ADD / ADHD, ADD / ADHD Medication, Medication

Concerta: What Every Parent Should Know

Concerta is one of the big name Methylphenidate stimulants used to treat ADHD. The main difference between Ritalin and Concerta is that Concerta is a timed-release formula that is designed to give out a steady supply of stimulant through-out the day. It was first introduced in 2000 and since become major seller with Johnson & Johnson reporting sales $0.9 billion. A rise of 20% over 2005.

The original patent for Concerta expired in 2004 but the FDA have not approved any generic substitute drugs yet. To extract as much money as possible from Concerta, Johnson & Johnson have taken out two other patents on Concerta relating to its slow release mechanism. This has resulted in legal action against Andrx who are trying to produce a generic version.

Concerta tablets come in four strengths containig 18, 27, 36, or
54 mg of methylphenidate. One tablet should be taken daily and the company claims it provides effective treatment for 12 hours. The tablet has an outer coating of methylphenidate that dissolves within an hour of swallowing providing an immediate dose.

Over the next few hours, liquid from the stomach seeps into the tablet through a semi-permeable coating causing a reaction that forces the medication out of the Concerta tablet through a tiny laser drilled hole in the tablet. After six hours the rate of release increases to counteract the diminishing effect of the initial outer coating. The FDA found that Concerta in the blood stream increases rapidly reaching an initial maximum at about 1 hour, followed by gradual ascending concentrations over the next 5 to 9 hours after which a gradual decrease begins. Average times to reach peak effect across all doses of Concerta occurs between 6 to 10 hours.

The biologically inert components of the Concerta tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that Concerta tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized. The methylphenidate is most passed out of the body in urine.

In patients, there were no difference in the performance of Concerta when administered after a high fat breakfast. There is no evidence of the effectiveness of Concerta being effected by the presence or absence of food.

Concerta approval by the FDA is based on four double blind, active and placebo controlled studies. Three of the studies were on a total of 416 children aged 6 to 12 and each study lasted only a few weeks. The effectiveness of Concerta was measured by the teachers assessing the children’s behaviour for inattention or overactivity. The result showed a statistically significant reduction in symptoms, about 30-40%. However the value of such subjective measures is debatable and it is only with access to the full data set from the studies can you get an accurate understanding of Concerta’s impact.
One trial on teenagers taking Concerta was run, involving 177 adolescents between 13 and 18. Over a four week trial, Concerta led to a reduced score on an ADHD rating scale compared to a placebo.

No trials were run using Concerta on adults or on its effectiveness when used for more than 4 week. The FDA recommend that doctors prescribing Concerta for extended period regularly be reassessed to ensure the drug remain effective and safe.

What Concerta actual does to alleviate ADHD symptoms is in unknown. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. But it has not been proven that this is linked to the changes of ADHD symptoms reported by uses of Concerta.

The contrainciations of Concerta are numerous. Particularly patients with marked anxiety, tension, agitation, glaucoma and tics may find their symptoms increase whilst on Concerta. Patients who are taking monoamine oxidase inhibitors (antidepressants) should discontinue their treatment and leave a 14 day gap before taking Concerta. Because of the indigestible nature of the tablet, Concerta should not be used by people with gastrointestinal problems. Adverse reaction to Concerta include insomnia, twitching, nervousness, emotional lability, abdominal pain, and anorexia.

In addition to the active ingredient, methylphenidate, Concerta contain also contains the following ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid,
synthetic iron oxides, titanium dioxide, and triacetin.

Sources:
Concerta Patents
Johnson & Johnson 2006 Annual Report [ PDF ]
FDA Concerta Product Information [ PDF ]

24 Comments

  1. my granson is on concerta,what i would like to know is , is it still affective if you take it one week and then not.And then another week. Does it not defeat the odject of it. He is 12 & taking 45mg.

    Concerned Gran.

  2. vickie

    If you drink mountain dew or any high caffeine drink right after taking the concerta 27 mg…can it have a side effect as my son was trembling, etc and had to go to the hospital

  3. abbie larson

    thanks for the info. i am doing a school project i am on concert but i didnt know this much about this drug thanks again

  4. Father of 4

    To the mother that feeds her son Mountain Dew…

    Don’t blame the Concerta. It’s prescribed. Loading your son with Caffeine is adding additional stimulation and will cause the jitters. Switch to Caffeine free soda. Or better yet since there is such a high rate of obese children in the US. How about saving soda for special occasions only. Milk, juice, water and sugar-free treats like Crystal Lite.
    Come on parents, use your brain.

  5. Jennifer

    My 10 yr old son was on Concerta for about a month and a half and developed motor tics. we had to take him off the Concerta and start a non-stimulant med for his A.D.D.
    Has this happened to anyone else, and if so, how long did it take for the tic to resolve?

