Oesophagealclinic.com

PRESCRIBING INFORMATION
should be considered. Nexium Tablets contain sucrose. Patients with rare hereditary Adverse events should be reported to AstraZeneca UK Medical NEXIUM® 20mg/40mg Tablets (esomeprazole). Consult Summary of Product Characteristics problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase
before prescribing. Use: Nexium is a proton-pump inhibitor. NEXIUM® Tablets: Gastro insufficiency should not take Nexium Tablets. Ketoconazole or itraconazole absorption may be
Information (Tel: 0800 783 0033). In addition, information about Oesophageal Reflux Disease (GORD). Helicobacter pylori eradication in combination reduced. When Nexium is combined with drugs metabolised by CYP2C19, such as diazepam, adverse event reporting can be found at www.yel owcard.co.uk treatment with antibiotics. Healing of gastric ulcers and prevention of gastric and duodenal citalopram, imipramine, clomipramine, phenytoin, etc. a dose reduction could be needed. ulcers associated with NSAID therapy. Zol inger El ison Syndrome. Presentation: Gastro- This should be considered especial y when prescribing Nexium for on-demand therapy.
resistant tablets containing 20mg or 40mg esomeprazole. Dosage and administration: Adults: Plasma concentrations of phenytoin should be monitored when treatment with Nexium
(including the elderly) and adolescents: NEXIUM® 20mg/40mg Tablets: GORD: Adults and is introduced or withdrawn. In warfarin, or other coumarine derivative-treated patients,
adolescents from the age of 12, treatment of Reflux Oesophagitis: 40mg once daily (od) for monitoring is recommended when initiating and ending concomitant treatment. Pregnancy &
4 weeks. An additional 4 weeks treatment is recommended for patients in whom oesophagitis Lactation: Limited data on exposed pregnancies are available. Avoid in pregnancy unless no
has not healed or who have persistent symptoms. Long-term management of patients with safer alternative. It is not known whether esomeprazole is excreted in breast milk. Discontinue healed oesophagitis to prevent relapse: 20mg od. Symptomatic treatment of GORD: 20mg od breast-feeding if Nexium is considered essential. Undesirable events: None of the fol owing
(in patients without oesophagitis). If symptoms have not been control ed after 4 weeks, the were found to be dose-related. Blood and lymphatic system disorders – Rare: leukopenia,
patient should be further investigated. Once symptoms have resolved, subsequent symptom thrombocytopenia; Very rare: agranulocytosis, pancytopenia. Immune system disorders
control can be achieved in adult patients using on-demand Nexium 20mg od, when needed. – Rare: hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock.
Helicobacter pylori eradication (in combination with appropriate antibiotics): Adults only, Metabolism and nutrition disorders – Uncommon: peripheral oedema; Rare: hyponatraemia
healing of H. pylori associated duodenal ulcers and prevention of relapse of peptic ulcers Psychiatric disorders – Uncommon: insomnia; Rare: agitation, confusion, depression; Very
in patients with H. pylori associated ulcers. Nexium 20mg, amoxycil in 1g, clarithromycin rare: aggression, hal ucinations. Nervous system disorders – Common: headache; Uncommon:
500mg, al twice daily for 7 days. Patients requiring continued NSAID therapy: Adults dizziness, paraesthesia, somnolence; Rare: taste disturbance.
only, healing of gastric ulcers associated with NSAID therapy: The usual dose is 20mg Eye disorders – Rare (Tablets):
once daily. The treatment duration is 4-8 weeks. Prevention of gastric and duodenal ulcers blurred vision. Irreversible visual impairment has been reported in isolated cases of critical y associated with NSAID therapy in patients at risk: 20mg once daily. In NSAID treated patients il patients who have received omeprazole (the racemate) intravenous injection, especial y at risk of developing gastric and duodenal ulcers, subsequent symptom control using an at high doses, but no causal relationship has been established. Ear and labyrinth disorders
on-demand regimen is not recommended. Treatment of Zol inger El ison Syndrome: Adults – Uncommon: vertigo. Respiratory, thoracic and mediastinal disorders – Rare: bronchospasm.
