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Dextromethorphan hydrobromide and quinidine sulfate capsules are 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 neurological disease or injury. …

• Starting dose: one capsule daily by mouth for 7 days
• Maintenance dose: After 7 days, 1 capsule every 12 hours
• Recommended Dose The recommended starting dose of dextromethorphan hydrobromide and quinidine sulfate capsules is one capsule daily by mouth for the initial seven days of therapy
• On the eighth day of therapy and thereafter, the daily dose should be a total of two capsules a day, given as one capsule every 12 hours
• The need for continued treatment should be reassessed periodically, as spontaneous improvement of PBA occurs in some patients

Dextromethorphan hydrobromide and quinidine sulfate capsules contain 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate in dark brown opaque cap/dark brown opaque body hard gelatin capsules imprinted with ‘ RJ86 ’ on cap in white ink. Capsules: Dextromethorphan hydrobromide 20 mg/quinidine sulfate 10 mg. (3)

• Concomitant use with quinidine, quinine, or mefloquine
• Patients with a history of quinidine, quinine or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions
• Patients with known hypersensitivity to dextromethorphan
• Use with an MAOI or within 14 days of stopping an MAOI
• Allow 14 days after stopping dextromethorphan hydrobromide and quinidine sulfate before starting an MAOI. …

Desipramine: Exposure increases 8-fold. Reduce desipramine dose and adjust based on clinical response. ( 7.5 , 12.4 ) Paroxetine: Exposure increases 2-fold. Reduce paroxetine dose and adjust based on clinical response. ( 7.5 , 12.4 ) Digoxin: Increased digoxin substrate plasma concentration may occur. ( 7.6 ) 7.1 MAOIs Do not use dextromethorphan hydrobromide and quinidine sulfate with monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days [see Contraindications (4.3) ] . …

Thrombocytopenia or other hypersensitivity reactions: Discontinue if occurs. ( 5.1 ) Hepatitis: Discontinue if occurs. ( 5.2 ) QT Prolongation: Monitor ECG if concomitant use of drugs that prolong QT interval cannot be avoided or if concomitant CYP3A4 inhibitors used. ( 5.3 ) Left ventricular hypertrophy (LVH) or left ventricular dysfunction (LVD): Monitor ECG in patients with LVH or LVD. ( 5.3 ) CYP2D6 substrate:Dextromethorphan hydrobromide and quinidine sulfate inhibits CYP2D6. Accumulation of parent drug and/or failure of metabolite formation may decrease safety and/or efficacy of concomitant CYP2D6 metabolized drugs. …

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). …

IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of dextromethorphan hydrobromide and quinidine sulfate in pregnant women. …

Evaluation and treatment of dextromethorphan hydrobromide and quinidine sulfate overdose is based on experience with the individual components, dextromethorphan and quinidine. Metabolism of the dextromethorphan component of dextromethorphan hydrobromide and quinidine sulfate is inhibited by the quinidine component, such that adverse effects of overdose due to dextromethorphan hydrobromide and quinidine sulfate might be more severe or more persistent compared to overdose of dextromethorphan alone. …

Dextromethorphan hydrobromide and quinidine sulfate is a low-affinity uncompetitive NMDA antagonist and sigma-1 receptor agonist that has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. However, dextromethorphan hydrobromide and quinidine sulfate is a combination product containing dextromethorphan and quinidine, and cases of dextromethorphan abuse have been reported, predominantly in adolescents. …

Tome assim que lembrar, a menos que esteja quase na hora da próxima dose. Nesse caso, pule a dose esquecida. Nunca tome duas doses de uma vez para compensar. Confira a bula, pois alguns medicamentos são diferentes.