- Risk of arrhythmia
- Myasthenia gravis
Supplemental Patient Information
- Instruct patients to promptly seek medical help if they experience any hypersensitivity reactions following therapy initiation
- Advise patients to contact their physician immediately if they feel faint or lose consciousness after taking dextromethorphan/quinidine
Pregnancy Category:C
Breastfeeding: No studies conducted on the excretion of dextromethorphan in milk or its effect on breastfed infants. However, this medication can be administered to infants as young as 1 month of age. It is unlikely that with usual maternal doses amounts in milk are as large as those given directly to infants or that breastfed infants would be harmed by the drug in breastmilk, especially in infants over 1 month of age. Avoid use of products with a high alcohol content while nursing. Limited data indicate that maternal quinidine doses up to 1.8 g/day produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants, particularly if the infant is >2 months of age. Exclusively breastfed infants should be carefully monitored if quinidine is used during lactation, possibly including measurement of serum levels to rule out toxicity if there is a concern. This information is based upon LactMed database http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 August 2011). Manufacturer advises caution.
US Trade Name(s)
US Availability
Nuedexta (dextromethorphan/quinidine)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Nuedexta 20-10 MG CAPS [Bottle] (AVANIR PHARMACEUTICALS)
LLC mg = $30
mg = $90
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
