side effects, dosage, reviews, how to take & discontinue, uses, pros & cons, and more
Table of Contents (hide)
- 1. Other brand names & branded generic names1
- 2. FDA Approved Uses of Stavzor (valproic acid delayed release)
- 3. FDA Approved Uses of Depakene (valproic acid)
- 4. Off-Label Uses of Stavzor (valproic acid delayed release) and Depakene (valproic acid)
- 5. Stavzor & Depakene (valproic acid) Pros and Cons
- 6. Stavzor (valproic acid) Side Effects
- 7. Interesting Stuff Your Doctor Probably Won’t Tell You about Stavzor (valproic acid) Delayed Release Capsules
- 8. Stavzor (valproic acid) Delayed Release Capsules Dosage and How to Take Stavzor (valproic acid) Delayed Release Capsules
- 9. How Long Stavzor (valproic acid delayed release) & Depakene (valproic acid) Take to Work
- 10. How to Stop Taking Stavzor (valproic acid delayed release) and Depakene (valproic acid)
- 11. Stavzor (valproic acid delayed release) and Depakene (valproic acid) Half-Life & Average Time to Clear Out of Your System
- 12. Days to Reach a Steady State
- 13. Shelf life
- 14. How Stavzor (valproic acid delayed release) and Depakene (valproic acid) Work
- 15. Comments
- 16. Stavzor Ratings, Reviews, & Other Sites of Interest
- 17. References
|US brand name: Stavzor|
|Generic name: valproic acid|
Other Forms: The immediate-release form under the brand name Depakene (and numerous generics) is available in capsules and as syrup
1. Other brand names & branded generic names1
- Depakene - US brand name for immediate-release valproic acid
- There are so many brand and branded generic names in so many different countries for regular valproic acid, but there’s no point in listing them here. Aside from being lazy, if you’re prescribed a particular brand of valproic acid, valproic acid itself, or any valproate other than Stavzor it’s going to be totally random-seeming as to what you get.
- Acute treatment of manic episodes associated with bipolar disorder
- Monotherapy (by itself) and adjunctive therapy (with another med) of complex partial seizures and simple and complex absence seizures
- Adjunctive therapy in patients with multiple seizure types that include absence seizures
- Prophylaxis (prevention) of migraine headaches
- Monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures
- Monotherapy and adjunctive therapy in the treatment of simple and complex absence seizures
- Adjunctive therapy in patients with multiple seizure types which include absence seizures.
4. Off-Label Uses of Stavzor (valproic acid delayed release) and Depakene (valproic acid)
In spite of it being on the market for four years, I can’t find anything in the way of off-label uses specific to Stavzor. Old-fashioned Depakene has a shitload. Here is just a small sample:
- Bipolar disorder, migraines, and treating any form of epilepsy not listed above is an off-label use of Depakene / generic valproic acid.
- If you were prescribed Depakote (divalproex sodium / valproate semisodium) prior to July 2008 and got valproic acid instead, you were getting an off-label prescription. So if that happened to you, and you have the same insurance now as you had then and they’re giving you shit about an off-label prescription, ask them why off-label valproic acid was OK.
- Fibromyalgia and neuropathic pain
- Schizophrenia & Schizoaffective Disorder
- Social anxiety disorder (SAnD)
- Panic disorder
- All sorts of cancer, but prostate cancer seems to be where most of the research is happening. This is the least technical of over a dozen articles in PubMed covering valproic acid and prostate cancer.
- More recent articles include valproic acid in a class of chemotherapy medications. E.g. Histone Deacetylase Inhibitor Valproic Acid Inhibits Cancer Cell Proliferation via Down-regulation of the Alzheimer Amyloid Precursor Protein. Histone Deacetylase Inhibitors are possibly a class of crazy meds - Tegretol may be one as well - but they are generally considered anticancer drugs.
- Fortunately there are clinical trials underway to evaluate valproic acid as an add-on, and even a stand-alone form of chemotherapy when everything else failed.
