Nuedexta

Before taking dextromethorphan and quinidine,

• tell your doctor and pharmacist if you are allergic to dextromethorphan, quinidine (Quinidex), quinine (Qualaquin), mefloquine (Lariam), any other medications, or any of the ingredients in combination dextromethorphan and quinidine capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you are taking mefloquine (Lariam), pimozide (Orap), quinine (Qualaquin) thioridazine, or or another product containing quinidine (Quinidex). Your doctor will probably tell you not to take dextromethorphan and quinidine if you are taking one or more of these medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants including clomipramine (Anafranil), desipramine (Doxepin, Sinequan), fluoxetine (Prozac, Sarafem), nefazodone, and paroxetine (Paxil, Pexeva); aprepitant (Emend); clarithromycin (Biaxin, Prevpac); cough and cold medications containing dextromethorphan; cisapride; digoxin (Lanoxin, Digitek); erythromycin (E.E.S. E-Mycin, Erythrocin); fluconazole (Diflucan); itraconazole (Sporanox); ketoconazole (Nizoral); certain medications for human immunodeficiency virus (HIV) such as atazanavir (Reyataz), amprenavir (Agenerase), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); medications for irregular heart beat such as amiodarone (Cordarone),diltiazem (Cardizem, Cartia, Tiazac, others), disopyramide (Norpace), dofetilide (Tikosyn), procainamide (Procanbid, Pronestyl),sotalol (Betapace), and verapamil (Calan, Covera, Isoptin, Verelan, in Tarka); medications for pain such as codeine, hydrocodone (in Hydrogesic, Lorcet, Lortab, Vicodin, Zydone, others), and methadone; moxifloxacin (Avelox); sparfloxacin (Zagam); and teliththromycin (Ketek). Also tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: MAO inhibitors including isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with dextromethorphan and quinidine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have or have ever had the following conditions while taking quinidine, quinine, or mefloquine: decrease in the number of blood cells in your bone marrow, lupus (a condition in which the body attacks its own tissues causing damage and swelling), or hepatitis (swelling of the liver). Also tell your doctor if you have or have ever had abnormal heart rhythms or heart failure. Your doctor will probably tell you not to takedextromethorphan and quinidine.
• tell your doctor if you have or have ever had myasthenia gravis (a disorder of the nervous system that causes muscle weakness), a history of street drug use or prescription drug misuse, high blood pressure, a stroke, low levels of potassium or magnesium in your blood, or heart, kidney, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking the combination of dextromethorphan and quinidine, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking dextromethorphan and quinidine.
• you should know that dextromethorphan and quinidine may make you dizzy. It is important to be careful to avoid falls while taking this medication.
• ask your doctor about the safe use of alcoholic beverages while you are taking dextromethorphan and quinidine. Alcohol can make the side effects from this medication worse.

Skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed one. Be sure to allow 12 hours between doses.

Contraindications

Hypersensitivity

History of quinine, mefloquine, or quinidine-induced thrombocytopenia, hepatitis, bone marrow depression, or lupus-like syndrome

Concomitant use with drugs containing quinidine, quinine, or mefloquine

Coadministration of MAOIs or use within 14 d

Drugs that both prolong QT interval and are metabolized by CYP2D6 (eg, thioridazine, pimozide)

Complete AV block (without implanted pacemakers)

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

Cautions

Quinidine can cause immune-mediated thrombocytopenia (discontinue if thrombocytopenia occurs)

Hepatotoxicity reported within first few weeks following initiation of quinidine

Monitor for QTc prolongation if concomitant use of drugs taht prolong QT interval cannot be avoided or concomitant CYP3A4 used

Quinidine may cause anticholinergic effects and exacerbate certain conditions (eg, myasthenia gravis)

Monitor ECG in patients with left ventricular hypertrophy or left ventricular dysfunction

Dextromethorphan may cause serotonergic effects; monitor for worsening in myasthenia gravis and other sensitive conditions

Use caution with CYP2D6 poor metabolizers

CYP3A4 inhibitors may increase quinidine serum levels and risk for QT prolongation

