Nuedexta (dextromethorphan/quinidine)

Drugs

What is Nuedexta?

Nuedexta is a brand-name prescription drug that’s used to treat pseudobulbar affect (PBA) in adults. This condition makes you have episodes of crying or laughing that are involuntary and out of your control.

Nuedexta contains a combination of two drugs: dextromethorphan hydrobromide and quinidine sulfate. Dextromethorphan belongs to a class of drugs called morphinans. Quinidine is part of a class of drugs called antiarrhythmics. These drugs work together in your body to help reduce the number of PBA episodes that you have.

Nuedexta comes as capsules that are taken by mouth. Each capsule contains 20 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate.

In a clinical study, people with PBA had fewer episodes when treated with Nuedexta. Those taking Nuedexta had 82% fewer PBA episodes after 12 weeks of treatment. People taking a placebo (treatment with no active drug) had 45% fewer PBA episodes.

Nuedexta generic

Nuedexta contains a combination of two active drugs: dextromethorphan hydrobromide and quinidine sulfate. It’s only available as a brand-name medication. There aren’t any generic forms of this combination medication available.

Each of the active drug ingredients in Nuedexta are available separately as generic drugs. However, these individual drugs haven’t been approved to treat PBA.

Nuedexta cost

As with all medications, the cost of Nuedexta can vary. To find current prices for Nuedexta in your area, check out GoodRx.com:

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance

If you need financial support to pay for Nuedexta, or if you need help understanding your insurance coverage, help is available.

Avanir Pharmaceuticals, Inc., the manufacturer of Nuedexta, offers a Co-Pay Savings Card and access to health insurance support services. For more information and to find out if you’re eligible, call 855-468-3339 or visit the program website.


Nuedexta uses

The Food and Drug Administration (FDA) approves prescription drugs such as Nuedexta to treat certain conditions. Nuedexta may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Nuedexta for pseudobulbar affect

Nuedexta is FDA-approved to treat pseudobulbar affect (PBA) in adults. This condition affects your nervous system. It causes you to lose control over how you express certain emotions.

The most common symptoms of PBA are episodes of uncontrollable crying or laughing. These episodes occur suddenly and don’t always reflect how you’re feeling at the time.

PBA is thought to be caused by underlying issues, such as:

Effectiveness

In a 12-week clinical study, Nuedexta was given to people with either amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS) who also had PBA. People treated with Nuedexta had 82% fewer PBA episodes. Those who were treated with a placebo (treatment with no active drug) had 45% fewer PBA episodes.

Two other clinical studies looked at using Nuedexta treatment in people with PBA caused by either ALS or MS. The Nuedexta dosage given in these studies was higher than the currently approved dosage.

In these studies, people’s responses to treatment were measured using a scale called the Center for Neurologic Study-Liability Scale (CNS-LS). This scale has a range of scores from 7 points (no symptoms) to 35 points (many symptoms). A score of 13 points or higher is typically used to diagnose PBA.

  • The first study, which lasted 4 weeks, looked at people with ALS and PBA. For people taking Nuedexta, their CNS-LS scores were reduced by 3.3 to 3.7 points more than those taking either dextromethorphan or quinidine (the two individual drugs in Nuedexta) alone.
  • The second study, which lasted 12 weeks, looked at people with MS and PBA. The CNS-LS scores were reduced in people treated with Nuedexta by 7.7 points. Scores were lowered by 3.3 points in people treated with a placebo (treatment with no active drug).

In a separate clinical study, Nuedexta was given to people with dementia, stroke, or traumatic brain injury who had PBA. This study also used CNS-LS scores to measure people’s response to treatment.

The average CNS-LS score prior to treatment with Nuedexta was 20.4 points. After taking Nuedexta for 90 days, people’s scores reduced to an average of 12.8 points. The number of PBA episodes people had each week were also lowered with Nuedexta treatment. Before treatment, people had about 12 episodes each week. After treatment, they had about 2 episodes each week.

