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Nuedexta

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Nuedexta Capsules

Nuedexta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) Capsules is a central nervous system agent used to treat involuntary outbursts of crying or laughing in people with certain neurological disorders. Common side effects of Nuedexta include diarrhea, gas, stomach pain, muscle spasm, dizziness, weakness, cough, and swelling of your hands or feet.

The recommended dose of Nuedexta is one capsule a day for 7 days, and 2 capsules a day after that. Emend, Tagamet, Lanoxin, codeine, Strattera, Desoxyn, Prozac, Zoloft, Biaxin, Oracea, Pediazole, Diflucan, Doxil, Cardizem, Rescriptor, and OxyContin may interact with Nuedexta. Tell your doctor all medications you take. Before taking Nuedexta tell your doctor if you have slow heartbeats or any other type of heart rhythm disorder, an electrolyte imbalance, bladder or bowel obstruction, myasthenia gravis, or a family history of long QT syndrome. If you are pregnant only take Nuedexta if the potential benefit outweighs the potential risk to the fetus. Exercise caution when taking Nuedexta while breastfeeding.

Our Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) Capsules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Nuedexta in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using dextromethorphan and quinidine and call your doctor at once if you have a serious side effect such as:

  • severe dizziness, fainting, fast or pounding heartbeat;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • pain or burning when you urinate;
  • fever, chills, flu symptoms, nausea, vomiting, feeling light-headed;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; or
  • joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions).

Less serious side effects may include:

  • diarrhea, gas, mild stomach pain;
  • muscle spasm;
  • dizziness, weakness;
  • cough; or
  • swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nuedexta (Dextromethorphan Hydrobromide and Quinidine Sulfate Capsules) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Nuedexta Overview - Patient Information: Side Effects

SIDE EFFECTS: Diarrhea, dizziness, cough, vomiting, weakness, or swelling in the hands/ankles/feet may occur. Infrequently, slight drowsiness may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur: easy bruising/bleeding, dark urine, muscle spasms, signs of infection (such as fever, persistent sore throat), stomach/abdominal pain, yellowing eyes/skin, lupus-like symptoms (joint/muscle pain, chest pain).

Get medical help right away if any of these serious side effects occur: fainting, fast/irregular heartbeat, severe dizziness.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Nuedexta (Dextromethorphan Hydrobromide and Quinidine Sulfate Capsules)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Nuedexta FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

A total of 946 patients participated in four Phase 3 controlled and uncontrolled PBA studies and received at least one dose of the combination product of dextromethorphan/quinidine in various strengths at the recommended or higher than the recommended dose. Of those patients, 393 patients were exposed for at least 180 days and 294 patients were exposed for at least one year. Median exposure was 168 days.

Controlled trials enrolled only patients with either ALS or MS. Uncontrolled studies enrolled 136 patients with PBA secondary to a wide variety of underlying neurological conditions including stroke (45 patients) and traumatic brain injury (23 patients). Consequently, patients with other underlying neurologic diseases may experience other adverse reactions not described below.

Clinical Trials Experience

A 12-week, placebo-controlled study evaluated NUEDEXTA (dextromethorphan 20 mg/quinidine 10 mg) (N=107) and a 30 mg dextromethorphan/10 mg quinidine combination (N=l 10) compared to placebo (N=109). Approximately 60% of patients had ALS and 40% had MS. Patients were 25 to 80 years of age, with a mean age of approximately 51 years. Three (3) ALS patients in each drug treatment arm and 1 ALS patient in the placebo arm died during the 12-week placebo-control period. All deaths were consistent with the natural progression of ALS.

Adverse Reactions Leading to Discontinuation

The most commonly reported adverse reactions (incidence ≥ 2% and greater than placebo) that led to discontinuation with the 20 mg dextromethorphan/10 mg quinidine twice daily dose were muscle spasticity (3%), respiratory failure (1%), abdominal pain (2%), asthenia (2%), dizziness (2%), fall (1%), and muscle spasms (2%).

Most Common Adverse Reactions

Adverse drug reactions that occurred in ≥ 3% of patients receiving the 20 mg dextromethorphan/10 mg quinidine twice daily dose, and at an incidence of ≥ 2 times placebo in short-term clinical trials in ALS and MS are provided in Table 1. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Table 1: Adverse Drug Reactions with an Incidence of ≥ 3% of Patients and ≥ 2x Placebo in NUEDEXTA-treated Patients by System-Organ Class and Preferred Term

  NUEDEXTA
N=107
%
Placebo
N=109
%
Diarrhea 13 6
Dizziness 10 5
Cough 5 2
Vomiting 5 1
Asthenia 5 2
Peripheral edema 5 1
Urinary tract infection 4 1
Influenza 4 1
Increased gamma- glutamyltransferase 3 0
Flatulence 3 1

Long-Term Exposure with NUEDEXTA

The experience in open-label clinical trials is consistent with the safety profile observed in the placebo-controlled clinical trials

Safety Experience of Individual Components

The following adverse reactions have been reported with the use of the individual components of NUEDEXTA, dextromethorphan and quinidine, from post-marketing experience. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dextromethorphan

Drowsiness, dizziness, nervousness or restlessness, nausea, vomiting, and stomach pain.

Quinidine

Cinchonism is most often a sign of chronic quinidine toxicity, but it may appear in sensitive patients after a single moderate dose of several hundred milligrams. Cinchonism is characterized by nausea, vomiting, diarrhea, headache tinnitus, hearing loss, vertigo, blurred vision, diplopia, photophobia, confusion, and delirium.

Convulsions, apprehension, and ataxia have been reported with quinidine therapy, but it is not clear that these were not simply the results of hypotension and consequent cerebral hypoperfusion in patients being treated for cardiovascular indications. Acute psychotic reactions have been reported to follow the first dose of quinidine, but these reactions appear to be extremely rare. Other adverse reactions occasionally reported with quinidine therapy include depression, mydriasis, disturbed color perception, night blindness, scotomata, optic neuritis, visual field loss, photosensitivity, keratopathy, and abnormalities of skin pigmentation.

Read the entire FDA prescribing information for Nuedexta (Dextromethorphan Hydrobromide and Quinidine Sulfate Capsules) »

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Nuedexta Capsules - User Reviews

Nuedexta Capsules User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Nuedexta Capsules sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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