1 Gastro-intestinal system
1.1 Dyspepsia and gastro-oesophageal reflux disease
1.1.1 Antacids and simeticone 1.1.2 Compound alginate preparations
Dyspepsia
Dyspepsia covers pain, fullness, early satiety, bloating, and nausea. It can occur with gastric and duodenal ulceration (section 1.3), gastro-oesophageal reflux disease, gastritis, and upper gastro-intestinal motility disorders, but most com-monly it is of uncertain origin.
Children with dyspepsia should be advised about lifestyle changes (see Gastro-oesophageal reflux disease, below). Some medications may cause dyspepsia—
these should be stopped, if possible.
A compound alginate preparation (section 1.1.2) may provide relief from dys-pepsia; persistent dyspepsia requires investigation. Treatment with a H2-receptor antagonist (section 1.3.1) or a proton pump inhibitor (section 1.3.5) should be initiated only on the advice of a hospital specialist.
Helicobacter pylori may be present in children with dyspepsia. H. pylori eradication therapy (section 1.3) should be considered for persistent dyspepsia if it is ulcer-like. However, most children with functional (investigated, non-ulcer) dyspepsia do not benefit symptomatically from H. pylori eradication.
Gastro-oesophageal reflux disease
Gastro-oesophageal reflux disease includes non-erosive gastro-oesophageal reflux and erosive oesophagitis. Uncomplicated gastro-oesophageal reflux is common in infancy and most symptoms, such as intermittent vomiting or repeated, effortless regurgitation, resolve without treatment between 12 and 18 months of age. Older children with gastro-oesophageal reflux disease may have heartburn, acid regurgitation and dysphagia. Oesophageal inflammation (oeso-phagitis), ulceration or stricture formation may develop in early childhood; gastro-oesophageal reflux disease may also be associated with chronic respiratory disorders including asthma.
Parents and carers of neonates and infants should be reassured that most symp-toms of uncomplicated gastro-oesophageal reflux resolve without treatment. An increase in the frequency and a decrease in the volume of feeds may reduce symptoms. A feed thickener or pre-thickened formula feed (Appendix 2) can be used on the advice of a dietician. If necessary, a suitable alginate-containing preparation (section 1.1.2) can be used instead of thickened feeds.
Older children should be advised about life-style changes such as weight reduction if overweight, and the avoidance of alcohol and smoking. An alginate-containing antacid (section 1.1.2) can be used to relieve symptoms.
Children who do not respond to these measures or who have problems such as respiratory disorders or suspected oesophagitis need to be referred to hospital.
On the advice of a paediatrician, ahistamine H2-receptor antagonist (section 1.3.1) can be used to relieve symptoms of gastro-oesophageal reflux disease,
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1.1 Dyspepsia and gastro-oesophageal reflux disease BNFC 20091Gastro-intestinalsystem
promote mucosal healing and permit reduction in antacid consumption. Aproton pump inhibitor (section 1.3.5) can be used for the treatment of moderate, non-erosive oesophagitis that is unresponsive to an H2-receptor antagonist. Endosco-pically confirmed erosive, ulcerative, or stricturing disease in children is usually treated with a proton pump inhibitor. Reassessment is necessary if symptoms persist despite 4–6 weeks of treatment; long-term use of an H2-receptor antago-nist or proton pump inhibitor should not be undertaken without full assessment of the underlying condition. For endoscopically confirmed erosive, ulcerative, or stricturing disease, the proton pump inhibitor usually needs to be maintained at the minimum effective dose.
Motility stimulants (section 1.2), such as domperidone or erythromycin may improve gastro-oesophageal sphincter contraction and accelerate gastric empty-ing. Evidence for the long-term efficacy of motility stimulants in the management of gastro-oesophageal reflux in children is unconvincing.
For advice on specialised formula feeds, see section 9.4.2.
1.1.1
Antacids and simeticoneAntacids (usually containing aluminium or magnesium compounds) can be used for short-term relief of intermittent symptoms of ulcer dyspepsia and non-erosive gastro-oesophageal reflux (see section 1.1) in children; they are also used in functional (non-ulcer) dyspepsia, but the evidence of benefit is uncertain.
