Nuedexta Capsules

DRUG DESCRIPTION

NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) is an oral formulation of dextromethorphan hydrobromide USP and quinidine sulfate USP in a fixed dose combination.

Dextromethorphan hydrobromide is the pharmacologically active ingredient of NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) that acts on the central nervous system (CNS). The chemical name is dextromethorphan hydrobromide: morphinan, 3-methoxy-17-methyl-, (9?, 13?, 14?), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O with a molecular weight of 370.33. The structural formula is:

Dextromethorphan hydrobromide  Structural Formula Illustration

Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used in NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) to increase the systemic bioavailability of dextromethorphan. The chemical name is quinidine sulfate: cinchonan-9-01,6'-methoxy-, (9S) sulfate (2:1), (salt), dihydrate. Quinidine sulfate dihydrate has the empirical formula of (C20H24N2O2)2H2SO42H2O with a molecular weight of 782.96. The structural formula is:

The combination product, NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) , is a white to off-white powder. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) is available for oral use as NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate capsules) which contains 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate. The active ingredients are dextromethorphan hydrobromide monohydrate USP and quinidine sulfate dihydrate USP. Inactive ingredients in the capsule are croscarmellose sodium NF, microcrystalline cellulose NF, colloidal silicon dioxide NF, lactose monohydrate NF, and magnesium stearate NF.

What are the precautions when taking dextromethorphan hydrobromide and quinidine sulfate capsules (Nuedexta Capsules)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to dextromethorphan, quinidine, quinine, or mefloquine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorder (such as low platelets/white blood cells/red blood cells), kidney disease, liver disease, lupus-like syndrome, myasthenia gravis.

Quinidine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe...

Read All Potential Precautions of Nuedexta Capsules


Nuedexta Capsules Consumer (continued)

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 rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs (see also Drug Interactions section). Get medical help right away if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, unexplained fever, severe nausea/vomiting/diarrhea, twitching muscles.

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.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to dextromethorphan, quinidine, quinine, or mefloquine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorder (such as low platelets/white blood cells/red blood cells), kidney disease, liver disease, lupus-like syndrome, myasthenia gravis.

Quinidine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm. Before using quinidine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, heart block, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using quinidine safely.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk. Consult your doctor before breast-feeding.



Related Drugs Index: