Infant Reflux Medication

The flow of food into and out of the stomach is moderated by the lower esophageal sphincter, or LES, which is a muscle at the bottom of the esophagus.  When the LES functions improperly, it allows food to flow back up through the esophagus.  This can be painful since the stomach contents contain acid that would normally aid in digestion.
Your doctor might prescribe one or more medicines to control the acid in your child’s stomach. These typically fall into six (6) categories:

  1. Acid Neutralizers
  2. Proton Pump Inhibitors (PPIs)
  3. Prokinetic Agents
  4. Histamine H2-receptor antagonists (H2-Blockers)
  5. Cytoprotective Agent 
  6. Other

ACID NEUTRALIZERS

Names of acid neutralizers

  • TUMS
  • Liquid Cherry Supreme varieties (Used to be: Mylanta Cherry Supreme, mcs).  Generic store brands are often found at CVS or Dollar General.

Over the counter (no prescription required) medication that neutralizes the stomach acid.
Can be given with H2 receptor antagonist medications
Must be spaced three hours from any PPI medications
Excess use can cause diarrhea due to Magnesium
“Supreme” Liquid Antacids is recommended as it does not contain aluminum which has been link to possible CNS side effects.

Liquid Antacid Dosing Suggestions:

newborn to 12 months
1/2 teaspoon (2.5 ml)
1 to 2 years old
1/2 – 1 teaspoon (3ml – 5ml)
2 years and older
1 teaspoon (5 ml)
*Maximum of 3tsp per day.

PPI's (PROTON PUMP INHIBITORS)

Names of PPIs Generic, Brand

  • Omeprazole (Prilosec)
  • Omeprazole with bicarbonate (Zegerid)
  • Lansoprazole (Prevacid)
  • Esomeprazole (Nexium)
  • Pantoprazole (Protonix)

Prescription medication used to reduce gastric acid production
They stop the release of acid from the active pumps
PPI’s work more efficiently at stopping acid production than H2s

PROS:

Usually more effective than H2 medications
Can be easier to administer than H2 medications
Block acid and promote healing faster and more effectively than H2 meds

CONS:

A delayed release PPI must be given on an empty stomach 30 min. prior to a meal.
Nexium is the only FDA PPI approved for children under 1 year old.
Can cause decreased appetite; long term use can cause calcium deficiencies.
Delayed release PPI’s should not be given within 3 hours of an acid neutralizer.
Can take up to 2 weeks to see results. **(when switching from an H2 medication to a PPI, you should continue to give your child the H2 medication for 2 weeks to provide coverage until the PPI is working. The only precaution is that you should space the H2 and PPI medications 4 hours apart).

PPI DELAYED VS. IMMEDIATE RELEASE PPI

Delayed Release (Enterically Coated)

The active ingredient is contained within enteric coated granules/beads that are resistant to stomach acid. The coating only comes off when they reach the higher pH (less acidic) environment of the stomach/small intestine and the medication is then absorbed into the blood stream. The delayed release PPIs should be given on an empty stomach as food within the stomach can both lower the level of absorption and raise the pH in the stomach. This causes the enteric coating on the drug to dissolve, which then leaves the drug vulnerable to acid exposure in the stomach & can destroy the active ingredient.

If necessary, the delayed release PPI (beads from within the capsule after opening) can be given with some acidic food (applesauce or apple juice). If given with milk, formula or another non-acidic food, the enteric coating will dissolve and degrade before having the ability to reach the proton pumps.

***There is now a product available that is made from the perfect combination of buffers that minimize gas and maximize acid neutralization. Don’t want to wait two hours for your baby to feel better? That’s where TummyCare Max and BellyBuffers comes in. Along with their process called compounding. You mix the PPI with these buffer products to create an immediate release PPI. So your baby will have instant relief no matter what PPI you use. For more info read here.

Immediate Release

Currently only available as Zegerid packets(omeprazole)
The PPI granulates are in a buffer solution that neutralizes the stomach acid (in place of the enteric coating) so that the granules/beads are not destroyed on their way to shut off the acid producing pumps. As zegerid is very new, clinical trials have not been completed for use in infants and it is therefore only currently approved for children over 12 years. Because of this and how new it is, some doctors and GI specialists will not prescribe for babies. Capsules are now available OTC.

PPI DOSAGE GUIDELINES (MARCI-KIDS):

Omeprazole (Prilosec®, Zegerid® and generic forms) and Esomeprazole (Nexium®)

All other PPI drugs (Nexium®, Prilosec®, Zegerid® as well as the generic versions of Omeprazole) are typically mixed at a 2mg per ml concentration.

