Talk:Nimodipine

This was inserted:


 * "FDA ALERT [1/2006): The FDA has requested that Bayer add a boxed warning to the nimodipine (Nimotop) labeling to warn about medication administration errors with nimodipine. Nimodipine is approved for oral administration to improve neurological outcome after subarachnoid hemorrhage. When administered intravenously or parenterally, it can cause serious adverse events, including death.  Nimodipine must not be administered intravenously or by any parenteral route."  http://www.fda.gov/CDER/drug/InfoSheets/HCP/nimodipineHCP.htm  Pqmos 07:56, 18 January 2007 (UTC)

I'll rephrase this a bit, but it sounds serious. I thought intravenous nimodipine was in use once upon a time. JFW | T@lk  14:53, 2 March 2007 (UTC)


 * Greetings from over 12 years in the future. See a section below, but I just reviewed the patents and marketing approval applications (and grants) from 1971 through 1990-ish, all of which were initiated by Bayer. I am not sure how common it was, but Bayer patented IV use several times in several countries, and they asked for permission to market ampules of parenteral nimodipine several times in several countries. It is apparently not an immediately terrible idea, because they spent a lot of money asking for permission to market this over the course of a decade. So, parenteral nimodipine may be something that it turns out is a bad idea, but they didn't realize it for two decades. That sounds like exactly why you add a boxed warning to a 20-year-old drug. Nimotop is a brand name for capsules for oral administration, the label did not have this warning in 1988, but they added a warning. Of note: The IV preparation would not have been named "Nimotop", and it would have been ampules. Bayer had plans. Crushing, dissolving, and injecting pills is possibly dangerous for reasons that have nothing to do with why Bayer is not allowed to sell ampules of parenteral nimodipine under a different brand name. However - it also may be related. But quite honestly, Bayer got marketing approval for other IV antihypertensives that had "younger patents" (at least in the US), so that may be why US physicians were apparently crushing and injecting pills of a different chemical while Bayer had stopped throwing money into the pit of "let's get the FDA to approve parenteral nimodipine". Good medicine and good business are very different. Bayer thought IV nimodipine was good business in the 1970s, but then they abandoned this idea, possibly because they do have other products in that market segment with younger patents. Fluoborate (talk) 21:32, 11 April 2019 (UTC)

I'm surprised that my edit was revised, Nimodipine should never be administered via IV, this practice has become very strongly discouraged, I understand the FDA made warnings in '06 against this but they have reemphasized this as of four days ago, via the FDA: "[08-02-2010] The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals that nimodipine capsules should be given ONLY by mouth or through a feeding tube (nasogastric tube). This oral medication should NEVER be given by intravenous administration. FDA continues to receive reports of intravenous nimodipine use, with serious, sometimes fatal, consequences. Intravenous injection of nimodipine can result in death, cardiac arrest, severe falls in blood pressure, and other heart-related complications." http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220386.htm The link above has the full information. Anyway, it would be a bit of a disservice to suggest IV usage is still somehow appropriate. This practice is being eliminated due to its dangers, I wont re-edit the entry, but to who undid my entry, please take this into consideration and act accordingly. —Preceding unsigned comment added by Tunafizzle (talk • contribs) 06:03, 6 August 2010 (UTC)

Synthesis

Do we know anything about its synthesis? I'm interested in how they make it asymmetric. 129.67.128.35 (talk) 22:03, 28 October 2010 ( (UTC)

Bipolar
A non-MEDRS source was used to discuss the experimental use of nimodipine in bipolar disorder. JFW &#124; T@lk  10:52, 12 August 2018 (UTC)

Regarding edits on 2019-04-11 to patent date and approval date
Until I added two references a few moments ago, the entire lede section had only one reference (it was the first numbered citation until my edits, it is now the third numbered reference), that one reference was a paper book, and the superscript "(1)" came at the end of the entire lede section, so I'm honestly not sure what the paper book says. Does it say all of that? Quite possibly. I don't have that book.

There was only one thing in the lede section that does not look obviously true without checking, it said "nimodipine was approved for clinical use in 1985." Where? Apparently "Germany" is a valid answer to that question. It may not be the only true and valid answer. So I didn't delete the year 1985, but I did add "in Germany". I can't read German well, but I can see the 1985, that is in Hindu-Arabic numerals, and I read German well enough that this looks exactly like the US FDA NDA from 1988. (Edit to add: I did not guess that Germany was the answer. The paper book which I do not have is from Germany. I can see the book title and date and page number (although I cannot see that page), and I can see that is is German. With this information, but lacking the book itself, I confirmed that Germany did indeed grant marketing approval in 1985, which is what the original Wikipedia text said, and it is likely in the paper book, and it is a true and verifiable claim. The German book could have been referring to Sri Lanka or some other country, so someone who has the paper book may realize this citation is now misleading. I didn't want to delete the citation because, as I said before, it may be the source of a lot of the lede section, I just don't have that book.)

The lede section has the correct patent date of 1971. I added a citation to the patent itself. I used the "cite web" template, but honestly, if you don't know how to search the UK Patent Office, you may need to ask a librarian. Or me. I included a link to Espacenet (that is why I used "cite web"), but that is NOT the full PDF of the patent (which is in English). The full PDF of the patent should be available from any university library, it is in English, it has been cited many times as the first patent for this molecule, and it is recognized as having priority for the molecule in and of itself. There is another very important patent for certain therapeutic applications of the molecule. This was "important" in the sense that it granted a monopoly in some countries for many additional years.

Nimodipine gained marketing approval for the first time in the US in 1988. I added a citation to the NDA itself. Again, I used the "cite web" template, but the FDA website is aggressively unfriendly to hyperlinks that take you to a document. The document is available in a web browser, but you need to type the NDA number. The citation does include the NDA number. It is a real shame, but you need to click buttons with your mouse to see the actual document. The URL that I included is the "best possible" given how the FDA website works. It has a date and a drug name, but it does NOT have a link to the full text, you need to click the "back" button, and then your browser will give an HTTP 500 error. I don't run the US federal government, I am sorry that they do not allow this to be linked via URL. That is the NDA number (the application number from the US FDA). Fluoborate (talk) 21:07, 11 April 2019 (UTC)