Racecadotril 11-Feb-2016 l INDICATIONS AND DOSE
4.1 Dyspepsia
Dyspepsia
Overview
Dyspepsia covers upper abdominal pain, fullness, early satiety, bloating, and nausea. It can occur with gastric and duodenal ulceration and, gastric cancer, but most commonly it is of uncertain origin.
Urgent endoscopic investigation is required if dyspepsia is accompanied by‘alarm features’(e.g. bleeding, dysphagia, recurrent vomiting, or weight loss). Urgent investigation should also be considered for patients over55years with unexplained, recent-onset dyspepsia that has not responded to treatment.
Patients with dyspepsia should be advised about lifestyle changes (avoidance of excess alcohol and of aggravating foods such as fats); other measures include weight reduction, smoking cessation, and raising the head of the bed. Some medications may cause dyspepsia—these should be stopped, if possible.
Antacids may provide some symptomatic relief, however if symptoms persist inuninvestigated dyspepsia, treatment involves aproton pump inhibitorfor up to4weeks. A proton pump inhibitor can be used intermittently to control symptoms long term. Patients with uninvestigated dyspepsia, who do not respond to an initial trial with a proton pump inhibitor, should be tested forHelicobacter pyloriand given eradication therapy ifH. pyloriis present.
Alternatively, particularly in populations whereH. pylori infection is more likely, the‘test and treat’strategy forH.
pylorican be used before a trial with a proton pump inhibitor.
IfH. pyloriis present in patients withfunctional (investigated, non-ulcer) dyspepsia, eradication therapy should be provided. If symptoms persist, treatment with either aproton pump inhibitoror ahistamine H2 -receptor antagonistcan be given for4weeks. These antisecretory drugs can be used intermittently to control symptoms long term. However, most patients with functional dyspepsia do not benefit symptomatically fromH.
pylorieradication therapy or antisecretory drugs.
ANTACIDS
Antacids
Overview
Antacids (usually containing aluminium or magnesium compounds) can often relieve symptoms inulcer dyspepsia and innon-erosive gastro-oesophageal reflux; they are also sometimes used in functional (non-ulcer) dyspepsia but the evidence of benefit is uncertain. Antacids are best given when symptoms occur or are expected, usually between meals and at bedtime, although additional doses may be required. Conventional doses of liquid magnesium–
aluminium antacids promote ulcer healing, but less well than antisecretory drugs; proof of a relationship between healing and neutralising capacity is lacking. Liquid preparations are more effective than tablet preparations.
Aluminium-andmagnesium-containingantacids (e.g.
aluminium hydroxide p.964, magnesium carbonate p.69, co-magaldrox p.68and magnesium trisilicate p.69), being relatively insoluble in water, are long-acting if retained in the stomach. They are suitable for most antacid purposes.
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 accumulation does not appear to be a risk if renal function is normal.
The acid-neutralising capacity of preparations that contain more than one antacid may be the same as simpler preparations. Complexes such ashydrotalciteconfer no special advantage.
Sodium bicarbonate p.950should no longer be prescribed alone for the relief of dyspepsia but it is present as an ingredient in many indigestion remedies. However, it retains a place in the management of urinary-tract disorders and acidosis.
Bismuth-containingantacids (unless chelates) are not recommended because absorbed bismuth can be neurotoxic, causing encephalopathy; they tend to be constipating.
Calcium-containingantacids can induce rebound acid secretion: with modest doses the clinical significance is doubtful, but prolonged high doses also cause
hypercalcaemia and alkalosis, and can precipitate the milk-alkali syndrome.
Simeticone
Simeticone p.70(activated dimeticone p.1134) is added to an antacid as an antifoaming agent to relieveflatulence.
These preparations may be useful for the relief of hiccup in palliative care.
Alginates
Alginatestaken 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’) thatfloats on the surface of the stomach contents, thereby reducing symptoms of reflux.
The amount of additional ingredient or antacid in individual preparations varies widely, as does their sodium content, so that preparations may not be freely interchangeable.
ANTACIDS
›
ALGINATEAlginic acid
lINDICATIONS AND DOSE GAVISCON INFANT®POWDER SACHETS Management of gastro-oesophageal reflux disease
▶BY MOUTH
▶Child 1–23 months (body-weight up to 4.5 kg):1dose as required, to be mixed with feeds (or water, for breast-fed infants); maximum6doses per day
▶Child 1–23 months (body-weight 4.5 kg and above):2doses as required, to be mixed with feeds (or water, for breast-fed infants); maximum12doses per day lCONTRA-INDICATIONSIntestinal obstruction
.
pretermneonates
.
where excessive water loss likely (e.g. fever, diarrhoea, vomiting, high room temperature) GAVISCON INFANT®POWDER SACHETSConcurrent use of preparations containing thickening agentslHEPATIC IMPAIRMENTIn patients withfluid retention, avoid antacids containing large amounts of sodium. Avoid antacids containing magnesium salts in hepatic coma if there is a risk of renal failure.
lRENAL IMPAIRMENTIn patients withfluid retention, avoid antacids containing large amounts of sodium.
lPRESCRIBING AND DISPENSING INFORMATIONEach half of the dual-sachet is identified as‘one dose’.
