Part 1: Indications, efficacy, dosage, titration, discontinuation, pros and cons, adverse events, availability and how supplied.

> Cymbalta (duloxetine) Review


The Cymbalta (duloxetine) Overview is a briefer, more consumer-friendly version of this article. The information in this article comes from twelve separate pages, with more explanatory material, to which the overview links. The title of each section on both pages of this article is also a link to each of those pages.

Click here for Part 2: Warnings, clinical pharmacology, interactions, additional comments and consumer experiences

Abstract

Consumers need more information than what is provided in the patient information literature, but are intimidated by, or have no desire to read all of, the prescribing information for a drug. This review of the drug Cymbalta (duloxetine) provides what the educated consumer wants, highlighting its use as, and comparing it with other {{$$drugclass2}}. Also discussed are off-label uses, efficacy, adverse events and how to mitigate them, titration and discontinuation schedules, clinical pharmacology, other aspects of using Cymbalta (duloxetine), and consumer experiences.

Classification

Primary Drug Class

Indications

A review of Cymbalta’s prescribing information, the literature, and consumer experience. Regarding off-label applications: if something is to be considered as “clinically significant” there need to be large, double-blind studies or clinical trials in addition to lots of consumer experiences, otherwise it will still be considered as experimental.

FDA-Approved Indications

  • Major Depressive Disorder (MDD) - approved August 2004
  • Diabetic Peripheral Neuropathic Pain - approved November 2004
  • Generalized Anxiety Disorder (GAD) - approved February 2007
  • Fibromyalgia - approved June 2008
  • Chronic Musculoskeletal Pain - approved November 2010

Drugs sometimes have different approvals in different countries.1 Consumers want to know this if they are running out of treatment options; or if they are researching their treatment options they may wish to know if, and why, a medication is approved for something in the US but not anywhere else.

Approved Uses Outside of the US

Urinary stress incontinence in the EU under the trade name Yentreve.

Clinically Significant or Otherwise Common Off-Label Uses

  • Stress urinary incontinence in women (It’s officially approved in Europe for this problem)
    • for men as well.
  • Bulimia.
  • ADD/ADHD.
  • Smoking cessation.

Less Common/Experimental Off-Label Uses

Failed off-label uses

Potentially dangerous off-label uses

Efficacy & Comparisons with Other

A review of prescribing information, the literature and consumer experiences. In addition to review sites, which don’t skew as negative as one would think, consumer experiences with medications are frequently reported on social media sites that have nothing to do with medications or illnesses. There is such a consistent overlap in many demographics (e.g. women with bipolar 2 and/or migraines and scrapbooking) to provide a great deal of data on efficacy and adverse reactions from a very natural environment where consumers discuss their conditions and how to treat them that is free of almost all prejudices regarding medications and other treatment options.

Onset of Action

Between three days and a month, with an average of around two weeks.

Efficacy for its Approved Indications

As with most SNRIs, your chances are pretty damn good that Cymbalta will work for depression and anxiety spectrum disorders. They’re not the solution for everyone, but they all have a decent response rate, they are far less likely to poop-out than SSRIs, and Cymbalta is no different.

When it comes to pain, the odds are decent Cymbalta will work. It’s about as good as a TCA, but with fewer side effects, which basically makes it a coin-toss.

For Off-Label Applications

Cymbalta versus Other Antidepressants for Approved Indications

For Off-Label Uses



These are not prescribing guidelines per se. For consumers they are an antidote to the direct-to-consumer marketing phrase “Talk to your doctor about…” regarding the advertised drug. For physicians they are likewise an antidote to drugs being pushed on them by pharm reps.

A synthesis of the literature and consumer experiences can provide good rules of thumb as to when consumers should and should not talk to their doctors, and when doctors should and should not talk to their patients, about particular drugs the first time they discuss treatment options. If at all.

Why/When Cymbalta (duloxetine) Should Be Recommended

  • Effexor and/or Pristiq sort of worked for you.
  • You failed two (or more) SSRIs, and Wellbutrin didn’t work, your doctor doesn’t want to try you on it yet, or you and your doctor know Wellbutrin is a Bad Idea.

Why/When Cymbalta (duloxetine) Should Not Be Recommended

  • Effexor and/or Pristiq didn’t do crap for you.
  • Especially if the discontinuation syndrome was an absolute nightmare.

Dosage, Titration, and Discontinuation

A review of Cymbalta’s prescribing information, the literature, and consumer experience. We have found that for most consumers in an out-patient situation the titration schedule published in the prescribing information is often too aggressive. Many would often be better served by starting at a dosage lower than recommended by the manufacturer and, instead of a fixed target dosage, the dosage where symptoms are controlled within a given range is the goal. Patients could adjust their dosage as needed without having to schedule an appointment with their prescriber.

Dosage and Doses

Eli Lilly’s recommendations, per the PI sheet
For MDD: start at 40–60mg, taken either in one or two doses. The target dosage is 60mg a day, with a maximum of 120mg a day.
For GAD: start at 60mg once a day, with a maximum of 120mg.

