Clarification on Zegerid please–Joel!!

[Anonymous]

Over the past several hours I have read with great interest many posts here after finding you through my yahoo search.

I just started my 3 mos old son on Prevacid 4 days ago and could not figure out why he was acting like he was still in such pain the past couple of days (I was also continuing the Zantac). Then I saw that the Solutabs have lactose in them! Mon Dieux! Truman has a dairy protein sensitivity and it does seem like he was having a lot of abdominal cramping that some of your posts described. I will not be giving him anymore Solutabs!

So what do I give him? I read about Zegerid and that sounds great (if my doctor will prescribe it and my insurance will cover it!). Truman is a big eater and I don’t think I’d be able to stall him 30 minutes on an empty stomach. But when I went to the Zegerid website they make no such claims as being able to eat immediately after taking it. In fact they instruct that it should be taken on an empty stomach and not to eat for an HOUR afterwards.

So what gives here? Am I misunderstanding something or are they just not wanting to make those claims? Am I to assume that real people have indeed been able to feed their baby immediately after giving Zegerid? And does it have to be on an empty stomach, because if you have to give it 3x/day rather than once a day for the Prevacid, that’s a much bigger challenge for me.

So I am better off asking for the Prevacid capsules, then? And if so, what is the best way to administer?

If you’ve made it this far through my long-winded post, I tip my hat to you. And if you are able to impart some wisdom to my muddled mind I thank you heartily!

[Anonymous]

Hi,

My little guy Haden (5 mos. and 16+pounds) has been on Zegerid for 2 1/2 months. We too tried the Prevacid compounded and Solutabs with not much success. It was so hard to wait that 30 minutes, Haden would get so worked up crying that this only aggravated the reflux. Zegerid can be given with no regards to food. I usually give Haden his dose at 7:00 and then feed him immediately after (I do give 3 doses a day) Since starting Zegerid we have stopped the Mylanta, Pepcid and thickening his bottles. We were doing all of these everyday just to get by and control his reflux.

At first Haden did not like the taste of the Zegerid. But within the past month he has started to take it like a little bird -with his mouth open wide

Haden is on 22mg’s- the right dose is key!!!

Good luck!!!!!!!

Oh,,,there is also a coupon on the Zegerid website which should save you $30.

[hellbennt]

hi & welcome!

please find the time to read my welcome/intro that I post for all newcomers– it’s loong, but full of info & links to info to help you- you might want to bookmark it & return to it as questions arise: https://www.infantreflux.org/forum/forum_posts.asp?TID=853&am p;am p;am p;PN=1&TPN=1

you also have another option- to get your pharmacy/pharmacist to order caracream or chocbase from Flavorx company and then you can have compounded prevacid done the ‘right’ way (there’s a link to this info from the above link, look for ‘Prevacid 101’ and click on it & you’ll see this from there)

glad you found us!

~laura

[Anonymous]

I’m glad you asked this question! My ped GI would not prescribe Zegerid as she said according to the drug website you do have to give it an hour before food. She said that all PPIs need to be administered on an empty stomach a half hour to an hour before eating and there’s no way around that.

Thanks in advance for your guidance Joel.

[Anonymous]

The reason that the makers of Zegerid have to put the meal timing instructions on the package instructions is because they are required by the FDA to use the instructions from the only other form of omeprazole (Prilosec) until they go through specific studies which show that Zegerid can be given without regard to a meal. The drug representatives and much of the staff of the company are ignorant of this and are also not allowed to advertise anything different.

But here’s why it is true that it can be given without regard to a meal and why all of the other kinds of PPIs must be given on an empty stomach and 30 minutes before a meal. I know these things because Zegerid was created here at the University of Missouri by the doctor that I work for.

Enteric Coated (Delayed Release) PPIs

1) All other forms of PPI (besides Zegerid) come from the manufacturer with an “enteric coating”. This coating is put on the granules or tablets in order to protect the drug inside from the acid in the stomach. If the drug were exposed directly to the acid in its naked form, it would be degraded and destroyed. The coating is specifically designed not to come off until it reaches the higher pH environment of the duodenum (the first section of the small intestine). Here the drug is absorbed into the blood stream.

