Gastric and duodenal ulceration

4.2 Gastric and duodenal

patients with a history of upper gastro-intestinal bleeding may provide further protection against recurrence.

GASTROPROTECTIVE COMPLEXES AND CHELATORS

Chelates and complexes

Overview

Sucralfate below may act by protecting the mucosa from acid-pepsin attack in gastric and duodenal ulcers. It is a complex of aluminium hydroxide and sulfated sucrose but has minimal antacid properties.

Sucralfate

lINDICATIONS AND DOSE

Benign gastric ulceration|Benign duodenal ulceration

▶BY MOUTH

▶Child 15–17 years:2g twice daily, dose to be taken on rising and at bedtime, alternatively1^g4times a day for 4–6weeks, or in resistant cases up to12weeks, dose to be taken1hour before meals and at bedtime;

maximum8^{g per day}

▶Adult:2g twice daily, dose to be taken on rising and at bedtime, alternatively1^g4times a day for4–6^weeks, or in resistant cases up to12weeks, dose to be taken 1hour before meals and at bedtime; maximum8^{g per} day

Chronic gastritis

▶BY MOUTH

▶Adult:2g twice daily, dose to be taken on rising and at bedtime, alternatively1^g4times a day for4–6^weeks or in resistant cases up to12weeks, dose to be taken 1hour before meals and at bedtime; maximum8^{g per} day

Prophylaxis of stress ulceration in child under intensive care

▶BY MOUTH

▶Child 15–17 years:1^g6times a day; maximum8^{g per} day

Prophylaxis of stress ulceration

▶BY MOUTH

▶Adult:1^g6times a day; maximum8^{g per day}

lUNLICENSED USE

▶In childrenTablets not licensed for prophylaxis of stress ulceration.

lCAUTIONSPatients under intensive care (Important:

reports of bezoar formation)

CAUTIONS, FURTHER INFORMATION

▶Bezoar formationFollowing reports of bezoar formation associated with sucralfate, caution is advised in seriously ill patients, especially those receiving concomitant enteral feeds or those with predisposing conditions such as delayed gastric emptying.

lINTERACTIONS→Appendix1: sucralfate lSIDE-EFFECTS

▶Common or very commonConstipation

▶UncommonDry mouth

.

nausea

▶Rare or very rareBezoar

.

rash

▶Frequency not knownBack pain

.

bone disorders

.

diarrhoea

.

dizziness

.

drowsiness

.

encephalopathy

.

_flatulence

.

headache

.

vertigo

lPREGNANCYNo evidence of harm; absorption from gastro-intestinal tract negligible.

lBREAST FEEDINGAmount probably too small to be harmful.

lRENAL IMPAIRMENTUse with caution; aluminium is absorbed and may accumulate.

lDIRECTIONS FOR ADMINISTRATIONAdministration of sucralfate and enteral feeds should be separated by1^hour and for administration bymouth, sucralfate should be given1hour before meals.Oral suspensionblocksfi ne-bore feeding tubes. Crushedtabletsmay be dispersed in water.

lPRESCRIBING AND DISPENSING INFORMATIONFlavours of oral liquid formulations may include aniseed and caramel.

lMEDICINAL FORMSThere can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: tablet, oral suspension

Tablet

CAUTIONARY AND ADVISORY LABELS5

▶Sucralfate (Imported)

Sucralfate 1 gramSulcrate1g tablets|100tablet^s Carafate1g tablets|100tablets

H2-RECEPTOR ANTAGONISTS

H

₂

-receptor antagonists

Overview

Histamine H2-receptor antagonistshealgastric and duodenal ulcersby reducing gastric acid output as a result of histamine H₂-receptor blockade; they are also used to relieve symptoms ofgastro-oesophageal reflux disease. H₂-receptor antagonists should not normally be used forZollinger-Ellison syndromebecause proton pump inhibitors are more effective.

