DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

Electrolyte / Mineral

Oral

Mechanism of Action

12.1 Mechanism of Action Dextromethorphan (DM) is a sigma-1 receptor agonist and an uncompetitive NMDA receptor antagonist. Quinidine increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6, which catalyzes a major biotransformation pathway for dextromethorphan. The mechanism by which dextromethorphan exerts therapeutic effects in patients with pseudobulbar affect is unknown.

Indications

1 INDICATIONS AND USAGE NUEDEXTA 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

Contraindications

• 4 CONTRAINDICATIONS Concomitant use with quinidine
• quinine
• or mefloquine. ( 4.1 ) Patients with a history of quinidine
• quinine or mefloquine-induced thrombocytopenia
• hepatitis

FDA Warnings

5 WARNINGS AND PRECAUTIONS Thrombocytopenia or other hypersensitivity reactions: Discontinue if occurs
5 ) Serotonin syndrome: Use of NUEDEXTA with selective serotonin reuptake inhibitor (SSRIs) or tricyclic antidepressants increases the risk
1 Thrombocytopenia and Other Hypersensitivity Reactions Quinidine can cause immune-mediated thrombocytopenia that can be severe or fatal
NUEDEXTA should be discontinued immediately if thrombocytopenia occurs, unless the thrombocytopenia is clearly not drug-related, as continued use increases the risk for fatal hemorrhage

Known Side Effects

10 documented side effects by frequency

Drug Not Working

>10%

Dizziness

>10%

Diarrhea

1-10%

Nausea

1-10%

Fatigue

1-10%

Headache

1-10%

Vomiting

1-10%

Shortness of Breath

1-10%

Cough

1-10%

Drowsiness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral