BNF 85 (British National Formulary) March 2023 - Gastro-intestinal System PDF

Diverticular disease and diverticulitis 37 1 Chapter 1 Gastro-intestinal system CONTENTS 1 Chronic bowel disorders 1.1 1.2 1.3 1.4 1.5 2 2.1 2.2 3 4 5 6 6.1 page 37 37 37 38 48 50 Coeliac disease Diverticular disease and diverticulitis Inﬂammatory bowel disease Irritable bowel syndrome Short bowel syndrome Constipation and bowel cleansing Bowel cleansing Constipation Diarrhoea Exocrine pancreatic insufficiency Food allergy Gastric acid disorders and ulceration Dyspepsia 51 51 54 68 71 73 73 73 1 Chronic bowel disorders 1.1 Coeliac disease 6.2 6.3 6.4 7 8 8.1 8.2 9 10 10.1 10.2 11 Gastric and duodenal ulceration Gastro-oesophageal reﬂux disease Helicobacter pylori infection Gastro-intestinal smooth muscle spasm Liver disorders and related conditions Biliary disorders Oesophageal varices Obesity Rectal and anal disorders Anal ﬁssures Haemorrhoids Stoma care page 76 88 89 91 93 93 97 97 100 100 100 105 Conﬁrmed cases of refractory coeliac disease should be referred to a specialist centre. Treatment with prednisolone p. 756 can be considered for initial management while awaiting specialist advice. h Useful Resources Coeliac disease 25-Jul-2016 Description of condition Coeliac disease is an autoimmune condition which is associated with chronic inﬂammation of the small intestine. Dietary proteins known as gluten, which are present in wheat, barley and rye, activate an abnormal immune response in the intestinal mucosa, which can lead to malabsorption of nutrients. Copyright © 2023. Pharmaceutical Press. All rights reserved. Aims of treatment The management of coeliac disease is aimed at eliminating symptoms (such as diarrhoea, bloating and abdominal pain) and reducing the risk of complications, including those resulting from malabsorption. Non-drug treatment The only effective treatment for coeliac disease is a strict, life-long, gluten-free diet. A range of gluten-free products is available for prescription (see Borderline substances). h g Drug treatment Patients who have coeliac disease are at an increased risk of malabsorption of key nutrients (such as calcium and vitamin D). Their risk of osteoporosis and the need for active treatment of bone disease should form part of the ongoing management of coeliac disease. Supplementation of key nutrients may be required if dietary intake is insufﬁcient. Patients who have coeliac disease should be advised not to self-medicate with over-the-counter vitamins or mineral supplements. Initiation of supplementation should involve a discussion with a member of the patient’s healthcare team in order to identify the individual needs of the patient and to allow for appropriate ongoing monitoring. g Coeliac disease: recognition, assessment and management. National Institute for Health and Care Excellence. Clinical guideline 20. September 2015. www.nice.org.uk/guidance/ng20 1.2 Diverticular disease and diverticulitis Diverticular disease and diverticulitis 20-Feb-2020 Description of condition Diverticulosis is an asymptomatic condition characterised by the presence of diverticula (small pouches protruding from the walls of the large intestine). Its prevalence is difﬁcult to determine but it is age dependent, with the majority of patients aged 40 years and over. Diverticular disease is a condition where diverticula are present with symptoms such as abdominal tenderness and/or mild, intermittent lower abdominal pain with constipation, diarrhoea, or occasional large rectal bleeds. Symptoms of diverticular disease may overlap with other conditions such as Irritable bowel syndrome p. 48, colitis (bowel inﬂammation related to Crohn’s disease p. 38, Ulcerative colitis p. 39, ischaemia or microscopic colitis), and malignancy. Acute diverticulitis occurs when diverticula suddenly become inﬂamed or infected. Signs and symptoms include constant lower abdominal pain (usually severe) together with features such as fever, a sudden change in bowel habits and signiﬁcant rectal bleeding, lower abdominal tenderness, or a palpable abdominal mass. Complicated acute diverticulitis refers to diverticulitis associated with Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. Gastro-intestinal system BNF 85 38 Chronic bowel disorders Gastro-intestinal system 1 complications such as abscess, bowel perforation and peritonitis, ﬁstula, intestinal obstruction, haemorrhage, or sepsis. For further information on signs and symptoms of acute diverticulitis or complicated acute diverticulitis, see NICE clinical guideline: Diverticular disease (see Useful resources). Aims of treatment Treatment aims to relieve symptoms of diverticular disease, improve quality of life, manage episodes of acute diverticulitis, and reduce the risk of recurrence and complications. Non drug management Patients and their family and/or carers, where appropriate, should be provided with information about diet and lifestyle changes, the course of the disease and likelihood of progression, symptoms and symptom management, investigations and treatment options, and when and how to seek further medical advice. Patients with diverticulosis or diverticular disease should be advised to eat a healthy, balanced diet including whole grains, fruit and vegetables. In patients with constipation and on a low ﬁbre diet, a gradual increase of dietary ﬁbre may minimise ﬂatulence and bloating. Patients increasing dietary ﬁbre should be advised to drink an adequate amount of ﬂuid, especially if dehydration is a risk. Advice should also be given about the