Recommended regimens forHelicobacter pylorieradication in adults

Acid suppressant Antibacterial

Price for7-day course Amoxicillin Clarithromycin Metronidazole

Esomeprazole20^mg

twice daily 1g twice daily

— 500mg twice daily

250mg twice daily —

400mg twice daily

£6^.63

£4^.30 Lansoprazole30^mg

twice daily 1g twice daily

1g twice daily

—

500mg twice daily 250mg twice daily—

400mg twice daily— 400mg twice daily

£5^.52

£3^.70

£3^.19 Omeprazole20^{mg twice}

daily

1g twice daily 500^mg3times a day

—

500mg twice daily 250mg twice daily—

400^mg3—times a day 400mg twice daily

£5^.36

£3^.40

£3^.03 Pantoprazole40^mg

twice daily 1g twice daily

— 500mg twice daily

250mg twice daily

400mg twice daily—

£5^.48

£3^.15 Rabeprazole sodium

20mg twice daily 1g twice daily

— 500mg twice daily

250mg twice daily

400mg twice daily—

£6^.04

£3^.71

BNF78

Gastric and duodenal ulceration 73

Gastro-intestinalsystem

1

Maintenance treatment with low doses for the prevention of peptic ulcer disease has largely been replaced inHelicobacter pyloripositive patients by eradication regimens.

In adults, H₂-receptor antagonists are used for the treatment offunctional dyspepsiaand may be used for the treatment ofuninvestigated dyspepsiawithout alarm features.

H₂-receptor antagonist therapy can promote healing of NSAID-associated ulcers (particularly duodenal).

Treatment with a H₂-receptor antagonist has not been shown to be beneficial in haematemesis and melaena, but prophylactic use reduces the frequency of bleeding from gastroduodenal erosions in hepatic coma, and possibly in other conditions requiring intensive care. H2- receptor antagonists also reduce the risk ofacid aspirationin obstetric patients at delivery (Mendelson’s syndrome).

H

2

-receptor antagonists

f

lCAUTIONSSigns and symptoms of gastric cancer (in adults)

CAUTIONS, FURTHER INFORMATION

▶Gastric cancer

▶In adultsH₂-receptor antagonists might mask symptoms of gastric cancer; particular care is required in patients presenting with‘alarm features’in such cases gastric malignancy should be ruled out before treatment.

lSIDE-EFFECTS

▶Common or very commonConstipation

.

diarrhoea

.

dizziness

.

fatigue

.

headache

.

myalgia

.

skin reactions

▶UncommonConfusion

.

depression

.

erectile dysfunction

.

gynaecomastia

.

hallucination

.

hepatic disorders

.

leucopenia

.

nausea

.

tachycardia

▶Rare or very rareAgranulocytosis

.

alopecia

.

arthralgia

.

atrioventricular block

.

fever

.

galactorrhoea

.

pancytopenia

.

thrombocytopenia

.

vasculitis

eiii^Fabovei

Cimetidine

lINDICATIONS AND DOSE Benign duodenal ulceration

▶BY MOUTH

▶Adult:400mg twice daily for at least4weeks, to be taken with breakfast and at night, alternatively800^mg once daily for at least4weeks, to be taken at night;

increased if necessary up to400^mg4times a day;

maintenance400mg once daily, to be taken at night, alternatively maintenance400mg twice daily, to be taken in the morning and at night

Benign gastric ulceration

▶BY MOUTH

▶Adult:400mg twice daily for6weeks, to be taken with breakfast and at night, alternatively800mg daily for 6weeks, to be taken at night; increased if necessary up to400^mg4times a day; maintenance400^{mg once} daily, to be taken at night, alternatively maintenance 400mg twice daily, to be taken in the morning and at night

NSAID-associated ulceration

▶BY MOUTH

▶Adult:400mg twice daily for8weeks, to be taken with breakfast and at night, alternatively800mg daily for 8weeks, to be taken at night; increased if necessary up to400^mg4times a day; maintenance400mg daily, to be taken at night, alternatively maintenance400^mg twice daily, to be taken in the morning and at night Reflux oesophagitis

▶BY MOUTH

▶Adult:400^mg4times a day for4–8^weeks

Prophylaxis of stress ulceration

▶BY MOUTH

▶Adult:200–400^{mg every}4–6^hours Gastric acid reduction in obstetrics

▶BY MOUTH

▶Adult:Initially400mg, to be administered at start of labour, then increased if necessary up to400^{mg every} 4hours, do not use syrup in prophylaxis of acid aspiration; maximum2^.4^{g per day}