Nuedexta for other conditions

Nuedexta has been studied for the following conditions, but it isn’t approved to treat them.

Nuedexta for ALS (not an approved use)

While Nuedexta is FDA-approved to treat PBA in people with amyotrophic lateral sclerosis (ALS), it’s not approved to treat ALS alone. However, it is being studied as a treatment option to improve symptoms of ALS, such as trouble speaking or swallowing.

One clinical study looked at treating ALS symptoms with either Nuedexta or a placebo (treatment with no active drug). The study found that people taking Nuedexta had fewer symptoms than people taking the placebo.

More studies are needed to know whether Nuedexta is safe and effective to treat ALS.

Nuedexta for depression (not an approved use)

Nuedexta isn’t FDA-approved to treat depression, but there have been some studies looking at using it to treat this condition.

One clinical study looked at using Nuedexta in people with treatment-resistant depression (TRD). This is a form of depression that hasn’t responded to at least two different antidepressant medications. After 10 weeks of treatment, people taking Nuedexta had fewer symptoms of depression.

Another clinical study looked at Nuedexta treatment in people with bipolar disorder. After 90 days of treatment, people taking Nuedexta reported improvement in their depression symptoms.

Nuedexta treatment hasn’t been studied in people with anxiety disorders. The studies shown above for TRD and bipolar disorder were small in size and didn’t compare Nuedexta to placebo or other medications.

More studies are needed to know whether Nuedexta is safe or effective to treat depression or other mental health conditions.

Nuedexta for agitation in Alzheimer’s disease (not an approved use)

Nuedexta is also being studied as treatment for agitation in people with Alzheimer’s disease. But it hasn’t been approved for this use yet.

Two phase III trials are currently looking at Nuedexta for this use. Phase III trials compare a treatment (in this case, Nuedexta) to treatment already used for a certain condition. One of these studies has been completed and the other study is set to be completed by the end of 2019.

The latest completed phase II study showed that people with Alzheimer’s disease who took Nuedexta had fewer symptoms of agitation and aggression than people taking a placebo.

More studies are needed to know whether Nuedexta is safe and effective to treat Alzheimer’s disease.

Nuedexta for irritability in autism (not an approved use)

Nuedexta has been studied to treat irritability and improve functioning in adults with autism spectrum disorder. But Nuedexta isn’t FDA-approved for this use.

In a very small 21-week clinical study, people with autism who were treated with Nuedexta had greater improvement in their symptoms than people treated with a placebo (treatment with no active drug).

More studies are needed to know whether Nuedexta is safe and effective to treat this condition.


Nuedexta dosage

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Nuedexta comes as gelatin capsules that are taken by mouth. Each capsule contains 20 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate.

Dosage for pseudobulbar affect

The dosage of Nuedexta to treat pseudobulbar affect (PBA) starts at a lower amount for the first week and then increases.

  • For the first week (days 1 to 7) of treatment, the typical dosage of Nuedexta is one capsule taken once each day.
  • Starting on day 8, the typical dosage of Nuedexta is one capsule taken twice each day (every 12 hours).

You’ll likely continue to take Nuedexta twice daily for however long you use this drug.

What if I miss a dose?

If you miss your dose of Nuedexta, take it as soon as you remember. If it’s almost time for your next dose, just skip your missed dose and take your next scheduled dose.

Don’t try to make up for your missed dose by taking more than one dose of Nuedexta at a time. This can increase your risk of having certain side effects.

Will I need to use this drug long term?

Nuedexta may be used as a long-term treatment. If you and your doctor determine that the drug is safe and effective for you, you’ll likely take it long term or as long as you have symptoms or episodes of pseudobulbar affect (PBA).

You should have regular appointments with your doctor to determine if you need to continue taking Nuedexta.

Alternatives to Nuedexta

Other drugs are available that can treat pseudobulbar affect (PBA). Some may be better suited for you than others. If you’re interested in finding an alternative to Nuedexta, talk with your doctor. They can tell you about other medications that may work well for you.

