I have noticed my liver enzymes are up as well since taking Bempedoic Acid and Ezetemibe.
4 Likes
@DeStrider, but still in healthy range <50! - it is good! In my case - AST is elevated and ALT and GGT are normal, it is less likely that liver disease is the cause of the elevation… so I should track it over time.
2 Likes
One thing to consider is that third-world generics may not distribute the active drug evenly throughout the tablet, such that you could split the pill in half and get an 80% dose in one half and only 20% of the dose in the second half. See this 2007 paper:
https://www.researchgate.net/profile/Michael-Veronin-2/publication/6242785/figure/fig1/AS:601689027534860@1520465251291/mages-of-the-innovator-product-simvastatin-tablet-and-generic-versions-imported-from_W640.jpg
“Tablet A is the US innovator product and tablets B, C, D, and E are from Mexico, Thailand, Brazil, and India, respectively. … Bottom row, left to right: near-infrared spectroscopic images of the same tablets, revealing their internal compositions. Clumps of the active pharmaceutical ingredient are visible as bright spots. In samples B, D, and E, the active pharmaceutical ingredient particles are agglomerated and not evenly distributed.”
https://journals.sagepub.com/doi/10.1345/aph.1H680
4 Likes
cl-user
#76
If the blend is so badly mixed that to can get a 80/20% distribution by splitting a pill in half that’s basically 50% ± 30% and that would imply that the variance of the content of the full pills would be approximatively 100% ± 42% so 58 to 142% for the whole pill which looks very high to me.
I don’t know the regulations but I’m pretty sure that a 42% variation per pill is too much. Hopefully!
1 Like
I would argue (based on the information in the book by Katherine Eban; Bottle of Lies) that there is wide variability between the different Indian generic drug manufacturers. If you focus on the major vendors that also sell to the USA, you are very likely to get products that are very comparable to the US products.
She talks in the book about tiers of manufacturers, the lowest tier companies sell their products for very low prices to Africa (etc.) and those products are very inferior. Other products are manufactured for higher prices by the larger Indian Pharma and they are close to, or meet, the US FDA standards.
See list of major Indian Pharma companies here: Rapamycin etc., Purchase Price Comparison Spreadsheet, and Issues Discussion - #40 by RapAdmin
3 Likes
It totally would not pass muster for a drug manufactured by a branded, approved product. The point is that many people on this forum are not buying the branded, approved product, but Indian generics, not all of which are even nominally regulated by FDA.
I’m sure you’re less likely to have these troubles with manufacturers whose products are approved as generics for the USA. But the many failed inspections for the manufacturers of such products and the horror shows documented in Eban’s book even for those who are approved generics argues that this can provide only limited assurance. Not to mention the possibility of fraud when Company X’s pill is bought online from India rather than in the US from a regulated pharmacy.
2 Likes
This website appears legit, and may suggest that splitting bempedoic acid tablets is OK. They have ezetimibe + bemp tablets listed on the ‘do not crush’ list, but don’t have either eze or bemp on their own. Since we know that eze tabs can be split (provided they’re properly dispersed, as above), I think that implies that while there is some fancy footwork involved in putting the two of them into one, either alone may be split without messing with their delivery.
AnUser
#80
I think if there isn’t an enteric coating the tablet can be safely split.
Unless the active ingredients are not distributed evenly. Also enteric coating is not the only kind of coating. What of coatings that are put on in order to prevent oxygen or moisture penetration - if you split those, and leave one half for another day, you may be exposing the left over part to moisture and/or air, which may not be desirable; undesirable chemical reactions might take place. There might be coatings that are designed to expose the contents of the pill to the stomach and not anywhere else, so exposing part of the surface to saliva might also not be optimal. There are so many possibilities, that unless I know for sure, I don’t just assume pill splitting is always safe.
2 Likes
AnUser
#82
If they weren’t the variation between whole pills could’ve been quite significant.
In addition to the examples @CronosTempi listed, there’s also extended-release tablets, whose properties could be buggered by splitting; tablets with coatings designed to protect the throat from highly acidic or caustic contents; and nanocrystalline formulations, like the one used in Pfizer’s Rapamune.
3 Likes
Now I made similar expirience with Brillo EZ…
I took half of a Nexlizet tablet (90 mg bempedoic acid + 5 mg ezetimibe) for two months, and it had a measurable impact on my LDL levels (they went from 98 to 66). However, after switching to the same dose of Brillo EZ from Jagdish (splitted tablet), my LDL went back up to 86.
Has anyone else had a similar experience with Brillo EZ? Could this be a matter of splitting, quality, or individual dynamic?
2 Likes
I used to take 2/4 mg of Pitavastatin along with1/2 Brillo EZ. Changed Pitavastatin to atorvastatin 20 mg with the same 1/2 Brillo EZ. Also added a low dose 45 mg of Fenofibrate. Latest LDL 27, APO b 38. Very pleased. Will repeat in another three months to see if it continues.
Cheers, Mantheunknown
2 Likes
Davin8r
#86
Yes, I also seemingly have had no significant effect of Brillo EZ from the same source (Jagdish), certainly not the crushing of LDL that I expected since I also take Repatha and eat a low sat fat diet. In my case, though, I never tried the branded version since it’s so expensive and my insurance won’t cover it. Your experience makes me even more suspicious that this product is garbage.
2 Likes
I’ve seen great results from a full tablet of Brillo EZ from Jagdish. My LDL went from 122 to 68. My father had similar results.
2 Likes
This could easily be an issue of some medication stored in poor conditions (e.g. very hot) somewhere in the supply chain, while another batch of medications not stored in suboptimal conditions.
This is perhaps one of the biggest risks with purchasing from Indian pharmacies; the opacity of the supply chain and storage conditions since manufacture.
7 Likes
PBJ
#89
I agree, and the best time to order is now.
Nexlizet (bempedoic acid 90 mg + ezetimibe 5 mg) can be affected by improper storage, including warm temperatures. The manufacturer recommends storing Nexlizet at room temperature (68°F to 77°F or 20°C to 25°C), with permissible short-term excursions between 59°F to 86°F (15°C to 30°C).
Ezetimibe is known to be sensitive to heat and humidity, potentially leading to a loss of effectiveness.
4 Likes
@PBJ , I am storing it in the fridge by +4 - that should be okay, here are “conditions for safe storage, including any incompatibilities” → ezetimibe
bempedoic acid:
Until now, I have had two batches of Brillo EZ: one bought in a pharmacy in India (phisically in course of business tirp) and one ordered by Jagdish. Neither of them seems to work for me, in contrast to Nexlizet. I will try a full pill of Brillo EZ, as @DeStrider suggested, and if there’s no impact, I’ll switch back to Nexlizet.
4 Likes
PBJ
#91
Interesting. I would have assumed excessive heat in shipping caused the issue, but maybe the product is of poor quality or inconsistent.
2 Likes