Gastric acid reduction during surgical procedures

▶BY MOUTH

▶Adult:400mg, to be given90–120minutes before induction of general anaesthesia

Short-bowel syndrome

▶BY MOUTH

▶Adult:400mg twice daily, adjusted according to response, to be taken with breakfast and at bedtime To reduce degradation of pancreatic enzyme supplements

▶BY MOUTH

▶Adult:0^.8–1^.6^{g daily in}4divided doses, dose to be taken1–1½ hours before meals

lINTERACTIONS→Appendix1^{: H}2receptor antagonists lSIDE-EFFECTS

▶Rare or very rareAnaphylactic reaction

.

aplastic anaemia

.

nephritis tubulointerstitial

.

pancreatitis

.

sinus bradycardia

lPREGNANCYManufacturer advises avoid unless essential.

lBREAST FEEDINGSignificant amount present in milk—not known to be harmful but manufacturer advises avoid.

lHEPATIC IMPAIRMENTIncreased risk of confusion.

Dose adjustmentsReduce dose.

lRENAL IMPAIRMENTOccasional risk of confusion.

Dose adjustmentsReduce dose to200^mg4times daily if eGFR30–50^mL/minute/1^.73^m2.

Reduce dose to200^mg3times daily if eGFR 15–30^mL/minute/1^.73^m2.

Reduce dose to200mg twice daily if eGFR less than 15^mL/minute/1^.73^m2.

lEXCEPTIONS TO LEGAL CATEGORYCimetidine can be sold to the public for adults and children over16^years (provided packs do not contain more than2^weeks’supply) for the short-term symptomatic relief of heartburn, dyspepsia, and hyperacidity (max. single dose200^mg, max. daily dose800mg), and for the prophylactic management of nocturnal heartburn (single night-time dose100^mg).

lMEDICINAL FORMSThere can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension Oral solution

EXCIPIENTS:May contain Propylene glycol

▶Cimetidine (Non-proprietary)

Cimetidine 40 mg per 1 mlCimetidine200mg/5ml oral solution sugar free sugar-free|300ml^P £14.24–£14.25DT = £14.25

▶Tagamet(Essential Pharma Ltd)

Cimetidine 40 mg per 1 mlTagamet200mg/5ml syrup| 600ml^P£28.49DT = £28.49

Tablet

▶Cimetidine (Non-proprietary)

Cimetidine 200 mgCimetidine200mg tablets|60tablet^P

£45.59DT = £18.15|120tablet^P £120.00

Cimetidine 400 mgCimetidine400mg tablets|60tablet^P

£120.00DT = £15.91

Cimetidine 800 mgCimetidine800mg tablets|30tablet^P

£15.48DT = £15.48

▶Tagamet(Chemidex Pharma Ltd)

Cimetidine 400 mgTagamet400mg tablets|60tablet^P

£22.62DT = £15.91

Cimetidine 800 mgTagamet800mg tablets|30tablet^P

£22.62DT = £15.48

74 Disorders of gastric acid and ulceration

BNF78

Gastro-intestinalsystem

1

eiii^F74i

Famotidine

lINDICATIONS AND DOSE

Treatment of benign gastric and duodenal ulceration

▶BY MOUTH

▶Adult:40mg once daily for4–8weeks, dose to be taken at night

Maintenance treatment of duodenal ulceration

▶BY MOUTH

▶Adult:20mg once daily, dose to be taken at night Reflux oesophagitis

▶BY MOUTH

▶Adult:20–40mg twice daily for6–12^weeks;

maintenance20mg twice daily

lINTERACTIONS→Appendix1^{: H}2receptor antagonists lSIDE-EFFECTS

▶UncommonAppetite decreased

.

dry mouth

.

taste altered

.

vomiting

▶Rare or very rareAnxiety

.

chest tightness

.

drowsiness

.

insomnia

.

interstitial pneumonia

.

libido decreased

.

muscle cramps

.

neutropenia

.

paraesthesia

.

psychiatric disorder

.

seizures

.

severe cutaneous adverse reactions (SCARs)

lPREGNANCYManufacturer advises avoid unless potential benefit outweighs risk.

lBREAST FEEDINGPresent in milk—not known to be harmful but manufacturer advises avoid.

lRENAL IMPAIRMENTSeizures reported very rarely.

