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|Dosing of Strattera||Side Effects|
Effectiveness of Strattera
|Any Disadvantages to Strattera?|
|Links to Websites about Strattera||
Key Points of Dr.Floyd
sponsored by Lilly on
Key Points from
Dr. Rick Bower's presentation sponsored by Lilly on
Strattera is the latest drug for ADD/ADHD from the Eli Lilly Company. It became available in pharmacies in January 2003.
Strattera however has several interesting features that makes it of great interest.
1. It is not a Schedule II drug. That
means that your physician can now:
a. Give free samples
b. Write a prescription for more than a month at a time
c. Call prescriptions into the pharmacy, rather than requiring you to pick them up each month
2. Less abuse potential. It appears to have no abuse potential if it ends up in the hands of someone who who would wish to abuse it. It does not become addicting in high doses.
3. It is not a stimulant. Rather it is an NRI, an norepinephrine reuptake inhibitor. Norepinephrine has been known to play a key role in ADHD and depression for a long time. Some of the older antidepressants that impact norepinephrine, such as imipramine (Tofranil) and desipramine (Norpramin) have been used for the treatment of ADHD. However their side effect profile is quite severe, and requires close monitoring for heart rhythm problem. Thus careful monitoring should be done. In addition, those older antidepressants cause many physically uncomfortable side effects, such as dry mouth.
4. It is the only drug that has specifically been approved by the FDA for adults. This is more a big deal for the Lilly Company than anyone else. It is the only drug that can legally be marketed to help adult ADHD. Remember, that it is quite proper for a physician to use a drug for purposes other than what has been approved by the FDA. So adults have many choices other than Strattera.
5. It may also be more easily prescribed to those adolescents and adults who are "addiction prone." There has always been a great concern for giving stimulants to those who have problems with alcohol or drugs. This has unfortunately kept many people away from treatment, since it is well known substance abuse is a great risk factor for those with ADHD. This may open the door for many more people for treatment. Strattera does not stimulate the pleasure centers of the brain as do the stimulants.
6. It appears to provide 24-hours per day coverage. The stimulants last no longer than part of a day, ranging from 4-12 hours. Since Strattera carries over until the next day, this will help the "getting going" that is so difficult with most people with ADHD.
7. Since it has antidepressant properties, it may provide especially effective treatment for those with depressive and anxious features alongside ADD/ADHD.
8. It does not appear to make tics or Tourette's Syndrome worse, as the stimulants often do.
Strattera may be administered in either a once or twice a day dosing . A morning and late afternoon dosing schedule appears to have been used in most of the clinical trials. However, once a day appears to work well. It doesn't seem to be so critical on the exact timing of the dosage.
The dosage in the child-adolescent studies were based on weight. The dosage that seemed to be started was at .5 mg/kg/day. The most effective dose appeared to be about 1.2 to 1.4 mg/kg/day. For adolescents, regardless of weight, the maximum dosage appears to be recommended to not exceed 80 mg for the first month or so, and then perhaps go up to 100 mg per day. Adults appear to need 80 mg to 100 mg per day if they weigh more than 175 pounds or so.
Consult with your physician before adjusting the dosage as this information is preliminary and based on Eli Lilly dosing instructions. It appears that most physicians are being very cautious and thus underdosing. This will be quite noticeable with people who have been on stimulants. It also appears to take a while for Strattera to start working. It might be advisable to continue the stimulant, and then taper it as the impact of Strattera is made.
Poor metabolizers of the drug appeared to have the most positive impact.
Now that Strattera has been on the market for several years, the side effects are becoming better known. The most noticeable side effect appears to be sleepiness.
The side effects appear to be somewhat more common than with the psychostimulant medications. The primary concerns appear to still be appetite suppression, sleep disruption (insomnia), and an increase in heart rate and blood pressure. There have been some reports of rapid heart rate (tachycardia). As with the psychostimulant medications, side effects appear to resolve when the medication is stopped. Generally the appetite suppression that is such a problem in the stimulants seem to be minimal with Strattera.
Overall, there appears to be more side-effects with Strattera than was originally promised or hoped for. There seems to be a lot more people trying it and discontinuing it. There are also a fair number of people who seem to have minimal or no benefit from Strattera.
There seem to be a lot of anecdotal reports of daytime sleepiness that appears bothersome for many people. This may be related to the fact that most of the drug trials used twice a day dosing, but then Eli Lilly decided that once a day dosing was therapeutically equivalent to twice a day dosing. So to overcome drowsiness, one strategy may be to switch the time of dosing to evening, or split dosing to twice a day.
