approved indications and clinically-significant off-label uses, as well as experimental and failed applications
Brain Cooties Aren’t Contagious
Medicated For Your Protection
Psychopharmacological Need for Approval
Drugs are officially approved to be used for certain things, and they may be approved for one thing in one country but something else entirely in another.1
Meds are often prescribed for conditions (e.g. Topamax for bipolar disorder), or people (e.g. adolescents being prescribed any SSRI or SNRI except Prozac or Lexapro) they aren’t approved to treat. This is known as off-label prescribing. Some off-label prescribing is so common that lots of people think the medication is a first-line treatment for the condition it’s prescribed to treat (e.g. Trileptal for bipolar disorder). If a drug company’s sales force (a.k.a. pharm reps) is too aggressive in pushing a med for off-label applications where it doesn’t work as well as people think, the FDA will now come down hard on them (e.g. Novartis getting heavily fined for promoting Trileptal as a treatment for bipolar disorder).
Off-label prescribing is not necessarily bad. Drugs that almost, or would almost, pass a clinical trial for some indication still work for a lot of people. As long as the reason for not clearing the hurdles of phase III clinical trials wasn’t the death of too many participants, or some other intolerable side effect.
Geodon is US FDA-Approved to Treat:
SchizophreniaGeodon (ziprasidone) was approved 5 February 2001 for the treatment of schizophrenia. Geodon is approved for both acute (short-term, usually 3 to 6 weeks) and long-term (maintenance) of stable adult schizophrenic inpatients. “Long-term” isn’t defined, and the key word here is inpatient. The FDA and Pfizer make no guarantee of Geodon (ziprasidone HCl) keeping you less crazy than usual outside of a hospital.
Bipolar I Disorder
Geodon (ziprasidone) has two approvals for bipolar disorder. Geodon is approved for use by itself (monotherapy) for the acute treatment of manic or mixed episodes associated with bipolar I disorder.
Acute Treatment of Agitation in SchizophreniaGeodon intramuscular (ziprasidone mesylate) was approved 21 June 2002 for the treatment of acute psychomotor agitation in schizophrenic patients who need intramuscular antipsychotic medication to calm the hell down right away. I’ll let Pfizer explain it:
“Psychomotor agitation” is defined in DSM-IV as “excessive motor activity associated with a feeling of inner tension.”
Schizophrenic patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care, e.g., threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior, leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation. —
In other words, the stereotype of a crazy person. Unfortunately this does happen in the surreal world of psych hospitals, as I’ve seen. Often enough to require medications like IM Geodon and Zyprexa, but far less often than most people think. As the staff was waiting on finding a family member or getting a court order to be able to medicate the poor bastard, they actually had to put him in a straitjacket and strap him down to a bed like it was the 19th century.
Geodon (ziprasidone) is Approved Elsewhere for:
Clinically Significant or Otherwise Common Off-Label Uses of Geodon (ziprasidone)
- Bipolar depression
- Unipolar depression (with or without an antidepressant)
- Long-term outpatient treatment of schizophrenia
- Combat PTSD
Just because a medication is approved or commonly prescribed for a particular condition doesn’t necessarily mean you should be taking it for that condition. There could be a drug that might be better to try first, or at least talk to your doctor about trying first, such as Topamax instead of Depakote as a daily med to prevent migraines (and Topamax has its own reasons why you should and should not take it). Or the condition you have isn’t bad enough to warrant medication at all. E.g. any antidepressant if you’re not so depressed that you can function at relatively the same level as you do when you’re not depressed.
When/Why You Should Take Geodon (ziprasidone)
- You have more problems with negative symptoms than positive symptoms in schizophrenia; or your doctor thinks depression is more of a problem than mania in bipolar disorder.
- Because I’m bipolar and I know how many of my bipolar brothers and sisters are addicted to mania and just bitch more about depression than all the trouble they get into when manic.
- You really need to take an antipsychotic but you have, or have a family history of, diabetes, high cholesterol, or other problems that all the other antipsychotics are far more likely to cause or make worse.