Dose adjustmentsUse normal dose every36–48^{hours or} use half normal dose if eGFR less than

50^mL/minute/1^.73^m2.

lEXCEPTIONS TO LEGAL CATEGORYFamotidine can be sold to the public for adults and children over16^years (provided packs do not contain more than2^weeks’supply) for the short-term symptomatic relief of heartburn, dyspepsia, and hyperacidity, and for the prevention of these symptoms when associated with consumption of food or drink including when they cause sleep disturbance (max. single dose10mg, max. daily dose20^mg).

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

Tablet

▶Famotidine (Non-proprietary)

Famotidine 20 mgFamotidine20mg tablets|28tablet^P

£12.25–£22.00DT = £21.98

Famotidine 40 mgFamotidine40mg tablets|28tablet^P

£39.00DT = £38.98

eiii^F74i

Nizatidine

lINDICATIONS AND DOSE

Benign gastric, duodenal or NSAID-associated ulceration

▶BY MOUTH

▶Adult:300mg once daily for4–8weeks, dose to be taken in the evening, alternatively150mg twice daily for4–8weeks; maintenance150mg once daily, dose to be taken at night

Gastro-oesophageal reflux disease

▶BY MOUTH

▶Adult:150–300mg twice daily for up to12^weeks

lINTERACTIONS→Appendix1^{: H}2receptor antagonists lSIDE-EFFECTS

▶Rare or very rareAnaemia

.

hyperuricaemia

.

serum sickness

▶Frequency not knownHyperhidrosis

lPREGNANCYManufacturer advises avoid unless essential.

lBREAST FEEDINGAmount too small to be harmful.

lHEPATIC IMPAIRMENTManufacturer advises caution.

lRENAL IMPAIRMENT

Dose adjustmentsUse half normal dose if eGFR 20–50^mL/minute/1^.73^m2.

Use one-quarter normal dose if eGFR less than 20^mL/minute/1^.73^m2.

lEXCEPTIONS TO LEGAL CATEGORYNizatidine can be sold to the public for the prevention and treatment of symptoms of food-related heartburn and meal-induced indigestion in adults and children over16years; max. single dose75^mg, max. daily dose150mg for max.14^days.

lMEDICINAL FORMSThere can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension, oral solution

Capsule

▶Nizatidine (Non-proprietary)

Nizatidine 150 mgNizatidine150mg capsules|30capsule^P

£12.20DT = £3.90

Nizatidine 300 mgNizatidine300mg capsules|30capsule^P

£15.43DT = £15.43

eiii^F74i

Ranitidine

lINDICATIONS AND DOSE

Benign gastric ulceration|Duodenal ulceration

▶BY MOUTH

▶Child 1–5 months:1^mg/kg3times a day (max. per dose 3^mg/kg3times a day)

▶Child 6 months–2 years:2–4mg/kg twice daily

▶Child 3–11 years:2–4mg/kg twice daily (max. per dose 150^mg)

▶Child 12–17 years:150mg twice daily, alternatively 300mg once daily, dose to be taken at night

▶Adult:150mg twice daily for4–8weeks, alternatively 300mg once daily for4–8weeks, dose to be taken at night

Chronic episodic dyspepsia

▶BY MOUTH

▶Adult:150mg twice daily for6weeks, alternatively 300mg once daily for6weeks, dose to be taken at night NSAID-associated gastric ulceration

▶BY MOUTH

▶Adult:150mg twice daily for up to8^weeks, alternatively300mg once daily for up to8weeks, dose to be taken at night

NSAID-associated duodenal ulcer

▶BY MOUTH

▶Adult:300mg twice daily for4weeks, to achieve a higher healing rate

Prophylaxis of NSAID-associated gastric ulcer| Prophylaxis of NSAID-associated duodenal ulcer

▶BY MOUTH

▶Adult:300mg twice daily Gastro-oesophageal reflux disease

▶BY MOUTH

▶Adult:150mg twice daily for up to8weeks or if necessary12weeks, alternatively300mg once daily for up to8weeks or if necessary12weeks, dose to be taken at night