An interesting, but apparently harmless side effect, is enlarged pupils. For some reason that has not been widely mentioned, but some parents have expressed concern, and one parent reported to this author that the teacher commented about it. This could be mistaken for illegal substance abuse, when it appears that norepinephrine is responsible for that effect.
Prozac and Paxil are inhibitors of the metabolism of Strattera. For that reason, it is best to be very careful when using Strattera with either of those. The recommendation seems to be to start at .5 mg/kg/day if the person is using either Prozac or Paxil.
Males have reported some problems with genito-urinary side effects. Symptoms similar to prostatitis have been reported. Painful urination and urinary retention have occurred. Some of the chat rooms have indicated pain and unusual symptoms following sexual intercourse.
It has been shown to be effective in a variety of settings and studies. It has been demonstrated to improve the ADHD and ADD symptoms in children, adolescents and adults. It may also have special effectiveness for people who have depressive symptoms.
The FDA does not require that a medication be better than another medication on the market. It merely has to be better than placebo. So the fact that Strattera works for ADHD does not mean that it is superior to other medications.
Strattera appears to become effective within a couple of days to one week, and may be somewhat effective prior to reaching its optimal dose. Some people suggest waiting 4-6 weeks before deciding that the dosage is ineffective.
It seems to impact nicely "quality of life" issues. Several parents have said, "I like my child better." One mother and son sat in my office kidding each other, something that had never happened before. This may be attributable to its antidepressant properties.
It may help with executive functioning issues better than the stimulants.
Overall, Strattera appears to have a somewhat weaker impact than the stimulants. This may be noticeable on those who have a "sluggish cognitive tempo." It may not impact hyperactivity as much as is necessary.
In reality many psychiatrists are using it alongside the stimulant medications.
The following may be some disadvantages:
1. There may be too little follow-up with it. Presently there is rarely enough follow-up with the stimulant medications to make sure that the person is doing as well as possible. The ease of prescribing is likely to create a situation of too little follow-up. In the long run that leaves many people disappointed in the treatment of ADHD. A recent study indicated that the average person who received medication for their ADHD child reported no significant improvement after one year. That is caused almost entirely by inadequate monitoring, follow-up, and learning to understand the nature of ADHD.
2. This is no great cure all. No one drug will help everyone. It is still going to have some of the side-effects of the stimulants, without the "bad name" of the stimulants. And it will surely be ineffective for some people.
3. Any new drug means that the exact way it will work in the "real world" is not yet known. Many people who will take the drug would have been excluded for certain reasons in the studies. Typical studies eliminate "complicated cases." In real life, there are many issues to deal with in a given person.
4. It is not necessarily safer in the long run than the stimulants. People fear the long-term side effects of the stimulant drugs. But Ritalin has been used for over 30 years with extremely few known side effects. The long-term side effects of Strattera is obviously totally unknown.
5. Cost and Insurance constraints. Some insurance companies are refusing to pay for it. And if you have to pay for it out of pocket...it is quite pricey. A recent check with a local pharmacy indicated that #30 60 mg pills cost over $100, and #60 40 mg pills cost over $200 (to get the 80 mg dosage)!!! The pharmacist said, "No one pays for these out of pocket!"
6. One may need to add a stimulant along side of it. Strattera does not seem to impact hyperactivity as much as the stimulant medications. That tends to defeat the argument that you can avoid a Schedule II drug.
7. It appears difficult to adjust. One psychiatrist stated recently somewhat to the effect: "With the stimulants I knew within a couple of months how they worked and what to expect. With Strattera, I believe that a year from now I still won't have a really good handle on it. It may well become a drug for psychiatrists, rather than primarily care physicians, since it is so complicated to use."
For more information you may wish to go to these websites:
Strattera.com This is the website sponsored by the Eli Lilly Company that makes and markets the drug. It has good information, but obviously they will only tell you the advantages. The FDA also regulates what they are able to say about the drug.
Psychopharmacology Alert's Review of the Clinical Trials that led to FDA approval of Atomoxetine (Strattera). This review from Manessis Communications is the best summaries that Mr. Swank has found to date with some detail about the study parameters, dosages used, side effects and results.