2) Acid is produced in the stomach by cells in the stomach lining called “parietal cells”. Inside these cells are little structures called “proton pumps”, which do the actual work of producing the hydrochloric acid. These pumps have two states: active (producing acid) and inactive. A PPI or Proton Pump Inhibitor can only block those pumps that are in an active state. The primary way that these pumps are activated is when you eat a full meal. This raises the pH in the stomach, which (through a string of events) triggers the pumps to begin producing acid again.

Keeping these two important pieces of information in mind, it’s easier to see how the timing is important. What you are trying to do is to have the PPI drug absorbed into the blood stream and reach peak levels right about the same time that a meal comes in, raises the pH in the stomach, and turns on the proton pumps, which are then blocked by the PPI. You want as many pumps in an active state as possible so that as many as possible are blocked by the drug. The time from when the drug is taken until it reaches peak levels in the blood stream is between one half hour to one hour.

If an enteric coated form of PPI is given along with food, the pH of the stomach contents will not remain low enough to keep the coating in place. If the coating dissolves while the drug is still in the stomach, it is then vulnerable to exposure to pockets of acid and degradation. The presence of food can also significantly lower the absorption of the drug.

Immediate Release PPI (Zegerid)

Rather than having an enteric coating to protect it from the stomach acid, Zegerid is protected by a buffer (sodium bicarbonate) that immediately neutralizes the stomach acid on contact. This also provides immediate relief to the discomfort of the acid.

Since the drug is not in a coated form, it can be absorbed into the bloodstream immediately, both in the stomach and in the small intestine. There is no need to wait for the granules/tablets to pass through and the coating to be dissolved.

Another important thing that the buffer does is that it does the job that a meal would normally do – turning on the proton pumps. In fact, it does this even more reliably than a meal, so even more pumps get turned on and then blocked by the drug.

All of these things combine to make an immediate release PPI like Zegerid work much faster and more effectively than its enteric coated counterparts.

Most doctors think that Zegerid is just another PPI and that all PPIs work the same way. Although it is true that the actual drug in Zegerid (omeprazole) is not new and it works in the same way as any other PPI (blocking active proton pumps), the way in which it is delivered makes a very big difference, both in speed of delivery and in effectiveness.

I hope this information helps and hasn’t muddied the waters any further. Let me know if you need anything else.

RefluxSol2006-4-10 10:19:58

[Anonymous]

Tell us more Joel!!!

So Joel, what makes Zegerid (or even Caracream compound) different then just compounding prilosec in sodium bicarbonate like most pharmacies are compounding it???

What else is in the Zegerid and caracream that makes them different/more effective then the sodium bicarbonate compound that most people are using???

thanks

[Anonymous]

Well, there are a couple of issues here Kim.

1) A PPI compound needs to be both stable enough to keep the drug from degrading before it is used, and it needs to contain enough buffer to adequately protect the drug from being degraded by the stomach acid after it is taken. The overwhelming majority of pharmacies that make these compound put ingredients into them (flavorings and other things) that cause the drug to degrade significantly within a week or less. When we were creating CaraCream here, we tested dozens of these recipes used by pharmacies, and they ALL became unstable inside of 7 days. Most pharmacies will claim that their compounds will remain stable for 14 to 30 days, but they have done no testing to prove this. If you ask them to show you such proof, they will have none. The only studies that have been conducted on both flavored and unflavored compounds of PPIs have been done by us here at the University of Missouri. Since I am neither a chemist or a pharmacist, I cannot tell you why it is that ChocoBase, CaraCream or Zegerid are able to keep the drugs stable. All I know is that we have the studies to prove that they do, and we have studied the other formulas enough to know that they don’t.

2) Santarus, the makers of Zegerid, holds the patent rights to any and all combinations of any PPI with any buffer. This technically makes it a violation of US patent law for any pharmacist to make such a compound now that Zegerid is available. Now it is unlikely that your pharmacist would get in legal trouble for making such a compound. But because of this law, I cannot recommend to anyone that they have a compound made that contains a PPI and a buffer.

Let me know if this all makes sense.

[Anonymous]

Thank you Joel! That helps a lot!

I haven’t found out yet if my insurance co. will cover Zegerid. We are switching insurances this month so its a bit confusing.