Aluminium- and magnesium-containing antacids, being relatively insoluble in water, are long-acting if retained in the stomach. Magnesium-containing antacids tend to be laxative whereas aluminium-containing antacids may be constipating;
antacids containing both magnesium and aluminium may reduce these colonic side-effects. Aluminium-containing antacids should not be used in children with renal impairment, or in neonates and infants because accumulation may lead to increased plasma-aluminium concentrations.
Complexes such ashydrotalcite confer no special advantage.
Calcium-containing antacids can induce rebound acid secretion; with modest doses the clinical significance of this is doubtful, but prolonged high doses also cause hypercalcaemia and alkalosis.
Simeticone (activated dimeticone) is used to treat infantile colic, but the evidence of benefit is uncertain. Simeticone is added to an antacid as an antifoaming agent to relieve flatulence; such preparations may also be useful for the relief of hiccup in palliative care (see Prescribing in Palliative Care, p. 27).
Alginates act as mucosal protectants in gastro-oesophageal reflux disease (sec-tion 1.1.2). The amount of addi(sec-tional ingredient or antacid in individual prepara-tions varies widely, as does their sodium content, so that preparaprepara-tions may not be freely interchangeable.
Interactions Antacids should preferably not be taken at the same time as other drugs since they may impair absorption. Antacids may also damage enteric coatings designed to prevent dissolution in the stomach. See alsoAppendix 1 (antacids, calcium salts).
Low Na+
The words ‘low Na+’ added after some preparations indicate a sodium content of less than 1 mmol per tablet or 10-mL dose.
Aluminium- and magnesium-containing antacids
ALUMINIUM HYDROXIDE
Cautions see notes above; interactions: Appen-dix 1 (antacids)
Renal impairment risk of aluminium accumula-tion and aluminium toxicity. Absorpaccumula-tion of alu-minium from alualu-minium salts is increased by
citrates, which are contained in many effervescent preparations
Pregnancy use with caution especially in first trimester
Contra-indications hypophosphataemia; neo-nates and infants
BNFC 2009 1.1.1 Antacids and simeticone
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Side-effects see notes above Indication and dose
Dyspepsiafor dose see preparations
Hyperphosphataemiasection 9.5.2.2
Co-magaldrox
Co-magaldrox is a mixture of aluminium hydroxide and magnesium hydroxide; the proportions are expressed in the form x/y where x and y are the strengths in milligrams per unit dose of magnesium hydroxide and aluminium hydroxide respectively
Maaloxc(Sanofi-Aventis)
Suspension, sugar-free, co-magaldrox 195/220 (magnesium hydroxide 195 mg, dried aluminium
hydroxide 220 mg/5 mL (low Na+)). Net price 500 mL = £2.79
Dose . By mouth
Child 14–18 years10–20 mL 20–60 minutes after meals and at bedtime, or when required
Mucogelc(Chemidex)
Suspension, sugar-free, co-magaldrox 195/220 (magnesium hydroxide 195 mg, dried aluminium hydroxide 220 mg/5 mL (low Na+)). Net price 500 mL = £1.71
Dose . By mouth
Child 12–18 years10–20 mL 3 times daily, 20–60 minutes after meals and at bedtime, or when required
MAGNESIUM TRISILICATE
Cautions heart failure, hypertension; metabolic or respiratory alkalosis, hypermagnesaemia; inter-actions: Appendix 1 (antacids)
Renal impairment increased risk of toxicity—
avoid or reduce dose. Magnesium trisilicate mix-ture has a high sodium content
Pregnancy use with caution especially in first trimester; avoid antacid preparations containing high sodium content
Contra-indications severe renal failure; hypo-phosphataemia
Side-effects see notes above; silica-based renal stones reported on long-term treatment Indication and dose
Dyspepsiafor dose see under preparation
Magnesium Trisilicate Mixture, BP (Magnesium Trisilicate Oral Suspension) Oral suspension, 5% each of magnesium trisilicate, light magnesium carbonate, and sodium bicarb-onate in a suitable vehicle with a peppermint fla-vour. Contains about 6 mmol Na+/10 mL Dose
. By mouth
Child 5–12 years5–10 mL with water 3 times daily or as required
Child 12–18 years10–20 mL with water 3 times daily or as required
Aluminium-magnesium complexes
HYDROTALCITE
Aluminium magnesium carbonate hydroxide hydrate
Cautions see notes above; interactions: Appen-dix 1 (antacids)
Side-effects see notes above Indication and dose
Dyspepsiafor dose see under preparation
Hydrotalcite(Peckforton)
Suspension, hydrotalcite 500 mg/5 mL (low Na+).