beneﬁts of exercise, weight loss (if overweight or obese), and Smoking cessation p. 537, in reducing the risk of symptomatic disease and acute diverticulitis. Patients with diverticular disease should also be informed that it may take several weeks for the beneﬁts of increasing ﬁbre in their diet to be achieved and that if a high-ﬁbre diet is tolerated, it should be continued for life. In patients with complicated acute diverticulitis, emergency or elective surgical management may be required. h For information on surgical management, see NICE clinical guideline: Diverticular disease (see Useful resources). g Drug treatment Copyright © 2023. Pharmaceutical Press. All rights reserved. Diverticulosis g As diverticulosis is an asymptomatic condition, speciﬁc treatments are not recommended. Bulk-forming laxatives can be considered for patients with constipation. h Diverticular disease g Antibacterials are not recommended for patients with diverticular disease. Bulk-forming laxatives should be considered when a highﬁbre diet is unsuitable, or for patients with persistent constipation or diarrhoea. Consider the use of simple analgesia such as paracetamol p. 483 in patients with ongoing abdominal pain, and antispasmodics in those with abdominal cramps. Nonsteroidal anti-inﬂammatory drugs and opioid analgesics are not recommended as their use may increase the risk of diverticular perforation. For patients with persistent symptoms or symptoms that do not respond to treatment, consider an alternative diagnosis. h Acute diverticulitis g Offer simple analgesia such as paracetamol to patients with acute diverticulitis who are systemically well. Consider a watchful waiting and a no antibacterial prescribing strategy, and advise patients to re-present if symptoms persist or worsen. h For guidance on antibacterial management, see Diverticulitis, acute in Gastro-intestinal system infections, antibacterial therapy p. 554. BNF 85 Patients with persistent or worsening symptoms should be reassessed in primary care and considered for referral to hospital for further assessment. Refer patients with suspected complicated acute diverticulitis and uncontrolled abdominal pain for same-day hospital assessment. Those presenting with signiﬁcant rectal bleeding should be referred to hospital urgently. Treatment with aminosalicylates or prophylactic antibacterials are not recommended to prevent recurrent acute diverticulitis. h g Useful Resources Diverticular disease: diagnosis and management. National Institute for Health and Care Excellence. NICE guideline 147. November 2019. www.nice.org.uk/guidance/ng147 1.3 Inflammatory bowel disease Crohn’s disease 20-Dec-2016 Description of condition Crohn’s disease is a chronic, inﬂammatory bowel disease that mainly affects the gastro-intestinal tract. It is characterised by thickened areas of the gastro-intestinal wall with inﬂammation extending through all layers, deep ulceration and ﬁssuring of the mucosa, and the presence of granulomas; affected areas may occur in any part of the gastro-intestinal tract, interspersed with areas of relatively normal tissue. Crohn’s disease may present as recurrent attacks, with acute exacerbations combined with periods of remission or less active disease. Symptoms depend on the site of disease but may include abdominal pain, diarrhoea, fever, weight loss and rectal bleeding. Complications of Crohn’s disease include intestinal strictures, abscesses in the wall of the intestine or adjacent structures, ﬁstulae, anaemia, malnutrition, colorectal and small bowel cancers, and growth failure and delayed puberty in children. Crohn’s disease may also be associated with extra-intestinal manifestation: the most common are arthritis and abnormalities of the joints, eyes, liver and skin. Crohn’s disease is also a cause of secondary osteoporosis and those at greatest risk should be monitored for osteopenia and assessed for the risk of fractures. Fistulating Crohn’s disease Fistulating Crohn’s disease is a complication that involves the formation of a ﬁstula between the intestine and adjacent structures, such as perianal skin, bladder, and vagina. It occurs in about one quarter of patients, mostly when the disease involves the ileocolonic area. Aims of treatment Treatment is largely directed at the induction and maintenance of remission and the relief of symptoms. Active treatment of acute Crohn’s disease should be distinguished from preventing relapse. The aims of drug treatment are to reduce symptoms and maintain or improve quality of life, while minimising toxicity related to drugs over both the short and long term. In ﬁstulating Crohn’s disease, surgery and medical treatment aim to close and maintain closure of the ﬁstula. Non-drug treatment In addition to drug treatment, management options for Crohn’s disease include Smoking cessation p. 537 and attention to nutrition, which plays an important role in supportive care. Surgery may be considered in certain patients with early disease limited to the distal ileum and in severe or chronic active disease. h g Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. Copyright © 2023. Pharmaceutical Press. All rights reserved. Drug treatment Treatment of acute disease Monotherapy g A corticosteroid (either prednisolone p. 756 or methylprednisolone p. 755 or intravenous hydrocortisone p. 754), is used to induce remission in patients with a ﬁrst presentation or a single inﬂammatory exacerbation of Crohn’s disease in a 12-month period. In patients with distal ileal, ileocaecal or right-sided colonic disease, in