When/Why You Should NOT Take Geodon (ziprasidone)
- You use triptans or ergotamine to treat migraines or other headaches, especially cluster headaches. While many antipsychotics act in ways that interfere with the ways triptans and ergotamine work, but Geodon goes the extra mile by binding to the one receptor no other drug touches: 5-HT1D
- You have a history of heart arrhythmia or something similar that a doctor would be concerned about. Family history, a cardiac problem that doesn’t seem to be a big deal, etc. means you and your doctor get to do a risk-benefit analysis and figure out how often you see a cardiologist for stress tests and the like.
- Sorry, I’m living in the past when I had really nice health insurance and actually did that sort of thing for other meds.
When all else fails and you’ve run out of other options, Geodon may be your last best chance at treating an obscure or treatment-resistant condition.
Less Common/Experimental Off-Label Uses of Geodon
- Psychotic symptoms in Parkinson’s
- Depressive mixed states. In this study they differentiate between a depressive mixed state and agitated depression.
- In the real world it’s hard enough to convince people there’s a difference between any mixed state and dysphoric mania, so good luck with that.
- On the other hand, Cephalon managed to get the FDA to believe “Shift Work Sleep Disorder” is a medical condition and approve Provigil to treat it, so almost anything in the surreal world of crazy meds.
- As an add-on to Celexa to treat psychotic depression in pregnant or lactating women. Actually this was just one woman, I just really liked the specificity of the abstract title and application.
- Weaning exacerbated COPD patients from mechanical ventilators - another great “who the hell thought of that?” study of amazing specificity.
- Delusional Parasitosis AKA Ekbom syndrome. AKA what you see in half the stereotype-laden TV shows and movies dealing with the mentally interesting, and every comedy sketch and satirical article involving meth: the invisible spiders crawling all over you. According to this review it happens to a whopping 80 people out of a million who don’t take meth. But the invisible bugs infesting our hands and arms are why we (the crazy, not the meth addicts) make so many typos, right?2
Medicine Is The Best Medicine
Vaccines Cause Immunity
Mental Illness is NOT Contagious
Medicated For Your Protection
Be careful! Some off-label uses have been total fails, and otherwise safe meds can be downright dangerous when used for some things.
You probably want to avoid using Geodon for the following:
Failed Off-Label Uses
- Borderline personality disorder
- Bipolar depression. I love this abstract. It reads like Pfizer is blaming the doctors and patients for not rating the results of the people taking Geodon correctly on the psych tests, specifically the Montgomery-Åsberg Depression Rating Scale, a ten item scale that practically guarantees a placebo will make a difference as long as somebody pays attention to and shows that they care about whoever is taking it.
Potentially Dangerous Off-Label Uses
- Prescribing it to children or adolescents. Why? Anything you have to take twice a day that has the potential for a withdrawal syndrome like Effexor or immediate-release Paxil is an incredibly stupid thing to give to someone apt to forget or not want to take their meds on a regular basis.
- Dementia-related psychosis. There’s a black box warning against this for a reason.
- Do not, under any circumstances, give Geodon or any other antipsychotic to someone who is old just because you can’t deal with their behavior. (See the Black Box Warning).
- I was a Certified Nurses’ Aide. I worked in a nursing home. I had to deal with senile old people on a daily basis. My coworkers and I could have treated them a hell of a lot better than we did, but at least we didn’t give them Thorazine when they were being pains in the ass.
- Unfortunately that wasn’t true for the even more understaffed swing- and graveyard-shifts.
- You don’t need APs to deal with someone who is not schizophrenic or bipolar. You need to do something like this:
- Put them in the TV room
- Strap them to their wheelchair and lock the wheels
- Put on something old people like to watch
- Arrange them so you have the people who like to talk to each other close to each other, and those who can’t stand each other are the furthest apart
- That last part was so not my job.
- Yes, physically restraining them sucks, but it’s better than putting them on an AP.
- Believe me, if it’s at the point where they were given an AP, they were probably restrained already. They just didn’t have any Matlock to watch or someone to complain with about kids and those baggy jeans they wear down at their knees.
- There are better solutions for individuals. In a perfect world there would be the time and smart employees to find what they are.
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1 Before Cymbalta (duloxetine) was approved as an antidepressant in the US it was already approved in the EU, but only for stress urinary incontinence and sold under the trade name Yentreve. Duloxetine is now sold in the EU as an antidepressant under the trade name Cymbalta.
