BNF for Children 2011-2012

BNFC 2011–2012 1.3.5 Proton pump inhibitors 451.3.5 Proton pump inhibitorsProton pump inhibitors inhibit gastric acid secretion byblocking the hydrogen-potassium adenosine triphosphataseenzyme system (the ‘proton pump’) of the gastricparietal cell. Omeprazole is an effective short-termtreatment for gastric and duodenal ulcers; it is alsoused in combination with antibacterials for the eradicationof Helicobacter pylori (see p. 42 for specific regimens).An initial short course of omeprazole is thetreatment of choice in gastro-oesophageal reflux diseasewith severe symptoms; children with endoscopicallyconfirmed erosive, ulcerative, or stricturing oesophagitisusually need to be maintained on omeprazole.Omeprazole is also used for the prevention and treatmentof NSAID-associated ulcers (see p. 43). In childrenwho need to continue NSAID treatment after an ulcerhas healed, the dose of omeprazole should not normallybe reduced because asymptomatic ulcer deteriorationmay occur.Omeprazole is effective in the treatment of theZollinger-Ellison syndrome (including cases resistantto other treatment). It is also used to reduce the degradationof pancreatic enzyme supplements (section 1.9.4)in children with cystic fibrosis.Lansoprazole is not licensed for use in children, butmay be considered when the available formulations ofomeprazole are unsuitable.Esomeprazole can be used for the management ofgastro-oesophageal reflux disease when the availableformulations of omeprazole and lansoprazole are unsuitable.Side-effects Side-effects of the proton pump inhibitorsinclude gastro-intestinal disturbances (includingnausea, vomiting, abdominal pain, flatulence, diarrhoea,constipation), and headache. Less frequent side-effectsinclude dry mouth, peripheral oedema, dizziness, sleepdisturbances, fatigue, paraesthesia, arthralgia, myalgia,rash, and pruritus. Other side-effects reported rarely orvery rarely include taste disturbance, stomatitis, hepatitis,jaundice, hypersensitivity reactions (includinganaphylaxis, bronchospasm), fever, depression, hallucinations,confusion, gynaecomastia, interstitial nephritis,hyponatraemia, blood disorders (including leucopenia,leucocytosis, pancytopenia, thrombocytopenia), visualdisturbances, sweating, photosensitivity, alopecia, Stevens-Johnsonsyndrome, and toxic epidermal necrolysis.By decreasing gastric acidity, proton pump inhibitorsmay increase the risk of gastro-intestinal infections(including Clostridium difficile infection).ESOMEPRAZOLECautions interactions: Appendix 1 (proton pumpinhibitors)Hepatic impairment child 1–12 years max. 10 mgdaily in severe impairment; child 12–18 years max.20 mg daily in severe impairmentRenal impairment manufacturer advises caution insevere renal insufficiencyPregnancy manufacturer advises caution—no informationavailableBreast-feeding manufacturer advises avoid—noinformation availableSide-effects see notes aboveLicensed use tablets not licensed for use in children1–12 yearsIndication and doseGastro-oesophageal reflux disease (in the presenceof erosive reflux oesophagitis). By mouthChild 1–12 yearsBody-weight 10–20 kg 10 mg once daily for 8weeksBody-weight over 20 kg 10–20 mg once daily for8 weeksChild 12–18 years 40 mg once daily for 4 weeks,continued for further 4 weeks if not fully healed orsymptoms persist; maintenance 20 mg dailySymptomatic treatment of gastro-oesophagealreflux disease (in the absence of oesophagitis). By mouthChild 1–12 years, body-weight over 10 kg10 mg once daily for up to 8 weeksChild 12–18 years 20 mg once daily for up to 4weeksNexium c (AstraZeneca) ATablets, f/c, esomeprazole (as magnesium trihydrate)20 mg (light pink), net price 28-tab pack = £18.50;40 mg (pink), 28-tab pack = £25.19. Counselling,administrationAdministration Swallow whole or disperse in water; do not chewor crush tabletsGranules, yellow, e/c, esomeprazole (as magnesiumtrihydrate) 10 mg/sachet, net price 28-sachet pack =£25.19. Label: 25, counselling, administrationAdministration Disperse the contents of each sachet in approx.15 mL water. Stir and leave to thicken for a few minutes; stir againbefore administration and use within 30 minutes; rinse containerwith 15 mL water to obtain full dose; can be administered throughnasogastric or gastric tubeLANSOPRAZOLECautions interactions: Appendix 1 (proton pumpinhibitors)Hepatic impairment use half normal dose in moderateto severe liver diseasePregnancy manufacturer advises avoidBreast-feeding avoid unless essential—present inmilk in animal studiesSide-effects see notes above; also glossitis, pancreatitis,anorexia, restlessness, tremor, impotence,petechiae, and purpura; very rarely colitis, raisedserum cholesterol or triglyceridesLicensed use not licensed for use in childrenIndication and doseGastro-oesophageal reflux disease, acidrelateddyspepsia, treatment of duodenal andbenign gastric ulcer including those complicatingNSAID therapy, fat malabsorptiondespite pancreatic enzyme replacement therapyin cystic fibrosis. By mouthChild body-weight under 30 kg 0.5–1 mg/kg(max. 15 mg) once daily in the morningChild body-weight over 30 kg 15–30 mg oncedaily in the morning1 Gastro-intestinal system