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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 p.497, 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

68 Disorders of gastric acid and ulceration

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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.1052, magnesium carbonate p.71, co-magaldrox p.70and magnesium trisilicate p.71), 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.1038should 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 (activated dimeticone) p.71is 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

ANTACIDS, ALGINATE

Alginic acid

03-Mar-2017 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

.

preterm

neonates

.

where excessive water loss likely (e.g. fever, diarrhoea, vomiting, high room temperature) GAVISCON INFANT®POWDER SACHETSConcurrent use of preparations containing thickening agents

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’.

lMEDICINAL FORMSThere 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 sachetp£4.82 DT = £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 above.

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 FORMSThere can be variation in the licensing of different medicines containing the same drug.

Oral suspension

ELECTROLYTES:May contain Potassium, sodium

Acidex Advance(Wockhardt UK Ltd)

Potassium bicarbonate 20 mg per 1 ml, Sodium alginate 100 mg per 1 mlAcidex Advance oral suspension peppermint sugar-free| 250mlp£1.92sugar-free|500mlp£3.84DT = £5.12

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Acidex Advance oral suspension aniseed sugar-free|250mlp £1.92 sugar-free|500mlp£3.84DT = £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| 150mlp £3.88sugar-free|250mlp £2.56sugar-free| 300mlp £6.46sugar-free|500mlp £5.12DT = £5.12 Gaviscon Advance oral suspension peppermint sugar-free|250mlp

£2.56sugar-free|300mlp £6.46sugar-free|500mlp£5.12DT

= £5.12 Chewable tablet

EXCIPIENTS:May contain Aspartame ELECTROLYTES:May contain Potassium, sodium

Gaviscon Advance(Reckitt Benckiser Healthcare (UK) Ltd) Potassium bicarbonate 100 mg, Sodium alginate 500 mgGaviscon Advance Mint chewable tablets sugar-free| 24tabletG£4.46sugar-free|60tabletG£3.07DT = £3.07 ANTACIDS

ANTACIDS, ALUMINIUM AND MAGNESIUM

Co-magaldrox

The properties listed below are those particular to the combination only. For the properties of the components please consider, aluminium hydroxide p.1052, magnesium hydroxide p.59.

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

.

magnesium 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.

MAALOX®Maalox®suspension is low in sodium.

MUCOGEL®Mucogel®suspension is low in sodium.

lMEDICINAL FORMSThere can be variation in the licensing of different medicines containing the same drug.

Oral suspension

Maalox(Sanofi)

Aluminium hydroxide 35 mg per 1 ml, Magnesium hydroxide 40 mg per 1 mlMaalox175mg/200mg/5ml oral suspension sugar-free|250mlG £2.33DT = £2.33

Mucogel(Chemidex Pharma Ltd)

Magnesium hydroxide 39 mg per 1 ml, Aluminium hydroxide gel dried 44 mg per 1 mlMucogel oral suspension sugar-free| 500mlG£2.99DT = £2.99

Co-simalcite

30-Jun-2018 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.

lRENAL IMPAIRMENT

Dose adjustmentsAntacids 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 FORMSThere 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| 500mlp£5.20DT = £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.71, aluminium hydroxide p.1052.

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 FORMSThere 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|250mlG £2.91

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ANTACIDS

ANTACIDS, MAGNESIUM

Magnesium carbonate

lINDICATIONS AND DOSE Dyspepsia

▶BY MOUTH USING ORAL SUSPENSION

Adult:10mL3times a day, dose to be taken in water lCONTRA-INDICATIONSHypophosphataemia lINTERACTIONS→Appendix1: antacids

lSIDE-EFFECTSDiarrhoea

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 IMPAIRMENTMagnesium carbonate mixture has a high sodium content; avoid in patients withfluid retention.

Dose adjustmentsAvoid or use at a reduced dose;

increased risk of toxicity.

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 FORMSNo 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-EFFECTSDiarrhoea

.

nephrolithiasis (long term use) lHEPATIC IMPAIRMENTAvoid in hepatic coma; risk of renal

failure.

lRENAL IMPAIRMENT

Dose adjustmentsAvoid or used at a reduced dose (increased risk of toxicity).

lMEDICINAL FORMSNo 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.1038.

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 failure

lCAUTIONSHeart failure

.

hypermagnesaemia

.

hypertension

.

metabolic alkalosis

.

respiratory alkalosis

lINTERACTIONS→Appendix1: antacids

.

sodium bicarbonate

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 IMPAIRMENTMagnesium 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 FORMSThere 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 = £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 FORMSThere 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 = £2.71sugar-free|55mlG£3.20 sugar-free|85mlG £4.66

Oral drops

Dentinox Infant(Dendron Ltd)

Simeticone 8.4 mg per 1 mlDentinox Infant colic drops| 100mlG£1.80DT = £1.80

Combinations available:Co-simalcite,p.70

.

Simeticone with aluminium hydroxide and magnesium hydroxide,p.70

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4.2 Gastric and duodenal

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