Drug reference
Misoprostol is a synthetic prostaglandin analogue that has antisecretory and protective properties, promoting healing of gastric and duodenal ulcers. Proton pump inhibitors inhibit gastric acid secretion by blocking the hydrogen-potassium adenosine triphosphatase enzyme system (the ‘proton pump’) of the gastric parietal cell.
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CYTOTEC ® Benign gastric ulcer | Benign duodenal ulcer | NSAID- induced peptic ulcer ▶BY MOUTH ▶Adult: 400 micrograms twice daily, alternatively 200 micrograms 4 times a day continued for at least 4 weeks or may be continued for up to 8 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 micrograms 2–4 times a day
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CYTOTEC ® Conditions where hypotension might precipitate severe complications (e.g. cerebrovascular disease, cardiovascular disease). conditions which predispose to diarrhoea (e.g. inflammatory bowel disease) Can 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 (including Clostridioides difficile infection). may mask the symptoms of gastric cancer (in adults). patients at risk of osteoporosis CAUTIONS, FURTHER INFORMATION ▶Risk of osteoporosis Patients at risk of osteoporosis should maintain an adequate intake of calcium and vitamin D, and if necessary, receive other preventative therapy. ▶Gastric cancer ▶In adults Particular care is required in those presenting with ‘alarm features’, in such cases gastric malignancy should be ruled out before treatment. ▶Elderly Prescription potentially inappropriate (STOPP criteria) for uncomplicated peptic ulcer disease or erosive peptic oesophagitis at full therapeutic dosage for longer than 8 weeks (dose reduction or earlier discontinuation indicated). See also Prescribing in the elderly p. 33.
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A proton pump inhibitor should be prescribed for appropriate indications at the lowest effective dose for the shortest period; the need for long-term treatment should be reviewed periodically. eiiii F 82
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GENERAL SIDE-EFFECTS ▶Common or very common Nausea. rash. vomiting ▶Uncommon Uterine rupture SPECIFIC SIDE-EFFECTS ▶Common or very common Constipation. diarrhoea. dizziness. flatulence. gastrointestinal discomfort. Gastro-intestinal system headache ▶Uncommon Fever. haemorrhage. menstrual cycle irregularities. postmenopausal haemorrhage. uterine cramps ▶Frequency not known Chills SIDE-EFFECTS, FURTHER INFORMATION Diarrhoea may occasionally be severe and require withdrawal, reduced by giving single doses not exceeding 200 micrograms and by avoiding magnesium-containing antacids. ▶Common or very common Abdominal pain. constipation. diarrhoea. dizziness. dry mouth. gastrointestinal disorders. headache. insomnia. nausea. skin reactions. vomiting ▶Uncommon Arthralgia. bone fractures. confusion. depression. drowsiness. leucopenia. malaise. myalgia. paraesthesia. peripheral oedema. thrombocytopenia. vertigo. vision disorders ▶Rare or very rare Agranulocytosis. alopecia. gynaecomastia. hallucination. hepatic disorders. hyperhidrosis. hyponatraemia. nephritis tubulointerstitial . pancytopenia. photosensitivity reaction. severe cutaneous adverse reactions (SCARs). stomatitis. taste altered ▶Frequency not known Hypomagnesaemia (more common after 1 year of treatment, but sometimes after 3 months of treatment). subacute cutaneous lupus erythematosus
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CYTOTEC ® Manufacturer 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.
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CYTOTEC ® Manufacturer advises avoid—induces uterine contractions, and associated with abortion and birth defects; teratogenic in first trimester.
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Manufacturer 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 for 5 hours after a dose. k
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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.
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Measurement of serum- magnesium concentrations should be considered before and during prolonged treatment with a proton pump inhibitor, especially when used with other drugs that cause hypomagnesaemia or with digoxin.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 21 ▶Cytotec (Pfizer Ltd) Misoprostol 200 microgram Cytotec 200microgram tablets | 60 tablet P £10.03 DT = £10.03 PROTON PUMP INHIBITORS Proton pump inhibitors Overview Proton pump inhibitors are effective short-term treatments for gastric and duodenal 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 of dyspepsia and 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 cystic fibrosis. They can also be used to control excessive secretion of gastric acid in Zollinger–Ellison syndrome; high doses are often required. Proton pump inhibitors f
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Driving and skilled tasks Manufacturer advises patients should be cautioned on the effects on driving and performance of skilled tasks—increased risk of dizziness.
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400 micrograms twice daily, alternatively
First-line fragment. Read the complete Indications and Dose section above.
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200 micrograms 2–4 times a day
First-line fragment. Read the complete Indications and Dose section above.
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