Coadministration with CYP2D6 substrates other than dextromethorphan that cause accumulation of parent drug and/or failure of metabolite formation may decrease safety and/or efficacy of concomitant CYPD6 metabolized drugs; adjust dose of CYPD6 substrate or use alternative therapy when indicated

Concomitant use of dextromethorphan with serotonergic drugs (eg, SSRIs, TCAs) may increase risk for serotonin syndrome

Quinidine may increase digoxin levels (as much as double) by inhibiting P-glycoprotein

Coadministration with alcohol or other CNS depressants may cause additive effects

May cause dizziness; use precautions to reduce falls

Nuedexta is a prescription medication approved for the treatment of pseudobulbar affect (PBA), a condition characterized by involuntary, sudden, uncontrolled episodes of laughing or crying, when there appears to be nothing to laugh or cry about.

Nuedexta contains a combination of two medications, dextromethorphan hydrobromide and quinidine sulfate. Dextromethorphan is in a class of medications called central nervous system agent (nerve tissues that control activities of the body) and the way it works in the brain to treat PBA is not known. Quinidine is in a class of medications called antiarrhythmics (abnormal heart rhythm). When combined with dextromethorphan, quinidine works by increasing the amount of dextromethorphan in the body. It comes in the form of a capsule and is typically taken once or twice a day.

Common side effects of Nuedexta may include diarrhea and vomiting. Nuedexta can also cause dizziness. Do not drive or operate heavy machinery until you know how Nuedexta affects you.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Monoamine oxidase inhibitors (MAOIs) such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), selegiline (Emsam, Eldepryl, Zelapar) and rasagiline (Azilect). MAO inhibitors should not be taken in combination or two weeks before or after taking Nuedexta. 

• Selective Serotonin reuptake inhibitors (SSRIs), Tricyclic Antidepressants and other medications that could lead to serotonin syndrome such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), isocarboxazid (Marplan), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil), and linezolid (Zyvox)

• Medications that use the enzyme CYP2D6 such as desipramine, dextromethorphan, atomoxetine
• Medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil), and paroxetine (Paxil)
• Medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• Drugs that can cause an arrhythmia called Torsades des Point such as:
  • certain anti-arrhythmia medications including procainamide, sotalol (Betapace), quinidine, dofetilide (Tikosyn), amiodarone (Nexterone, Pacerone, Cordarone), ibutilide (Corvert)
  • certain fluoroquinolone antibiotics including levofloxacin (Levaquin), ciprofloxacin (Cipro), gatifloxacin (Zymar), moxifloxacin (Avelox)
  • certain macrolide antibiotics including clarithromycin (Biaxin), erythromycin (EES, others)
  • certain azole antifungals including ketoconazole (Nizoral), itraconazole (Sporanox, Onmel)
  • certain antidepressants including amitriptyline, desipramine (Norpramin), imipramine (Tofranil), doxepin (Silenor), fluoxetine (Prozac, Sarafem), sertraline (Zoloft), venlafaxine (Effexor XR)
  • certain antipsychotics including haloperidol (Haldol), droperidol (Inapsine), quetiapine (Seroquel XR), thioridazine, ziprasidone (Geodon), pimozide (Orap)
  • other medications including cisapride, sumatriptan (Treximet, Imitrex, Alsuma, Zecuity), zolmitriptan (Zomig),  arsenic trioxide (Trisenox), dolasetron (Anzemet), and methadone (Methadone, Dolophine)

This is not a complete list of Nuedexta drug interactions. Ask your doctor or pharmacist for more information.

Ask your healthcare provider if you are not sure if you are taking any of these medications. 

Your healthcare provider or pharmacist can tell you if it is safe to take Nuedexta with your other medicines. You should carry a list and update your medication changes each time you visit the doctor, pharmacy or if are admitted to the hospital. 

STORAGE

• Store Nuedexta at room temperature and away from excess heat, light and moisture (not in bathroom). 
• Keep this and all medicines tightly closed out of the reach of children.
• Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about proper disposal of your medication.