  6. Nancy Christiansen

    My 16 year old son who has gotten into alot of trouble with the law and school, major mood swings, irritablity, withdrawal type sysmtons since Aug/07 in taken Ritalin SR. Since he started taken Concerta SR 36mg he’s the great boy i remember, mannerly, focused, calm, Happy, an angel in fact, now if i can just get converage here in Ontario i am on a disability plan. I am so happy i just can’t believe the difference in his behaviour and no moodiness. Wow

  7. Nancy Christiansen

    My 16 year old son who has gotten into alot of trouble with the law and school, major mood swings, irritablity, withdrawal type symptons since Aug/07 in taken Ritalin SR. Since he started taken Concerta SR 36mg he’s the great boy i remember, mannerly, focused, calm, Happy, an angel in fact, now if i can just get coverage here in Ontario i am on a disability plan. I am so happy i just can’t believe the difference in his behaviour and no moodiness. Wow

  8. My 9 1/2 year old had been on Concerta 18 mg from May ’05 to Mar. ’08. His meds were increased to 27 mg in Mar. ’08. This week we have noticed that he definitely as developed a motor tic of rapid, stong head nodding (down sometimes; to the right sometimes). He has several in a row and then none for a few minutes. We have put him back on the lower 18 mg dose starting today and we are taking him to the doctor next week.

  9. Julie

    I am having major problems with Concerta…please contact me with your story. I need to hear from you! I am a parent of a 10 year old who was put on Concerta. Juliee73@verizon.net. I promise your confidetiality! This is so important to me. I need to talk to more parents with the problem with tics and hear your story.Please share your story with me. I have info. for you also.

  10. Julie

    Valerie,
    You should be aware that even if you have no family history of tics or tourrettes, this can occur!! I would strongly advise alternate NON-stimulant meds first…try them first and use stimulants as a last resort…stratterra is a great non-stimulant. Do research on Concerta..not a good med! my e-mail is juliee73@verizon.net.

  11. erin

    You have to find the right drug for each child. My son has been on Concerta for a year (54mg) with no side effects and great results. Everything can have side effects! (even aspirin) Concerta, Stratterra, Adderall all are known to have bad results for some. Point being… watch your kid, know your kid, there is no magic solution. What works for your child may have tragic results for another. You can’t say one is good or bad for all.

  12. Julie

    As parents we should be warned of the side effects that could be life long side effects… when we are not made aware of these, how do we not get upset when they occur and are stuck for life w/ the consequences? These doctors are receiveing huge kick backs from the major drug companies at the expense of our children! I can say when a drug is bad!

  13. Belinda

    I have a 6year old who just started Concerta 18mg. He was on Focalin XR and it stopped being beneficial. How long should it take the Concerta to actually start helping? Does it have to build up in his system or is it the type that it works that day for that day?

  14. My son is 4 1/2 and has been asked to leave a PRE school becasue of his ADHD. We have been on Concerta 18mg for 2 days. I have noticed a difference for about 30 minutes each day and that’s it. During this 30 minutes he is sad and crys over silly things. I have not seen a significant change in his behavior. I am wondering if we should ask the doctor for a different medicine or a higher dosage of Concerta?

  15. LISA

    My son was prescribed concerta 18 mg. We are suppose to start this morning! After reading this NO WAY IN HELL! He will have to remain a daydreamer, who gets C’s on his report card, I will LOVE HIM JUST THE SAME!

  16. alexis

    its been a several weeks now since iv been on concerta. im 18, female and also taking zoloft for anxiety. ever since a young age, i wanted to be skinnier. (before i started taking concerta i was 130 lbs, now im 124). i love loosing the weight and for a week, i felt i could now have the power to just not eat. its giving me the power to loose weight like i havent ever before. im hardly ever hungry and for the last week, started thinking i could easily develop a serious case of anorexia. i havent spok with my doc about this feeling, but since i just read in this article that anorexia is a possible noted reaction, i just may mention it. my parents notice im losing weight, but i like it. im more focused on weight now than other important things. my concerta medicine starts to ware off tough after 4 or 5 hrs…but the urge to not eat is ALWAYS there

  17. chris

    My son has been on concerta for 6 years & it is worth its weight in gold. his dosage has increased a little every year but it really keeps him focused and able to sit still. The only drawback is it affects his appetite so when it wears off he is starving!

  18. randall

    Alexis,

    PLEASE talk to your doctor about your concerns. I was in the exact situation as you, and I suffered from anorexia for nearly three years because of Concerta. I was prescribed as a seventeen year old, and I took it until shortly after I turned twenty. I, too, liked that it completely did away with my appetite, and I lied to the doctors about how I was feeling. When I was 19, I was at my worst: I lost my period, and my skin was horrible. But as long as I was skinny, I didn’t care. Stopping Concerta was one of the best things I ever did for myself. If I had kept going, I know that something really serious would have happened. I didn’t realize until recently how dangerous my behavior was, and I know that if I had kept going, something really bad could have happened.