- Sydenham’s chorea
- Diamond-Blackfan anemia
- Adult cyclical vomiting syndrome
Proven to be effective for wide spectrum of epileptic disorders, as well as migraines and bipolar mania. Valproic acid has been around for so long (approved for use in France since 1967) that the long-term effects are well known and well documented. If you can get past the initial side effects and get used to a valproate medication, you probably don’t have to worry about anything biting your ass in the long run. In that your doctor should know all the potentially serious bad shit that can happen, like liver failure, and how to prevent it, like making you get a liver function test between one and four times a year2.
When you first take a valproate, or take one at high dosages, the side effects suck donkey dong! Especially since they tend to start you off at a high dosage for bipolar disorder. The valproates are among the harshest of commonly-prescribed meds to take. Everyone (read: the bipolar) hates them so much that they’ve given the entire class of anticonvulsants a bad name.
The usual for antiepileptic drugs - strange dreams, wanting to sleep a lot, your memory will be a bit iffy and so forth. Plus a special set for valproates: instant old age. You’ll get fat, bald, tired, confused, dry & itchy skin, uninterested in sex, unable to hold your liquor, lose your teeth, and whatever you don’t puke will give you heartburn and/or the runs. Fortunately these side effects are both dosage-dependent (the more valproic acid you take the more likely it is you’ll get them and/or the worse they’ll be) and most, like the nausea and other GI problems, are usually temporary. Unfortunately two side effects people complain about the most - weight gain and hair loss - tend to stick around, as does the occasional tremor and urge to yell at kids to get off of your lawn. At least you can take antacids like Maalox to deal with the GI problems. You cannot take Pepto-Bismal and valproic acid, as its active ingredient is related to aspirin, and aspirin and valproates is a big no-no. Sometimes a really big no-no. The same goes for Alka-Seltzer.
Incontinence3, acne4, lack of menstrual periods and other embarrassing female complaints, and instead of thinning your hair can change texture and/or color.
Valproates are almost as bad as Lamictal (lamotrigine) when it comes to serious rashes. Like lamotrigine the likelihood of a serious, potentially life-threatening rash increases with your dosage. Unlike Lamictal it’s not so freaking random, especially when it comes to being exposed to things you’ve been using prior to taking valproic acid, like laundry detergent or hand lotion. It’s still a good idea to look at the Lamictal page on SJS.
Not all that much. All the warnings, precautions, and listings in the PI sheet for rare adverse effects are from Depakene, and not the fake Depakene PI sheets with Depakote’s side effects either. The only semi-wacky event I could find that is peculiar to Stavzor involved an overdose: Acute overdose of enteric-coated valproic acid and olanzapine: unusual presentation and delayed toxicity. That’s it. Unless you’ve got an account with access to everything don’t bother, as there’s no abstract.
Depakene (valproic acid)
There are a few, although for a med that is as old as I am5 I’d expect a hell of a lot more. Most of the really freaky ones, like Fanconi syndrome (constant peeing), onychomadesis (your finger and toe nails fall off and don’t grow back), and gingival overgrowth happen to children. Or if an overdose is taken, and weird things like imitation brain death can happen.
7. Interesting Stuff Your Doctor Probably Won’t Tell You about Stavzor (valproic acid) Delayed Release Capsules
I haven’t found anything interesting about Stavzor, other than it’s so under the radar that I wrote about it shortly after its release four years ago and have since completely forgotten its existence. In the first 100 results from a Google search fewer than five are from people who take it or have questions about it. The rest are the usual PDR regurgitations from drugs.com, rxlist.com, etc., press releases, ambulance-chasing lawyers.
- No, you’re not taking generic Depakote (divalproex sodium). I don’t care what anyone said, Depakote (valproate semisodium) wasn’t available as a generic until 2008, or about when Stavzor was approved. Notice how Depakote has not one, but two generic names that are not valproic acid. Valproic acid is an ingredient of Depakote.