As usual, we disagree.
For MDD & GAD we suggest starting at 20mg a day, and increasing by 20mg a day as required. We also suggest taking Cymbalta twice a day due to its short half-life, but since you can take it only once a day at 20mg, if you need to increase your dosage you’ll know soon enough which works better for you.

Dosing Schedule

Titration Schedule



One aspect of taking a medication that is frequently missing from patient information, as well as prescribing information, is how to stop taking it. Consumers are left with nothing more than the warning to not stop taking their medication without first talking to their doctor. Circumstances do not always allow for that. Many consumers feel better if they have the knowledge about what they should do.

How to Discontinue

Very slowly. If 20mg per day every week is too fast, try to get some samples from your doctor so you can step down by 10mg per day until you hit 20mg. Cymbalta comes in 20, 30 and 60mg capsules. Now do the math.

Discontinuation Symptoms

Notes, Tips, etc. About Discontinuing Cymbalta

Pros, Cons, and Interesting Information

Even though they want more information than the patient information literature provides, consumers also want a very high-level synopsis. A synthesis of the prescribing information, the literature, and consumer experience provides the pros and cons of using Cymbalta (duloxetine) for its approved indications and clinically-significant or otherwise common off-label uses.

Pros

Works quickly with a fairly low side effect profile for an SNRI. Less likely to poop-out than an SSRI. Probably the best painkiller around as far as approved antidepressants are concerned (because Savella (milnacipran) is not approved in the US as an antidepressant).

Cons

It’s an SNRI, which means a discontinuation syndrome from hell if you want/need to stop taking it.


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Mentally Interesting

When doing their own research about a medication, the educated consumer, and perhaps medical students and healthcare professionals may find interesting pieces of information that are rarely discussed in a prescriber-patient setting. Such information may be rarely discussed because it is trivial, but many people tend to remember interesting, albeit trivial information about something along with other information associated with it. There may be something here to get a patient to remember a more important point about a medication. The other side of that mnemonic coin is what a medication is best known for, something a drug-naïve consumer might not know. While prescribers don’t always assume their patients are aware of a drug’s trait that is “common knowledge,” consumers who do some research don’t want to feel like idiots. They want to know something that isn’t misinformation. Prescribers can always couch questions about well-known traits in forms like “You’re aware that Panacea can cause significant giddiness, right?”

Interesting Things Doctors Rarely Tell Their Patients

  • Cymbalta is more effective when taken in the morning than in the evening. This has nothing to do with meals, it all has to do with our circadian rhythms.
  • Smoking decreases Cymbalta’s bioavailability by about one-third in smokers. Eli Lilly doesn’t recommend any changes to how much you take or how fast to increase the dosage if you smoke, but don’t be surprised if you need to take more sooner than you thought.

What Cymbalta (duloxetine) is Best Known for

Relieving one symptom of depression most medications, and doctors, tend to ignore: physical pain.
With SNRIs - unlike SSRIs - you should not drink alcohol. While drinking when taking other SNRIs like Effexor or Pristiq will just make you miserable, mixing booze and Cymbalta can kill you.

Noted Traits & Effects

Adverse Events

A review of prescribing information, the literature, and consumer experiences. One thing this review has found is no matter which neurological/psychiatric drug someone takes, one or more of these adverse events will happen and usually be gone, or at least will diminish to the point where they are barely noticed, within a week or two.

  • Headache
  • Drowsiness/fatigue - even when taking stimulants in some circumstances.
  • Insomnia, instead of or alternating with the drowsiness.
  • Nausea
  • Assorted other minor GI complaints (constipation, diarrhea, etc.)
  • Generally feeling spacey / out of it
    • Which can all add up to the ever-helpful ”flu-like symptoms” listed as an adverse event on the PI sheet of practically every medication on the planet used to treat almost any condition humans and other animals could have.
  • Will affect dreams. There is no way of telling if that will be good or bad, the extent of the change, let alone if this side effect is permanent or temporary.

Potential side effects are often used as a rationalization to not take a medication, and that is a valid reason why prescribers don’t like their patients looking up medications on The Internet. It’s a delicate balancing act between providing too little or too much information about side effects. What may be contrary to popular belief, reports of side effects from consumers on sites run by either medical professionals or consumers themselves are generally not too far outside what is published in the literature after a drug has been on the market.

Common Adverse Events

The usual for SNRIs:

  • headache
  • nausea
  • dry mouth
  • sweating
  • urinary hesitancy (it is a med for urinary incontinence after all)
  • sleepiness or insomnia
  • constipation
  • weight gain - although less likely than SSRIs
  • loss of libido and a host of other sexual dysfunctions

Most everything but the constipation, urinary hesitancy and weight gain, if any, will go away in a couple of weeks. Sexual dysfunction is a coin toss, although some women will get a sexual boost instead of a sexual dampening.