MONITOR

• Contact you healthcare provider if PBA symptoms persist or worsen. The need for continued treatment should be reassessed      periodically, as spontaneous improvment of PBA occurs in some patients.
•  An ECG an electrocardiogram ECG (measure electrical acitivity in the heart) will need to be done before and while taking Nuedexta.
• Lab tests including liver function, complete blood count and levels of potassium or magnesium in your blood need to be monitored before and while taking Nuedexta.

Fixed combination of dextromethorphan (a sigma-1 [σ1] receptor agonist and N-methyl-d-aspartate [NMDA] receptor antagonist) and quinidine (a class IA antiarrhythmic agent).1 2 6 10 11 Quinidine, a competitive inhibitor of CYP2D6, is used in the fixed combination to increase the systemic bioavailability of dextromethorphan.1 2 3 4 5 6

• Risk of hypersensitivity reactions.1 Importance of advising patients to seek immediate medical attention if they experience symptoms suggestive of a hypersensitivity reaction.1 (See Contraindications and Thrombocytopenia and Other Hypersensitivity Reactions under Cautions.)

• Risk of cardiac effects.1 Importance of patients informing their clinician of any personal or family history of QTc-interval prolongation.1 Importance of advising patients to immediately contact their clinician if they feel faint or lose consciousness.1 (See Contraindications and Cardiac Effects under Cautions.)

• Risk of dizziness.1 Importance of advising patients to take precautions to reduce the risk of falls, especially if they have motor impairment affecting gait or a history of falls.1

• Importance of advising patients to take dextromethorphan/quinidine exactly as prescribed, with an interval of approximately 12 hours between doses and no more than 2 capsules (each containing dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) in a 24-hour period.1 Importance of advising patients not to take a double dose if they miss a dose.1

• Importance of advising patients to contact clinician if symptoms of PBA persist or worsen.1

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., QTc-interval prolongation or other cardiac disease).1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of dextromethorphan and quinidine combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dextromethorphan and quinidine combination in the elderly.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Aurothioglucose
• Bepridil
• Cisapride
• Clorgyline
• Colchicine
• Dronedarone
• Fingolimod
• Fluconazole
• Grepafloxacin
• Iproniazid
• Isocarboxazid
• Itraconazole
• Ketoconazole
• Levomethadyl
• Mesoridazine
• Mifepristone
• Moclobemide
• Nelfinavir
• Nialamide
• Pargyline
• Phenelzine
• Pimozide
• Piperaquine
• Posaconazole
• Procarbazine
• Rasagiline
• Ritonavir
• Safinamide
• Saquinavir
• Selegiline
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tipranavir
• Toloxatone
• Tranylcypromine
• Vernakalant
• Voriconazole
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetazolamide
• Afatinib
• Ajmaline
• Alefacept
• Alfentanil
• Alfuzosin
• Almotriptan
• Amiodarone
• Amitriptyline
• Amoxapine
• Amphetamine
• Amprenavir
• Anagrelide
• Apomorphine
• Aprindine
• Arbutamine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Atazanavir
• Atracurium
• Azithromycin
• Bedaquiline
• Benzphetamine
• Betrixaban
• Blinatumomab
• Boceprevir
• Brexpiprazole
• Buprenorphine
• Bupropion
• Buserelin
• Butorphanol
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabigatran Etexilate
• Dabrafenib
• Darunavir
• Dasabuvir
• Dasatinib
• Decamethonium
• Degarelix
• Delamanid
• Delavirdine
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dextroamphetamine
• Digitoxin
• Digoxin
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Duloxetine
• Efavirenz
• Eliglustat
• Eluxadoline
• Enflurane
• Enzalutamide
• Erythromycin
• Escitalopram
• Etravirine
• Fentanyl
• Flecainide
• Fluoxetine
• Fluvoxamine
• Fosamprenavir
• Foscarnet
• Gatifloxacin
• Gemifloxacin
• Golimumab
• Gonadorelin
• Goserelin
• Granisetron
• Guselkumab
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxytryptophan
• Hydroxyzine
• Ibutilide
• Idelalisib
• Imipramine
• Infliximab
• Isavuconazonium Sulfate
• Isoflurane
• Isradipine
• Ivabradine
• Lanreotide
• Lapatinib
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Lidocaine
• Lidoflazine
• Linezolid
• Lisdexamfetamine
• Lopinavir
• Lorcainide
• Lorcaserin
• Lumacaftor
• Lumefantrine
• Mefloquine
• Memantine
• Meperidine
• Methadone
• Methamphetamine
• Methylene Blue
• Metronidazole
• Mexiletine
• Milnacipran
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Nalidixic Acid
• Nebivolol
• Netupitant
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Ombitasvir
• Ondansetron
• Oxycodone
• Oxymorphone
• Paliperidone
• Palonosetron
• Pancuronium
• Panobinostat
• Paritaprevir
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentazocine
• Pimavanserin
• Pirmenol
• Pitolisant
• Pixantrone
• Prilocaine
• Probucol
• Procainamide
• Prochlorperazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Remifentanil
• Ribociclib
• Salmeterol
• Secukinumab
• Sertraline
• Sevoflurane
• Sibutramine
• Simeprevir
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• Succinylcholine
• Sufentanil
• Sulfamethoxazole
• Sulpiride
• Sunitinib
• Tacrolimus
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tizanidine
• Topotecan
• Toremifene
• Tramadol
• Trazodone
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Tubocurarine
• Ulipristal
• Valbenazine
• Vandetanib
• Vardenafil
• Vasopressin
• Vecuronium
• Vemurafenib
• Venetoclax
• Venlafaxine
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vortioxetine
• Ziprasidone
• Zolmitriptan
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abarelix
• Abiraterone
• Amiloride
• Atenolol
• Cimetidine
• Clobazam
• Dalfopristin
• Dextromethorphan
• Dicumarol
• Fosphenytoin
• Galantamine
• Haloperidol
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Nifedipine
• Nisoldipine
• Paroxetine
• Phenobarbital
• Phenytoin
• Propranolol
• Quinidine
• Quinupristin
• Rifapentine
• Tolterodine
• Tramadol
• Verapamil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems caused by quinidine, quinine, or mefloquine, history of or
• Heart block without a pacemaker or
• Heart failure or
• Heart rhythm problems (e.g., congenital long QT syndrome, prolonged QT interval, or a history of torsade de pointes) or
• Hepatitis caused by quinidine, quinine, or mefloquine, history of or
• Lupus-like syndrome caused by quinidine, quinine, or mefloquine, history of or
• Thrombocytopenia (low platelets in the blood) caused by quinidine, quinine, or mefloquine, history of—Should not be used in patients with these conditions.