A better known, if slightly different example is bupropion. According to the 2007 edition of Mosby's Drug Consult, and my highly-skilled Google-fu, in the US, Canada and Singapore you can get both Wellbutrin (bupropion) as an antidepressant or as Zyban (bupropion) to stop smoking. In Korea, Thailand and most of South America (but not Brazil) you can get bupropion (under various trade names) only as an antidepressant. In Brazil, the EU & UK, Israel, India, Australia and New Zealand it's only available as Zyban to help you stop smoking.
2 I guess it was sheer luck that not a single person with whom I shared time in the lock ward during my timeout from polite society complained of invisible bugs of any kind. So, how many of the people complaining about beg buds in NYC are nutjobs? And how many of the mentally interesting who live on the streets have real lice and other critters living on them?
If you have any questions not answered here, please see the Crazymeds Geodon discussion board. We welcome criticisms of the articles, notifications of bad links, site problems, consumer experiences with medications, etc. I’m not always able to write back. Hence I never answer questions about meds via e-mail that are answered by this or other articles. Especially if they have been repeatedly asked on the forum. That’s why we write these damn things. Questions about which meds are best for your condition should also be asked on the forum; because this is a free site, so the price of admission is making things easier for somebody else searching for the same answer. We don’t deal with children on the forum or in private because after doing this for ten years I don’t have the emotional stamina to deal with kids who have brain cooties. How to contact Crazymeds. — Jerod Poore, CME, Publisher Crazymeds (crazymeds.us)
|Last modified on Sunday, 17 April, 2016 at 18:58:03 by JerodPoore||Page Author Jerod Poore||Date created Friday, 28 December 2012 at 12:49:43|
|“Geodon (ziprasidone): a Review for the Educated Consumer.” by Jerod Poore is copyright © 2012 Jerod Poore||Published online 2012/12/29|
|Citation options to copy & paste into your article:|
|Plain text:||Poore, Jerod. “Geodon (ziprasidone): a Review for the Educated Consumer.” Crazymeds (crazymeds.us). (2012).|
Geodon, and all other drug names on this page and used throughout the site, are a trademark of someone else. Geodon’s PI Sheet will probably have the name of the manufacturer and trademark owner (they’re not always the same company) at or near the very bottom. Or ask Google who the owner is. The way pharmaceutical companies buy each other and swap products like Monopoly™ real estate, the ownership of the trademark may have changed without my noticing. It may of changed hands by the time you finished reading this article.
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Almost all of the material on this site is by Jerod Poore and is copyright © 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014, 2015, and 2016 Jerod Poore. Except, of course, the PI sheets - those are the property of the drug companies who developed the drugs the sheets are about - and any documents that are written by other people which may be posted to this site will remain the property of the original authors. You cannot reproduce this page or any other material on this site outside of the boundaries of fair use copying without the express permission of the copyright holder. That’s usually me, so just ask first. That means if want to print out a few pages to take to your doctor, therapist, counselor, support group, non-understanding family members or something like that - then that’s OK to just do. Go for it! Please. As long as you include this copyright notice and something along the lines of following disclaimer, I’m usually cool with it.
All rights reserved. No warranty is expressed or implied in this information. Consult one or more doctors and/or pharmacists before taking, or changing how you take any neurological and/or psychiatric medication. Your mileage may vary. What happened to us won’t necessarily happen to you. If you still have questions about a medication or condition that were not answered on any of the pages you read, please ask them on Crazy Talk: the Crazymeds Forum.
The information on Crazymeds pertains to and is intended for adults. While some information about children and adolescents is occasionally presented (e.g. US FDA approvals), pediatric-specific data such as dosages, side effects, off-label applications, etc. are rarely included in the articles on drugs or discussed on the forum. If you are looking for information regarding meds for children you’ll have to go somewhere else. Plus we are big pottymouths and talk about S-E-X a lot.
Know your sources!