only, initial dose 40mg bd, then to be individualised, treatment to continue for as long as Gastrointestinal disorders – Common: abdominal pain, constipation, diarrhoea, flatulence,
needed. Patients usual y control ed on 80 to 160mg daily doses. Doses above 80mg to be taken nausea/vomiting; Uncommon: dry mouth; Rare: stomatitis, gastrointestinal candidiasis. bd. Renal impairment: No dose adjustment needed. Patients with severe renal insufficiency Hepatobiliary disorders – Uncommon: increased liver enzymes; Rare: hepatitis with or
should be treated with caution. Hepatic impairment: No dose adjustment needed except in without jaundice; Very rare: hepatic failure, encephalopathy in patients with pre-existing
patients with severe liver impairment where a maximum daily dose of 20mg should not be liver disease. Skin and subcutaneous tissue disorders – Uncommon: dermatitis, pruritus,
exceeded. Adolescents: Nexium Tablets may be used for GORD in adolescents from the age rash, urticaria; Rare: alopecia, photosensitivity; Very rare: erythema multiforme,
of 12. Children below the age of 12 years: Nexium should not be used in children since no data Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN). Musculoskeletal, connective
is available. Elderly: No dose adjustment needed. Contraindications: Known hypersensitivity tissue and bone disorders – Rare: arthralgia, myalgia; Very rare: muscular weakness. Renal
to esomeprazole, substituted benzimidazoles or any other constituents of Nexium. and urinary disorders – Very rare: interstitial nephritis. Reproductive system and breast
Esomeprazole, like other PPIs, should not be administered with atazanavir. Precautions: In the disorders – Very rare: gynaecomastia. General disorders and administration site conditions
presence of any alarm symptoms and when gastric ulcer is suspected or present, malignancy – Rare: malaise, increased sweating. Legal category: POM. Marketing authorisation number:
should be excluded, as treatment may al eviate symptoms and delay diagnosis. Patients Nexium® 20mg Tablets PL 17901/0068; Nexium® 40mg Tablets PL 17901/0069. Basic NHS cost:
on long-term treatment should be kept under regular surveil ance. Patients on on-demand Tablets 20mg: Blisters of 7 tablets (Hospital pack): £4.63; 28 tablets*: £18.50; Tablets 40mg:
treatment should contact their physician if their symptoms change in character. When Blisters of 7 tablets (Hospital pack): £6.30; 28 tablets*: £25.19 (*also available in hospital prescribing Nexium for on-demand therapy, the implications for interactions with other unit doses). Further information is available from the Marketing Authorisation holder:
pharmaceuticals should be considered. When prescribing Nexium for H. pylori eradication, AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK. NEXIUM® is a trade mark possible drug interactions for al components in the triple therapy, particularly clarithromycin, of the AstraZeneca group of companies. AZ 05/2007.
PRESCRIBING INFORMATION
4-12 weeks. Renal impairment: No dose adjustment needed. Hepatic impairment: maximum
Adverse events should be reported to AstraZeneca UK Medical LOSEC® Capsules and LOSEC MUPS® (omeprazole) Consult Summary of Product daily dose of 20mg. Patients with swal owing difficulties: MUPS may be dispersed in a
Characteristics before prescribing. Use: Treatment of oesophageal reflux disease, duodenal smal amount of water or juice, capsules may be opened and dispersed in the same way.
Information (Tel: 0800 783 0033). In addition, information about and benign gastric ulcers. Relief of associated dyspeptic symptoms. Helicobacter pylori Contraindications: Known hypersensitivity to omeprazole or product constituents. In
adverse event reporting can be found at www.yel owcard.co.uk eradication in combination with antibiotics. Prophylaxis of acid aspiration. Zol inger-El ison gastric ulcers, exclude malignancy before starting therapy. Not to be administered with syndrome. 10 and 20mg strengths only for relief of reflux and ulcer-like symptoms associated atazanavir. Precautions: Monitor patients for flare up of disease symptoms when switching
with acid-related dyspepsia. 10 and 20mg strengths only for treatment and prophylaxis of from capsules to MUPS. Treatment with acid-reducing drugs may lead to increased NSAID-benign gastric/duodenal ulcers and gastroduodenal erosions. Presentation: Losec risk of gastrointestinal infections. Monitor serum B levels when treating severely ill
Capsules and Tablets containing 10, 20 and 40mg of omeprazole. Dosage and administration:
children long term. Patents with galactose intolerance or related conditions should not Adults including the elderly: Oesophageal reflux disease including reflux oesophagitis: take Capsules. Interactions: Ketoconazole and itraconazole absorption may be reduced.