- Valproic acid interacts with aspirin. Aspirin prevents you from metabolizing valproates properly, so you’re better off with Aleve (naproxen sodium) or Tylenol (acetaminophen). Ibuprofen is OK, but only if you’re taking no more than 400mg a day. While there is no documented interaction, and , I’d be too freaking paranoid to take Tylenol and a valproate at the same time for more than a couple of days.
- Valproates can sap your body of vitamin D, folic acid, and maybe even calcium. So ask your doctor about tests for vitamin D and calcium levels and supplements. You should probably take 400–1,000mcg of folic acid in any event, but no more than that, otherwise it might interfere with how well valproic acid works. That folic acid may help you feel a lot less lethargic.
- Bipolar women are able to tolerate more valproate than epileptic women, while epileptic men can tolerate more valproate than bipolar men.
- Your doctor had better damn well be telling you about the regular blood work you need, to check your valproate levels and to make sure your liver is functioning normally.
I Forgot Why I Cake Topamax
8. Stavzor (valproic acid) Delayed Release Capsules Dosage and How to Take Stavzor (valproic acid) Delayed Release Capsules
The recommended initial dose is 750 mg daily in divided doses. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect or the desired range of plasma concentrations. In placebo-controlled clinical trials of acute mania, patients were dosed to a clinical response with a trough plasma concentration between 50 and 125 mcg/mL. Maximum concentrations were generally achieved within 14 days. The maximum recommended dosage is 60 mg/kg/day. —the Stavzor PI sheet
As usual, we disagree. Not with the “the lowest therapeutic dose which produces the desired clinical effect,” as that is the only sane target dosage and we applaud Noven and Abbott (as the wording for Stavzor’s bipolar dosage and administration is nearly a word-for-word copy from the Depakote PI sheet) for recognizing that. Of course they had to ruin it with “or the desired range of plasma concentrations [of] 50 and 125 mcg/mL.”
If you’re so bouncing-off-the-ceiling manic that someone else is reading this page, why the hell aren’t you on Zyprexa or some other antipsychotic for now? In our opinion such a rapid titration is best left for someone who needs to calm the hell down right the hell now! and, for whatever reason, can’t take an antipsychotic. Which is probably why you’re taking Stavzor, right?
Our suggestion if you aren’t bouncing-off-the-ceiling-manic is starting out at 250–500mg a day (one 125mg or 250mg capsule twice a day) and increasing the dosage by 125–250mg a day every three to four days. While taking valproic acid, even the delayed-release flavor, three times a day would be best, we realize what a pricey pain in the ass that would be. Again, Noven demonstrates they know what they’re doing; this time by recognizing you can do only so much with a valproate and that once-a-day dosing is probably a pipe dream.
The recommended starting dose is 250 mg twice daily. Some patients may benefit from doses up to 1000 mg/day. In clinical trials, there was no evidence that higher doses led to greater efficacy. —the Stavzor PI sheet
We can’t find anything wrong with that. If you’re more comfortable starting at 250mg a day total, taking two 125mg capsules, that’s good.
Noven’s recommendations from the PI sheet are incredibly complicated, and take into account:
- seizure type
- is this the first AED you’ve taken
- other medications you’re taking
- if you plan to keep taking them or stop taking them
- your weight
- your gender
Our suggestion assumes that Stavzor is the med you and your doctor agree is the best one. The real question now is - are your seizures happening too often for you to deal with? If so, then you and your doctor should plan a titration schedule (how much to increase the dosage every however many days) to get you taking as much Stavzor/Depakene/valproic acid as quickly as possible until your seizures are under control. If your seizures are infrequent-to-more-or-less-under-control, then you and your doctor can consider a titration schedule with a much more gradual increase in the dosage, so the side effects won’t be so bad.
Stavzor (valproic acid delayed release)
I honestly don’t know. There just aren’t enough data on it.
Depakene (valproic acid)
Will stomp out mania anywhere from a few days to a couple of weeks, depending on how quickly you take how much. Take enough soon enough and valproic acid is almost as effective in calming you the hell down as an antipsychotic. When it comes to bipolar depression it’s anywhere from a month to never. Stavzor is approved to treat bipolar mania, and the FDA got this one right.