Uncommon Adverse Events

  • controlled narrow glaucoma (but you already have to be at risk for eye problems to start with)
  • elevated liver serum (an annual liver panel with this med probably isn’t a bad idea)
  • blurry vision
  • muscle cramps
  • weight loss - file under: not all side effects are bad, or for some people this is a problem

Potentially Dangerous Adverse Events

That liver thing can be really, really bad. It’s rare, but drinking and SNRIs don’t mix.

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Never underestimate the value of gallows humor when confronted with a condition that comes with the dual stigmata of having a mental illness or other neurological disorder and treating it with a medication that everyone from family members to movie stars and other misinformed celebrities say is worse than the condition itself. It’s not for all consumers, but those who have been using the Internet most of their lives generally appreciate it.

Freaky Rare Side Effects:

Ways to counter / minimize / mitigate / deal with some side effects

Names, Availability, Brand vs. Generic Issues, Forms

Consumers not only travel, they often live in other countries for extended periods. Thus they need to know if the medications they take are available in those countries, what trade names are used, and if the less-expensive generic version is available.

Available as Cymbalta in these countries

* Argentina
  • Brazil
  • Chile
  • Colombia
  • EU
  • Ireland
  • Japan
  • Korea
  • Mexico
  • Peru
  • UK

Other trade name(s) for Cymbalta used in these countries

  • Ariclaim: EU (diabetic peripheral neuropathy)
  • Duxetin: Argentina
  • Xeristar: Argentina, Chile, Mexico, Spain
  • Yentreve: EU (stress urinary incontinence)

Generic Name and Availability

US Generic name/INN:duloxetine
US Generic available?Pending

duloxetine is available in these countries2

  • Venezuela - duloxetina

Branded Generic Names3 & Transcribed or Transliterated INN/Generic Name4

  • clorhidrato de duloxetina (Spanish-language INN)
  • duloxetina como clorhidrato (another Spanish-language INN)
  • Dakermina (Venezuela)

Not all generic medications are created equal. Consumers have noted differences in the quality of medications produced by different manufacturers. See the article on on the differences between brand and generic medications for more information.

Specific generics with complaints, or preferred generics manufacturers

Generics with independently-tested bioequivalence

How Supplied

Available/Supplied As

20, 30, and 60mg capsules.

Shelf Life

3 years

Rate this article

If you feel like it, you may rate this article on a scale of 0 (worst) to 5 (best). The more value-judgments the better, even if you can criticize each only once.

Please rate Cymbalta (duloxetine): a review of the literature and consumer experience.

0 stars Everybody hates me.


Click here for Part 2: Warnings, clinical pharmacology, interactions, additional comments and consumer experiences




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References

  1. Hughes, Shannon, and David Cohen. “Can online consumers contribute to drug knowledge? A mixed-methods comparison of consumer-generated and professionally controlled psychotropic medication information on the internet.” Journal of medical Internet research 13.3 (2011).
  2. Faught, Edward. “Topiramate in the treatment of partial and generalized epilepsy.” Neuropsychiatric disease and treatment 3.6 (2007): 811-821.
  3. Cymbalta’s Full US Prescribing Information
  4. Mosby’s Drug Consult 2007 (Generic Prescription Physician’s Reference Book Series) © 2007 ISBN:978-0323040587
  5. Article I, Section 8 of the US Constitution
  6. Greenstone Pharmaceuticals’ Product List. Greenstone LLC Last accessed 04 July 2014
  7. History of Pfizer and Warner-Lambert; 2000 to Present. Pfizer.com Last accessed 04 July 2014

{{$$bigbiblio}}


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 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 In some countries the INN / generic name is transcribed into a local phonetic equivalent. In Spanish it's often so close as to be redundant (e.g. topiramato vs. topiramate). In Finnish it's close to being a different drug (e.g. escitalopram vs. essitalopraami). I can understand the need to transliterate the INN / generic name into another alphabet (topiramate becomes топирамат in Russian), but giving a med a different generic name using the Latin alphabet just makes it difficult to find.


If you have any questions not answered here, please see the Crazymeds Cymbalta 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 Sunday, 22 September, 2013 at 21:02:34 by JerodPoorePage Author Date created
“Cymbalta Complete Page” by Jerod Poore is copyright © Jerod Poore Published online 2011/04/05
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Cymbalta, and all other drug names on this page and used throughout the site, are a trademark of someone else.

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.




Page design and explanatory material by Jerod Poore, copyright © 2004 - 2014. All rights reserved.
Keep up with Crazymeds and and/or my slow descent into irreparable madness boring life. Pick your preferred social media target(s):

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.
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 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. 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.
Very little information about visitors to this site is collected or saved. From time to time I look at search terms used and which pages they bring up in an effort to make the information I present more relevant. And the country of origin, just because I’m geeky like that. That’s about it. Depending on how you feel about Schrodinger, our privacy policy should either assuage or exacerbate your paranoia.
Crazymeds is optimized for the browser you’re not using on the platform you wish you had. Between you and me, it all looks a lot cleaner using Safari or Chrome, although more than half of the visitors to this site use either Safari or Internet Explorer, so I’m doing my best to make things look nice for IE as well. I’m using Firefox and running 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.
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 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.

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