PPI Dosing information is based on the principles of MarciKids dosing. This is all evidence based medicine and supported by the studies done at the University of Missouri by Jeffrey Phillips Pharm. D (Dr. P) and Marcella Bothwell ENT (Marci). Think of this page as an important reference and tool for you and your health care team. If you decide to use a proton pump inhibitor (PPI) and TummyCare Max® to treat your baby's reflux or GERD this treatment regimen can be applied with any PPI drug on the market.
Some of this information on the PPI dosing information page might sound a little confusing but we want you to know that we've done all the heavy lifting and at the end of the day, the only information you'll need to figure out your baby's correct dose, based on the MarciKids study, is your baby's age and your baby's weight to enter into the MarciKids dosing calculator below. So don't let all the technical talk scare you. This information is merely here to give you an understanding of why PPI dosing is so important.
We're also here for questions anytime. Just contact us and we'll respond within a few hours.
We'd also like to stress the importance of reviewing and discussing all infant acid reflux treatment intentions with your doctor and we encourage you to refer anybody in your care provider team to review this website and this page.For your convenience we have a printable version in PDF form that contains a brief outline of the medical literature that support these treatment suggestions in addition to the doctors and researchers that are successfully applying these treatments. Or you can use this PDF outline of this webpage for your doctor as well.
PPI stands for proton pump inhibitor. PPI's stop the production of acid at the parietal cell where production occurs. PPI’s can only shut down the pumps that are active or producing acid. If they aren’t pumping acid then the PPI has no effect. Some products that might sound familiar are Nexium, Prilosec, Prevacid, Omeprazole and Lanzoprazole. Any of these products, whether they are OTC or Rx can be used with TummyCare Max®. More on PPI's here.
A Drug regimen is the combination of when you take a drug and how much of it you take on a regular basis. For example, a common drug regimen for adult suffering from acid reflux in the esophagus would be Prevacid® (lansoprazole) 30mg twice per day. In this case the dose is 30mg and the dosage interval is twice per day. Most drug regimens used in children are based on adult information.
Half life is the time required for the drug concentration in the bloodstream to drop by ½. It is used to determine the dosage interval (number of doses per day) and is measured in minutes or hours.
Volume of distribution relates to how the drug moves into the tissues of the body. It is used to determine the dosage.
Does that make sense so far?
Note that each of the listed PPI drugs below are currently approved by the FDA for pediatric use.
PPI drugs have an effect on the production of acid. That effect is related to the amount of drug that is absorbed into the body. This amount of drug is known as the AUC or Area Under the Curve. So, when planning out a drug regimen with a PPI drug, the best thing to do is to try to achieve an AUC that is known to be enough of a dose to inhibit acid in twenty four hours and reduce damage and symptoms. In other words, you have to give enough quantity of the PPI drugs and frequently enough to get the desired effect.
When the dosing level of the PPI drug is too little your baby will continue to suffer from the acid reflux and the symptoms will continue or worsen. This is also the primary cause of what is commonly referred to as the acid battle. Or your baby's symptoms may be misdiagnosed. This could contribute to the assumption that PPI drugs do not have an effect on infants.
The natural concern for any parent is whether you can over dose (give too much) PPI medication to your baby?
The short answer is no!
PPI's are very specific in where they work in the body and are only active in a very specific place, the acid secreting portion of a cell called parietal cell. Since PPI drugs only work on the acid secreting cell the chance of side effects is very, very low even if you give three times more then your child needs.
Additionally, PPI drugs are known as prodrugs because they are not active as they pass from the bloodstream to parietal cell. PPI's only become active when they pass into the acid secreting portion of the parietal cell.
This PPI dosing information page, the dosing chart and the dosing calculator below will assist you in figuring out the optimal dose for your baby based on the age and weight of your child. You should use this reference and return to it as your baby grows in age and weight and adjust accordingly.
Some infants or children just require a higher dose to control acid reflux symptoms so there may be times when you would want to increase the milligram (mg) per milliliter (mL) concentration. That's what this PPI dosing information page is here for. To act as a guide in optimizing, adjusting, and at one point weaning your baby off PPI drugs all together when your baby has out grown or over come infant acid reflux.
Remember that a drug regimen is made up of a dose and a dosage interval. We discussed that an adult might take Prevacid® (lansoprazole) 30mg twice per day. So the dose is 30mg and the interval is the twice per day. We need to calculate a dose and an interval for your child. Determining the drug regimen can be done in two ways. One is the recreate the study done by the University of Missouri. That would include taking blood draws multiple times after administering the PPI and doing a pharmacokinetics study.
Or, you can take the easiest approach to determine the correct drug regimen for your child is to find a study that has already evaluated the pharmacokinetics of children and reported the half-life and the volume of distribution for various weights and ages of children. That's what the Marci-Kids study did and since they did all the heavy lifting with over 20 years of treatment history we get to use those tools to help you and your baby.
Tran A, Rey E, Pons G, Pariente-Khayat A, d'Athis P, Sallerin V, Dupont C. Pharmacokinetic-pharmacodynamic study of oral lansoprazole in children. Clinical Pharmacology and Therapeutics. 2002;71: 359-367.
Based on this process indicated on this PPI dosing information page, the estimated half-life for this child would be 0.5 hours. Published data indicates that the normal adult has half-life of 1.5 hours for lansoprazole. By dividing the adult half-life of 1.5 hours by this child's half-life of 0.5 hours (as indicated on the table above), we know this child would eliminate the lansoprazole three times faster then the adult.