To avoid errors prescribe with directions in terms of
‘dose’.
BNF74
Dyspepsia 67
Gastro-intestinalsystem
1
lMEDICINAL FORMS
There can be variation in the licensing of different medicines containing the same drug.
Powder
ELECTROLYTES:May contain Sodium
▶Gaviscon Infant(Forum Health Products Ltd)
Magnesium alginate 87.5 mg, Sodium alginate 225 mgGaviscon Infant oral powder sachets sugar-free|15dual dose sachetG
£4.82DT price = £4.82
Sodium alginate with potassium bicarbonate
The properties listed below are those particular to the combination only. For the properties of the components please consider, alginic acid p.67.
lINDICATIONS AND DOSE
Management of mild symptoms of dyspepsia and gastro-oesophageal reflux disease
▶BY MOUTH USING CHEWABLE TABLETS
▶Child 6–11 years (under medical advice only):1tablet, to be chewed after meals and at bedtime
▶Child 12–17 years:1–2tablets, to be chewed after meals and at bedtime
▶Adult:1–2tablets, to be chewed after meals and at bedtime
▶BY MOUTH USING ORAL SUSPENSION
▶Child 2–11 years (under medical advice only):2.5–5mL, to be taken after meals and at bedtime
▶Child 12–17 years:5–10mL, to be taken after meals and at bedtime
▶Adult:5–10mL, to be taken after meals and at bedtime lPRESCRIBING AND DISPENSING INFORMATIONFlavours of
oral liquid formulations may include aniseed or peppermint.
lMEDICINAL FORMS
There can be variation in the licensing of different medicines containing the same drug.
Oral suspension
ELECTROLYTES:May contain Potassium, sodium
▶Acidex Advance(Pinewood Healthcare)
Potassium bicarbonate 20 mg per 1 ml, Sodium alginate 100 mg per 1 mlAcidex Advance oral suspension peppermint sugar-free| 250mlp £2.21sugar-free|500mlp £4.42DT price = £5.12 Acidex Advance oral suspension aniseed sugar-free|250mlp £2.21 sugar-free|500mlp£4.42DT price = £5.12
▶Gaviscon Advance(Reckitt Benckiser Healthcare (UK) Ltd) Potassium bicarbonate 20 mg per 1 ml, Sodium alginate 100 mg per 1 mlGaviscon Advance oral suspension aniseed sugar-free|150 mlp £3.23sugar-free|250mlp £2.56sugar-free|300mlp
£5.82sugar-free|500mlp £5.12DT price = £5.12
Gaviscon Advance oral suspension peppermint sugar-free|250mlp
£2.56sugar-free|300mlp£5.82sugar-free|500mlp£5.12DT price = £5.12
Chewable tablet
EXCIPIENTS:May contain Aspartame ELECTROLYTES:May contain Potassium, sodium
▶Sodium alginate with potassium bicarbonate (Non-proprietary) Potassium bicarbonate 100 mg, Sodium alginate 500 mgSodium alginate500mg / Potassium bicarbonate100mg chewable tablets sugar free sugar-free|60tabletG no price available DT price =
£3.07
▶Brands may include Gaviscon Advance
ANTACIDS
›
ALUMINIUM AND MAGNESIUMCo-magaldrox
The properties listed below are those particular to the combination only. For the properties of the components please consider, aluminium hydroxide p.964, magnesium hydroxide p.57.
lINDICATIONS AND DOSE MAALOX®
Dyspepsia
▶BY MOUTH
▶Child 14–17 years:10–20mL, to be taken20–60minutes after meals, and at bedtime or when required
▶Adult:10–20mL, to be taken20–60minutes after meals, and at bedtime or when required MUCOGEL®
Dyspepsia
▶BY MOUTH
▶Child 12–17 years:10–20mL3times a day, to be taken 20–60minutes after meals, and at bedtime, or when required
▶Adult:10–20mL3times a day, to be taken 20–60minutes after meals, and at bedtime, or when required
lINTERACTIONS→Appendix1: antacids lPRESCRIBING AND DISPENSING INFORMATION
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.