    I never thought that I would ever have an eating disorder. But then Concerta came into my life and suddenly I was able to suspend my appetite. This is WRONG, and I strongly believe that this drug should be taken off the market. This is something I feel very strongly about. PARENTS, DON’T LET YOUR CHILDREN’S LIVES BE DESTROYED BY THIS POWERFUL DRUG THAT IS BASICALLY COCAINE IN A CAPSULE!!!

  19. Beckie

    My son Daniel, is the youngest of my 3 children. The other two always caught on to things right away, so it took me a long time to notice that Daniel didn’t have a clue to life. His ADHD had kept him from understanding the basics for going through a day. He would watch everyone, but would never ask how to do something, or why something was a certain way. He had fits if he wanted something I didn’g give him. He still has a hard time with sarcasm and inference, and what is being put forth is not what is being meant. Anyway, he got kicked out of preschool, and I had the school disctrict assess him, they are required to test him by law it is called an IEP. I was still very clueless, but took the medication route and we started with Ritalin and Adderall and a couple other stimulant brands. We always started with the lowest amount and met back with the doctor in 30 days to see how he was doing. I stayed in touch with his first grade teacher (by now) daily. I would know if the medication was too strong and was like a zombie or the meds weren’t lasting long enough. One medication helped with his hyperactivity, but not his focus. Meanwhile, while we are trying to get in there and bring Daniel out so he can understand and focus on school, we are also challenged with the fact that he has basically missed Kindergarten and most of first grade by not understanding what he was supposed to focus on. The school wants him to take summer school, the school wants to retain him. Both of these move would be very detrimental to his self esteem. I say no, there has to be another way, We wind up on concerta, 36mg, a few group therapy sessions on ADHD through our HMO, several very expensive private phychiatry appointmnts. I even enrolled him in SCORE, which was a computer based tutorial learning that we atteneded 2-3 times a week for 1-2 hour a day to reintroduce academic skills. I finally reallized that I was doing more that anyone else, more than the teacher, (and we had GOOD teachers!, more than the expensive psychologyst, more than the therapy groups, more than SCORE, more than even Daneil! I was/am on the computer EVERYDAY trying to FIX THIS! OK, I know there is no cure, we even tried taking fish oils for the summer. Daniel needed more help at school, and the only way to get that was to go through another IEP (Indiviualized Education Plan) and have the school put Daniel in a smaller learning enviroment (like 1:1 or 1:2) Daneil goes to the speech specialist 2 times, the school psychologyst once a week. He is out of the regular classroom 21percent of the time. He has accomodation, also. He will always sit in the front row, near the teacher, some tests won’t be timed. All of this follow under the IDEA and ADA, but you have to go through the IEP process first and get your child qualified. Daniel actually qualified under Other Health Impaired. This gets really convuluted, and I know I am losing most of you with this story, but I was getting lost, too, so I hired a Specieal Education Advocate. They know the laws inside and out and exactly when the school is not doing what it is supposed to do to full educate your chid. The only other thing I want to touch on is CogMed. It is a computer based program that your child does in your home. There are 25 intense sessions 5 sesseions a week for 5 weeks. Each session is supposed to take 30-40 minutes. This program helps build working memory, see http://www.cogmed.com
    Daniel did CogMed over the holidays 08, so we are about 6 weeeks out from being done with cogmed. There is a definate diffence in his ability to focus, but please read the cogmed website for information on that.

    There is not a one stop answer. I think I am writing the Neverending Story. But this is where we are in the story. We have a review IEP coming up in April, time to call Carol, my special ed representative.

  20. Jennifer

    Beckie from March 11th
    can i suggest that you look into IRLEN SYNDROME. it is new most teachers haven’t even heard of it my son has it and it helps ADHD symptoms and his ability to read and do school work is amazingly different. just a little tip

  21. Beckie thank you for what you just said. Because my little brother literally went through the same thing that your son did. I’m 17 years old and he is 15. I really appreciate that you shared that story because now I hope I can help him out by telling my parents about everything you and your son went through to help him. He is on 27 mg of concerta but I do not see any difference in his behavior and is ability to focus. So I’m going to see if I can do what you did for your kid.
    THANK YOU SO MUCH!

  22. Stacey

    I am a therapist and I specialize in ADHD, ODD, Asperger’s, Dyslexia and otherlearning sifficuties. Have you ever looked into Asperger’s? It is a high functioning Autism. Check it out. A great deal of what you share about your child sounds a lot like Asperger’s. Good luck

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