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[td]Side effects of brexanolone include dizziness (10β20%), [[sedation]] (13β21%), headache (18%), nausea (10%), dry mouth (3β11%), loss of consciousness (3β5%), and [[flushing (physiology)|flushing]] (2β5%).<ref name="Zulresso label" /><ref name="FDA2019" /><ref name="Scott2019" /><ref name="Review of Allopregnanolone Agonist">{{cite journal | vauthors = Walkery A, Leader LD, Cooke E, VandenBerg A | title = Review of Allopregnanolone Agonist Therapy for the Treatment of Depressive Disorders | language = English | journal = Drug Design, Development and Therapy | volume = 15 | pages = 3017β3026 | date = 2021-07-09 | pmid = 34267503 | pmc = 8276990 | doi = 10.2147/DDDT.S240856 | doi-access = free }}</ref> It can produce [[euphoria]] to a degree similar to that of [[alprazolam]] (3β13% at infusion doses of 90β270 ΞΌg over a one-hour period).<ref name="Zulresso label" /> Serious or severe adverse effects are rare but may include [[altered state of consciousness]], [[Syncope (medicine)|syncope]], presyncope, fatigue, and [[insomnia]].<ref name="Review of Allopregnanolone Agonist"/>[/td] [td][/td]
[td][/td] [td]In the US, the food and drug administration requires a Risk Evaluation and Mitigation Strategy(REMS) to counteract the risks of excessive sedation and loss of consciousness. It requires that all patients be monitored for those symptoms every 2 hours in planned non sleep periods and that oxygen saturation be monitored with continuous pulse oximetry.<ref>{{cite web |title=Risk Evaluation and Mitigation Strategy (REMS) Document ZULRESSO (brexanolone) REMS Program |url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211371Orig1s000REMS.pdf |publisher=US Food and Drug Administration(FDA) |access-date=2 September 2025}}</ref>[/td]
[td]In the US, the Food and Drug Administration requires a Risk Evaluation and Mitigation Strategy(REMS) to counteract the risks of excessive sedation and loss of consciousness. It requires that all patients be monitored for those symptoms every 2 hours in planned non sleep periods and that oxygen saturation be monitored with continuous pulse oximetry.<ref>{{cite web |title=Risk Evaluation and Mitigation Strategy (REMS) Document ZULRESSO (brexanolone) REMS Program |url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211371Orig1s000REMS.pdf |publisher=US Food and Drug Administration(FDA) |access-date=2 September 2025}}</ref>[/td] [td][/td]
[td][/td] [td]==Biological function==[/td]
[td]==Biological function==[/td]
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[td]Side effects of brexanolone include dizziness (10β20%), [[sedation]] (13β21%), headache (18%), nausea (10%), dry mouth (3β11%), loss of consciousness (3β5%), and [[flushing (physiology)|flushing]] (2β5%).<ref name="Zulresso label" /><ref name="FDA2019" /><ref name="Scott2019" /><ref name="Review of Allopregnanolone Agonist">{{cite journal | vauthors = Walkery A, Leader LD, Cooke E, VandenBerg A | title = Review of Allopregnanolone Agonist Therapy for the Treatment of Depressive Disorders | language = English | journal = Drug Design, Development and Therapy | volume = 15 | pages = 3017β3026 | date = 2021-07-09 | pmid = 34267503 | pmc = 8276990 | doi = 10.2147/DDDT.S240856 | doi-access = free }}</ref> It can produce [[euphoria]] to a degree similar to that of [[alprazolam]] (3β13% at infusion doses of 90β270 ΞΌg over a one-hour period).<ref name="Zulresso label" /> Serious or severe adverse effects are rare but may include [[altered state of consciousness]], [[Syncope (medicine)|syncope]], presyncope, fatigue, and [[insomnia]].<ref name="Review of Allopregnanolone Agonist"/>[/td]Revision as of 08:25, 2 September 2025
[/td][td]Side effects of brexanolone include dizziness (10β20%), [[sedation]] (13β21%), headache (18%), nausea (10%), dry mouth (3β11%), loss of consciousness (3β5%), and [[flushing (physiology)|flushing]] (2β5%).<ref name="Zulresso label" /><ref name="FDA2019" /><ref name="Scott2019" /><ref name="Review of Allopregnanolone Agonist">{{cite journal | vauthors = Walkery A, Leader LD, Cooke E, VandenBerg A | title = Review of Allopregnanolone Agonist Therapy for the Treatment of Depressive Disorders | language = English | journal = Drug Design, Development and Therapy | volume = 15 | pages = 3017β3026 | date = 2021-07-09 | pmid = 34267503 | pmc = 8276990 | doi = 10.2147/DDDT.S240856 | doi-access = free }}</ref> It can produce [[euphoria]] to a degree similar to that of [[alprazolam]] (3β13% at infusion doses of 90β270 ΞΌg over a one-hour period).<ref name="Zulresso label" /> Serious or severe adverse effects are rare but may include [[altered state of consciousness]], [[Syncope (medicine)|syncope]], presyncope, fatigue, and [[insomnia]].<ref name="Review of Allopregnanolone Agonist"/>[/td] [td][/td]
[td][/td] [td]In the US, the food and drug administration requires a Risk Evaluation and Mitigation Strategy(REMS) to counteract the risks of excessive sedation and loss of consciousness. It requires that all patients be monitored for those symptoms every 2 hours in planned non sleep periods and that oxygen saturation be monitored with continuous pulse oximetry.<ref>{{cite web |title=Risk Evaluation and Mitigation Strategy (REMS) Document ZULRESSO (brexanolone) REMS Program |url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211371Orig1s000REMS.pdf |publisher=US Food and Drug Administration(FDA) |access-date=2 September 2025}}</ref>[/td]
[td]In the US, the Food and Drug Administration requires a Risk Evaluation and Mitigation Strategy(REMS) to counteract the risks of excessive sedation and loss of consciousness. It requires that all patients be monitored for those symptoms every 2 hours in planned non sleep periods and that oxygen saturation be monitored with continuous pulse oximetry.<ref>{{cite web |title=Risk Evaluation and Mitigation Strategy (REMS) Document ZULRESSO (brexanolone) REMS Program |url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211371Orig1s000REMS.pdf |publisher=US Food and Drug Administration(FDA) |access-date=2 September 2025}}</ref>[/td] [td][/td]
[td][/td] [td]==Biological function==[/td]
[td]==Biological function==[/td]
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