Childs Age Doses per pound of body weight Doses per day
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&nbsp 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

Lansoprazole (Prevacid®) is typically mixed at a 3mg per ml concentration.

Childs Age Doses per pound of body weight Doses per day
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

IMPORTANT NOTE ABOUT LIQUID DELAYED RELEASE PPIS

Despite what the pediatrician, pediatric GI or pharmacist tell you; we recommend having your script filled without flavoring every two weeks. This is because when a medication is compounded, the PPI granules/beads are suspended in a buffer solution (generally a neutralizing bicarbonate) to help prevent stomach acid degradation. However, many pharmacies do not add enough buffer to protect the PPI. Furthermore, the medications do not handle being in such an altered state and can degrade much more quickly. The active ingredient then becomes inactive and ineffective in a shorter time period than the typically dispensed thirty day bottle (typically 5-7 days according to studies done by the Midwest Acid Reflux Children’s Institution). Our suggestion is to find a pharmacy that specializes in compounding custom medications and have them fill the script for you.

The MARCI-KIDS team recommends that the concentration of active ingredient is between 2 mg/mL and 4 mg/mL. This means that for every milliliter of suspension, you are giving between 2 and 4 milligrams of medication. Ask that your pharmacist make the compound with 16.8% sodium bicarbonate if the total volume of each dose is less than 7 mL. If the total volume of each dose is greater than 7 mL, ask that your pharmacist make the compound with at least 8.4% sodium bicarbonate. It is also not recommend that you give less than 3.5 mL of a PPI suspension at any concentration. This is because doses smaller than 3.5 mL do not provide enough buffer to adequately protect the drug from being destroyed by the acid that is present in the stomach (From the Midwest Acid Reflux Children’s Institute).

PROKINETICS (For Delayed Gastric Emptying)

Names of prokinetics

  • Metoclopramide (Reglan )
  • Cisapride (Propulsid) – no longer available in the US
  • Erythromycin / Eryped
  • Domperidone

Prokinetics or motility drugs, are medications that make the muscles of the GI tract contract more frequently and/or harder in order to help move food through the system more efficiently. Please note that these medications are NOT indicated for reflux. They are for a condition called Delayed Gastric Emptying or Gastroparesis (one of the side effects of which is reflux).
Below are some symptoms of DGE:

  • Nausea
  • Heartburn
  • Reflux/vomiting
  • Vomiting large amounts hours after eating
  • Abdominal gas pain and bloating
  • Feeling full after very small amounts of food
  • Lack of appetite
  • Irregular blood sugar levels
  • Difficulty gaining weight
  • Chronic constipation

Please note that some of these symptoms can also be caused by food allergies/MSPI (due to the inability to digest the proteins found in milk/soy or other foods). The only way confirm DGE is with diagnostic testing (Scinta Scan) that determines how long it takes the stomach to empty after ingestion of formula or food. See our tests page for more informaiton on the Scinta Scan.

Metoclopramide (Reglan)

This drug stimulates stomach muscle contractions to help emptying. Metoclopramide also helps reduce nausea and vomiting. Metoclopramide is taken 20 to 30 minutes before meals and bedtime. Side effects of this drug include fatigue, sleepiness, depression, anxiety, and problems with physical movement (NDDIC)*. Recent studies show that this medication can cause severe side effects and has been given a black box warning by the FDA. “The boxed warning will highlight the risk of tardive dyskinesia, Video Link or involuntary and repetitive movements of the body, with long-term or high-dose use of metoclopramide, even after the drugs are no longer taken” (from WebMD) at http://www.webmd.com/digestive-disorders/news/20090227/metoclopramide-drugs-get-black-box-warning.

Erythromycin / Eryped

This antibiotic also improves stomach emptying. It works by increasing the contractions that move food through the stomach. Side effects include nausea, vomiting, and abdominal cramps (NDDIC)*. Long term use of antibiotics can irritate the GI tracts and kill healthy, necessary bacteria as well as harmful bacteria. For these reasons, it’s recommended that this medication be used short-term only. Probiotic use may help to offset some of the side effects and re-establish healthy bacteria in the intestinal tract.

Domperidone

This drug works like Metoclopramide to improve stomach emptying and decrease nausea and vomiting. The FDA is reviewing Domperidone, which has been used elsewhere in the world to treat gastroparesis. Use of the drug is restricted in the United States (NDDIC)*.

