Medications

Medications used in the Treatment of Gastric Reflux in Infants and Children in New Zealand

The information provided on Crying Over Spilt Milk is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her existing physician. Please do not change your child’s medical treatment without first consulting their registered health professionals.


Before thinking about medication, we need to understand Gastric Reflux:

Gastric Reflux / Gastro-Oesophageal Reflux / GOR / Spilling / Posseting / Regurgitation:  These babyGRDiagram1are all common in an infant due to an immature sphincter at the top of the stomach / bottom of the oesophagus (lower oesophageal sphincter).[1]  The baby may be a bit unsettled and may have periods of crying.  Crying in a normal infant with Gastric Reflux will usually peak in the second month and settle around three to four months.[2]  They may have short bouts of painful crying associated with a spill, but this crying is not prolonged.  Spilling may also disturb sleep.  “The constant mess, cleaning, laundry etc. can lead to tiredness and isolation and others don’t necessarily understand why parents aren’t coping with something that is so normal that it affects more than 50% of babies.”  (Ballantyne, 2014)  Gastric Reflux does not need to be treated with conventional medication.

Gastro-Oesophageal Reflux Disease/ GORD / GERD (American abbreviation) – This is when Gastric Reflux causes some sort of complication usually including pain.  The predominant symptom may be a high-pitched pained scream although this is not always the case.  Some babies may have feeding difficulties, not grow well or have problems with sleep.[3]  GORD can be managed in a variety of ways including diet, upright positioning, parenting techniques and as a last resort medications.  Not all cases of GORD will need medical treatment and there is a move away from prescribing for GORD by many Health Professionals unless there appears to be significant pain, severe complications, growth issues or difficulties feeding.

In summary, GOR in infancy is common and does not require medical treatment.  GORD is relatively rare, and is managed in a variety of ways depending on the cause and severity.  You need to take your baby to a doctor for a proper diagnosis if you think they may have gastric reflux and it is a problem.

See this page with ideas for “Preparing for your doctor’s visit”: http://healthinfo.org.nz/index.htm?toc.htm?134738.htm.  If your baby is diagnosed with possible GOR / GORD and you think they need treatment with medication or their current medication needs reviewing, use the types of questions suggested instead of asking the doctor for this directly.  Other  open ended questions related to medications that you could include if needed are those such as “What do you think about …” or “Do you think … would be helpful?”

Adapted from September 2014 GRSNNZ Newsletter “The Many Faces of Gastric Reflux Explained” © Roslyn Ballantyne (RN), National Coordinator, Gastric Reflux Support Network New Zealand for Infants and Children Charitable Trust, October 2014
Works Cited
Ballantyne, R. (2014, May). …there needs to be more awareness of infant Gastric Reflux. Retrieved October 2014, from Crying Over Spilt Milk: https://www.cryingoverspiltmilk.co.nz/there-needs-to-be-more-awareness-of-infant-Gastric-Reflux/
References
[1]https://www.cryingoverspiltmilk.co.nz/reflux/whatisgastricreflux/
[2]http://purplecrying.info
[3]http://healthinfo.org.nz/index.htm?toc.htm?12789.htm

NB: In 2011 there have been views expressed that medical treatment is rarely needed for “infant reflux or GORD” and that these medications made “no difference in irritability or crying”. (10)


The following information on medications is intended to be used for informative purposes only and not be interpreted as: professional advice for treatment; or a recommendation for a specific treatment, product, course of action or healthcare provider. 

In providing this information, Crying Over Spilt Milk Gastric Reflux Support Network New Zealand for Parents of Infants and Children Charitable Trust is not recommending the use of medications in the treatment of GORD in Infants and Children, nor advising against treatment if it is deemed necessary by a registered health professional.  Please do not discontinue your child’s medications against medical advice.


Please note that GRSNNZ does not provide advice on dosages of complementary or conventional medications.