Nuedexta is the only medication that’s FDA-approved to treat PBA. Other medications have been used off-label to treat this condition. This means those drugs were approved to treat other conditions but have been used to treat PBA.

Examples of drugs that are sometimes used off-label to treat PBA include:

  • fluoxetine (Prozac)
  • sertraline (Zoloft)
  • citalopram (Celexa)
  • nortriptyline (Pamelor)
  • amitriptyline

Nuedexta vs. Prozac

You may wonder how Nuedexta compares to other medications that are prescribed for similar uses. Here we look at how Nuedexta and Prozac are alike and different.

General

Nuedexta contains the drugs dextromethorphan and quinidine. Prozac contains the drug fluoxetine. These drugs belong to different classes of medications.

Uses

Nuedexta is FDA-approved to treat PBA in adults.

Prozac is sometimes used off-label to treat PBA. Prozac is FDA-approved for use in adults and children (ages 7 and older) to treat the following conditions:

Prozac is FDA-approved for use in combination with olanzapine to treat these conditions:

  • acute depressive episodes related to bipolar I disorder
  • treatment-resistant depression (depression that hasn’t responded to previous treatment)

Drug forms and administration

Nuedexta comes as gelatin capsules that are taken by mouth. Each capsule contains 20 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate. Nuedexta is taken once daily for the first week of treatment. After the first week, it’s taken twice daily.

Prozac comes in two forms of capsules that are taken by mouth. The first type of capsule, which is taken once or twice daily, is available in the following strengths:

  • 10 mg
  • 20 mg
  • 40 mg

The second type of capsule contains 90 mg of the drug. This type of capsule is taken by mouth once each week.

In addition to capsules, Prozac also comes as a liquid solution that’s taken by mouth. The liquid form is helpful for people who have trouble swallowing pills.

Side effects and risks

Nuedexta and Prozac are different medications, but they can cause some similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Nuedexta, with Prozac, or with both drugs (when taken individually).

  • Can occur with Nuedexta:
  • Can occur with Prozac:
    • unusual dreams
    • loss of appetite
    • tremors
    • insomnia (trouble sleeping)
    • anxiety
  • Can occur with both Nuedexta and Prozac:
    • diarrhea
    • vomiting
    • dizziness
    • fatigue (lack of energy)
    • upper respiratory infections, such as the flu
    • gas and bloating
    • muscle cramps or weakness

Serious side effects

These lists contain examples of serious side effects that can occur with Nuedexta, with Prozac, or with both drugs (when taken individually).

  • Can occur with Nuedexta:
    • thrombocytopenia (low platelet count)
    • hepatitis (inflammation of your liver)
    • falls, caused by dizziness
  • Can occur with Prozac:
    • suicidal thoughts in children, adolescents, and young adults (less than 25 years of age)*
    • worsening of bipolar disorder and increased episodes of mania
    • seizures
    • weight loss
    • increased risk of easy bleeding, when taken with other drugs (such as anticoagulants)
    • angle-closure glaucoma (buildup of pressure inside your eye)
    • hyponatremia (low sodium levels), which can lead to serious events such as fainting, coma, or death
    • anxiety
  • Can occur with both Nuedexta and Prozac:
    • serotonin syndrome (buildup of serotonin in your body)
    • severe allergic reaction
    • irregular heart rhythm

* This is a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Nuedexta and Prozac have different FDA-approved uses, but they can both be used to treat pseudobulbar affect (PBA). Nuedexta is the only drug approved by the FDA to treat this condition. Prozac has been studied as a treatment for PBA and is currently used off-label for this condition.

These drugs haven’t been directly compared in clinical studies, but studies have found that both Nuedexta and Prozac are effective for treating PBA.

Costs

Nuedexta and Prozac are both brand-name drugs. There are currently no generic forms of Nuedexta. Prozac is available as a generic drug called fluoxetine. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Nuedexta is more expensive than Prozac. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.