Moderate to severe gastro-oesophageal reflux disease

▶BY MOUTH

▶Adult:600mg daily in2–4divided doses for up to 12^weeks

Long-term treatment of healed gastro-oesophageal reflux disease

▶BY MOUTH

▶Adult:150mg twice daily continued

→

BNF78

Gastric and duodenal ulceration 75

Gastro-intestinalsystem

1

Gastric acid reduction (prophylaxis of acid aspiration) in obstetrics

▶BY MOUTH

▶Adult:150mg, dose to be given at onset of labour, then 150^{mg every}6^hours

Gastric acid reduction (prophylaxis of acid aspiration) in surgical procedures

▶INITIALLY BY INTRAMUSCULAR INJECTION, OR BY SLOW INTRAVENOUS INJECTION

▶Adult:50mg, to be given45–60minutes before induction of anaesthesia, intravenous injection diluted to20mL and given over at least2^minutes,

alternatively (by mouth)150mg, to be given2^hours before induction of anaesthesia and also when possible on the preceding evening

Prophylaxis of stress ulceration

▶INITIALLY BY SLOW INTRAVENOUS INJECTION

▶Adult:50^{mg every}8hours, dose to be diluted to20^mL and given over at least2minutes, then (by mouth) 150mg twice daily, may be given when oral feeding commences

Reflux oesophagitis and other conditions where gastric acid reduction is beneficial

▶BY MOUTH

▶Child 1–5 months:1^mg/kg3times a day (max. per dose 3^mg/kg3times a day)

▶Child 6 months–2 years:2–4mg/kg twice daily

▶Child 3–11 years:2–4mg/kg twice daily (max. per dose 150mg); increased to up to5mg/kg twice daily (max.

per dose300mg), dose increase for severe gastro-oesophageal disease

▶Child 12–17 years:150mg twice daily, alternatively 300mg once daily, dose to be taken at night, then increased if necessary to300mg twice daily for up to 12weeks in moderate to severe gastro-oesophageal reflux disease, alternatively increased if necessary to 150^mg4times a day for up to12weeks in moderate to severe gastro-oesophageal reflux disease

Conditions where reduction of gastric acidity is beneficial and oral route not available

▶BY INTRAMUSCULAR INJECTION

▶Adult:50^{mg every}6–8^hours

▶BY SLOW INTRAVENOUS INJECTION

▶Adult:50mg, dose to be diluted to20mL and given over at least2minutes; may be repeated every 6–8^hours

lUNLICENSED USE

▶In childrenOralpreparations not licensed for use in children under3^years.

▶In adultsDoses given for prophylaxis of NSAID-associated gastric or duodenal ulcer, and prophylaxis of stress ulceration, are not licensed.

lINTERACTIONS→Appendix1^{: H}2receptor antagonists lSIDE-EFFECTS

GENERAL SIDE-EFFECTS

▶Rare or very rareBone marrow depression

.

bradycardia

.

breast conditions

.

dyskinesia

.

nephritis acute interstitial

.

pancreatitis acute

.

vision blurred

▶Frequency not knownDyspnoea SPECIFIC SIDE-EFFECTS

▶Rare or very rare

▶With parenteral useAnaphylactic shock

.

cardiac arrest lPREGNANCYManufacturer advises avoid unless essential,

but not known to be harmful.

lBREAST FEEDINGSignificant amount present in milk, but not known to be harmful.

lRENAL IMPAIRMENT

Dose adjustments▶In adultsUse half normal dose if eGFR less than50^mL/minute/1^.73^m2.

▶In childrenUse half normal dose if estimated glomerular filtration rate less than50^mL/minute/1^.73^m2.

lDIRECTIONS FOR ADMINISTRATIONForintravenous infusion (Zantac^®), give intermittently in Glucose5% or Sodium Chloride0^.9^%.

lPATIENT AND CARER ADVICEIn fat malabsorption syndrome, give oral doses1–2hours before food to enhance effects of pancreatic enzyme replacement.

