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Drug Interactions between deutetrabenazine and Paxil CR

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

PARoxetine deutetrabenazine

Applies to: Paxil CR (paroxetine) and deutetrabenazine

ADJUST DOSE: Coadministration with a strong CYP450 2D6 inhibitor may increase the plasma concentrations of the pharmacologically active dihydro-metabolites of deutetrabenazine, alfa- and beta-HTBZ (dihydrotetrabenazine), which may increase the risk of adverse effects, including somnolence, clinically relevant QT interval prolongation, parkinsonism, akathisia, neuroleptic malignant syndrome, depression, and suicidality. The interaction was evaluated in 25 healthy subjects given a single 22.5 mg dose of deutetrabenazine following 8 days of administration of the strong CYP450 2D6 inhibitor paroxetine (20 mg daily). An approximately 3-fold increase in systemic exposure for total (alfa and beta)-HTBZ was observed in the presence of paroxetine compared to deutetrabenazine given alone. Poor CYP450 2D6 metabolizer status (approximately 7% of Caucasians and 2% of Asians and those of African descent) is also predicted to increase exposure to alfa- and beta-HTBZ. Data are not available on the effect of moderate or weak CYP450 2D6 inhibitors on the exposure of deutetrabenazine and its metabolites.

GENERALLY AVOID: Deutetrabenazine has been associated with modest QT prolongation. A single 24 mg dose has been shown to increase the QTc by approximately 4.5 msec in a study in healthy male and female subjects. Coadministration with a strong CYP450 2D6 inhibitor may increase the plasma concentrations of the pharmacologically active metabolites of deutetrabenazine. However, data evaluating the effects at higher exposures to deutetrabenazine or its active metabolites are lacking. In general, the risk of an individual agent or a combination of agents causing ventricular arrhythmia in association with QT prolongation is largely unpredictable but may be increased by certain underlying risk factors such as congenital long QT syndrome, cardiac disease, and electrolyte disturbances (e.g., hypokalemia, hypomagnesemia). In addition, the extent of drug-induced QT prolongation is dependent on the particular drugs involved and dosages of the drugs.

MANAGEMENT: Pharmacologic response to deutetrabenazine should be monitored more closely whenever a strong CYP450 2D6 inhibitor (e.g.,fluoxetine, paroxetine, or quinidine) is added to or withdrawn from therapy. Deutetrabenazine is not recommended for use in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. Assessment of baseline QT interval and periodic monitoring during therapy may be considered. The maximum recommended dosage of deutetrabenazine is 18 mg per dose and 36 mg per day during coadministration with a potent CYP450 2D6 inhibitor or in patients who are poor metabolizers of CYP450 2D6. Patients and their caregivers should be advised to notify their physician if they experience new or worsening depression, suicidal thoughts, parkinsonism, restlessness, agitation, dysphagia, and/or excessive sedation while taking deutetrabenazine. Patients should also be advised to seek prompt medical attention if they experience symptoms that could indicate the occurrence of torsade de pointes such as dizziness, lightheadedness, fainting, palpitation, irregular heart rhythm, shortness of breath, or syncope. Ambulatory patients should be counseled to avoid hazardous activities requiring mental alertness and motor coordination until they know how these agents affect them, and to notify their doctor if they experience excessive or prolonged CNS effects that interfere with their normal activities.

References

  1. (2017) "Product Information. Austedo (deutetrabenazine)." Teva Pharmaceuticals USA

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Drug and food interactions

Moderate

PARoxetine food

Applies to: Paxil CR (paroxetine)

GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of CNS-active agents. Use in combination may result in additive central nervous system depression and/or impairment of judgment, thinking, and psychomotor skills.

MANAGEMENT: Patients receiving CNS-active agents should be warned of this interaction and advised to avoid or limit consumption of alcohol. Ambulatory patients should be counseled to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.

References

  1. Warrington SJ, Ankier SI, Turner P (1986) "Evaluation of possible interactions between ethanol and trazodone or amitriptyline." Neuropsychobiology, 15, p. 31-7
  2. Gilman AG, eds., Nies AS, Rall TW, Taylor P (1990) "Goodman and Gilman's the Pharmacological Basis of Therapeutics." New York, NY: Pergamon Press Inc.
  3. (2012) "Product Information. Fycompa (perampanel)." Eisai Inc
  4. (2015) "Product Information. Rexulti (brexpiprazole)." Otsuka American Pharmaceuticals Inc
View all 4 references

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.


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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.