The average adult takes 1 dose per day (baseline from above) to achieve good acid control, so this one year old child would be expected to need 3 doses per day (3 x 1). So we know that this child will need 3 doses per day. The MarciKids study showed that infants responded best to 3 doses a day because they metabolize so quickly.
Now lets calculate the dose. The amount of PPI is determined by multiplying the volume of distribution and the child's weight. For lansoprazole and omeprazole, research has shown that the V.dist (volume of distribution) is 3 to 3.5 times larger in infants than in adults. The average adult dose is approximately 0.2 mg/pound, therefore,
3 x 0.2 mg/pound = 0.6 mg/pound per dose and
3.5 x 0.2 mg/pound = 0.7 mg/pound per dose
There is variation in the measurement of V.dist in most infants and as such this is an approximation. Some infants or children just require a higher dose to control acid reflux symptoms so there may be times when you would want to increase the milligram (mg) per milliliter (mL) concentration and/or the dose.
Let's begin figuring out your baby's dose. It's a simple as entering in your baby's age in the MarciKids dosing calculator.
This is the easy part. Just enter in your baby's weight in the appropriate age category. When entering your baby's age please use actual age and not adjusted age if your baby was born prematurely. Weight should be entered in pounds.
These charts below are conclusions to effective dosing of PPI's in infants according to Marcikids and can be used as a reference as you continue to use PPI's to treat your baby's reflux or GERD.
| Childs Age|| Doses per pound of body weight|| Doses per |
|Under 3 months old||0.7mg to 0.8mg of PPI per pound of body weight||3 times per day|
|3 to 6 months old||0.6mg to 0.7mg of PPI per pound of body weight||3 times per day|
|7 months to 2 years old||0.45mg to 0.6mg of PPI per pound of body weight||3 times per day|
|2 years old or older||0.45mg of PPI per pound of body weight||2 to3 times per day|
|5 years old or older||0.35mg to 0.45mg of PPI per pound of body weight||2 times per day|
| Childs Age||Doses per pound of body weight|| Doses per |
|Under 3 months old||0.7mg of PPI per pound of body weight||3 times per day|
|3 to 6 months old||0.6mg of PPI per pound of body weight||3 times per day|
|7 months to 2 years old ||0.45mg of PPI per pound of body weight||3 times per day|
|2 years old or older||0.45mg of PPI per pound of body weight||2 to 3 times per day|
|5 years old or older||0.35mg of PPI per pound of body weight||2 times per day|
If you begin using a compounded suspension or TummyCare Max®
and are following the guidelines above but you are not seeing
satisfactory results (significant or complete relief from the acid
reflux) a higher dose might be required. This can be accomplished by
giving your baby a little more (one or two milliliters) of the
suspension at each dosing time. Or if your baby is experiencing excess
gas it may be useful to mix the suspension at a higher mg per ml
It is generally a good idea to wait seven to ten days before making any additional adjustments as it could take this long for the PPI drugs to have their full effect. Don't be afraid to increase dose. There are many Moms that use well over the baseline suggested doses of MarciKids. The important thing is to get your baby out of pain with an effective dose for your child.
The acid in the stomach is very high in concentration when starting a proton pump inhibitor medication and a drug regimen. This of course is what's causing the infant acid reflux symptoms. It also causes the biggest difficulty when beginning your infants drug regimen. This is called "The Acid Battle" and we get into great detail about this subject on "The Acid Battle" page.
We also go into detail about how to wean or titrate your baby up or down from proton pump inhibitors to assist in the process and making the dosing up process as smooth as possible. Please read about it here on the Weaning page.
If you are currently giving your child a compounded suspension of a PPI such as Prevacid® made by a pharmacy, you should know that there is a good potential for the medication to become inactive (and therefore ineffective) in a much shorter time period than your pharmacist may be aware. The loss of activity is related to the effect of the flavorings added by the pharmacies. Some of the flavorings may cause the PPI to become unstable and break down so it can no longer inhibit acid secretion.
In addition, many pharmacies do not add enough buffer in their suspensions to protect the drug from degradation by stomach acid. This is particularly a problem if the child is receiving a very low-volume dose (less than 3 ml, for example) because the amount of buffer most likely will not be enough to protect the PPI from degradation by stomach acid.
The Harriet Lane Handbook, a trusted source of pediatric PPI dosing information for more then fifty years also states, "The extemporaneously compounded oral suspension product MAY BE LESS BIOAVAILABLE owing to the loss of the enteric coating."
John Hopkins: The Harriet Lane Pediatric Handbook 17th ed., Copyright© 2005 Mosby.
Note: The doses recommended on our PPI dosing information page as well as in the dosing chart are not recommended or discouraged by any proton pump inhibitor manufacturer or distribution company.
There are many articles that support evidence suggesting different approaches to the dosing of PPI medicines (such as omeprazole, lansoprazole, esomeprazole) in infants (after 4 to 6 weeks of age) and younger children (toddlers) when compared to older children (teens) and adults. Some of the data shows that there is a relationship between age and half-life. Other data does not show this age to half-life relationship. Some data suggests using higher doses and more frequent doses in in infants (after 4 to 6 weeks of age) and younger children and other recommendations are for lower doses, or once a day dosing. This pages primary focus is on the MarciKids dosing study.
In many cases of GERD in infants and toddlers, your physician/medical team may not want to use a PPI medicine at all and may want to use a medicine such as ranitidine (which is an H2 blocker) or use no medicine at all.
This is why it is very important that you follow your physician/medical teams advice with regard to the treatment of acid reflux disease for your infant/toddler.