Proton pump inhibitors are used for treating gastroesophageal reflex disease (GERD) and gastric bleeding, especially when other treatments have failed. GERD is a common condition in pediatric patients, including newborns. These patients often benefit from a compounded suspension that can be administered orally in a drinkable form or with a nasogastric tube. Compounding pharmacies can make the most common PPIs into formulations customized for the patient’s needs.

What is GERD?

Infantile colic (or reflux) is when an infant cries for long periods of time. A common definition of colic is crying that occurs for greater than 3 hours at a time more than 3 times per week in infants that are otherwise healthy and well-fed. There are numerous opinions on this classification, however, and there may be some cultural factors at play. In general, the criteria for colic may be more closely aligned with how much crying parents find tolerable and when they seek the help of a medical professional.

GERD is “a condition, which develops when the reflux of stomach contents causes troublesome symptoms and/or complications.” This means that the acid produced in the stomach is pushed up into the esophagus, leading to heartburn and regurgitation. GERD is thought to be common in infants because their digestive system is still maturing. Since crying and regurgitating are common in most infants, it can sometimes be difficult to accurately diagnose whether an infant is suffering from GERD or not. Despite that many doctors continue to prescribe proton pump inhibitors for relief of the symptoms of GERD in infants. Patients of all ages are prescribed PPIs, but pediatric patients in particular benefit the most from the preparation of a liquid oral suspension.

Proton Pump Inhibitors

Since they were first launched commercially in 1989, PPIs have become some of the highest selling medications in the United States. The commercially available proton pump inhibitors are usually made in tablets or capsules. Well-known brand name medications include Prevacid (lansoprazole) and Prilosec (omeprazole). These medications block the sites of acid production in the stomach. Because of the large quantity of cells that are producing stomach acid, it is impossible to completely block all of them. In this way, PPIs help reduce acid production while still allowing digestive processes to continue.

In clinical trials, PPIs usually outperform the other class of drugs commonly used to treat GERD, which are H2 blockers. H2 blockers, which also depress the production of stomach acid to a lesser degree, were the first-line treatment for GERD prior to the development of proton pump inhibitors. PPIs take some time to work, so results can not be expected immediately after taking them. Some over-the-counter medications work quickly to stop heartburn but do not have the same effect as a PPI.

Side Effects of PPIs

Most patients should not be treated with PPIs long-term. The side effects of high doses given over longer periods of time are still being studied. Some research shows there could be adverse effects from this type of treatment including increased risk of bone fractures, c difficile infections, and pneumonia. Since some adult patients will take these types of medications for years, being aware of side effects is important. Short-term side effects are generally mild, however, and may involve nausea, diarrhea, and headache. For short-term use, monitored by a physician, there have not been significant adverse effects reported. This is the recommended way to use PPIs, with short treatment courses with time in between them.

Compounding Proton Pump Inhibitors

Pediatric patients often benefit from the use of a liquid suspension that is easier to take. A suspension is also useful for patients with enteral feeding tubes, especially those who are critically ill. Taking a commercially available product and crushing it can be time consuming, may provide inaccurate dosing, and can cause medication instability. These are all reasons why a compounding pharmacy should make PPI suspensions from bulk ingredients – not by crushing tablets or emptying capsules.

Compounded formulations of omeprazole, lansoprazole, and pantoprazole are usually made with sodium bicarbonate. The high pH of sodium bicarbonate protects the active ingredients and improves the stability of the formulation. For pediatric patients, it may be beneficial to add a flavor to the suspension as well.

Example Formulations

Lansoprazole – 3mg/ml, 6mg/ml

Omeprazole – 2mg/ml, 5mg/ml

Pantoprazole – 3mg/ml

Articles

Compatibility of proton pump inhibitors in a preservative-free suspending vehicle. – European Journal of Hospital Pharmacy (PubMed)

GERD or not GERD: the fussy infant. – Journal of Perinatology

Proton-pump inhibitors – Harvard Health

Prescribing Guidelines For Gastroesophageal Reflux (GER) – PartnersForKids.org