Nuedexta and alcohol

Alcohol and Nuedexta may interact with each other in your body. This is because both Nuedexta and alcohol affect your central nervous system (CNS). Taking Nuedexta with alcohol can increase the effects of alcohol in your body, leading to the following symptoms:

  • impaired judgement
  • reduced coordination, which may increase your risk of falling
  • blurry vision
  • sleepiness

Talk with your doctor about whether it’s safe for you to drink alcohol while using Nuedexta. You may need to limit the amount of alcohol you consume while you’re using this drug.

Nuedexta interactions

Nuedexta can interact with several medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make your side effects more severe.

Nuedexta and other medications

Below are lists of medications that can interact with Nuedexta. These lists do not contain all the drugs that may interact with Nuedexta.

Before taking Nuedexta, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Drugs that cause abnormal heart rhythm

In some people, Nuedexta may cause abnormal heart rhythms (a heartbeat that’s too fast, too slow, or irregular). Taking Nuedexta with other medications that also affect your heart rhythm may cause life-threatening heart problems.

Because of this serious side effect, certain medications that affect your heart rhythm can’t be taken with Nuedexta. You shouldn’t take Nuedexta if you are taking either of these drugs:

  • thioridazine
  • pimozide

If you take other medications that affect your heart rhythm, your doctor may need to check your heart before you start taking Nuedexta. Examples of medications that may cause abnormal heart rhythms include:

  • heart rhythm medications, such as:
    • amiodarone (Pacerone, Nexterone)
    • dronedarone (Multaq)
    • dofetilide (Tikosyn)
    • sotalol (Betapace, Sorine, Sotylize)
  • certain antimicrobials, such as:
    • clarithromycin
    • levofloxacin
    • ketoconazole
  • certain antidepressants, such as:
    • amitriptyline
    • desipramine (Norpramin)
    • imipramine (Tofranil)
    • doxepin (Silenor)
    • nortriptyline (Pamelor)
    • fluoxetine (Prozac)

It’s important to talk with your doctor about all medications you take. If you are taking any of the medications listed above, you’ll need to talk with your doctor to see if Nuedexta is safe for you to use.

Drugs that increase the effects of Nuedexta

Nuedexta can interact with certain medications that are broken down (metabolized) in your body by a similar process. This interaction may slow down the metabolism of Nuedexta, which can increase the effects of the drug.

Examples of medications that may increase the overall effects of Nuedexta include:

  • Certain antimicrobials, such as:
    • clarithromycin (Biaxin)
    • erythromycin
    • fluconazole (Diflucan)
    • itraconazole (Sporanox)
    • ketoconazole (Nizoral, Extina, others)
    • telithromycin (Ketek)
  • Certain HIV medications, such as:
    • atazanavir (Reyataz)
    • fosamprenavir (Lexiva)
    • indinavir (Crixivan)
    • nelfinavir (Viracept)
    • ritonavir (Norvir)
    • saquinavir (Invirase)
  • Certain heart medications, such as:
    • diltiazem (Cartia, Diltzac)
    • verapamil (Calan, Ispotin)
    • amiodarone (Cordarone, Nexterone, Pacerone)
  • Certain antidepressants, such as:
    • escitalopram (Lexapro)
    • fluoxetine (Prozac)
    • sertraline (Zoloft)
    • nefazodone (Serzone)
  • Other medications, such as:
    • aprepitant (Emend)
    • tamoxifen (Nolvadex, Soltamox)
    • cyclosporine (Gengraf, Neoral, Sandimmune)

If you’re currently taking any of the drugs listed above, talk with your doctor. You may need a lower dose of the medication or a different medication altogether.

Drugs that work differently when taken with Nuedexta

Some drugs may work differently in your body when they’re taken with Nuedexta. This interaction can affect your treatment from those drugs.