20mg once daily for 4 weeks, continue to 8 weeks if required. In reflux oesophagitis refractory Diazepam, phenytoin and warfarin elimination can be prolonged, phenytoin and warfarin cases 40mg once daily for 8 weeks, a 20mg daily dose may be continued. Acid Reflux disease: dose may need to be reduced. When used concomitantly omeprazole and clarythromycin
10mg once daily for long-term maintenance increasing to 20mg once daily if required. plasma concentrations are increased. May increase digoxin bioavailability if used Duodenal and benign gastric ulcers: 20mg once daily for 4-8 weeks, in severe/recurrent simultaneously. Serum tacrolimus levels may increase if used simultaneously. Pregnancy
cases increase to 40mg once daily. Long-term therapy 20mg once daily reducing to 10mg and lactation: can be used in pregnancy, excreted in breast milk but not likely to impact
once daily in certain cases if necessary. Prevention of relapse with duodenal ulcers 10mg on child. Undesirable events: General y mild and reversible, include headache, diarrhoea,
once daily increasing to 20mg once daily of required. Helicobacter pylori eradication in peptic constipation, abdominal pain, nausea/vomiting and flatulence. Dizziness, light headedness,
ulcer disease: 40mg once daily or 20mg once daily if using antimicrobial agents in triple or feeling faint, somnolence, insomnia and vertigo. Increased liver enzymes. Rash, pruritis or
dual therapy. Triple therapy (duodenal ulcer disease) amoxicil in 500mg and metronidazole urticaria. Malaise. Mental confusion, aggitaion, aggression, depression, and hal ucinations 400mg three times a day for 1 week, or clarithromycin 250mg and metronidazole 40mg or in severely il patients. Gynaecomastia. Dry mouth, stomatitis gastrointestinal candidiasis. tonodazole 500mg twice a day for 1 week, or amoxicil in 1g and clarithromycin 500mg twice Leukopenia, thrombocytopenia, agranulocytosis and pancytopenia. Encephalopathy, a day for one week. Dual therapy (duodenal ulcer disease) amoxicil in 750mg-1g twice daily, hepatitis, jaundice, hepatic failure. Arthritic and myalgic symptoms, muscular weakness. or clarithromycin 500mg three times a day for 2 weeks. Dual therapy (gastric ulcer disease) Impotence. Photosensitivity, bul ous eruption erythema multiforme, Stevens-Johnson amoxicil in 750mg-1g twice daily for 2 weeks. Prophylaxis of acid aspiration: 40mg in the syndrome, toxic epidermal necrolysis, alopecia. Hypersensitivity reactions. Increased
evening and 2-6 hours before surgery. Zol inger-El ison syndrome: 60mg once daily and sweating, peripheral oedema, blurred vision, taste disturbance and hyponatraemia. Legal
adjusted as needed in the range of 20-120mg per day. If use 80-120mg per day divide dose category: POM Marketing authorisation number: Losec Capsules PL 17901/0132-34. Losec
and give twice daily. Acid-related dyspepsia: 10-20mg once daily for 2-4 weeks, investigate if MUPS PL 17901/0137-39. Basic NHS cost: Losec 10, 20, 40mg capsules and MUPS: £19.34,
no response. NSAID-associated gastric/duodenal ulcers or gastroduodenal erosions: 20mg £29.22 and £14.61 respectively. Further information is available from the Marketing
once daily for 4 weeks, 4 further weeks can be taken if needed. If patients have a previous Authorisation holder: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU,
history of gastroduodenal lesions use 20mg once daily continuously. Children over 1 with UK. Losec and Losec MUPS are trade mark(s) of the AstraZeneca group of companies.
severe ulcerating reflux oesophagitis: Weight control ed, 10-20kg dosage is 10mg once AZ 09/2006
daily, above 20kg dosage is 20mg once daily. If needed increase to 20, 40mg respectively for Date of Preparation: September 2007 NEXP12949 Integrated Care Pathway
this document has been produced to provide
an example of an ICP in the gI area.
the reproduction complies with the aBPI Code of Practice.
Permission to reproduce has been granted by the authors.
See reverse for further guidance & advice alarm signals:
unexplained and persistent recent-onset d C205 referral
refer for opinion via
tier two dyspepsia ser
refer for opinion to
Ith new or
gP w Pe sym
ysPePsIa-ty
Presents to t d
PatIent re
Give lifestyle advice and antacids +/- algina tients who fail to respond to the above regime Consider coprescription of a PPI or misoprostol omeprazole 20mg capsules
treatment
calcium channel blockers particularly nifedipine, Ids and use alternative analgesics where possible
testing and
xacerbating
atient is also taking corticosteroids or anticoa atient has a serious co-morbid condition e.g.
h.pylori
treatment
lansoprazole 30mg capsules or
review the need/benefit after a 4-week trial period.
drugs affecting lower oesophageal sphincter tone
drugs causing oesophageal mucosal injur
try to stop
If symptoms persist refer for endoscopy
tients with recurrent epigastric pain or tients are often anxious and need reassuring disease (
dyspepsia
Acid suppressor drugs may be of little benefit as symptoms ar The role of H.pylori in NUD remains controversial – eradica Avoid large meals and excessive amounts of fluid – in particul dyspepsia
gastro-oesophageal
The predominant symptom of GORD is heartburn.
“heartburn is a burning feeling rising from your stomach or lower chest towards your
• Reflux may occur with normal endoscopic a • Reflux symptoms which respond to trea Functional
Peptic Ulceration
• Stop the use of NSAIDs where possible (see guidance) lifestyle
• Raise the head of the bed by 6 inches

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