Gastric Reflux Suppressants

Gaviscon (Trade Name) – Infant powder
Use:
Gastric reflux suppressant
Gaviscon Infant works by mixing with the stomach contents, stabilising and thickening them to reduce the amount of reflux occurring. It is produced in a powder form and comes in one-dose sachets.
Administration: Bottle-fed babies can have the dose added straight to the bottle (medium flow teats may be necessary).
In breastfed babies, it is mixed with a little cooled boiled water, formula or expressed breast-milk (5 ml is usually adequate) and fed before, during or after a feed. It is generally better accepted at the beginning of a feed and then helps to prevent reflux occurring during that feed. The dose can be administered from a syringe or spoon, or some breastfeeding parents prefer to mix the dose with 20mls of liquid and to feed from a bottle before a feed.
Side effects: Include constipation.
You can try warm relaxing baths or gentle baby massage  such as rubbing baby’s tummy gently in a clockwise direction.(12)  After three months of age up to 50 ml of cool boiled water twice a day between feeds may be helpful. Alternatively (also after three months of age) 5 ml of pure apple or pear juice in 50 ml of cool boiled water once or twice a day may relieve constipation.(13) However, fruit is acidic and may aggravate pain due to reflux. Coloxyl drops or Lactulose syrup are two medications used for constipation. If these are necessary please see your doctor for medical advice.
Warning: Gaviscon Infant is “Not for infants under 1 year except under medical supervision.”   Do not use Gaviscon Infant with AR (thickened) formula or other feed thickeners.(11)

Gaviscon, Acidex (Trade Names) – Liquid
Use:
Gastric reflux suppressant
Gaviscon syrup is similar to Gaviscon Infant but does contain different ingredients. Instead of thickening the stomach contents it forms a ‘raft’ on the top of the stomach contents to reduce the amount of reflux occurring. (15)  The formulations and strengths of the different versions vary e.g Gaviscon, Gaviscon Dual Action, Acidex etc..
Side effects: Include constipation. See Gaviscon Infant for further information.
Warning: Children under 6 years: Only on doctor’s advice.

Please note that the ingredients of the various forms of Gaviscon vary in some countries. The medications referred to here are those available in New Zealand.

ACID REDUCING MEDICATIONS

The dosages of Ranitidine and Omeprazole in particular need to be carefully adjusted so that the minimum amount of medication is given for the biggest clinical effect. The dosages should be started on the low side and slowly increased. Starting at too high a dose can sometimes precipitate side effects.

Mylanta Original (Trade Name)
Use:
Antacid with anti-flatulent
Mylanta is a liquid antacid, which works by neutralising acid in the stomach so that reflux burns less. It can provide quick relief, and therefore many parents find it useful when a baby is suffering from reflux pain. It will not decrease spilling or vomiting. Mylanta is not suitable for long-term treatment of reflux, and has a high aluminum load. It does not reduce stomach acid quantities enough to be the complete treatment for babies with significant reflux symptoms (intense discomfort, very poor sleeping or feeding patterns, respiratory symptoms such as cough or wheeze etc.) If Mylanta is required on a daily basis please seek further medical advice.
Administration: Other medication should not be taken within two hours of Mylanta.
Side effects: May include diarrhoea.
Warning: Children under 12 years: Only on doctor’s advice. (14)  Not recommended for infants. (10)

Ranitidine (Generic Name)
Zantac, Peptisoothe (Trade Names)
Use:
Histamine H2-receptor antagonist.
Ranitidine reduces the amount of stomach acid produced and thus prevents reflux causing inflammation in the oesophagus, and also allows existing inflammation to heal. It does not decrease the amount of spilling or vomiting.  It may take from a few days to a few weeks to see an improvement in your baby/child after starting Ranitidine. The dosage may need adjusting for weight as the baby grows.
Administration: It comes in syrup form.  Peptisoothe is spearmint flavoured and is the only fully subsidised Ranitidine syrup. It can be flavoured (a pinch of chocolate instant pudding mix is one idea) to encourage the baby to take it. Diluting is unlikely to make this medication more acceptable and we do not recommend doing so. If it is diluted it needs to be used immediately as it affects the preservative and the medication will become cloudy.
It is important not to give Gaviscon or Mylanta within two hours of giving Ranitidine, as these antacids will reduce its effect. The magnesium in these two medications reduces the absorption of Ranitidine by 20-25%. Magnesium containing supplements should also not be given within two hours of Ranitidine.
Side effects: Side effects are rare, but the more common ones may include headache and dizziness.
Warning: Ranitidine syrup contains ethanol (alcohol) and was not formulated for paediatric use.