Examples of medications that may be affected by Nuedexta include:

  • desipramine (Norpramin)
  • paroxetine (Paxil, Pexeva)
  • carvedilol (Coreg)
  • duloxetine (Cymbalta)
  • hydrocodone (Vicodin)
  • risperidone (Risperdal)
  • tramadol (Ultram)

If you’re currently taking any of the drugs listed above, talk with your doctor. You may need a different dose of the medication or a different medication altogether.

Certain antidepressant medications

Taking Nuedexta with certain antidepressants increases your risk of serotonin syndrome. This condition is caused by a buildup of serotonin in your body. Serotonin is a neurotransmitter (chemical messenger) that controls many processes inside your body. High levels of serotonin interfere with these processes. In some cases, serotonin syndrome can be life-threatening.

Certain antidepressants called monoamine oxidase inhibitors (MAOIs) should be avoided if you’re taking Nuedexta. You shouldn’t take Nuedexta within 14 days of taking an MAOI. Example of MOAIs include:

  • socarboxazid (Marplan)
  • phenelzine (Nardil)
  • selegiline (Emsam)
  • tranylcypromine (Parnate)

Other antidepressants that should be used cautiously with Nuedexta include:

  • amitriptyline
  • citalopram (Celexa)
  • doxepin
  • escitalopram (Lexapro)
  • fluoxetine (Prozac)
  • imipramine (Tofranil)
  • nortriptyline (Pamelor)
  • protriptyline (Vivactil)
  • sertraline (Zoloft)
  • vilazodone (Viibryd)

Before starting Nuedexta, talk with your doctor about any antidepressant drugs you’re taking. You may need a lower dose of your antidepressant or a different medication altogether.

Digoxin

One of the drugs (called quinidine) found in Nuedexta interacts with how digoxin is broken down in your body. This interaction increases your levels of digoxin, which can lead to digitoxin poisoning. Symptoms of this condition include:

  • nausea
  • vomiting
  • high potassium levels
  • abnormal heart rhythm

If you are taking digoxin, talk with your doctor before you start using Nuedexta. You may need a lower dose of digoxin or a different medication altogether.

Quinidine

Quinidine is one of the drugs contained in Nuedexta. Don’t take Nuedexta if you are taking other drugs that contain quinidine or medications similar to quinidine. Taking these drugs together can increase your risk of serious side effects.

Examples of these medications include:

  • quinidine
  • quinine (Qualaquin)
  • mefloquine

Before starting Nuedexta, talk with your doctor if you’re taking any of the medications listed above. It may not be safe for you to take Nuedexta.

Nuedexta and foods

It’s best to avoid eating grapefruit or drinking grapefruit juice while you’re taking Nuedexta. Grapefruit and its juice can increase the amount of Nuedexta in your body. Sometimes the drug levels can become too high, which may be dangerous.

Talk with your doctor about how much grapefruit or grapefruit juice is safe for you to consume while you’re taking Nuedexta.


Nuedexta side effects

Nuedexta can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Nuedexta. These lists don’t include all possible side effects.

For more information on the possible side effects of Nuedexta, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Nuedexta can include:

  • diarrhea
  • dizziness
  • cough
  • vomiting
  • fatigue (lack of energy)
  • muscle cramps or weakness
  • peripheral edema (swelling in your hands, lower legs, or feet)
  • urinary tract infection (UTI)
  • influenza
  • increased liver enzymes
  • gas and bloating

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Nuedexta aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects, which are discussed in more detail below, can include the following:

  • thrombocytopenia (low platelet count)
  • liver problems, such as hepatitis (inflammation in your liver)
  • abnormal heart rhythm
  • serotonin syndrome (a buildup of serotonin levels)
  • quinidine poisoning
  • falls, caused by dizziness
  • severe allergic reaction

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on some of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Nuedexta. Clinical studies didn’t report how often allergic reactions occurred in people taking the drug. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Nuedexta. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Thrombocytopenia

Thrombocytopenia is a possible side effect of Nuedexta. This condition occurs when your body doesn’t have enough platelets. Your body uses platelets to help you stop bleeding if you’re injured. Thrombocytopenia may increase your risk of serious bleeding.

