QT time prolongation
Adverse drug events
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Explanations of the substances for patients
We have no additional warnings for the combination of prothipendyl and abarelix. Please also consult the relevant specialist information.
The reported changes in exposure correspond to the changes in the plasma concentration-time curve [ AUC ]. We do not expect any change in exposure for prothipendyl, when combined with abarelix (100%). We do not expect any change in exposure for abarelix, when combined with prothipendyl (100%).
The pharmacokinetic parameters of the average population are used as the starting point for calculating the individual changes in exposure due to the interactions.
The bioavailability, half-life, and volume of distribution of prothipendyl are unknown to us.
The bioavailability of abarelix is unknown. The terminal half-life [ t12 ] is rather long at 316.8 hours and constant plasma levels [ Css ] are only reached after more than 1267.2 hours. The protein binding [ Pb ] is 97.5% strong. The metabolism via cytochromes is currently still being worked on.
|Serotonergic Effects a||0||Ø||Ø|
Rating: According to our knowledge, neither prothipendyl nor abarelix increase serotonergic activity.
|Kiesel & Durán b||0||Ø||Ø|
Rating: According to our knowledge, neither prothipendyl nor abarelix increase anticholinergic activity.
QT time prolongation
Rating: In combination, prothipendyl and abarelix can potentially trigger ventricular arrhythmias of the torsades de pointes type.
General adverse effects
|Side effects||∑ frequency||pro||aba|
|Orthostatic hypotension||1.0 %||+||n.a.|
Venous thromboembolism: prothipendyl
Based on your answers and scientific information, we assess the individual risk of undesirable side effects. These recommendations are intended to advise professionals and are not a substitute for consultation with a doctor. In the restricted test version (alpha), the risk of all substances has not yet been conclusively assessed.
Abstract: OBJECTIVE: Specific sedation of acute psychotic patients with iv Haloperidol has been repeatedly criticized due to its cardiac risk on the basis of QTc prolongation, cumulating in the fact that iv application is no longer recommended according to the producer. Since Haloperidol still provides the only iv formulation of a high potency neuroleptic medication, and iv application offers some crucial advantages over other forms of application, we wanted to objectify QTc prolongation of Haloperidol iv as well as QTc prolongation of Prothipendyl iv, a low potency neuroleptic medication for unspecific sedation. METHODS: In our department all treatments with Haloperidol and Prothipendyl iv are ECG monitored and documented following an appointed guideline. Over 3 years all treatments according to this scheme and additionally treatments with Lorazepam iv have been analyzed regarding QTc prolongation. Non-parametric tests have been applied due to missing normal distribution of the data. RESULTS: 99 patients have been included in the survey. According to the iv medication applied patients have been divided into different subgroups. A significant QTc prolongation compared to the Lorazepam control group could be seen in the Haloperidol/Prothipendyl combination group as well as in the Prothipendyl monotherapy group, but not in the haloperidol monotherapy group. When patients were included, who additionally had received Lorazepam, results did not differ essentially with the exception that the Haloperidol/Prothipendyl combination had a significant greater prolongation than the Haloperidol group. CONCLUSIONS: Our data proves the well known fact that Haloperidol iv causes a pronounced QTc prolongation. However QTc prolongation by iv Prothipendyl is still more pronounced according to our data. Most potent in producing a QTc prolongation proved a combination of Prothipendyl and Haloperidol, a fact that most likely depicts a dose effect. Since we assume, that there will be continuing need for iv medication with Haloperidol and Prothipendyl in the future, due to lack of arguable alternatives, we recommend safety measures like ECG monitoring not only for Haloperidol, but too for unspecific sedation with iv Prothipendyl.