Omeprazole (Generic Name)
Losec, Omezol Relief, Dr Reddy’s Omeprazole (Trade Names), Prilosec (Trade Name in other countries)
Use:
Proton pump inhibitor
From August 2011, Omezol Relief has been the fully funded brand of Omeprazole in New Zealand.  Omeprazole turns off most of the pumps that are responsible for stomach acid production. This allows for inflammation in the oesophagus to heal. If your child has just commenced Omeprazole, it may take a week or more to see any improvement. This is because although the acid production is reduced almost immediately it can take longer for any damage (inflammation) in the oesophagus to heal. Omeprazole will not decrease the amount of spilling/vomiting.
The dosages should be started on the low side and slowly increased. Starting at too high a dose can sometimes precipitate side effects.  One dose does not fit all of the same weight with the same severity of reflux, and it appears to be very individual as to what dose suits each child/person. High and very high doses should be managed with the oversight of a paediatrician.
When stopping or reducing Omeprazole there can initially seem to be a deterioration in symptoms due to an acid rebound (see Warning). Because of this it is best to reduce the dose slowly, and wait for a week before deciding to increase the dose again, for this “rebound acidity” to settle.
Administration: The complete dosage may be taken as a single morning dose, or divided into two separate doses to be administered morning and night as prescribed. It is most effective if given half an hour before a meal (1).
Omeprazole capsules (or the granules from inside the capsule) or Omeprazole suspension may be prescribed depending on your child’s health conditions, age and registered health professional’s preference.
To achieve a smaller dose than available in a capsule, it is opened and the granules divided into a child sized dose as prescribed i.e. if giving 5 mg per dose, approximately half of a 10 mg capsule is given and the remainder is kept for the next dose. The granules should then be mixed with something acidic before administration as mixing with other substances, e.g. milk will reduce its effectiveness. A ½ to 1 teaspoon of pureed fruit or fruit yoghurt is ideal. The granules must not be crushed and older children may need to be reminded to swallow but not chew. The Omeprazole should be taken within 30 minutes of preparation.  There has been a concern raised by some health professionals that opening a capsule and giving part doses might lead to inaccurate dosing, and potential aspiration. However, your registered health professional will decide if this method is appropriate for your child.
Omeprazole is made into a liquid form using a sodium bicarbonate solution, and was initially intended only for administration via a naso-gastric tube. It is not pleasant tasting, is light sensitive and it is important to shake the bottle. The suspension is best given with something alkaline so a drink of milk immediately after the dose is recommended. It is thought that Omeprazole may be less effective as a suspension, and it contains a large amount of sodium as does Gaviscon and Mylanta. (Please check the amount with your pharmacist if this is a concern).
Side effects: Side effects are rare, but more common with very high doses (nausea and headache).
Warning: A study has shown an increased risk of community acquired pneumonia and there is an increased risk of gastroenteritis due to decreased gastric acid. When trying to stop or wean Omeprazole, there can be a rebound acidity which can make it difficult to discontinue. (16)

NB: Omeprazole stops the acid pumps producing too much acid. Acid is released into the stomach in response to a meal. For this reason, if Omeprazole is prescribed once daily in capsule/granule form, it should be given before the first feed of the day. Even infants consume most of their food during the day and “eat” less overnight.  (If Omeprazole is prescribed in suspension form, give the first dose with the first feed of the day.)

Information on: Weaning Omeprazole

MOTILITY MEDICATIONS

Prepulsid (Trade Name)
Cisapride (Generic Name)
Use:
Gastroprokinetic
Cisapride was withdrawn in NZ on 31/07/2004, but was still being used occasionally in the early 2000s by one paediatrician.  If you need information on it, please contact GRSNNZ.