Symptoms of this condition can include:

  • feeling lightheaded
  • chills
  • fever
  • red, purple, or brown bruises (called purpura) on your skin
  • small red or purple dots (called petechiae) on your skin
  • nosebleeds
  • bleeding that lasts longer than usual or doesn’t stop on its own
  • blood in your stool
  • blood in your urine

If you have symptoms of thrombocytopenia while using Nuedexta, tell your doctor right away. They may advise that you stop taking this drug.

Liver problems

Liver problems, including hepatitis (inflammation in your liver) can occur while taking Nuedexta. Symptoms of liver problems can include:

  • fatigue (lack of energy)
  • flu-like symptoms
  • dark-colored urine
  • pale-colored stool
  • abdominal pain
  • loss of appetite
  • weight loss
  • jaundice (yellow color to your skin and the whites of your eyes)

This side effect typically occurs within the first couple of weeks after you start taking Nuedexta.

If you have symptoms of liver problems while using Nuedexta, tell your doctor right away. They may advise that you stop using this medication.

Abnormal heart rhythms

Nuedexta can cause abnormal heart rhythms in some people. These abnormal rhythms are caused by an increase in your QT interval (a measurement on an EKG). An increased QT interval can cause abnormal heartbeat patterns or can worsen certain heart problems you might already have.

In a clinical study, about 4% of people taking Nuedexta at its approved dosage had an increased QT interval. About 6.6% of people taking a placebo (treatment with no active drug) had an increased QT interval. People taking Nuedexta in doses greater than its approved dosage had a slightly higher risk (about 7%) of having an abnormal heart rhythm.

Symptoms of abnormal heart rhythm can include:

  • fatigue (lack of energy)
  • feeling weak
  • dizziness
  • fainting
  • fast heartbeat or chest pounding
  • trouble breathing
  • chest pain or pressure

Talk with your doctor if you have a history of any heart problems before you start taking Nuedexta. You may need heart monitoring before you start, or while you’re taking this drug.

Call your doctor right away if you have symptoms of an abnormal heart rhythm while using Nuedexta. This condition can sometimes be dangerous if not treated right away.

Serotonin syndrome

Serotonin is a neurotransmitter (chemical messenger) that’s involved with many processes in your body. Taking Nuedexta with certain other antidepressants can increase the levels of serotonin in your body. This may lead to a condition called serotonin syndrome.

Symptoms of serotonin syndrome can include:

  • confusion
  • irritability
  • anxiety
  • muscle spasms or rigidity
  • tremors
  • diarrhea
  • high blood pressure
  • nausea
  • hallucinations
  • loss of consciousness
  • coma
  • seizures
  • abnormal heart rhythm

Clinical studies didn’t report how often serotonin syndrome occurred in people taking Nuedexta. If you have symptoms of this condition while taking Nuedexta, call your doctor right away. You may need medical treatment.

Quinidine poisoning

One of the drugs contained in Nuedexta is called quinidine. If it’s given in doses that are too high, or if it’s used long term, this drug may cause poisoning. Symptoms of quinidine poisoning can include:

Clinical studies didn’t report how often this side effect occurred in people taking Nuedexta. If you have symptoms of quinidine poisoning while taking Nuedexta, call your doctor right away. You may need medical treatment.

Falls due to dizziness

Dizziness is a common side effect of Nuedexta. In a clinical study, 10% of people taking Nuedexta felt dizzy. About 5.5% of people taking a placebo (treatment with no active drug) felt dizzy.

In some people, feeling dizzy can lead to an increased risk of falls. In the same clinical study, 13% of people taking Nuedexta at its approved dosage experienced a fall. People who took Nuedexta in doses greater than its approved dosage had a higher risk of falling.

Talk with your doctor about your risks of feeling dizzy or falling while using this medication. They can help you decide if the drug is safe for you and suggest ways to prevent falls while you’re taking Nuedexta.

How to take Nuedexta

You should take Nuedexta according to your doctor or healthcare provider’s instructions.

