Methylphenidate revealed

The Pediatric Insider

© 2014 Roy Benaroch, MD

Warning: this isn’t really a general interest sort of post. It’s more for people who prescribe methylphenidate (commonly called Ritalin), and maybe parents whose kids take the stuff. It gets odd and picky and technical, but since I had to look at this stuff up to keep it straight in my mind, I figured someone else out there needed this kind of detail. Enjoy, or skip it!

What the heck is going on with methylphenidate (MPH)? Generic substitutions may not be what you expect. If you’re picky about the form and kinetics of what’s being prescribed, you have to pay attention.

Plain MPH is still easy. Tabs come as generic or “branded” as Ritalin or Methylin, in 5s, 10s (scored), and 20s (scored.)

When you get to the time release MPH, that’s when things get tricky. The oldest one used to be branded as Ritalin SR, and it’s still out there—20 mg of MPH in a wax-impregnated tablet, only at one dose (20 mg), with irregular breakdown and absorption. It falls apart when it wants to, and no two tabs are the same. A “generic”, of sorts, of Ritalin SR in a similar wax tablet came out as brand Metadate ER tabs (originally in 10s and 20s, now only in 20s.) You’ll see either marked as generic “methylphenidate ER tabs”—always in tablets, always 20 mg.

Metadate then extended their brand into capsules, marketing these as Metadate CD (available in 10, 20, 30, 40, 50, and 60 mg.) Rather than wadding up all of the MPH into one lump of wax, this line of capsules contains individual small beads of medicine, some of which are wax coated for delayed release. The Metadate CD line has 30% of the MPH uncoated (immediate release), and 70% coated for delayed release. Generics of these are called “methyphenidate ER capsules”—so beware, capsules and tabs are very different when you see methylphenidate ER. Caps = reliable sustained-release technology; tabs = blob of wax.

Ritalin LA brand is also a capsule of beads, though they use a 50:50 mix of immediate and delayed beads. If a patient on Metadate CD needs more of an AM “push”, switching to the same mg dose of Ritalin LA will provide more of an immediate action. Ritalin LA comes in 20, 30, and 40 mg capsules. Some pharmacies will substitute Ritalin LA, Metadate CD, and methylphenidate ER caps, even though they are NOT interchangeable because of the differing ratio of immediate to delayed beads in the caps. You want real 50:50 Ritalin LA? You’ve got to “Brand Necessary” the rx.

Concerta (or, at least, brand-name Concerta) uses a unique time-release delivery system for the MPH, called “OROS.” An undigestible shell surrounds a core of MPH, with a tiny sponge inside that slowly absorbs gut juice, expanding to push MPH out gradually through a tiny hole. Clever! And it really should provide even delivery. They also coat the outside of the shell with about 20% of the total MPH for an immediate effect (that’s less than Metadate CD’s 30% — Concerta is the time-release MPH that starts the slowest.) Concerta comes in weird doses: 18, 27, 36, and 54. There are now generics of Concerta, called methylphenidate ER (yes, the same name as other generic time-release methylphenidate), in the same weird milligram amounts. But only SOME of these generics use the OROS system. Others use some kind of wax matrix (that I suspect is as low-tech as old-school Ritalin SR.) The generic Concerta that doesn’t use OROS is still shaped like Concerta, making it difficult to spot, but the delivery is very different from real Concerta. If you want to ensure you’re getting the expected time-release technology, you have to either specify “Brand Necessary” Concerta, or write “only substitute generic with OROS delivery technology.”

Daytrana is still out there, plugging away. It’s a patch that delivers MPH very evenly over up to 9 hours (that’s what FDA says. It probably lasts longer, or could last longer if you leave it on.) Drug delivery starts about 1h after the patch is applied, and stops 2 hours after the patch is removed. It comes in 10, 15, 20, and 30 mg patches, all of which are pretty darn irritating to many patients.

