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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.

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. Sodium content is 0.92 mmol/sachet.
When first starting your baby on Gaviscon Infant, it will be need to be given regularly for around three days before you try to decide if it is helpful. If there is no change in the baby/child seek further medical advice.
Dosage and administration:
Babies less than 4.5kg: 1 sachet with each feed (of no less than 120ml fluid if bottle feeding), up to six times per day.
Babies over 4.5kg: 2 sachets with each feed (of no less than 250ml of fluid if bottle feeding). Maximum 12 sachets per day.
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 (5mls 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. After three months of age some cool boiled water twice a day between feeds may be helpful. Alternatively (also after three months of age) 5ml of pure apple or pear juice in 50ml of cool boiled water once or twice a day may relieve constipation. However, fruit is acidic and may aggravate pain due to reflux. Coloxyl drops or Lactulose syrup are two commonly used medications for constipation. If these are necessary please see your doctor for medical advice.

Gaviscon (Trade Name) - 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. Sodium content is 141mg/10ml.
Dosage and administration:
Children 6 - 12 years: 5 – 10ml after meals and half an hour before bedtime up to four times per day.
Children under 6 years: Only on doctor’s advice.
Side effects: Include constipation. See Gaviscon Infant for further information.

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

Mylanta Original (Trade Name)
Use: Antacid with antiflatulent
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 aluminium 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.
Dosage and administration:
Babies less than 3 months 2 - 4mls
Babies over 3 months 5 - 7mls
Each dose to be given no less than 4 hours apart.
Other medication should not be taken within two hours of Mylanta.
Side effects: May include diarrhoea.

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. Ranitidine syrup contains ethanol (alcohol) and was not formulated for paediatric use. It has however been used successfully in the treatment of reflux in children for many years.
Dosage and administration:
4 - 8mg per kilogram per day, in 2 - 3 divided doses. In some circumstances a three-times a day 2 - 4mg/kilo dosage of Ranitidine is sometimes required.
It comes in syrup form: 150mg in 10ml. Zantac is a bitter mint flavoured medication, and may not be accepted by the infant. 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.

Omeprazole (Generic Name)
Losec, Omezol, Dr Reddy's Omeprazole (Trade Names), Prilosec (Trade Name in other countries)
Use: Proton pump inhibitor
Omeprazole is an alternative for babies/children who do not respond to Ranitidine, and has been used in children in New Zealand since the early 1990’s. It 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. The dosage may need increasing as the child gains weight. Omeprazole will not decrease the amount of spilling/vomiting.
When stopping or reducing Omeprazole there can initially seem to be a deterioration in symptoms. 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.
For a picture of the Losec granules and capsules available in NZ please click here. The granules shown are those contained in a 10mg capsule. The two tone capsule is a 20mg capsule and the plain pink one a 10mg capsule. They are pictured with a teaspoon to give an idea of size.
From 01/05/2009 Dr Reddy's Omeprazole will be the only brand of Omeprazole funded by Pharmac. The presentation will differ from Losec but the active ingredient remains the same. Talk to your doctor if you do notice any differences in symptoms when the brand is changed. Click here for more on the change of Omeprazole brand.
Dosage and administration: Information shows that babies/children may respond to as little as 0.7mg per kilogram per day, or need as much as 3.3mg per kilogram per day. 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 person. The important fact here is to use the best dose to suit the child. High and very high doses should be managed with the oversight of a paediatrician.
Low dose range is 0.7 - 1.5mg per kilogram per day.
High dose range is 1.5 - 3.0mg per kilogram per day.
Very high dose range is up to 3.0 - 3.3mg per kilogram per day.
The complete dosage may be taken as a single morning dose, or divided into two separate doses to be administered morning and night. It is most effective if given half an hour before a meal (1).
Omeprazole is only available in capsule form in New Zealand. To achieve a smaller dose than available in a capsule it is opened and the granules divided into child sized doses. This does not need to be done exactly i.e. if giving 5mg per dose guess half of a 10mg capsule and keep the remainder for the next dose (unless you enjoy counting granules). The granules should then be mixed with something acidic before administration as mixing with other substances eg. milk will reduce its effectiveness. A few mls of fruit juice, or 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.
The pharmacist sometimes makes Omeprazole into liquid form. This is done by dissolving the granules in a sodium bicarbonate solution, and was initially intended only for administration via a naso-gastric tube. It is not pleasant tasting, is light sensitive (a colour change may occur on exposure to light to orange-to-black) 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. The sodium content is ?229mg per 10ml of suspension. (Please check the amount with your pharmacist if this is a concern). A letter for health professionals about Omeprazole suspension is available here.
Side effects: Side effects are rare.