Information on DGE in part from NDDIC: http://digestive.niddk.nih.gov/ddiseases/pubs/gastroparesis/

H2 RECEPTOR ANTAGONIST MEDICATIONS

Prescription drugs used to block the action of histamine on parietal cells thereby decreasing the production of acid by these cells. They block the receptors and keep most of the signals to begin acid production from ever reaching the acid-producing pumps.

PROS:

Good base line reflux medications; perhaps for use on baby with mild symptoms
FDA approved for use in children (Zantac and Axid)
Well tolerated, minimal side effects

CONS:

They do not block all receptors; therefore, the acid-producing pumps can still be turned on
Require multiple doses a day
Many infants develop a tolerance for these drugs very quickly
Very weight sensitive
Will not reduce or lessen reflux episodes but should make the spit-up less acidic

DOSING H2’s:

Names of H2-Blockers (Generic, Brand):

  • Cimetidine (Tagamet)
  • Ranitidine (Zantac)
  • Nizatidine (Axid)
  • Famotidine (Pepcid)

5-10mg/kg 5-10 mg/kg 0.5 to 1.0 mg/kg (divided 2-3 times a day)
Pepcid isn’t generally recommended in males because it can cause abnormal breast tissue growth.
Because Zantac is the most prescribed medication for infant reflux, the below chart is a helpful guide for dosing based on weight. The total range is the range of medication that should be given as a total for the day. Zantac, like any H2 medication, should be dosed approximately 2 to 3 times a day.
WEIGHT (in lb): TOTAL DAILY RANGE (in ml)
10: 1.5-3
12: 1.8-3.6
15: 2.3-4.5
18: 2.7-5.5
20: 3.0-6.1
Although many of the medications are the same as reflux medications given to adults just once per day (particularly the PPI’s), it was found by the Midwest Acid Reflux Children’s Institute that these medications work best in infants and children if dosed 2 to 3 times per day. Because babies have a faster metabolism than adults, the effect of the medications tend to wear off more quickly and they often need multiple doses in a day for adequate coverage.

DOSAGE ADJUSTMENT: STEP-UP vs. STEP-DOWN APPROACH

Many pediatricians and Pediatric GI’s will follow what’s called a step-up approach to medicating reflux. That means that they will start with the lowest possible dose and work their way up to larger doses. Often this is done for fear of over-dosing an infant.
The step-down approach is to dose reflux medications at the maximum dose until the baby/child gets to baseline in terms of pain management (in other words symptoms of reflux pain such as arching and food refusal are no longer present). Once baseline level is achieved, then the GI who follows this approach may reduce the medication dose to get to the lowest level that will still maintain the optimal baseline state. This approach is often better because it allows the baby/child to become symptom-free in the shortest amount of time possible. This is particularly important with medications such as PPIs that can take up to 2 full weeks to see obvious results.

WEANING FROM MEDICATION

There’s no real “right time” to wean from reflux medication and no standard as to when/if reflux stops. You will be told by various physicians that your baby will outgrow his/her reflux by 6 months or 9 months or a year or 15 months, etc. The truth is, many babies will improve considerably once they become more upright and start standing up more, but reflux can also last into the toddler years and beyond. If you and your doctor decide that your baby is ready to stop reflux medications, it is recommended that the baby be weaned gradually, particularly for PPI’s.
If multiple doses are given per day, drop one of the doses (either go to 1/3 if dosing 3 times per day or a half if dosing 2 times per day) for 2 weeks. Then reduce to once a day for 2 weeks and then either every other day or stop completely. This will let the body start producing acid again gradually and will reduce the chances of acid rebound (over-production of acid) from stopping cold-turkey.

CYTOPTROTECTIVE AGENT

Name of Cytoprotective Agent

  • Sulcralfate (Carafate)

Sucralfate works by forming a “barrier” or “coating” over the esophagus, stomach and duodenum. This helps with damage due to acidic reflux by coating the inflamed intestinal lining (like a band-aid) to promote healing. Sucralfate does not neutralize acid and actually needs acid to properly work. It can cause constipation and cannot be used with antacids, H2 receptor antagonist medications or with PPIs.

OTHER

Simethicone (Gas Drops)

Over the counter anti-foaming agent used to reduce pain and discomfort caused by excess gas
Can be given with other medications without a need for spacing
While it is not a reflux medication, it can help reduce gas which may increase acid refluxing episodes

Please note that we are not physicians and the following dosing information for all infant reflux medication (Antacids, H2 blockers and PPI’s) is based on various sources including our own children’s pediatricians, our children’s GI Drs, the MARCI-kids team and various other web resources. These are dosing guidelines to let you know if you have the option of discussing an increase in the dose with your child’s medical professional.