MUCOGEL® Mucogel®suspension is low in sodium.
MAALOX®Maalox®suspension is low in sodium.
lMEDICINAL FORMS
There can be variation in the licensing of different medicines containing the same drug.
Oral suspension
▶Maalox(Sanofi)
Magnesium hydroxide 39 mg per 1 ml, Aluminium hydroxide gel dried 44 mg per 1 mlMaalox oral suspension sugar-free|500 mlG£3.35DT price = £2.99
▶Mucogel(Chemidex Pharma Ltd)
Magnesium hydroxide 39 mg per 1 ml, Aluminium hydroxide gel dried 44 mg per 1 mlMucogel oral suspension sugar-free|500 mlG£2.99DT price = £2.99
Co-simalcite
lINDICATIONS AND DOSE Dyspepsia
▶BY MOUTH
▶Child 8–11 years:5mL4times a day as required, to be taken between meals and at bedtime
▶Child 12–17 years:10mL4times a day as required, to be taken between meals and at bedtime
▶Adult:10mL4times a day as required, to be taken between meals and at bedtime
lCONTRA-INDICATIONSHypophosphataemia
.
infants.
neonates
CONTRA-INDICATIONS, FURTHER INFORMATION
▶Aluminium-containing antacidsAluminium-containing antacids should not be used in neonates and infants because accumulation may lead to increased plasma-aluminium concentrations.
68 Disorders of gastric acid and ulceration
BNF74Gastro-intestinalsystem
1
lSIDE-EFFECTS
SIDE-EFFECTS, FURTHER INFORMATION
▶Constipation and diarrhoeaMagnesium-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.
lHEPATIC IMPAIRMENTAvoid; can cause constipation which can precipitate coma. Avoid in hepatic coma; risk of renal failure.
lRENAL IMPAIRMENTAntacids containing magnesium salts should be avoided or used at a reduced dose because there is an increased risk of toxicity.
▶In adultsThere is a risk of accumulation and aluminium toxicity with antacids containing aluminium salts.
Absorption of aluminium from aluminium salts is increased by citrates, which are contained in many effervescent preparations (such as effervescent analgesics).
▶In childrenAluminium-containing antacids should not be used in children with renal impairment, because accumulation may lead to increased plasma-aluminium concentrations.
lPRESCRIBING AND DISPENSING INFORMATIONAltacite Plus®is low in Na+.
lMEDICINAL FORMS
There can be variation in the licensing of different medicines containing the same drug.
Oral suspension
▶Altacite Plus(Peckforton Pharmaceuticals Ltd)
Simeticone 25 mg per 1 ml, Hydrotalcite 100 mg per 1 mlAltacite Plus oral suspension sugar-free|100mlp £4.00sugar-free|500 mlp £5.20DT price = £5.20
Simeticone with aluminium hydroxide and magnesium hydroxide
The properties listed below are those particular to the combination only. For the properties of the components please consider, simeticone p.70, aluminium hydroxide p.964.
lINDICATIONS AND DOSE Dyspepsia
▶BY MOUTH
▶Child 12–17 years:5–10mL4times a day, to be taken after meals and at bedtime, or when required
▶Adult:5–10mL4times a day, to be taken after meals and at bedtime, or when required
lINTERACTIONS→Appendix1: antacids lMEDICINAL FORMS
There can be variation in the licensing of different medicines containing the same drug.
Oral suspension
▶Maalox Plus(Sanofi)
Simeticone 5 mg per 1 ml, Magnesium hydroxide 39 mg per 1 ml, Aluminium hydroxide gel dried 44 mg per 1 mlMaalox Plus oral suspension sugar-free|180mlG£2.01
ANTACIDS
›
MAGNESIUMMagnesium carbonate
lINDICATIONS AND DOSE Dyspepsia
▶BY MOUTH USING ORAL SUSPENSION
▶Adult:10mL3times a day, dose to be taken in water lCONTRA-INDICATIONSHypophosphataemia
lINTERACTIONS→Appendix1: magnesium
lSIDE-EFFECTSBelching due to liberated carbon dioxide
.
diarrhoea
lHEPATIC IMPAIRMENTIn patients withfluid retention, avoid antacids containing large amounts of sodium. Avoid antacids containing magnesium salts in hepatic coma if there is a risk of renal failure.
lRENAL IMPAIRMENTAvoid or use at a reduced dose;
increased risk of toxicity. Magnesium carbonate mixture has a high sodium content; avoid in patients withfluid retention.
lPRESCRIBING AND DISPENSING INFORMATIONWhen prepared extemporaneously, the BP states Aromatic Magnesium Carbonate Mixture, BP consists of light magnesium carbonate3%, sodium bicarbonate5%, in a suitable vehicle containing aromatic cardamom tincture.
lMEDICINAL FORMS
There can be variation in the licensing of different medicines containing the same drug.