Domperidone (Generic Name)
Motilium (Trade Name)
(4)
Promotes emptying of the stomach and also aids in the pressure of the valve (ring of muscle) at the top of the stomach. These actions combine to reduce the amount of food and the ability of the valve to keep the remaining food in the stomach. The use of this medication in the treatment of children with reflux in New Zealand is becoming more common.
Administration: To be administered 15 – 30 minutes before meals and bed.
Side effects: Increases the amount of prolactin in the blood. Prolactin is the hormone responsible for milk production after childbirth, and so the main side effects of Domperidone include breast tenderness, production of breast milk and breast enlargement in males. These are dose related and generally resolve after discontinuing treatment.
Warning: Tablet dosage form is not suitable for children weighing less than 35kg and the film coated tablets contain lactose.

Metoclopramide (Generic Name)
Maxolon (Trade Name) Reglan (Trade Name in other countries)
(5)
Promotes increased motility in the upper gastrointestinal tract and relaxation of the sphincter at the bottom of the stomach, and therefore faster emptying of the stomach. Metoclopramide is rarely used in the treatment of children with reflux in New Zealand.
Side effects: Include sedation, fatigue, and diarrhoea.
Warning: Children are particularly susceptible to toxic effects, which include agitation and irritability, and may present as being restless and disoriented. It is not recommended for use in children due to this, unless there is a clear indication.

Erythromycin is also used as a motility medication. It is used here as an antibiotic and Gastric Reflux is not listed as an indication on New Zealand’s medication datasheet.

LAXATIVES (To counteract constipating effects of other medications)

Coloxyl (Trade Name) – Paediatric drops
Docusate sodium (Generic Name)

Use: Laxative – faecal softener.
Warning: Important to maintain adequate fluid intake.

Pacific Lactulose Syrup, Laevolac Syrup (Trade Names)
Lactulose (Generic Name)
Use:
Laxative – osmotic
Administration: This medication is very sweet, thick and sticky. It may be necessary to dilute it with water before administration.
Side effects: Initially flatulence (reduce dose or divide daily dose).
Warning: If used in children for more than one month it is recommended that it’s use is supervised by a doctor.

Further information on reflux medications and their effects on nutrients are available on the page Drug-Nutrient Interactions on Crying Over Spilt Milk.

References:
(1) Medscape – Gastroeosophageal Reflux Disease in Infants and Children
(2) This media release (Medsafe-prepulsid_alert)
(3) Medsafe-Prepulsid – datasheet no longer available.
(4) Medsafe-Domperidone
(5) Medsafe-Maxolon
(6) New Ethicals Catalogue and Compendium
(7) Medsafe data sheets
(8) www.gaviscon.co.uk
(9) http://www.medsafe.govt.nz/profs/Datasheet/p/Peptisoothesyrup.pdf
(10) http://www.bpac.org.nz/magazine/2011/november/infant_reflux.aspf
(11) http://www.pharmacylive.co.nz – Gaviscon Infant –  Website no longer available
(12) http://www.health.govt.nz/your-health/conditions-and-treatments/diseases-and-illnesses/constipation#babies
(13) http://www.plunket.org.nz/your-child/illness/health-conditions/constipation/
(14) http://www.pharmacylive.co.nz – Mylanta Original – Website no longer available
(15) http://www.nzf.org.nz/nzf_9894 Alginate raft-forming oral suspensions
(16) http://www.bpac.org.nz/BPJ/2011/november/infant-reflux.aspx – Irritable infants, reflux and GORD
ACKNOWLEDGMENTS:
GRASP (former New Zealand support group)
GSK NZ
Vicki Martin, Nutrition and Herbal Technical Consultant, Healtheries of New Zealand Limited
Rochelle Wilson (GRASP National Coordinator 1995 – 2001).
Dr Rodney Ford, Paediatrician, http://www.drrodneyford.com/
Reckitt Benckiser (New Zealand) Ltd
Written by Roslyn Ballantyne (RN), National Coordinator for © Crying Over Spilt Milk Gastric Reflux Support Network New Zealand for Parents of Infants and Children Charitable Trust February 2004. Updated April 2015.
Page may be printed or reproduced for personal use of families, as long as copyright and Crying Over Spilt Milk’s URL are included. It may not be copied to other websites or publications without permission and acknowledgement.