Both Stavzor (valproic acid delayed release) and Depakene (valproic acid) should work as well as they can for you in about two weeks.
There aren’t a lot of data for either Stavzor or generic valproic acid. Hell, there isn’t even a lot of data for Depakote and migraines. Most of the research is about sodium valproate, especially using the intravenous form (as Depacon - which is the only way you can get it in the US) for emergency room treatment of migraines.
Plus there’s the whole issue of defining efficacy when it comes to migraines, which is a 50% reduction in attacks and 50% reduction in severity. There is so much statistical wriggle room in what should be a very simple definition there’s a reason why I like to gather as much anecdotal evidence as possible, which isn’t much.
Slowly. Unlike many meds where ideally you’d discontinue as a mirror image of your titration - e.g. if you began taking Stavzor at 250mg a day and increased by 250mg a day every week you’d discontinue by 250mg a day every week until you weren’t taking it any more. As migraineurs, the bipolar who were already taking something and had valproic acid added to their cocktail, and people taking valproic acid for various off-label uses are the only ones who were likely to have had a gentle titration, those groups are the only people for whom the standard method of decrease-as-you-increased is going to work.
As neither Noven nor Abbott before them supplied discontinuation instructions other than “be freaking careful” our suggestion to talk to your doctor about is to reduce your dosage by 250–500mg a day every five to seven days. Based on the half-life of 16 hours you could make that three days, but with the PK being so non-linear combined with it doing weird shit like the tissue binding not being affected by weight above a certain point6, five to seven days is just safer. 7
11. Stavzor (valproic acid delayed release) and Depakene (valproic acid) Half-Life & Average Time to Clear Out of Your System
Half-life: 9 to 16 hours, plasma clearance: two to three days.
Usually two to three days.
Originally they thought that valproates increased the amount of GABA you had throughout your brain by inhibiting how it was broken down (much like how an MAOI works) as well as encouraging your brain to produce more, but little else. Current research shows that valproates do that as well as inhibit activity along the sodium and calcium ion channels like many AEDs. They may affect glutamate and/or NMDA as well.
I’ll say one thing for Noven Therapeutics, at least they did some new clinical trials for the approvals, with new side effect (adverse reaction) data. If you look at the Depakene PI sheet you’ll notice how everything is for Depakote, a drug approved years after Depakene was approved, and with a far less harsh side effect profile. I’d really like to know how Abbott got away with that. I had to dig up a 1999 copy of the PDR to get side effects specific to Depakene. On some of the few Stavzor-specific studies I could find, the epileptic said Stavzor’s side effects suck far, far less than seizures, including hair loss and getting fat.
They lowered the minimum therapeutic blood plasma level for the bipolar from 85 to 50 - which is the same minimum effective level as epilepsy. There’s a huge reason as to why the side effects can be a lot less harsh than Depakene and Depakote. You won’t necessarily take 40% less Stavzor than Depakote, but you may not need to take as much to make your doctor happy if you symptoms are under control.
In addition to getting their flavor of valproic acid approved for everything it was being prescribed off-label for in any event, which might be used as a kind of retroactive ass-covering for insurance companies and HMOs who forced everyone to take generic valproic acid instead of the Depakote ER their doctors prescribed, Noven’s big selling point for Stavzor is…the pill won’t choke a horse like Depakote. That and the gastrointestinal side effects are honestly more like Depakote ER instead of the generic valproic acid some people wound up getting in place of the Depakote ER their doctors prescribed them8. Patient-compliance is actually a big deal, so what they did is good. Although I think they need to change the color of their capsules. Those things look like vitamins (think D and E) and fish oil supplements. The only thing that distinguishes them from something you’d buy at Ye Oldde Supplemintt Shoppe is the barely-readable imprint. While I think taking vitamin E is usually a bad idea, vitamin D and omega-3 fish oil supplements are usually good ideas for the mentally interesting. It’s just too damn easy to take too much of one and too little of another when your meds look too much like your supplements.