No licensed medicines listed.
Magnesium trisilicate
lINDICATIONS AND DOSE Dyspepsia
▶BY MOUTH USING CHEWABLE TABLETS
▶Adult:1–2tablets as required lCONTRA-INDICATIONSHypophosphataemia lINTERACTIONS→Appendix1: antacids
lSIDE-EFFECTSBelching due to liberated carbon dioxide
.
diarrhoea
.
silica-based renal stones (with long-term treatment)lHEPATIC IMPAIRMENTAvoid in hepatic coma; risk of renal failure.
lRENAL IMPAIRMENTAvoid or used at a reduced dose (increased risk of toxicity).
lMEDICINAL FORMS
There can be variation in the licensing of different medicines containing the same drug.
No licensed medicines listed.
Magnesium trisilicate with magnesium carbonate and sodium bicarbonate
The properties listed below are those particular to the combination only. For the properties of the components please consider, magnesium trisilicate above, magnesium carbonate above, sodium bicarbonate p.950.
lINDICATIONS AND DOSE Dyspepsia
▶BY MOUTH
▶Child 5–11 years:5–10mL3times a day, alternatively as required, dose to be made up with water
▶Child 12–17 years:10–20mL3times a day, alternatively as required, dose to be made up with water
▶Adult:10–20mL3times a day, alternatively as required, dose to be made up with water
lCONTRA-INDICATIONSHypophosphataemia
.
Severe renal failurelCAUTIONSHeart failure
.
hypermagnesaemia.
hypertension
.
metabolic alkalosis.
respiratory alkalosis lINTERACTIONS→Appendix1: antacidslSIDE-EFFECTSBelching due to liberated carbon dioxide
.
diarrhoea
BNF74
Dyspepsia 69
Gastro-intestinalsystem
1
lHEPATIC IMPAIRMENTIn patients withfluid retention avoid antacids containing large amounts of sodium. Avoid antacids containing magnesium salts in hepatic coma if there is a risk of renal failure.
lRENAL IMPAIRMENT Magnesium trisilicate and
magnesium carbonate mixtures have high sodium content;
avoid in patients withfluid retention.
lPRESCRIBING AND DISPENSING INFORMATIONWhen prepared extemporaneously, the BP states Magnesium Trisilicate Mixture, BP consists of5% each of magnesium trisilicate, light magnesium carbonate, and sodium bicarbonate in a suitable vehicle with a peppermint flavour.
lMEDICINAL FORMS
There can be variation in the licensing of different medicines containing the same drug.
Oral suspension
▶Magnesium trisilicate with magnesium carbonate and sodium bicarbonate (Non-proprietary)
Magnesium carbonate light 50 mg per 1 ml, Magnesium trisilicate 50 mg per 1 ml, Sodium bicarbonate 50 mg per 1 mlMagnesium trisilicate oral suspension|200mlG £1.65DT price = £1.65
ANTIFOAMING DRUGS
Simeticone
(Activated dimeticone)
lDRUG ACTIONSimeticone (activated dimeticone) is an antifoaming agent.
lINDICATIONS AND DOSE DENTINOX®
Colic|Wind pains
▶BY MOUTH
▶Child 1 month–1 year:2.5mL, to be taken with or after each feed; may be added to bottle feed; maximum 6doses per day
INFACOL® Colic|Wind pains
▶BY MOUTH
▶Child 1 month–1 year:0.5–1mL, to be taken before feeds lPRESCRIBING AND DISPENSING INFORMATION
DENTINOX®The brand nameDentinox®is also used for other preparations including teething gel.
lPATIENT AND CARER ADVICE
INFACOL®Patients or carers should be given advice on use of theInfacol®dropper.
lLESS SUITABLE FOR PRESCRIBING
INFACOL®Infacol®is less suitable for prescribing (evidence of benefit in infantile colic uncertain).
DENTINOX®Dentinox®colic drops are less suitable for prescribing (evidence of benefit in infantile colic uncertain).
lMEDICINAL FORMS
There can be variation in the licensing of different medicines containing the same drug.
Oral suspension
▶Infacol(Teva UK Ltd)
Simeticone 40 mg per 1 mlInfacol40mg/ml oral suspension sugar-free|50mlG £2.71DT price = £2.71
Oral drops
▶Dentinox Infant(Dendron Ltd)
Simeticone 8.4 mg per 1 mlDentinox Infant colic drops|100 mlG£1.73
Combinations available:Co-simalcite,p.68