Then, the newest stuff: Quillivant XR, a liquid time-release MPH that the manufacturer claims lasts 8-12 hours. The strength is 5 mg/mL, and it’s non-substitutable. There’s also a traditional, ordinary, generic MPH liquid at both 5mg/5mL and 10 mg/5mL.

For you single-isomer buffs, Focalin (dexmethylphenidate) comes in 2.5, 5, and 10s, and there’s a generic available (though according to Goodrx.com via Epocrates, the generic is actually a little more expensive.) Focalin XR, their bead-technology time-release form, comes in all multiples of 5 from 5 to 40 and has no generic form… yet*!

I think I’ve covered all of them, but welcome any comments, especially from pharmacists. The complexities of prescribing this one compound are just silly, and I’m sure this is leading to all kinds of misadventures. The FDA should step in and require more-transparent, easily understood labeling. Until they do, I’ll keep ya posted.

 

*edit: see the comments below– Focalin XR does have a generic, since Nov 2013.

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11 Comments on “Methylphenidate revealed”


  1. I’m wondering about Focalin XR generics. When I search for its availability, I find nothing. Yet I’ve had a few patients report that they are getting it. Any pharmacists out there know the story?

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  2. Dr. Roy Says:

    Kristen, apparently there is a generic that’s being produced for Focalin XR. However, it doesn’t seem to be available in my area.

    These generic companies don’t have the sales force to get their products on pharmacy shelves the way the big companies do. Sometimes generics just barely trickle out….

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  3. Dr. Roy Says:

    UPDATE: I just spoke w/ my friendly neighborhood pharmacist (Hi Tren!)– she says from the moment it became available in her computer, Focalin XR generic has been “on backorder.” She says “it’s weird.”

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  4. Amelia Says:

    Very detailed and thoroughly researched post. Exactly what I needed. Thank You!

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  5. Lisa Says:

    Pediatric NP student doing my behavioral health rotation… googling because I’m sooooo confused on ADD meds… reading this, NO WONDER! So crazy! Thank you for the great explanation though… best one I’ve found!

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  6. Anita Tigner Says:

    Nice explanation! One other interesting note from a pharmacist is that Concerta mimics a “TID” dosing. The outer layer is an immediate release and then the OROS system has 2 drug compartments with the first peak drug action in 2 hours and then a slow increase over 3 to 4 hours with total duration of action 10 to 12 hours.

    Ritalin LA does come in an equivalent generic that is the same delivery system. It is made by BARR labs.

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  7. DT Says:

    Ugh…
    I’ve got my insurance refusing to cover generic Metadate CD and telling me that generic Ritalin SR is just as good. But they will cover generic Concerta. Now that the FDA pulled the non-OROS Concerta generic off the market we are just going to go with that. Funny thing is my insurer is going to pay more for generic Concerta than they would for generic Metadate CD. Not so funny thing is I’ve got to drive almost an hour to pick up a new script! Can’t call it in because of the drug class. DOH!

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  8. pam Says:

    very helpful explanation thank you, It is very confusing…all the substitutions and few of us would ever be aware of different delivery systems good to know….as We go forward

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  9. Brittany D Says:

    THANK YOU for this. It is useful beyond words; I had to educate the insurance company rep I was talking to so she could help me figure out the med change. (What used to not be covered is now preferred and what used to be covered is now not covered. Fun times.)

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  10. Holly Says:

    My son has been taking methylphenidate er(la) capsule, that’s what the bottle says. I just went to pick up his refill and noticed the bottle says methylphenidate cd capsule. They both say that the brand names are ritalin la and metadate cd. I’m wondering if there is an actual difference in the medications or if they are actually the same? I will be asking the doctor on monday but no knowing is going to drive me crazy. Any input?

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  11. Nicole Says:

    It is illegal for a pharmacy to interchange them. They are not AB rated with each other. If a doctor writes specifically for a certain brand they have to dispense the generic equilivant if available unless a DAW is hand written on the script. They can’t just dispense generic Ritalin LA when it’s written for Metadate CD. So if a pharmacy is doing that they are doing it illegally.

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