Table of Contents (hide)
- 1. Names, Availability, Brand vs. Generic Issues, Forms
- 1.1 US brand name: Seroquel-XR
- 1.2 Available as Seroquel-XR in these countries1
- 1.3 Other trade name(s) for Seroquel-XR used in these countries1
- 1.4 Generic Name and Availability
- 1.5 quetiapine fumarate is available in these countries2
- 1.6 Branded generic names3
- 1.7 Specific generics with complaints, or preferred generics manufacturers
- 1.8 Generics with independently-tested bioequivalence
- 1.9 Forms and Classes
- 2. Approved and Off-Label Uses
- 3. Chances of Working & Comparisons with Other Meds
- 4. Dosage, Titration, and Discontinuation
- 5. Pros, Cons, and Interesting Information
- 6. Side Effects and Pregnancy Category
This is essentially everything we know about Seroquel-XR (quetiapine fumarate) on two big-ass pages. On this page is brand / trade names to odds of working and comparisons with other meds, or pretty much everything most people want to know. Page two is pharmacokinetics to the bibliography, or: I’m sure somebody wants to read it.
The titles for most sections link to the pages for those sections. While all the information is on these two comprehensive pages, the individual section pages go into a little more detail about what it all means.
Just because a drug is available in one country doesn’t mean you can get it everywhere. Even if a medication is available elsewhere, it won’t necessarily have the same brand, or trade name everywhere it is sold.
1.2 Available as Seroquel-XR in these countries1
- Seroquel XR/XL is available in Australia the EU, Ireland, New Zealand, and the UK
- Immediate-release Seroquel is available in Australia the EU, Ireland, New Zealand, and the UK
1.3 Other trade name(s) for Seroquel-XR used in these countries1
A drug’s generic, or international nonproprietary name (INN) is how it is uniquely identified around the world. Or not. The generic version of a med is are often available in other countries long before they are in the US.
|Generic name/INN:||quetiapine fumarate|
|US Generic available?||No|
1.5 quetiapine fumarate is available in these countries2
- Only the immediate-release version of Seroquel (quetiapine fumarate) is available as a generic in the US and Canada. Seroquel XR is still on-patent and available only as a branded product. According to some AstraZeneca press releases November 2016 is the current forecast date for a generic version of extended-release quetiapine to be available in the US.
- Immediate-release quetiapine is also available in New Zealand
1.6 Branded generic names3
- quetiapin - Hungarian
In theory the generic version of a med is the same as the brand-name version. In practice that is usually, but not always the case. Especially with crazy meds. If we know of any problems with particular generics, or if some generics are better than others, we’ll let you know.
Also available as immediate release tablets, as Seroquel or a generic.
|Primary Drug Class:||Antipsychotics|
|Additional Drug Categories:|
|Antidepressants Anxiolytics/Anti-anxiety MoodStabilizers|
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.4
Immediate-release Seroquel was originally approved in September 1997 to treat schizophrenia in adults. Since then its approvals have been expanded to include:
- Treatment of schizophrenia in adolescents aged 13 to 17.
- Acute depressive episodes in bipolar disorder.
- Acute manic episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex, in adults as well as children and adolescents aged 10 to 17.
- Maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex.
Seroquel XR is rated XR, in that it is for adults only. Otherwise its approvals are almost identical to immediate-release Seroquel:
- Acute depressive episodes in bipolar disorder
- Acute manic or mixed episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex.
- Maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex.
- Bonus approval: adjunctive therapy to antidepressants in major depressive disorder.
Meds are often prescribed for conditions or people 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.
- Although it didn’t beat the placebo in this small study. Either Seroquel really works for you or does nothing.
- Then again, Seroquel seems to work best for sleep if you’re crazy.
- Like when combined with other meds to treat bipolar or unipolar depression.
- Or treatment-resistant depression.
- Or when used by itself to treat bipolar depression.
- Seroquel works great in Hungarian to prevent suicide in insomnia-exacerbated depression. Or you can read the abstract in English.
- Seroquel helps people with dementia sleep. Like all APs it must be used carefully given to someone with dementia.
- Seroquel and SSRIs are effective for the insomnia that accompanies schizophrenia in women with comorbid alcoholism, personality disorders, and a history of attempted homicide. Oh-kayyyy.
- Most of these studies support something we’ve known here at Crazy Meds since forever (i.e. 2004): that Seroquel is best for sleep at a dosage of 25–100mg a night.
