Need a Reference - Extended Release Diltiazem & Verapamil

[16846]

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I'm looking for a reference (preferably a website) that discusses what form the extended release matrix inside the Tiazac/Taztia XT & Verelan brand capsules is. Since I have read on a few different sites that the capsules can be opened and put on something like applesauce I am hoping that they are little beads/pellets (something like a SODAS matrix). I have a patient that needs a fractional dose of a once daily CCB and I am trying to find out if the contents of the capsules can be safely or easily divided for the dosage that is needed. Multi-dose CCB in a non-XR form were problematic as the patient was unintentionally non-compliant (LOL that lives by herself) but the standard doses available for the XR are too high.

Any info. or insight is appreciated.

 

[bananaface]

The nature of the extended release matrix should be described in the package insert. Those are all on the FDA website. www.fda.gov/cder

If you don't know what chemical properties are incurred by use of the particular matrix, you could try a pharmaceutics referece book such as Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems. That may be available electronically through your school library. If not, you gotta haul yourself to the reference section or seek out another reliable online resource.

You probably have access to some drug databases through school.

Keep in mind that a patient with known compliance issues may not be the best candidate for manual dose division.

 

[16846]

Keep in mind that a patient with known compliance issues may not be the best candidate for manual dose division.

Yeah, we thought of that. We plan on either asking the hospital pharmacist take care of it or write her a 3 month script and just have her bring it into her PMDs office and they do all the doses at once for her so she only has to have it done 4 times a year.

Thanks for the info.

 

[sdn1977]

Yeah, we thought of that. We plan on either asking the hospital pharmacist take care of it or write her a 3 month script and just have her bring it into her PMDs office and they do all the doses at once for her so she only has to have it done 4 times a year.

Thanks for the info.

This is not a good thing to do on many, many levels....but yeah - get your pharmacist involved - your pharmacist will have more info & accessibility into dosage forms/ways to get what you want done & to also bring in the component of what this lady's outpt insurance issues are.

But - having the PMD do this - ahhh not probably (they don't have capsules or powder paper, weights & measures that small & labeling). I'd hate to think of the office staff taking this on!😱

But, as for help here - what dose is your lol on? Perhaps we can help you better if we know what you've stabilzed her on right now.

 

[tussionex]

i second that...what's the dose?

 

[16846]

The dose she is stable at translates into approx. 60 mg of Tiazac/Taztia XR, 1/2 the lowest dose that is available (it was decided to drop the verapamil XR formulation from consideration since she seems to benefit from the vasodilation that is seen with diltiazem).

Darn FDA site, couldn't find what I was looking for regarding the capsule matrix. I guess I am just going to have to go down to the pharm. and ask the HoP to break one open and show me.

 

[npage148]

Cardizem LA 120mg can be cut in half.

Although it is not scored, Cardizem LA can be split without damaging the integrity of the release system. This is an added benefit for patients who cannot swallow a large capsule or tablet. The drug cannot, however, be chewed or crushed

reference:

https://secure.pharmacytimes.com/lessons/200503-03.asp

 

[bananaface]

Some pharmacies will split tablets and prepack them into monthly blister packs for a small charge. If the patient is unable to split the tablets cleanly herself, that would be an option that provided independence from your office staff. And, it would help her with compliance. An independent pharmacy is most likely to do this sort of packaging, but a few chains will do it. It just depends on the pharmacists.

 

[sdn1977]

Seriously, Eponym...I can't stress strongly enough - this is what your hospital pharmacist is for.

I don't care what people say on here - there are very few Medicare Part D plans which pay for Cardizem LA (unless you're a dual eligible or can wait for a prior auth) & having a pharmacy break & fill unit dose blisters will automatically relegate her to expensive options.

There is not a generic diltiazem extended release 60mg available in the US. But, you can (she can, even an lol with arthritis & a paring knife) can cut a generic Cardizem CD 120mg tablet easily.

Now - there are the issues of forgetfulness, compliance, wanting to cut them - all those - but those are not my primary concern.

You say....her dose "translates" into the equivalent of 60mg of extended release dilitiazem. Have you got her weaned off a drip? What happened when she went on the immediate release diltiazem? Did you get the hospital pharmacist involved? She may be getting too much too fast & metabolizing it too slowly.....or many other alternatives.

That's what we're there for. Call us!!!! You'll get me (if in the ICU) or tussiones or one of our colleagues. We can help you with the kinetics of the drugs available & available on the "outside" - meaning Medicare Part D - which is what is going to govern how soon she'll be back on your service.

Really - give your pharmacist a call. They'll be happy to help if you give them the whole story.

You really really don't want to open one of those capusules with the pellets inside.....they are designed to release slowly based on the stomach/intestine contents & if you put them into some kind of food - it changes the pH, etc.... You also cannot crush an extended release tablet (altho nurses do it willy nilly all the time then wonder why the bp goes crazy). Just think of your grandmother opening that capsule & sprinkling those pellets out - does she have cataracts????

All sorts of compliance issues which will lead her right back onto your service. Talk to your pharmacist!!!!

 

[tussionex]

i can't find a good solution to the OP's dilemma, except for the fact that i don't think there will be much compliance with any strange regimen. it's hard enough sometimes to get the LOL's to take one tab, once daily.

she may understand how to open capsules, or sprinkle on applesauce, etc...but think about how you learn to drive...you do it ALL right for the first few years, but as it gets more familiar, you cut corners. now, think about someone older and forgetful on top of it.

it's 7 am on a sunday morning. please, no kinetics for me! 😀

what other CCB's has she tried? is she really unable to deal with the compliance issues of immediate rel dilt?

 

[16846]

Thanks everyone for all your help with this issue. With regard to what SDN1977 said, the Cardizem LA is not in her formulary and would have been rather expensive for someone on a FI so that unfortunately wasn't an option. We considered the Cardizem CD but when we looked up relevant clinical research on geriatric patients it was not very encouraging, with most patients showing concentrations that were beyond the therapeutic range during the first 12 hours and then quickly falling into the sub-therapeutic range for the last 12 hours, just about the worst time/concentration curve.

I went down to the pharm. and asked the HoP about the matrix in the Taztia XT (supposed to have the best bioavailability curve of the Diltiazem ER's and it's generic), he looked it up and it said "multiple beads/extended release" which is rather broad language, so he got one out and popped it open and they were like tiny sprinkles. They were sorta what I expected, but much smaller (too small) and many more (way more) of them than I figured. I thought with a 120mg dose there would 30-60 of them, maybe 120, but there were over 200, so it obviously wasn't done by # (since that comes out to some weird fractional number per bead) but by weight. With that being the case I knew that only a pharmacist would be able to do anything about splitting the dose since they would have to be weighed out.

I called around and I was really disgusted with the "big box" pharms responses. When I asked them about fractioning the dose/putting them in capsules they sounded like they thought I was crazy ("We don't have the time to do that" *click*) or they wanted some obscene per capsule charge above and beyond the cost of the meds. I finally found an independent pharmacy that was willing to fraction the doses and put them in individual capsules gratis, and they also offered to set it up 4 weeks at a time with her other meds as well if we supplied the 7-day containers (which the HoP agreed to provide at no charge) so compliance would be less of an issue. I was really impressed that they were willing to do so much and my patient is very happy since better compliance = fewer (hopefully) trips to the ED and hospital stays.

Pharmacists really are a doc's (or medical students) best friend when it comes to continuity and quality of healthcare.