Net price 500-mL pack = £1.96
NoteThe brand name AltacitecD is used for hydrotalcite suspension; for Altacite Pluscsuspension, see below Dose
. By mouth
Child 6–12 years5 mL 4 times daily (between meals and at bedtime)
Child 12–18 years10 mL 4 times daily (between meals and at bedtime)
Antacid preparations containing simeticone Altacite Plusc(Peckforton)
Suspension, sugar-free, co-simalcite 125/500 (simeticone 125 mg, hydrotalcite 500 mg)/5 mL (low Na+). Net price 500 mL = £1.96 Dose
. By mouth
Child 8–12 years5 mL 4 times daily (between meals and at bedtime) when required
Child 12–18 years10 mL 4 times daily (between meals and at bedtime) when required
ALUMINIUM HYDROXIDE (continued)
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1.1.1 Antacids and simeticone BNFC 20091Gastro-intestinalsystem
Asilonec(Thornton & Ross)
Suspension, sugar-free, dried aluminium hydroxide 420 mg, simeticone 135 mg, light magnesium oxide 70 mg/5 mL (low Na+). Net price 500 mL = £1.95 Dose
. By mouth
Child 12–18 years5–10 mL after meals and at bed-time or when required up to 4 bed-times daily
Maalox Plusc(Sanofi-Aventis)
Suspension, sugar-free, dried aluminium hydroxide 220 mg, simeticone 25 mg, magnesium hydroxide 195 mg/5 mL (low Na+). Net price 500 mL = £2.79 Dose
. By mouth
Child 2–5 years5 mL 3 times daily Child 5–12 years5–10 mL 3–4 times daily Child 12–18 years5–10 mL 4 times daily (after meals and at bedtime) or when required
Simeticone alone
SIMETICONE
Activated dimeticone Indication and dose
Colic or wind painfor dose see under individual preparations
Dentinoxc(DDD) U
Colic drops(= emulsion), simeticone 21 mg/2.5-mL dose. Net price 100 mg/2.5-mL = £1.73
Dose . By mouth
Neonate2.5 mL with or after each feed (max. 6 doses in 24 hours); may be added to bottle feed
Child 1 month–2 years2.5 mL with or after each feed (max. 6 doses in 24 hours); may be added to bottle feed
NoteThe brand name Dentinoxcis also used for other preparations including teething gel
Infacolc(Forest)U
Liquid, sugar-free, simeticone 40 mg/mL (low Na+). Net price 50 mL = £2.26. Counselling, use of dropper
Dose . By mouth
Neonate0.5–1 mL before feeds
Child 1 month–2 years0.5–1 mL before feeds
1.1.2
Compound alginate preparationsAlginate taken in combination with an antacid increases the viscosity of stomach contents and can protect the oesophageal mucosa from acid reflux. Some alginate-containing preparations form a viscous gel (‘raft’) that floats on the surface of the stomach contents, thereby reducing symptoms of reflux. Algi-nate-containing preparations are used in the management of mild symptoms of dyspepsia and gastro-oesophageal reflux disease (see section 1.1). Antacids may damage enteric coatings designed to prevent dissolution in the stomach. For interactions, see Appendix 1 (antacids, calcium salts).
Preparations containing aluminium should not be used in children with renal impairment, or in neonates and infants.
Alginate raft-forming oral suspensions
The following preparations contain sodium alginate, sodium bicarbonate, and calcium carbonate in a suitable flavoured vehicle, and conform to the specifica-tion for Alginate Raft-forming Oral Suspension, BP.
Acidexc(Pinewood)
Liquid, sugar-free, sodium alginate 250 mg, sodium bicarbonate 133.5 mg, calcium carbonate 80 mg/
5 mL. Contains about 3 mmol Na+/5 mL, net price 500 mL (aniseed- or peppermint-flavour) = £1.70 Dose
. By mouth
Child 6–12 years5–10 mL after meals and at bedtime Child 12–18 years10–20 mL after meals and at bed-time
Peptacc(IVAX)
Suspension, sugar-free, sodium bicarbonate 133.5 mg, sodium alginate 250 mg, calcium carb-onate 80 mg/5 mL. Contains 3.1 mmol Na+/5mL.