- Even at a low dosage expect minor weight gain
- AstraZeneca was going for full-on, FDA approval for Seroquel XR to treat generalized anxiety disorder (GAD) and as monotherapy (used by itself) for major depression/depressive disorder (MDD). The FDA thinks Seroquel XR is effective in treating both, but the side effects suck too much when compared with what is already on the market. So Seroquel does work for GAD. Here are some of the data from the clinical trials:
- It can work in a week.
- It can keep you anxiety-free for a year.
- It works great as monotherapy for the combination of GAD and bipolar depression. One pill once a day for two conditions. That makes everyone’s lives easier.
- Seroquel vs. Paxil for GAD: Seroquel works better and faster than Paxil. You can take Seroquel and be fat, horny, lazy, and maybe shaky, or take Paxil and wait for it to work, and never want or be able to have sex.
- You can tell AstraZeneca was concerned about weight gain and associated conditions like diabetes. The giveaway: “with tolerability results consistent with the known profile of quetiapine.”
- Monotherapy for MDD - if antidepressants don’t do it for you, even if combined with other APs I can understand giving Seroquel a go. Unlike GAD, I agree with the FDA, who unanimously voted that the side effects don’t justify using Seroquel as monotherapy for depression.
When all else fails and you’ve run out of other options, the experimental use of some drug may be your best chance at treating something. Be careful! Otherwise safe meds can be downright dangerous when used for some things.
Othello syndrome in patients with Parkinson’s disease. Othello syndrome is a freaky rare side effect of dopamine agonists used to treat Parkinson’s and RLS, such as Mirapex (pramipexole) and Requip (ropinirole). Such drugs are commonly used off-label to treat depression, especially bipolar depression.
Seroquel for sleep apnea. This is actually a case report of two people with sleep apnea, one of whom wasn’t aware of it, were taking Seroquel for something else, and almost died. So it’s not fair to Seroquel to call it a side effect, but is a great warning to never, ever use Seroquel if you have sleep apnea or it is suspected.
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, or the condition you have isn’t bad enough to warrant medication at all.
- You’re depressed as hell and can’t sleep. So if you’re going to gain weight no matter what, because lack of sleep can lead to obesity and even diabetes 2, you may as well take Seroquel.
- You have GAD and SSRIs don’t do squat for you. Screw the FDA, you know which sucks less, and gaining 5–20 pounds sucks a lot less than GAD.
- Especially if you’re so severely depressed and anxious that either one would prevent you from leaving the house.
- Sleep isn’t a problem for you and you gained five pounds as soon as your doctor gave you a prescription for Zyprexa.
- Anxiety? What anxiety? You can sleep and you’re not anxious,
- Or you’re bipolar goddammit and you need something to deal with that right now!
- Which part of “right now!” is so difficult for your doctor to understand?
- While 4–7 days to work is fast for anxiety and depression, that’s forever for mania and schizophrenia, and that’s how long it also takes Seroquel to do anything except knock you out at night.
- You might have sleep apnea (see below).
Two of the most important things to know when deciding on which med is the best for a particular condition5: how likely is it to work and how long will it take.
The odds of a med working for a particular condition and how long it generally takes to work should be fairly easy to nail down, and not need to be summed up by the Internet shorthand YMMV (Your Mileage May Vary). Unfortunately because no one is quite sure exactly what causes various conditions - further complicated when everything is a spectrum disorder - and they’re never really sure about how a med works in the first place, especially when there are lots of contradictory and/or questionable studies,6 we can only give you an idea somewhat less vague than support groups and PI sheets, but certainly more accurate than the implied “it fixes everything all the time!” promises of pharmaceutical advertising.
See our page on the tests researchers use to measure the efficacy of medications, including during clinical trials to get FDA approval.
Unlike other antipsychotics, which can start getting your symptoms under control within 24 hours, Seroquel / Seroquel XR can take up to a week to work. It doesn’t matter what you’re taking Seroquel for, schizophrenia, bipolar mania, a mixed state, unipolar or bipolar depression, GAD, as an add-on or by itself, it’ll take 4–7 days before Seroquel does anything.
Unless you’re taking it for sleep. That first 25–50mg knocks out most people.
Pretty good for schizophrenia, so-so for bipolar mania, fairly good for bipolar depression, and as an add-on for MDD (XR only).
