Nuedexta

Drug name: Dextromethorphan hydrobromide/quinidine sulfate composite capsules

English name: Nuedexta

Indications

NUEDEXTA is a combination product containing dextromethorphan hydrobromide, a noncompetitive NMDA receptor antagonist and sigma-1 agonist, and quinidine sulfate, a CYP450 2D6 inhibitor) for the treatment of pseudobulbar affect (PBA).

Specifications

Capsules: dextromethorphan hydrobromide 20 mg/quinidine sulfate 10 mg, 60 capsules per bottle.

Dosage

The recommended starting dose of NUEDEXTA is one capsule taken orally daily for the first 7 days of treatment. On the 8th day of treatment and thereafter, the daily dosage should be 2 capsules per day, 1 capsule every 12 hours.

Common Side Effects

The most common adverse reactions in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, peripheral edema, urinary tract infection, influenza, elevated gamma-glutamyl transferase, and flatulence.

Contraindications

NUEDEXTA contains quinidine and should not be used concurrently with other medicines containing quinidine, quinine, or mefloquine.

NUEDEXTA is contraindicated in patients with a history of quinine, mefloquine, or quinidine-induced thrombocytopenia, hepatitis, myelosuppression, or lupus-like syndrome. NUEDEXTA is also contraindicated in patients with known hypersensitivity to dextromethorphan (e.g., rash, urticaria).

NUEDEXTA is contraindicated in patients with QT prolongation, congenital long QT syndrome, or a history suggestive of torsade de pointes, and in patients with heart failure.

Precautions

Quinidine can cause severe or fatal immune-mediated thrombocytopenia. Nonspecific symptoms, such as dizziness, chills, fever, nausea, and vomiting, may precede or occur simultaneously with thrombocytopenia. If thrombocytopenia occurs, discontinue use immediately NUEDEXTA, unless the thrombocytopenia is clearly unrelated to the drug, as continued use may increase the risk of fatal bleeding. Likewise, it should not be restarted in sensitized patients NUEDEXTA, because thrombocytopenia that is more rapid and severe than the initial onset may occur. Structurally related drugs (including quinine and mefloquine) should not be used if immune-mediated thrombocytopenia is suspected NUEDEXTA because cross-sensitivity may occur. Quinidine-associated thrombocytopenia is often but not always the case

Quinidine has also been associated with lupus-like syndromes involving polyarthritis, sometimes with a positive antinuclear antibody test. Other associations include rash, bronchospasm, lymphadenopathy, hemolytic anemia, vasculitis, uveitis, angioedema, agranulocytosis, Sjogren's syndrome, myalgia, elevated serum levels of skeletal muscle enzymes, and pneumonia.