When to take

For the first seven days of treatment, you’ll take Nuedexta once each day, at the same time every day. It doesn’t matter what time of day you take it.

Starting on day 8 of treatment and continuing forward, you’ll take Nuedexta twice each day. You should take it about every 12 hours. You shouldn’t take more than one dose every 12 hours.

Taking Nuedexta with food

Nuedexta can be taken with or without food.

Can Nuedexta be crushed, split, or chewed?

No, you shouldn’t crush, split, or chew Nuedexta. This medication, which comes as capsules, is meant to be swallowed whole.


How Nuedexta works

It’s not known for sure how Nuedexta treats pseudobulbar affect (PBA). This condition is thought to be caused by injury to your nervous system. PBA makes you have episodes of crying or laughing that are out of your control.

Nuedexta contains two drugs, which work together in your body to treat PBA. These drugs are:

  • Dextromethorphan. This drug works on receptors (attachment sites) on your nerves. Receptors attach to different chemicals in your body to help your nerves function. Dextromethorphan helps certain receptors (called sigma-1 receptors) work better, while it blocks (stops) other receptors (called NMDA receptors) from working.
  • Quinidine. This drug slows down your body’s metabolism (breakdown) of dextromethorphan and helps dextromethorphan work better.

How long does it take to work?

Nuedexta may start working within the first week after you start taking it.

In clinical studies of Nuedexta, people had 44% fewer episodes of PBA after just one week of treatment. This drug acts differently in different people, so it may take a shorter or longer time to work for you.

Nuedexta and pregnancy

There aren’t enough human studies to know if Nuedexta is safe to use during pregnancy. In animal studies, pregnant animals who were given Nuedexta had increased risks of birth defects (including fetal death) in their offspring. However, animal studies don’t always predict what will happen in humans.

If you’re pregnant or planning to become pregnant, talk with your doctor about the safety of Nuedexta. Together you and your doctor can decide if this drug is a safe option for you.

Nuedexta and breastfeeding

Many drugs are known to pass into human breast milk. But there haven’t been any studies to know for sure if Nuedexta does this.

Talk with your doctor if you’re breastfeeding or planning to breastfeed and are taking Nuedexta. They will help you decide if Nuedexta is right for you.


Common questions about Nuedexta

Here are answers to some frequently asked questions about Nuedexta.

Will I have any withdrawal symptoms if I stop taking Nuedexta?

It’s not common to have withdrawal symptoms after stopping Nuedexta. Withdrawal symptoms weren’t reported in people taking this drug during clinical studies.

However, dextromethorphan (a drug contained in Nuedexta) can sometimes be misused. In these cases, it has been reported to cause withdrawal symptoms in some people.

Is Nuedexta an antipsychotic?

No, Nuedexta isn’t an antipsychotic. But sometimes it’s used to treat health conditions that can also be treated with antipsychotics, such as depression. Nuedexta isn’t FDA-approved to treat these other conditions. It’s used off-label in these cases.

Does Nuedexta cure PBA?

No, Nuedexta doesn’t cure pseudobulbar affect (PBA). It’s only approved to treat symptoms of PBA by decreasing the severity and frequency of PBA episodes. There’s currently no drug available that cures PBA.

Will Nuedexta help with my depression?

Nuedexta isn’t FDA-approved to treat depression, but it is currently being studied for this use. In clinical studies, Nuedexta improved symptoms of depression. However, more studies are needed to know whether Nuedexta is safe and effective for this use.

Can I just take dextromethorphan instead of Nuedexta?

Nuedexta is a combination of dextromethorphan and quinidine. Dextromethorphan alone hasn’t been approved to treat PBA.

One 4-week study looked at PBA treatment with either Nuedexta or dextromethorphan alone. This study found that Nuedexta worked better than dextromethorphan to reduce symptoms of PBA.

If you have questions about other treatment options for PBA, talk with your doctor about other drugs that can be used to treat the condition.