While admittedly sponsored by Eli Lilly, the makers of Strattera, Floyd Sallee, MD and Ph. D. (Professor of Psychiatry and Pediatrics) at Cincinnati Children's Medical spoke of his experience as part of the drug trials for Strattera. He made the following points that I found helpful:
1. While Strattera has a half-life of about 5.2 hours, and targets primarily norepinephrine, the drug indirectly impacts dopamine action that continues beyond the time the drug is in the system. Thus one a day dosing is all that is necessary in most cases.
2. Dosing levels are very conservative if one follows the FDA dosing guidelines. The FDA does not suggest above 100 mg/ day. That may not be high enough for patients who weigh more. A 1.4-1.6 mg/kg/day formula may be a more realistic target dosage. Dosages up to 200 mg/day may not be unreasonable. Dr. Salle does not feel that there are any significant risk even with overdosage.
3. The only 2 psychotropic drugs to worry about taking with Strattera are Prozac and Paxil (Well, and the MAO inhibitors which are extremely rarely used). Use smaller doses when using along side them.
4. There is no problem using Strattera along side the psychostimulants such as Ritalin, Concerta, Metadate or Adderall.
5. Strattera appears to carry over to the next morning, impacting in a positive manner.
6. Strattera is rapidly absorbed, with maximal plasma levels reached in 1-2 hours after dosing.
7. Strattera has been found to be helpful with tic disorders comorbid with ADHD. Does not exacerbate tics or Tourette's Syndrome.
8. Regarding how long before it makes an impact is fairly rapid, a conservative approach should be to wait two weeks once one has reached a normal optimal dosage before increasing again.
9. A starting dosage of about .5 mg/kg/day should be increased to target dosage after about 3-4 days. This helps minimize the impact of side effects if started with a full dosage.
10. Strattera does not appear to potentiate the impact of alcohol.
11. While chemically different than Prozac, it may be helpful to think of it as a cousin of Prozac in terms of the way it works. However, its action is very specific to norepinephrine. It also appears to target most specifically the prefrontal cortex of the brain, which is the main brain center implicated in executive function and ADHD problems.
12. There are some reports of sexual dysfunction side effects in adult use.
Hope this is helpful,
Notes from Rick Bowers (MD, Psychiatrist) at Eli Lilly Sponsored symposium about Strattera held 03-04-03 in Troy, Ohio
1. Strattera may take 3-6 weeks to have full impact. During the time from starting medication until it takes full effect, there may be a noticeable gap of efficacy if the person has been on a psychostimulant medication. Thus one may want to keep the psychostimulant medication for a while until the Strattera reaches optimal impact. A tapering strategy may be the best. Thus may leave them on the stimulant for about two weeks before tapering off the psychostimulant. Dr. Bowers seemed to indicate that there was about a 25% impact in the first week, compared to full impact 3-6 weeks out.
2. Side effects tend to resolve after a week or two for most people.
3. The ideal candidates for Strattera may be:
a. Those people where regular medications have not been effect.
b. Those people who have side effects to stimulants: sleep, appetite, dysphoria, tics, personality blunting
c. Difficulty dispensing for fear for diversion, or out of town college students
d. Those with poor efficacy in the AM or PM, since Strattera seems to have carry-over effect.
4. If side effects, try dispensing with food (such as peanut butter), BID dosing or bedtime dosing if sleepiness is a problem
5. Using Strattera along side of stimulants may be necessary.
6. Dr. Bowers prefers a rotation strategy when starting medications, using trials of methylphenidate products, Adderall, and now Strattera. If one does not try all, one does not really know which one works best.
7. Strattera seems to be quite helpful with the functional or family interaction issues related to problems with ADHD or Oppositional Defiant Disorder.
8. It may have some really helpful benefits in the hard to treat Autistic/Asperger's/Pervasive Developmental Disorder population.
9. Dr. Bower's reported his experience that when used with Prozac or Paxil, that the dosage of Strattera needs to be cut about in half.
Other helpful comments:
Dr. Bowers pointed out that Ohio law allows physicians to write 3 month of stimulant medications at one time. The date that the prescription is written must be the date written, but one can write three different prescriptions for the three following months that state that they may not be filled until a certain date.
Focalin is sometimes helpful with fewer side effects than other stimulants that have proven to be bothersome.
Notes and responsibility for errors by John Swank. 03-04-03
© 2011 John E. Swank, MS, LPCC Swank Counseling , 21 Robinhood Lane, Troy, OH 45373
© 2014 John E. Swank, MS, LPCC Swank Counseling , 21 Robin Hood Lane, Troy, OH 45373
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