Is Your Child Outgrowing Her Generic Concerta Dose?

Methylphenidate (also known as Concerta).

Methylphenidate (also known as Concerta). (Photo credit: Wikipedia)

Written by Kristen Stuppy MD. Dr. Stuppy is a practicing pediatrician in Kansas. She feels privileged to be able to help families keep their children healthy and she loves watching entire families grow!  Dr Stuppy is active on Facebook and puts a more personal touch to pediatric topics on her blog.

Generic Concerta Not Working Like the Brand Used To? It might not be that you’re outgrowing the dose…

I used to be a huge fan of generics. They save money, right? They are equivalent to the brand name, right?

That’s what I’ve always been taught and what I teach.

I’ve been jaded by many problems and now disagree with the above. Generics aren’t always cheaper than the brand name. Some generics are not equivalent to the name brand.

A recent discussion on a psychology/pharmaceutical listserv I follow brought up the issue of generic Methylphenidate HCl not working as well as the brand name Concerta. Several members had some great insight into why this is.

The discussion peaked my interest in the issue and I started looking online for information earlier this week.

Ironically today I went to pick up a family member’s medicine. We have filled at the same pharmacy previously for generic “Concerta” and have always gotten the equivalent generic.

When I looked at the pills in the bottle today, I told the pharmacy tech they weren’t OROS (see below). She looked confused. She had no clue what I was talking about.

(Lesson to all: if you have any questions, ask to talk to the pharmacist. Hopefully they will understand the pharmacology better than the tech.)

Generics for Concerta (Methylphenidate HCl) might have the same active ingredient, but have a completely different time-release system, resulting in varying drug peaks in the bloodstream.

The original Concerta (from Watson pharmaceuticals) uses a special technology to time-release the active drug. This time-release technology is called OROS (osmotic controlled release oral delivery system). There are several other time-release methods.

The active ingredient may be imbedded in various substances from which the medicine must exit slowly or a gel cap is filled with beads that dissolve at different rates. With the technology used by Concerta, the capsule IS the time release. It doesn’t dissolve.

The medicine is slowly released through a small hole in one end of the capsule. The pill works like a pump, pulling in water from the intestines, pushing the medicine out of the tube slowly throughout the day. See this photo from Medscape.

Screen Shot 2013-05-13 at 9.43.07 AM

I have recently learned that not all generic formulations of Methylphenidate HCl are using this technology. This alters the time-release nature of the active medicine.  For some people this substitute might be just fine, or even preferable.

But if it seems like your medicine isn’t lasting long enough, has times that it works well followed by times it doesn’t until the next peak, or any other problems — check your pills!

You can tell the difference by closely looking at the capsules. The OROS capsules are a unique shape, a little more blunted than a standard capsule. If you look really closely at the ends, you will find that one has a “dimple” where there is a small hole covered by a thin layer matching the rest of the capsule. I just happen to have at least one of three dosages.

IMG_0564

So if any medicine doesn’t work like it used to, look closely at the pill itself to see if it is the same as previously. If you don’t have any left, ask the pharmacy for the company / maker of the medicines you’ve filled over the past several months.

Let your doctor know if you can’t use a substitution so they can specify “Watson brand only.”  If the new “brand” works better, be sure to ask for that manufacturer.

Do not ask your physician to simply increase dosing, because with the next prescription you might get the OROS pill, and the new dose will be too high.

Ask which manufacturer makes the generic for Concerta sold at your pharmacy. Watson Pharmaceuticals is the one that is approved by Ortho McNeill Janssen Pharmaceuticals to market the OROS system pills.

Mallinckrodt markets another type (not OROS) in the US. If your pharmacy doesn’t use your preferred pill type and you plan to shop elsewhere, be sure to let them know why!

 

Reporting Adverse Events: If you have an issue with the duration of action of a different brand of Methylphenidate HCl you should report it to the FDA. This will allow them to review cases and possibly stop the substitution of these non-equivocal products. Click on this link for the MedWatch Report.

Resources:

The Pre-MMA 180-Day Exclusivity Punt? What Gives? A legal blog explaining how medicines lose their exclusivity and can become generically available, specifically the Concerta dispute.

How To Tell The Difference Between Concerta and Generic Concerta A Canadian ADHD blog provided the picture of how to recognize the difference. Generic formulations have been available in Canada years prior to in the US.

Special thanks to the members of the Child-Pharm listserv!

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2 thoughts on “Is Your Child Outgrowing Her Generic Concerta Dose?

  1. Wow, I’m really upset to hear there’s a difference between brand name and generic meds. I had a practice question from boardvitals.com in pharm and I got it wrong, so I went searching for the answer and stumbled upon this post. That’s how I found this blog. Very helpful, but very upsetting! Thank you!

  2. Thank you for the information and explanation. It is interesting to have a fact-based, rationale explanation as to why a generic having the same active ingredient is not necessarily the same as the brand name.

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