Stahl prefers it for bipolar depression and schizophrenia’s negative symptoms, although its sedating properties can be useful for aggression. He also likes Seroquel for psychiatric applications if someone also has Parkinson’s or Lewy body dementia.
Everyone else treats Seroquel as a second-line med for its approved applications, with the consensus being it’s the first one to try if the problem is depression/negative symptoms combined with insomnia.
Looking at some of the online literature in addition
- A Randomized, Double-Blind, Placebo-Controlled Trial of Quetiapine in the Treatment of Bipolar I or II Depression
- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2515925/Quetiapine monotherapy for bipolar depression
- Quetiapine Monotherapy as Treatment for Anxiety Symptoms in Patients With Bipolar Depression: A Pooled Analysis of Results From 2 Double-Blind, Randomized, Placebo-Controlled Studies
Seroquel XR works so well when used by itself (monotherapy) for generalized anxiety disorder (GAD) the only reason the FDA didn’t approve it to treat GAD is because the side effects suck too much when compared with what is already on the market. Take a look at these randomized, double-blind studies:
- Seroquel works effectively and quickly as monotherapy for GAD.
- It prevents recurrence for a year.
- Seroquel treats both anxiety and bipolar depression.
3.4 Seroquel-XR versus other Antipsychotics for approved treatments:
Seroquel vs. Paxil for GAD: Seroquel works better and faster than Paxil. You can take Seroquel and be fat, horny, lazy, and maybe shaky, or take Paxil and wait for it to work, and never want or be able to have sex.
One of the most important aspects of any medication is how to go about taking it. This includes:
- how much to take (the dosage or dose)
- when and how often to take it (dosing schedule or doses)
- how much to start with and how to increase the dose/dosage until you’re taking the target amount (titration or titration schedule).
This information is always in the PI sheet, is usually in the information for patients leaflets, most doctors will give you some idea of what it will be like, and this is what every pharmacist is trained and paid to tell you.
We here at Crazy Meds often disagree with the official schedules found in the PI sheets. We usually advocate starting at a lower dosage than recommended. One of our core philosophies is increasing the dosages as slowly as one’s condition allows, and staying at the dosage that works instead of a target dosage7. More and more doctors are agreeing with us8. You and your doctor can always discuss increasing the dosage when you need to in advance.
For bipolar: PI sheet: start at 100mg a day in two 50mg doses and increase by 100mg to 400mg day by day four. If needed, up it by 200mg a day until reaching 800mg a day by day six.
We suggest starting with one 25–50mg dose at night if you’re taking another mood stabilizers, or the 100mg a day in two 50mg doses if you aren’t. If you need to increase by 25–50mg a day every 3–4 days and stay at whatever dosage gets your symptoms under control. Unless you’re seriously flipping out, in which case follow the PI sheet’s guidelines until your symptoms are under control or you hit 800mg a day. For schizophrenia: PI sheet: start at 50mg a day, divided into two 25mg doses, but they still want to ramp you up to 300–400mg a day by day four.
We suggest starting with 50mg a day and, as with bipolar disorder, increasing by 25–50mg every 3–4 days until your symptoms are under control. If you’re crazy enough to be getting coded messages in your cereal, then get to 300–400mg by day four.
One thing PI sheets and doctors infrequently discuss, and don’t go into enough detail about, is how to discontinue a medication. With some meds it’s not too bad, but with others it can be a nightmare.
Your doctor should be recommending that you reduce your dosage by 25–50mg a day every other day if you need to discontinue it. You can stop taking all it immediately if it’s an emergency (e.g. a life-threatening allergic reaction), but I wouldn’t recommend doing that without a doctor’s supervision. The major problem with stopping antipsychotics is a sudden return of your symptoms.
Every med has its good points and its bad points. This is what we think those are.
Doctors don’t have the time to tell you everything about a drug. Patient information leaflets leave out a lot. Even if the PI sheet covers everything the language is so dense and obtuse that the good stuff is often lost in information overload. Most meds have something interesting about them.
As one of the mildest - and most prescribed - of all antipsychotics it doesn’t really carry the antipsychotic stigma as heavily as the other meds. Less likely to cause side effects involving prolactin (e.g. leaking nipples or man boobs) or movement disorders.
You’ll sleep until next Tuesday. Of course, that could be a good thing, depending on how your life is at this moment. Other than the sleep thing, it takes longer than any other atypical antipsychotic to work. You’ll probably gain weight and you might come down with type 2 diabetes.