Medicines for Children leaflet: Ranitidine for acid reflux www.medicinesforchildren.org.uk/ranitidine-acid-reflux lEXCEPTIONS TO LEGAL CATEGORYRanitidine can be sold to

the public for adults and children over16years (provided packs do not contain more than2^weeks’supply) for the short-term symptomatic relief of heartburn, dyspepsia, and hyperacidity, and for the prevention of these symptoms when associated with consumption of food or drink (max. single dose75mg, max. daily dose300^mg).

lMEDICINAL FORMSThere can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension, oral solution, infusion

Tablet

▶Ranitidine (Non-proprietary)

Ranitidine (as Ranitidine hydrochloride) 150 mgRanitidine 150mg tablets|60tablet^P £2.12DT = £1.07 Ranitidine (as Ranitidine hydrochloride) 300 mgRanitidine 300mg tablets|30tablet^P £2.12DT = £1.08

▶Zantac(Omega Pharma Ltd, GlaxoSmithKline UK Ltd)

Ranitidine (as Ranitidine hydrochloride) 75 mgZantac75tablets

|24tablet^p£5.16|48tablet^p£7.75DT = £7.75 Ranitidine (as Ranitidine hydrochloride) 150 mgZantac150mg tablets|60tablet^P £1.30DT = £1.07

Ranitidine (as Ranitidine hydrochloride) 300 mgZantac300mg tablets|30tablet^P £1.30DT = £1.08

Solution for injection

▶Ranitidine (Non-proprietary)

Ranitidine (as Ranitidine hydrochloride) 25 mg per 1 mlRanitidine50mg/2ml solution for injection ampoules| 5ampoule^P £2.69–£5.00DT = £2.96

▶Zantac(GlaxoSmithKline UK Ltd)

Ranitidine (as Ranitidine hydrochloride) 25 mg per 1 mlZantac 50mg/2ml solution for injection ampoules|5ampoule^P £2.82 DT = £2.96

Effervescent tablet

CAUTIONARY AND ADVISORY LABELS13 ELECTROLYTES:May contain Sodium

▶Ranitidine (Non-proprietary)

Ranitidine (as Ranitidine hydrochloride) 150 mgRanitidine 150mg effervescent tablets|60tablet^P £36.50DT = £34.98 Ranitidine (as Ranitidine hydrochloride) 300 mgRanitidine 300mg effervescent tablets|30tablet^P £36.50DT = £34.98 Oral solution

EXCIPIENTS:May contain Alcohol

▶Ranitidine (Non-proprietary)

Ranitidine (as Ranitidine hydrochloride) 15 mg per 1 mlRanitidine75mg/5ml oral solution sugar free sugar-free| 100ml^P£2.07–£2.43sugar-free|300ml^P£21.55DT =

£6.39

Ranitidine (as Ranitidine hydrochloride) 30 mg per 1 mlRanitidine150mg/5ml oral solution sugar free sugar-free| 150ml^P£5.50–£7.01DT = £6.83

▶Zantac(GlaxoSmithKline UK Ltd)

Ranitidine (as Ranitidine hydrochloride) 15 mg per 1 mlZantac 150mg/10ml syrup sugar-free|300ml^P £20.76DT = £6.39

76 Disorders of gastric acid and ulceration

BNF78

Gastro-intestinalsystem

1

PROSTAGLANDIN ANALOGUES AND PROSTAMIDES

›

PROSTAGLANDINS, GASTROPROTECTIVE

Misoprostol

21-Feb-2018

lDRUG ACTIONMisoprostol is a synthetic prostaglandin analogue that has antisecretory and protective properties, promoting healing of gastric and duodenal ulcers.

lINDICATIONS AND DOSE CYTOTEC^®

Benign gastric ulcer|Benign duodenal ulcer| NSAID-induced peptic ulcer

▶BY MOUTH

▶Adult:400micrograms twice daily, alternatively 200^micrograms4times a day continued for at least 4weeks or may be continued for up to8^{weeks if} required, dose to be taken with breakfast (or main meals) and at bedtime

Prophylaxis of NSAID-induced peptic ulcer

▶BY MOUTH

▶Adult:200^micrograms2–4times a day lCAUTIONSConditions where hypotension might

precipitate severe complications (e.g. cerebrovascular disease, cardiovascular disease)

.

conditions which predispose to diarrhoea (e.g. inflammatory bowel disease) lSIDE-EFFECTS

GENERAL SIDE-EFFECTS

▶Common or very commonNausea

.

rash

.

vomiting

▶UncommonUterine rupture SPECIFIC SIDE-EFFECTS

▶Common or very commonConstipation

.

diarrhoea

.

dizziness

.

flatulence

.

gastrointestinal discomfort

.

headache

▶UncommonFever

.

haemorrhage

.

menstrual cycle irregularities

.

postmenopausal haemorrhage

.