Net price 500 mL (aniseed- or peppermint-fla-voured) = £2.16
Dose
Child 6–12 years5–10 mL after meals and at bedtime Child 12–18 years10–20 mL after meals and at bed-time
BNFC 2009 1.1.2 Compound alginate preparations
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Other compound alginate preparations Gastrocotec(Actavis)
Tablets, alginic acid 200 mg, dried aluminium hydroxide 80 mg, magnesium trisilicate 40 mg, sodium bicarbonate 70 mg. Contains about 1 mmol Na+/tablet. Net price 100-tab pack = £3.51 Cautions diabetes mellitus (high sugar content) Dose
. By mouth
Child 6–18 years1–2 tablets chewed 4 times daily (after meals and at bedtime)
Liquid, sugar-free, peach-coloured, dried alumin-ium hydroxide 80 mg, magnesalumin-ium trisilicate 40 mg, sodium alginate 220 mg, sodium bicarbonate 70 mg/5 mL. Contains 2.13 mmol Na+/5 mL. Net price 500 mL = £2.67
Dose . By mouth
Child 6–18 years5–15 mL 4 times daily (after meals and at bedtime)
GavisconcAdvance(R&C)
Tablets, sugar-free, sodium alginate 500 mg, potassium bicarbonate 100 mg. Contains 2.25mmol Na+, 1 mmol K+/tablet. Net price 60–tab pack (peppermint-flavour) = £3.24
Excipientsinclude aspartame (section 9.4.1) Dose
. By mouth
Child 6–12 years1 tablet to be chewed after meals and at bedtime (under medical advice only) Child 12–18 years1–2 tablets to be chewed after meals and at bedtime
Suspension, sugar-free, aniseed- or peppermint-flavour, sodium alginate 500 mg, potassium bicarbonate 100 mg/5 mL. Contains 2.3 mmol Na+, 1 mmol K+/5 mL, net price 250 mL = £2.70, 500 mL
= £5.40 Dose
. By mouth
Child 2–12 years2.5–5 mL after meals and at bedtime (under medical advice only)
Child 12–18 years5–10 mL after meals and at bed-time
GavisconcInfant(R&C)
Oral powder, sugar-free, sodium alginate 225 mg, magnesium alginate 87.5 mg, with colloidal silica and mannitol/dose (half dual-sachet). Contains 0.92 mmol Na+/dose. Net price 15 dual-sachets (30 doses) = £2.46
Dose . By mouth
Neonate body-weight under 4.5 kg1 ‘dose’ (half dual-sachet) mixed with feeds (or water, for breast-fed infants) when required (max. 6 times in 24 hours) Neonate body-weight over 4.5 kg2 ‘doses’ (1 dual-sachet) mixed with feeds (or water, for breast-fed infants) when required (max. 6 times in 24 hours) Child 1 month–2 years
Body-weight under 4.5 kgdose as for neonate Body–weight over 4.5 kg2 ‘doses’ (1 dual-sachet) mixed with feeds (or water, for breast-fed infants) when required (max. 6 times in 24 hours) NoteNot to be used in preterm neonates, or where excessive water loss likely (e.g. fever, diarrhoea, vomiting, high room temperature), or if intestinal obstruction. Not to be used with other preparations containing thickening agents
Safe PracticeEach half of the dual-sachet is identified as
‘one dose’. To avoid errors prescribe as ‘dual-sachet’
with directions in terms of ‘dose’
RenniecDuo(Roche Consumer Health)
Suspension, sugar-free, calcium carbonate 600 mg, magnesium carbonate 70 mg, sodium alginate 150 mg/5 mL. Contains 2.6 mmol Na+/5 mL. Net price 500 mL (mint flavour) = £2.67
Dose . By mouth
Child 12–18 years10 mL after meals and at bedtime;
an additional 10 mL may be taken between doses for heartburn if necessary, max. 80 mL daily Excipientsinclude propylene glycol
Topalc(Fabre)
Tablets, alginic acid 200 mg, dried aluminium hydroxide 30 mg, light magnesium carbonate 40 mg with lactose 220 mg, sucrose 880 mg, sod-ium bicarbonate 40 mg (low Na+). Net price 42-tab pack = £1.67
Cautions diabetes mellitus (high sugar content) Dose
. By mouth
Child 12–18 years1–3 tablets chewed 4 times daily (after meals and at bedtime)