Seroquel is marginally better absorbed with food. So if you feel you need just a little boost in the dosage, try taking it with dinner or a late night snack.
Like most drugs older people don’t clear it out of their systems as well, too the point that they may need a lower dosage. That’s not particularly interesting. What is interesting is that Seroquel seems to work better for people under 40 than over 40.
Potential side effects are used as a rationalization to not take a medication. Many people will stop taking an otherwise working drug because of one or more relatively minor, or often temporary side effects. There may even be ways to counter or mitigate side effects.
It all comes down to a very important question: which sucks less?
No matter what crazy med you take, it will probably make you feel spacey and generally out of it for the first few days (i.e. don’t operate heavy machinery), as well as make you drowsy. Even stimulants can make you drowsy. Seroquel-XR will probably affect your dreams as well, and there’s no way to tell if that will be a temporary or permanent side effect. Don’t be surprised if your stomach and/or other parts of your GI system complain for at least the first few days.
Most everyone gets at least one or two of these.
The usual short-term side effects for second-generation / atypical antipsychotics (SGA/AAP): headache, nausea, dry mouth, sleepiness or insomnia, diarrhea or constipation, not giving a damn about anything (a.k.a. the zombification effect). Most, if not all of these will go away in a couple of weeks. Except for the excessive sleepiness, which could hang around for as long as you take this med, but is usually not much of a problem once you’re taking more than 200mg a day.
And, of course, weight gain. Although it’s not as bad as Zyprexa.
You may or may not get one or more of these.
Diabetes. Manic reaction. Muscle aches and pains. Getting all sweaty for no good reason. Tremor. Irregular heart beat and prolonged QT interval. While the sexual dysfunctions aren’t as bad as Risperdal (risperidone) or Zyprexa (olanzapine), they can still happen.
If you have these, call your doctor ASAP. Or now. Or get the hell off of the Internet and go to the ER. NOW!
You won’t get these. Unless you already have and that’s why you’re here.
Infanticide. Priapism (i.e. the never-ending hard-on) from an overdose. Kids, don’t try this at home as a Cialis substitute The PI sheet also lists “bone pain” and “abnormal ejaculation” so I’d be especially careful about taking too much to stay hard.
1 EU: European Union. Currently Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom. Not all drugs approved in any one EU country are approved in all, but most crazy meds approved in several EU countries are at least obtainable in all EU countries on the European mainland. I'm not sure about Britain, Cyprus, Ireland, and Malta.
The UK and Ireland are listed separately because we're a primarily English-language site. Plus the UK tends to be more independent on more matters than any other EU member state, so it should probably be listed separately no matter what language a site like this is in.
While the EU is moving toward one brand name for the same med, that's not going to happen overnight. And people will still refer to meds by old brand names. So we'll list old brand names until they vanish.
2 Generic availability isn't fully harmonized in the EU. Sometimes a drug is available everywhere as a generic, sometimes it's available only in a few member states. We'll provide the best information we have.
3 The term "branded generic" has three meanings:
1) A generic drug produced by a generics manufacturer that is a wholly-owned subsidiary of the company that makes the branded version. E.g. Greenstone Pharmaceuticals makes gabapentin**, and they are owned by Pfizer***, who also own Parke-Davis, the makers of Neurontin.
2) A branded generic is also a generic drug given a 'brand' name by the manufacturer (e.g. Teva's Budeprion), but otherwise has the same active ingredient as the original branded version (Wellbutrin).
3) A branded generic is also a generic drug given a 'brand' name by the manufacturer (e.g. Sanofi-Aventis' Aplenzin, which is bupropion hydrobromide) and uses a salt of the active ingredient that is different from the original branded version and other generics (Wellbutrin, Budeprion and all the others are bupropion hydrochloride). We aren't sure if that really makes a difference or not. The FDA says they're the same thing. As usual, the data are contradictory, but most evidence indicates that the FDA is right and the differences are negligible.
For our purposes a "branded generic name" refers to the second and third definitions. We'll note if any preferred generics are manufactured by the pioneering company's subsidiary.
4 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, in the US, Canada and Singapore you can get both Wellbutrin (bupropion) as an antidepressant or 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.
5 Assuming you were correctly diagnosed in the first place.
6 Keep in mind that according to one study, most drug studies will skew in favor of the med made by the company that sponsored the study.***** That's one of my favorite "no shit Sherlock" studies, although it did help in getting conflicts of interest showing up on papers.