• Drug abuse or dependence, or history of—Dependence may be more likely to develop.

• Heart or blood vessel disease or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Hypertension (high blood pressure) or
• Stroke, history of—May increase risk for more serious side effects.

• Kidney disease, severe or
• Liver disease, severe—Higher blood levels of this medicine can occur, which increases the risk of serious side effects.

• Myasthenia gravis (severe muscle weakness)—Use with caution. May make this condition worse.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Feeling very tired or weak.
• Very bad dizziness.
• Very upset stomach or throwing up.
• Fever or chills.
• Swollen gland.
• Swelling in the arms or legs.
• Low mood (depression).
• Change in eyesight.
• A type of abnormal heartbeat (prolonged QT interval) can happen with Nuedexta. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

2.1       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.

Nuedexta is a low-affinity uncompetitive NMDA antagonist and sigma-1 receptor agonist that has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. However, Nuedexta is a combination product containing dextromethorphan and quinidine, and cases of dextromethorphan abuse have been reported, predominantly in adolescents.

While clinical trials did not reveal drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this experience the extent to which Nuedexta will be misused, diverted, and/or abused once marketed. Therefore, patients with a history of drug abuse should be observed closely for signs of Nuedexta misuse or abuse (e.g. development of tolerance, increases in dose, drug-seeking behavior). 

Nuedexta contains a combination of dextromethorphan and quinidine. Dextromethorphan affects the signals in the brain that trigger cough reflex and is generally used as a cough suppressant. Quinidine affects the way that the heart beats and is generally used in people with certain heart rhythm disorders.

Nuedexta is used to treat involuntary outbursts of crying or laughing in people with certain neurological disorders, including multiple sclerosis and amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease).

Nuedexta may also be used for purposes not listed in this medication guide.