uterine cramps

▶Frequency not knownChills

SIDE-EFFECTS, FURTHER INFORMATIONDiarrhoea may occasionally be severe and require withdrawal, reduced by giving single doses not exceeding200micrograms and by avoiding magnesium-containing antacids.

lCONCEPTION AND CONTRACEPTIONManufacturer advises do not use in women of childbearing potential unless pregnancy has been excluded; patients must use effective contraception during treatment, and be informed of the risks of taking misoprostol if pregnant.

lPREGNANCYManufacturer advises avoid—induces uterine contractions, and associated with abortion and birth defects; teratogenic infirst trimester.

lBREAST FEEDINGManufacturer advises avoid—present in milk, and may cause diarrhoea in nursing infants.g Tertiary sources state present in milk but amount probably too small to be harmful; to further reduce risk following termination of pregnancy, consider interrupting breastfeeding for5hours after a dose.k

lPATIENT AND CARER ADVICE

Driving and skilled tasksManufacturer advises patients should be cautioned on the effects on driving and performance of skilled tasks—increased risk of dizziness.

lNATIONAL FUNDING/ACCESS DECISIONS MYSODELLE^®VAGINAL DELIVERY SYSTEM

All Wales Medicines Strategy Group (AWMSG) decisions AWMSG No. 3627

TheAll Wales Medicines Strategy Grouphas advised (March 2018) that misoprostol (Mysodelle^®) is recommended as an option for use within NHS Wales for the induction of labour in women with an unfavourable cervix, from

36weeks gestation, in whom induction is clinically indicated.

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

Tablet

CAUTIONARY AND ADVISORY LABELS21

▶Cytotec(Pfizer Ltd)

Misoprostol 200 microgramCytotec200microgram tablets| 60tablet^P£10.03DT = £10.03

PROTON PUMP INHIBITORS

Proton pump inhibitors

Overview

Proton pump inhibitors are effective short-term treatments forgastricandduodenal ulcers; they are also used in combination with antibacterials for the eradication of Helicobacter pylori(see specific regimens). Following endoscopic treatment of severe peptic ulcer bleeding, an intravenous, high-dose proton pump inhibitor reduces the risk of rebleeding and the need for surgery. Proton pump inhibitors can be used for the treatment ofdyspepsiaand gastro-oesophageal reflux disease.

Proton pump inhibitors are also used for the prevention and treatment of NSAID-associated ulcers. In patients who need to continue NSAID treatment after an ulcer has healed, the dose of proton pump inhibitor should normally not be reduced because asymptomatic ulcer deterioration may occur.

A proton pump inhibitor can be used to reduce the degradation of pancreatic enzyme supplements in patients with cysticfibrosis. They can also be used to control excessive secretion of gastric acid inZollinger–Ellison syndrome; high doses are often required.

Proton pump inhibitors

f

lDRUG ACTIONProton pump inhibitors inhibit gastric acid secretion by blocking the hydrogen-potassium adenosine triphosphatase enzyme system (the‘proton pump’) of the gastric parietal cell.

IMPORTANT SAFETY INFORMATION

MHRA ADVICE: PROTON PUMP INHIBITORS (PPIS): VERY LOW RISK OF SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS (SEPTEMBER 2015)

Very infrequent cases of subacute cutaneous lupus erythematosus (SCLE) have been reported in patients taking PPIs. Drug-induced SCLE can occur weeks, months or even years after exposure to the drug.

If a patient treated with a PPI develops lesions— especially in sun-exposed areas of the skin—and it is accompanied by arthralgia:

.advise them to avoid exposing the skin to sunlight;

.consider SCLE as a possible diagnosis;

.consider discontinuing PPI treatment unless it is imperative for a serious acid-related condition; a patient who develops SCLE with a particular PPI may be at risk of the same reaction with another;

.in most cases, symptoms resolve on PPI withdrawal;

topical or systemic steroids might be necessary for treatment of SCLE only if there are no signs of remission after a few weeks or months.

lCAUTIONSCan increase the risk of fractures (particularly when used at high doses for over a year in the elderly)

.

may increase the risk of gastro-intestinal infections (includingClostridium difficileinfection)

.

may mask the symptoms of gastric cancer (in adults)

.

patients at risk of osteoporosis

BNF78

Gastric and duodenal ulceration 77

Gastro-intestinalsystem

1

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