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mittyri ★★ Russia, 2014-07-22 23:00 (3559 d 12:25 ago) Posting: # 13294 Views: 5,132 |
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Dear All, I would like to ask you about the safety concerns during the Moxifloxacin study. As you can see, the chapter Warnings of Prescribing information for Avelox states that "Moxifloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients. The drug should be avoided in patients with known prolongation of the QT interval..." So one can conclude that it will be important to add the exclusion criteria about size of QT. Good. The question is: what about the follow-up control of ECG for safety reasons? (just before dosing - to exclude in case of QT prolongation and after dosing - to monitoring possible significant prolongation) — Kind regards, Mittyri |
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Samaya B ☆ India, 2014-07-23 11:00 (3559 d 00:25 ago) @ mittyri Posting: # 13295 Views: 4,108 |
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Dear Mittyri, Ideally it is sufficient to take ECG (12-lead) at 0.00 hour (pre-dose) and at 2.50 hours (post-dose). The pre-dose ECG can be performed within 2 hours before dosing. Hope this would be helpful. Regards, Samaya. |
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Dr_Dan ★★ Germany, 2014-07-23 14:02 (3558 d 21:23 ago) @ mittyri Posting: # 13298 Views: 4,082 |
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Dear mittyri I would like to point out that follow-up controls of ECG are at the responsibility of the principal investigator and (s)he must decide what needs to be done i.e. how many ECG need to be recorded. Delayed repolarization of the heart following a heartbeat increases the risk of episodes of torsades de pointes. These episodes may lead to palpitations, fainting, and sudden death due to ventricular fibrillation. Therefore, IMHO ECG must be monitored before and after drug administration. Following a 400 mg oral dose peak concentrations of 3.1 mg/l are reached within 0.5 - 4 h post administration. At least this period of time needs to be monitored. I hope this helps. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz