IMPORTANT SAFETY INFORMATION
Quinidine and Related Drugs: NUEDEXTA contains quinidine,
and should not be used concomitantly with other drugs containing
quinidine, quinine, or mefloquine.
Hypersensitivity: NUEDEXTA is contraindicated in patients
with a history of NUEDEXTA-, quinine-, mefloquine-, or
quinidine-induced thrombocytopenia, hepatitis, bone-marrow
depression, lupus-like syndrome, or known hypersensitivity to
dextromethorphan (eg, rash, hives).
MAOIs: NUEDEXTA is contraindicated in patients taking
monoamine oxidase inhibitors (MAOIs), or in patients who have
taken MAOIs within the preceding 14 days, due to the risk of
serious and possibly fatal drug interactions, including serotonin
syndrome. Allow at least 14 days after stopping NUEDEXTA before
starting an MAOI.
Cardiovascular: NUEDEXTA is contraindicated in patients
with a prolonged QT interval, congenital long QT syndrome, history
suggestive of torsades de pointes, heart failure, patients
receiving drugs that both prolong QT interval and are metabolized
by CYP2D6 (eg, thioridazine and pimozide), patients with complete
atrioventricular (AV) block without implanted pacemaker, or at
high risk of complete AV block.
WARNINGS AND PRECAUTIONS
Thrombocytopenia and Other Hypersensitivity Reactions:
Quinidine can cause immune-mediated thrombocytopenia that can be
severe or fatal. Non-specific symptoms, such as lightheadedness,
chills, fever, nausea, and vomiting, can precede or occur with
thrombocytopenia. NUEDEXTA should be discontinued immediately if
Hepatotoxicity: Hepatitis, including granulomatous
hepatitis, has been reported in patients receiving quinidine,
generally during the first few weeks of therapy. Discontinue
immediately if this occurs.
Cardiac Effects: NUEDEXTA causes dose-dependent QTc
prolongation. QT prolongation can cause torsades de pointes–type
ventricular tachycardia, with the risk increasing as the degree of
prolongation increases. When initiating NUEDEXTA in patients at
risk for QT prolongation and torsades de pointes,
electrocardiographic (ECG) evaluation of QT interval should be
conducted at baseline and 3 to 4 hours after the first dose. Some
risk factors include use with CYP3A4 inhibitors or drugs that
prolong QT interval, electrolyte abnormalities, bradycardia, or
left ventricular hypertrophy or dysfunction. If patients taking
NUEDEXTA experience symptoms that could indicate the occurrence of
cardiac arrhythmias (eg, syncope or palpitations), NUEDEXTA should
be discontinued, and the patient further evaluated.
Concomitant Use of CYP2D6 Substrates: NUEDEXTA inhibits
CYP2D6 and may interact with other drugs metabolized by CYP2D6.
Adjust dose of CYP2D6 substrates as needed.
Dizziness: NUEDEXTA may cause dizziness. Take precautions
to reduce the risk of falls.
Serotonin Syndrome: Use of NUEDEXTA with selective
serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants
increases the risk of “serotonin syndrome.”
Anticholinergic Effects of Quinidine: Monitor for worsening
in myasthenia gravis.
The most common adverse reactions (incidence of ≥3% and two-fold
greater than placebo) in patients taking NUEDEXTA are diarrhea,
dizziness, cough, vomiting, asthenia, peripheral edema, urinary
tract infection, influenza, increased gamma-glutamyltransferase,
These are not all the risks for use of NUEDEXTA. Please see
Full Prescribing Information.
INDICATION AND USAGE
NUEDEXTA®(dextromethorphan HBr and quinidine sulfate) is indicated
for the treatment of pseudobulbar affect (PBA). PBA occurs
secondary to a variety of otherwise unrelated neurologic
conditions, and is characterized by involuntary, sudden, and
frequent episodes of laughing and/or crying. PBA episodes
typically occur out of proportion or incongruent to the underlying
emotional state. PBA is a specific condition, distinct from other
types of emotional lability that may occur in patients with
neurologic disease or injury.