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Pimavanserin and Ryzolt

Determining the interaction of Pimavanserin and Ryzolt and the possibility of their joint administration.

Check result:
Pimavanserin <> Ryzolt
Relevance: 01.05.2022 Reviewer: Shkutko P.M., M.D., in

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Consumer:

Using traMADol together with pimavanserin can increase the risk of an irregular heart rhythm that may be serious and potentially life-threatening, although it is a relatively rare side effect. You may be more susceptible if you have a heart condition called congenital long QT syndrome, other cardiac diseases, conduction abnormalities, or electrolyte disturbances (for example, magnesium or potassium loss due to severe or prolonged diarrhea or vomiting). In addition, using narcotic pain medications together with other medications that also cause central nervous system depression can lead to serious side effects including respiratory distress, coma, and even death. Talk to your doctor if you have any questions or concerns. Your doctor may already be aware of the risks, but has determined that this is the best course of treatment for you and has taken appropriate precautions and is monitoring you closely for any potential complications. You should seek immediate medical attention if you develop sudden dizziness, lightheadedness, fainting, shortness of breath, or heart palpitations during treatment with these medications, whether together or alone. Do not drink alcohol with these medications without your doctor's approval and do not exceed the doses or frequency and duration of use prescribed by your doctor. Also, you should avoid driving or operating hazardous machinery until you know how these medications affect you. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Professional:

GENERALLY AVOID: Pimavanserin may cause dose-related prolongation of the QT interval. Tramadol may also prolong the QT interval, and theoretically, coadministration of multiple agents that can prolong the QT interval may result in additive effects and increased risk of ventricular arrhythmias including torsade de pointes and sudden death. In a thorough QTc study conducted in 252 healthy subjects, the maximum mean change in QTc interval from baseline was 13.5 msec at twice the therapeutic pimavanserin dosage given to steady state. In 6-week premarketing placebo-controlled effectiveness studies, mean increases in QTc interval were approximately 5 to 8 msec in patients receiving the recommended pimavanserin dosage of 34 mg once daily. Sporadic Fridericia-corrected QT interval (QTcF) values of 500 msec or greater and change from baseline values of 60 msec or greater were observed in subjects treated with pimavanserin, although the incidence was generally similar to that reported for placebo groups. There were no reports of torsade de pointes arrhythmia or differences from placebo in any other adverse reactions associated with delayed ventricular repolarization due to pimavanserin. The effect of tramadol on the QT interval was evaluated in a randomized, double-blind, 4-way crossover, placebo- and positive-controlled, multiple-dose ECG study of 62 healthy subjects. The maximum placebo-adjusted mean change from baseline in QTcF was 5.5 msec in the 400 mg/day treatment arm (100 mg every 6 hours on days 1 through 3 with a single 100 mg dose on day 4) and 6.5 msec in the 600 mg/day treatment arm (150 mg every 6 hours on days 1 through 3 with a single 150 mg dose on day 4), both occurring at the 8-hour time point. 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). The extent of drug-induced QT prolongation is dependent on the particular drug(s) involved and dosage(s) of the drug(s).

GENERALLY AVOID: Concomitant use of opioids such as tramadol with other central nervous system (CNS) depressants such as pimavanserin may result in hypotension, profound sedation, respiratory depression, coma, and death.

MANAGEMENT: Coadministration of pimavanserin with tramadol should generally be avoided. If coadministration is necessary, the dosage and duration of each drug should be limited to the minimum required to achieve the desired clinical effect. Patients should have regular ECGs and be monitored for arrhythmias when the QT interval is prolonged. Persistent QTc measurements exceeding 500 msec will require suspension of pimavanserin therapy and immediate action to correct any concomitant risk factors before resuming treatment. Particular care should be exercised in patients suspected to be at an increased risk of torsade de pointes. Patients should 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. In addition, patients should be monitored closely for signs and symptoms of respiratory depression and sedation, and advised to avoid driving or operating hazardous machinery until they know how these medications affect them.

References
  • US Food and Drug Administration "FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning. Available from: URL: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM518672.pdf." ([2016, Aug 31]):
  • "Product Information. Nuplazid (pimavanserin)." Accelis Pharma, East Windsor, NJ.
Pimavanserin

Generic Name: pimavanserin

Brand name: Nuplazid

Synonyms: n.a.

Ryzolt

Generic Name: tramadol

Brand name: ConZip, Rybix ODT, Ryzolt, Ultram, Ultram ER

Synonyms: n.a.

In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.

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