Nuedexta precautions

Before taking Nuedexta, talk with your doctor about your health history. Nuedexta may not be right for you if you have certain medical conditions. These include:

  • Allergic reaction. If you’ve had an allergic reaction to dextromethorphan or quinidine, you shouldn’t take Nuedexta. Reactions caused by quinidine can lead to low platelets, hepatitis, lupus-like syndrome, or bone marrow suppression. Talk to your doctor if you have a history of allergic reactions to either drug contained in Nuedexta.
  • History of falls. Dizziness, which is a side effect of Nuedexta, can increase your risk of falls. If you have a history of falls, talk with your doctor to see if this drug is safe for you. They may recommend ways to help reduce your risk of falls while you’re taking Nuedexta.
  • Heart problems. Nuedexta can cause abnormal heart rhythms. It shouldn’t be used in people who already have abnormal heart rhythms or heart failure. The drug may worsen your condition, leading to serious, possibly fatal, side effects. Talk with your doctor if you have a history of heart problems. Together you can decide if Nuedexta is right for you.

Note: For more information about the potential negative effects of Nuedexta, see the “Nuedexta side effects” section above.

Nuedexta overdose

Using more than the recommended dosage of Nuedexta can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

  • abnormal heart rhythm
  • quinidine poisoning, which may cause:
    • abnormal heart rhythm
    • low blood pressure
    • headache
    • hearing loss or ringing in your ears
    • blurred vision
    • sensitivity to light
    • double vision
    • confusion
    • stomach problems, including pain, nausea, vomiting, or diarrhea

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Nuedexta expiration, storage, and disposal

When you get Nuedexta from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Nuedexta capsules should be stored at a room temperature of 77°F (25°C). Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Nuedexta and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

Professional information for Nuedexta

The following information is provided for clinicians and other healthcare professionals.

Indications

Nuedexta is FDA-approved to treat pseudobulbar affect (PBA) in adults.

Mechanism of action

Nuedexta contains the drugs dextromethorphan and quinidine. Dextromethorphan agonizes sigma-1 receptors and is an NMDA-receptor antagonist. The exact mechanism of action of dextromethorphan to treat PBA is not known.

Quinidine decreases the metabolism of dextromethorphan by inhibiting CYP2D6. This increases the bioavailability of dextromethorphan.

Pharmacokinetics and metabolism

Nuedexta contains the drugs dextromethorphan and quinidine, which are both metabolized by the liver. Dextromethorphan is primarily metabolized by CYP2D6, while quinidine is primarily metabolized by CYP3A4.

Maximum concentration of quinidine occurs approximately 1 to 2 hours after administration. Maximum concentration of dextromethorphan occurs approximately 3 to 4 hours after administration. The half-lives of dextromethorphan and quinidine are 13 and 7 hours, respectively.

Contraindications

Nuedexta is contraindicated in people:

  • taking quinidine, quinine, or mefloquine
  • who have had a prior hypersensitivity reaction to quinidine, including quinidine-induced thrombocytopenia, hepatitis, bone marrow depression, or lupus-like syndrome
  • with a history of hypersensitivity to dextromethorphan
  • taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the last 14 days
  • with heart problems including heart failure, a prolonged QT interval, congenital long QT syndrome, history of torsades de pointes, complete atrioventricular (AV) block, or those at a high risk of complete AV block
  • taking drugs that both prolong QT interval and are metabolized by CYP2D6, such as thioridazine or pimozide

Misuse and dependence

The potential for misuse, tolerance, and dependence of Nuedexta has not been studied. However, misuse of dextromethorphan, a compound in Nuedexta, is a common issue in adolescents.

Clinical studies did not identify any signs associated with drug misuse or dependence. However, these studies were not designed to do so. People with a history of drug misuse who are using Nuedexta should be monitored for signs of misuse or drug-seeking behavior.

Storage

Nuedexta should be stored at a controlled room temperature of 77°F (25°C). Nuedexta should be kept out of the reach of children.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and isn’t intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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