Nobody on this site is a doctor, a therapist, or a pharmacist. We don’t portray them either here or on TV. Only doctors can diagnose and treat an illness. While it’s not as bad as it used to be, some doctors still get pissed off by patients who know too much about medications, so tread lightly when and where appropriate. Diagnosing yourself from a website is like defending yourself in court, you suddenly have a fool for a doctor. Don’t be a cyberchondriac, thinking you have every disease you see a website about, or that you’ll get every side effect from every medication1. Self-prescribing is as dangerous as buying meds from fraudulent online pharmacies that promise you medications without prescriptions.
All information on this site has been obtained from the medications’ product information / summary of product characteristic (PI/SPC) sheets and/or medication guides - which is all you get from sites like WebMD, RxList,
NAMBLA NAMI, etc., the sources that are referenced throughout the site, our personal experience and the experiences family, friends, and what people have reported on various reputable sites all over teh intergoogles. As such the information presented here is not intended as a substitute for real medical advice from your real doctor, just a compliment to it. You should never, ever, replace what a real doctor tells you with something from a website on the Internet. The farthest you should ever take it is getting a second opinion from another real doctor. Educate yourself - always read the PI/SPC sheet or medication guide/patient information leaflet (PIL) that comes with your medications and never ever throw them away. OK, you can throw away duplicate copies, but keep at least one, as that’s your proof of purchase of having taken a med in case a doctor doubts your medical history. Plus they take up less space than a bottle, although keeping one inside of a pill bottle is even better.
Crazymeds is not responsible for the content of sites we provide links to. We like them, or they’re paid advertisements, or they’re something else we think you should read to help you make an informed decision about a particular med. Sometimes they’re more than one of those things. But what’s on those sites is their business, not ours.
Crazymeds is optimized for ridiculously large screens and browsers that don’t block ads. I use Firefox and Chrome, running under Windows 72. On a computer that sits on top of my desk. With a 23 inch monitor. Hey, at least you can make the text larger or smaller by clicking on the + or - buttons in the upper right hand corner. If you have Java enabled. Like 99% of the websites on the planet, Crazymeds is hosted on domain running an open source operating system with a variety of open source applications, including the software used to display what you’ve been reading. As such Crazymeds is not responsible for whatever weird shit your browser does or does not do when you read this site3.
Crazymeds now uses a secure server, but it is not so secure that you can discuss anything having to do with nuclear power facilities, air traffic control systems, aircraft navigation systems, weapons control systems, or any other system requiring failsafe operation whose failure could lead to injury, death or environmental damage. Just so you know. So if you’re mentally interesting and have a job that deals with that sort of thing, talk about said job elsewhere. Otherwise feel free to discuss your meds and brain cooties.
No neurologists, psychiatrists, therapists or pharmacists were harmed in the production of this website. Use only as directed. Void where prohibited. Contains nuts. Certain restrictions may apply. All data are subject to availability. Not available on all mobile devices, in the 12 Galaxies Guiltied to a Zegnatronic Rocket Society, or in all dimensions of reality. Hail Xenu!
‘Everything is true, nothing is permitted.’ - Jerod Poore
1 While there are plenty of books to help you with hypochondria, for some reason there’s not much in the way of websites. Then again, staying off of the Internet is a large part of curing/managing the disorder.
2 Remember kids, Microsloth operating systems are like TOS Star Trek movies with in that every other one sucks way, way more. With TOS Star Trek movies you don’t want to bother watching the odd-numbered ones. With Microsloth OS you don’t want to buy and install the even-numbered ones. Anyone who remembers ME and Vista knows what I mean.
3 Have I mentioned how open source operating systems for commercial applications is one of the dumbest ideas in the history of dumb ideas?* I don’t even need my big-ass rant any more. Heartbleed has made my case for me. And that’s just the one that got all the media attention. The very nature of an open source operating system makes security as much of an illusion as anonymity on teh Intergoogles. Before you flip out too much: the domain Crazymeds is hosted on uses a version of SSL that is not affected by the Heartbleed bug. That’s one of the many reasons why I pay a lot of money and keep this site on Lunarpages.
* Yes, I know I’m using open source browsers. I also test the site using the now-defunct IE and Safari browsers. Their popularity - and superiority - killed IE and Safari, so that’s why I rely on the open source browsers. It’s like brand vs. generic meds. Sometimes the generic is better than the brand.