Two additional papers along similar lines are Why Current Publication Practices May Distort Science******* and Why Most Published Research Findings Are False********. So in addition to the books we use as source material, this is why we also factor a lot of anecdotal evidence (personal experience, experiences of people we know, case reports, what people have sent us in e-mail, and what is posted all over the Internet) into our conclusions regarding the likelihood of meds working, the prevalence of various side effects, etc.
While the drug companies are getting a lot more transparent and publishing more data in the PI sheets regarding the results of the clinical trials, they still don't publish how many times a drug failed a clinical trial.********
7 Although not everyone has the luxury of stopping at a dosage when the symptoms abate and not increasing it unless the return. Sometimes you just have to keep going up until you reach that target dosage. E.g. you have a history of seizures that haven't yet responded to several medications.
8 Most notably Dr. Edward Faught, founder and Director of the Epilepsy Center, and vice chairman of the Department of Neurology, at the University of Alabama School of Medicine in Birmingham. His article on new antiepileptic drugs in Volume 7 issue 1 of Peer Review in Review stressed starting at low dosages, doing a slow titration, and stopping at the dosage where symptoms were under control. In Topiramate in the treatment of partial and generalized epilepsy****, the one free, full-text article I could find (that's not about geriatric patients), he again stresses the low and slow approach to avoid or lessen most side effects, while still achieving seizure control in the same amount of time.
*Article I, Section 8 of the US Constitution
**Greenstone Pharmaceuticals, makers of gabapentin
***Pfizer, owner of Parke-Davis and Greenstone
****Topiramate in the treatment of partial and generalized epilepsy
*****Drug studies favoring sponsors the study.
******Why Current Publication Practices May Distort Science
*******Why Most Published Research Findings Are False
********unpublished clinical trials
Date created 25 Jan 2011 - 17:03 Page Creator: Jerod Last edited by: Jerod Poore
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All information on this site has been obtained through our personal experience and the experiences family, friends, what people have reported on various reputable sites all over teh intergoogles, the medications’ product information / summary of product characteristic (PI/SPC) sheets, and from sources that are referenced throughout the site. 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 patient information leaflet (PIL) that comes with your medications and never ever throw them away.
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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?
[begin rant] I rent a dedicated server for Crazy Meds. It’s sitting on a rack somewhere in Southern California along with a bunch of other servers that other people have rented. The hardware is identical, but no two machines have exactly the same operating systems. I don’t even need to see what is on any of the others to know this. If somebody got their server at the exact same time, with the exact same features as I did, I’m confident that there would be noticeable differences in some aspects of the operating systems. So what does this mean? For one thing it means that no two computers in the same office of a single company have the same operating system, and the techs can spend hours figuring out what the fuck the problem could be based on that alone. It also means that application software like IP board that runs the forum here has to have so many fucking user-configurable bells and whistles that even when I read the manual I can’t find every setting, or every location that every flag needs to be set in order for a feature to run the way I want it to run. And in the real world it means you can get an MBA not only with an emphasis on resource planning, but with an emphasis on using SAP - a piece of software so complex there are now college programs on how to use it. You might think, “But don’t people learn how to use Photoshop or Adobe Illustrator in college?” Sure, in order to create stuff. And in a way you’re creating stuff with SAP. But do you get a Bachelor of Fine Arts degree with an emphasis on Photoshop?
Back in the Big Iron Age the operating systems were proprietary, and every computer that took up an entire room with a raised floor and HVAC system, and had less storage and processing power than an iPhone, had the same operating system as every other one, give or take a release level. But when a company bought application software like SAP, they also got the source code, which was usually documented and written in a way to make it easy to modify the hell out of it. Why? Because accounting principles may be the same the world over, and tax laws the same across each country and state, but no two companies have the same format for their reports, invoices, purchase orders and so forth. Standards existed and were universally ignored. If something went wrong it went wrong the same way for everyone, and was easy to track down. People didn’t need to take a college course to learn how to use a piece of software.
I’m not against the open source concept entirely. Back then all the programmers read the same magazines, so we all had the same homebrew utilities. We even had a forerunner of QR Code to scan the longer source code. Software vendors and computer manufacturers sponsored conventions so we could, among other things, swap recipes for such add-ons and utilities. While those things would make our lives easier, they had nothing to do with critical functions of the operating system. Unless badly implemented they would rarely cause key application software to crash and burn. Whereas today, with open source everything, who the hell knows what could be responsible some part of a system failing. [/end rant]
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