If I’m not able to get Zegerid can someone tell me the best way to administer the Prevacid capsules? Or should I assume that he will also have the abdominal cramping with the capsules as he did with the solutabs?

Thanks so much for all your help!

[Anonymous]

So Joel,

Just to make sure I get it ……..More then likely on day one…..the compound made by the pharmacist, would probably be nearly as effective as Zegerid or one made with caracream……but, by day seven it is likely that the pharmacy compound will have degraded some amount, due to stability issues…..where as with the zegerid and caracream..this is not the case. They are more stable.

Is this correct???

[hellbennt]

I’m not joel, but yes

there’s lots of info from the welcome/info link I posted above- from there look for ‘Prevacid 101’ and there’s a lot there

[Anonymous]

Saucy,

If your child is old enough to take it this way, the best way to give the Prevacid capsules would be on a little bit of applesauce, given on an empty stomach, 30 minutes before a full meal.

The other way that I would recommend for giving Prevacid would be the Solutabs, and the timing around meals would be the same. The other moms here can give you their tips for how best to administer these.

Kim,

Sorry, one other thing I forgot to mention in my last post is that pharmacies usually do not put enough buffer in the compounds to adequately protect the drug from degradation from the acid after the dose is given.

According to our research, if each dose is less than 7 mL, the compound must contain 16.8% sodium bicarbonate. And each dose even at this level of buffering must be at least 3.5 mL in order to provide enough buffering to protect the drug.

So in answer to your question, no, most pharmacy made compounds do not even start off as good as CaraCream or Zegerid because they do not usually have enough buffer in them.

If the compound were made with nothing but water, 16.8% sodium bicarbonate, and a PPI, and if it were mixed at a concentration of between 1.5 and 5 mg/mL, then it should be as stable and effective as Zegerid or CaraCream. But it will not taste very good at all. Also, as I said, I cannot legally recommend that anyone do this, as it would be in violation of the patents held by Santarus.

[Anonymous]

Thanks so much Joel – your explanation convinced my dr to prescribe Zegerid. Now we’ll keep our fingers crossed! My DD was taking Solutabs for two weeks and they never helped, I think because she wasn’t eating enough to activate the medication (I can only get an ounce or two into her at a time). When do you think I can expect to see some improvement with the Zegerid?

[Anonymous]

Beth, what is your daughter’s current age and weight and what dose of Zegerid has the doctor prescribed? I’m glad to hear that you were able to get a script for it and I hope that it works well for you. You should mix it according to the instructions found on the MARCi-Kids website (2mg/mL concentration), NOT according to the package instructions, which are designed for adults. Email me if you need any additional help: [email protected].

[Anonymous]

Joel,

She is 8.5 lbs. and is taking 15 mg split 3x day. She is 12 weeks old and was premature – 4 weeks early. I have been making it using the 2mg/mL concentration. This works out to 2.5 mL 3x day (please check my math just in case).

Question: I tried gave her the Zegerid at her 3:00 AM feeding and fed her right after. She ended up throwing up in her crib. She is normally a silent refluxer so throwing up is not the norm. I’m assuming that the Zegerid followed immediately by formula didn’t agree with her. Do the three doses need to be spread evenly at every eight hours or can I give them all during the day? She still does eat a few times a night so I’m worried the meds will wear off during the night…

[Anonymous]

The drug in Zegerid (omeprazole) is protected by a buffer (sodium bicarbonate). But if each dose is not large enough, then it will not contain enough buffer to neutralize the acid that is in the stomach, which will leave the drug vulnerable to degradation by the remaining acid.

When mixing a 20 mg packet of Zegerid at a 2mg/mL concentration, you must give at least 3.5 mL per dose in order to provide an adequate amount of buffer to protect the drug. This is very important.

What I would do in your case would be to split up the 15 mg into two doses of 3.75 mL instead of giving 3 doses of 2.5 mL. If you find that this does not adequately cover her for the day, you should add another dose of 3.5 mL of Zegerid to her regimen. As I have said before, since PPIs only affect the acid producing cell, there is no need to worry about overdosing or side-effects.

You can spread out her doses however you find best takes care of her symptoms. If giving them all during the day works, then go with that. If she seems to be suffering more during the night, add a nighttime dose.

[Author]

Posts