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Medicated For Your Protection
16.3 Full US PI sheet, Global SPCs & PILs, Other Consumer Review & Rating Sites, check for drug-drug interactions
Depakene immediate-release (valproic acid)
It’s always a good idea to check for drug-drug interactions yourself. Just because most people in the crazy meds business know about really important interactions (e.g. MAOIs and a lot of stuff, warfarin and everything on the planet) doesn’t mean the person who prescribed your meds told you about them, or the pharmacist has all the meds you take at their fingertips like they’re supposed to. Or they have the time to do their jobs properly when not dealing with complete idiots or playing Angry Farmers on the Faecesbooks.
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Stahl’s Essential Psychopharmacology: Neuroscientific Basis and Practical Applications (Essential Psychopharmacology Series) Third edition by Stephen M. Stahl © 2008 Published by Cambridge University Press
The Prescriber’s Guide (Essential Psychopharmacology Series) Third edition by Stephen Stahl © 2009 Published by Cambridge University Press.
Physicians’ Desk Reference Editions 53, 56, & 64 © 1999, 2002, & 2010
Instant Psychopharmacology 2nd Edition Ronald J. Diamond MD © 2002. Published by W.W. Norton
Essential Neuropharmacology: The Prescriber’s Guide Stephen D. Silberstein, Michael J. Marmura © 2010
Pharmacotherapy for Mood, Anxiety, and Cognitive Disorders Stuart A. Montgomery, Halbreich Uriel © 2000
Antiepileptic Drugs René H. Levy, Richard H. Mattson, Brian S. Meldrum, Emilio Perucca © 2003
1 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.
2 The vast majority of liver problems show up in the first 6 to 12 months of use, especially in the bipolar, as we usually get the most aggressive titration schedules (in English: the highest dosages the fastest) and our livers are often fucked-up to start with thanks to mania-inspired hepatitis, cirrhosis, and other problems. For most people an annual liver function test is more than enough. For anyone who takes a high dosage of a [[Meds/valproate]], smokes, takes other medications (regardless of what they treat) that induce CYP or UGT enzymes, drinks alcohol, or eats a lot of charbroiled meat (I'm not joking), more than one liver function panel and an annual complete blood count would be a good idea.
3 Both kinds. What did I tell you about getting old?
4 So you can feel young again, right? Or just be old with even shittier skin.
5 OK, I'm not that old. Valproic acid was approved as an AED 50 years ago. The substance itself has been around since the late 19th century.
6 In English…uh, well, you know how they like to base the dosage on how much you weigh, because it has to do with how well the drug sticks to your innards? No? Then I can't do much more than that. Sorry.
7 If you've been taking valproic acid, or any drug, for years and have been adjusting the dosages up and down - as is often the case with AEDs - a perfect mirror-image taper is obviously not going to work.
8 It didn't happen to me or anyone I know. I have read quite a few accounts of people getting "generic Depakote" in 2003-2006. They had all sorts of GI problems that were way out of proportion to those listed in the PI sheet and to the anecdotal evidence I've collected regarding Depakote ER. Big Pharma, HMOs and the health insurance cartels have gotten away with, or have been barely punished for much worse, but this is so blatant that even the National Institute of Health's Daily Med website has Depakene's prescribing information where the clinical trials and adverse reactions are from Depakote, a drug approved decades after Depakene was approved and for which valproic acid is an ingredient, along with sodium valproate.
9 Thank you! I'll be here all weak. Be sure to tip your content provider. And don't try the veal, it's cruelicious!
If you have any questions not answered here, please see the Crazymeds Stavzor 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.us
|Last modified on Tuesday, 08 July, 2014 at 10:59:52 by JerodPoore||Page Author Jerod Poore||Date created|
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Almost all of the material on this site is by Jerod Poore and is copyright © 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, and 2014 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.
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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? 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 of anonymity. 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.