Omeprazole is available in tablet form (MUPS) in some countries but not New Zealand currently. Click here to view the Datasheet for Losec Tablets.

MOTILITY MEDICATIONS

Prepulsid (Trade Name)
Cisapride (Generic Name)
Use: Gastroprokinetic
Cisapride works by increasing muscle tone at the lower end of the oesophagus, as well as increasing the speed with which the milk/food passes through the digestive system. These result in less milk/food being refluxed. The medicine may be mixed with milk, fruit juice or water, or administered by itself. Cisapride may take up to 10 days to reach it's full effect, and the dosage may need adjusting as the child gains weight.
There are several medications which should NEVER be prescribed/used when a child is on Cisapride. The most common is Erythromycin (commonly prescribed for ear infections, whooping cough etc.). Whenever something new is prescribed for your baby make the doctor aware that she/he is taking Cisapride as the combination of some of these medicines can be fatal. Grapefruit and it’s juice should also not be taken by anyone on Cisapride.
Cisapride has been withdrawn from use in America due to concerns about it's safety. In New Zealand it’s use is strictly controlled (2, 3). An ECG should be done before commencing Cisapride to rule out any heart problems which could be further affected by it’s use. A special authority number (applied for by a specialist) is also needed to get this medication subsidised.
Dosage and administration:
0.2mg per kilogram per dose, 3 - 4 doses daily.
It is recommended for best effect that it should be given 15 minutes before a feed or meal. It will work if given at other times, and this is preferable to letting a baby cry for food, as the crying will increase reflux. It can either be given with the feeds/meals or 6 hourly.
Side effects: There may be stomach cramps (usually transient i.e. settle with time), diarrhoea and headache.

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. There are no dosages listed for children less than two years of age but it is used for these children in some instances.
Dosage and administration: Children aged two and above - 0.2 - 0.4mg per kilogram (at 4 - 8 hourly intervals), 3 - 4 times per day. The maximum daily dose is 2.4mg per kilogram (but not exceeding a total dose of 80mg per day). To be administered 15 - 30 minutes before meals and bed. Tablet dosage form is not suitable for children weighing less than 35kg and the film coated tablets contain lactose.
Antacids (eg Mylanta, Gaviscon) and Histamine H2-receptor antagonists (eg. Ranitidine) should not be given within a half to one hour of Domperidone as they decrease it's availability.
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.

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.
Dosage:
Under 1 year: 1mg twice a day
1 - 3 years: 1mg two to three times a day
3 - 5 years: 3mg two to three times a day
5 - 14 years: 2.5 - 5mg three times a day
15 - 20 years: 5 - 10mg three times a day
Adults: 10mg three times a day
Total daily dose should not exceed 0.5mg per kilogram.
Side effects: Include sedation, fatigue, and diarrhoea. 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 for Erythromycin.

LAXATIVES (To counteract constipating effects of other medications)

Coloxyl (Trade Name) - Paediatric drops
Docusate sodium (Generic Name)
Important to maintain adequate fluid intake.
Use: Laxative – faecal softener.
Dosage:
Children under 6 months: 10 drops, 3 times daily
Children 6 – 18 months: 15 drops, 3 times daily
Children 18 months – 3 years: 25 drops, 3 times daily

Pacific Lactulose Syrup, Laevolac Syrup (Trade Names)
Lactulose (Generic Name)
Use: Laxative – osmotic
If used in children for more than one month it is recommended that it’s use is supervised by a doctor.
Dosage and administration:
Dosages seem to vary depending on which form of lactulose is used. Please refer to your pharmacist or health professional for appropriate dosages for your child. The following dosages are a guideline only, are taken from the New Ethical’s Laevolac Syrup instructions and the maintenance dosages don’t make sense.
Children up to 14 years: initially 15ml daily, maintenance 2.5 – 5ml daily
Infants and small children: initially 5-10ml daily, maintenance 5ml daily.
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.)

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

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.htm 
(10) http://www.pharmac.govt.nz/pdf/SU.pdf  (Page 17) - Document moved?

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

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Written by Roslyn (Roz) Ballantyne (RN), Regional Coordinator for © Crying Over Spilt Milk- Gastric Reflux Support Network New Zealand for Parents of Infants and Children Charitable Trust February 2004. Updated September 2005 with further advice from Dr Rodney Ford, Paediatrician and GSK NZ and August 2006 with advice from Reckitt Benckiser.  Reprint November 2007.

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