whom a conventional corticosteroid is unsuitable or contra-indicated, budesonide p. 45 may be considered. Budesonide is less effective but may cause fewer side-effects than other corticosteroids, as systemic exposure is limited. Aminosalicylates (such as sulfasalazine p. 44 and mesalazine p. 41) are an alternative option in these patients. They are less effective than a corticosteroid or budesonide, but may be preferred because they have fewer side-effects. Aminosalicylates and budesonide are not appropriate for severe presentations or exacerbations. h Add-on treatment g Add on treatment is prescribed if there are two or more inﬂammatory exacerbations in a 12-month period, or the corticosteroid dose cannot be reduced. Azathioprine p. 915 or mercaptopurine p. 1001 [unlicensed indications] can be added to a corticosteroid or budesonide to induce remission. In patients who cannot tolerate azathioprine or mercaptopurine or in whom thiopurine methyltransferase (TPMT) activity is deﬁcient, methotrexate p. 1001 can be added to a corticosteroid. Under specialist supervision, the tumour necrosis factoralpha inhibitors adalimumab p. 1226 and inﬂiximab p. 1232 are options for the treatment of severe, active Crohn’s disease, following inadequate response to conventional therapies or in those who are intolerant of or have contraindications to conventional therapy. Vedolizumab p. 47 is recommended for moderate to severely active Crohn’s disease when therapy with adalimumab or inﬂiximab is unsuccessful, is contra-indicated or not tolerated. Ustekinumab p. 1219 is recommended for moderate to severely active Crohn’s disease when conventional therapy or therapy with adalimumab or inﬂiximab is unsuccessful, is contra-indicated or not tolerated. See also National funding/access decisions for adalimumab, inﬂiximab, ustekinumab p. 1219, and vedolizumab. Adalimumab and inﬂiximab can be used as monotherapy or combined with an immunosuppressant although there is uncertainty about the comparative effectiveness and longterm side-effects of therapy. h Maintenance of remission g Patients who choose not to receive maintenance treatment during remission should be made aware of the symptoms that may suggest a relapse (most frequently unintended weight loss, abdominal pain, diarrhoea and general ill-health). For those who choose not to receive maintenance treatment during remission, a suitable follow up plan should be agreed upon and information provided on how to access healthcare if a relapse should occur. Azathioprine or mercaptopurine [unlicensed indications] as monotherapy can be used to maintain remission when previously used with a corticosteroid to induce remission. They may also be used in patients who have not previously received these drugs (particularly those with adverse prognostic factors such as early age of onset, perianal disease, corticosteroid use at presentation, and severe presentations). Methotrexate can be used to maintain remission only in patients who required methotrexate to induce remission, or who are intolerant of or are not suitable for azathioprine or mercaptopurine for maintenance. Corticosteroids or budesonide should not be used. h Inﬂammatory bowel disease 39 Maintaining remission following surgery g Azathioprine in combination with up to 3 months’ postoperative metronidazole p. 597 [unlicensed indication] should be considered to maintain remission in patients with ileocolonic Crohn’s disease who have had complete macroscopic resection within the previous 3 months. Azathioprine alone should be considered for patients who cannot tolerate metronidazole p. 597. h Aminosalicylates are no longer recommended due to the lack of clinical efﬁcacy. NICE do not consider mercaptopurine to be a costeffective treatment and do not recommend its use. g Biologic therapies should no longer be used to maintain remission after complete macroscopic resection of ileocolonic Crohn’s disease because of limited evidence. Budesonide should also not be used in these patients. h Other treatments g Loperamide hydrochloride p. 69 or codeine phosphate p. 492 can be used to manage diarrhoea associated with Crohn’s disease in those who do not have colitis. h Colestyramine p. 216 is licensed for the relief of diarrhoea associated with Crohn’s disease. See also Diarrhoea (acute) p. 68. Fistulating Crohn’s disease Perianal ﬁstulae are the most common occurrence in patients with ﬁstulating Crohn’s disease. g Treatment may not be necessary for simple, asymptomatic perianal ﬁstulae. When ﬁstulae are symptomatic, local drainage and surgery may be required in conjunction with the medical therapy. Metronidazole p. 597 or ciproﬂoxacin p. 616 [unlicensed indications], alone or in combination, can improve symptoms of ﬁstulating Crohn’s disease but complete healing occurs rarely. Metronidazole p. 597 is usually given for 1 month, but no longer than 3 months because of concerns about peripheral neuropathy. Other antibacterials should be given if speciﬁcally indicated (e.g. in sepsis associated with ﬁstulae and perianal disease) and for managing bacterial overgrowth in the small bowel. Either azathioprine p. 915 or mercaptopurine p. 1001 [unlicensed indications] is used to control the inﬂammation in ﬁstulating Crohn’s disease and they are continued for maintenance. Inﬂiximab p. 1232 is recommended for patients with active ﬁstulating Crohn’s disease who have not responded to conventional therapy (including antibacterials, drainage and immunosuppressive treatments), or who are intolerant of or have contra-indications to conventional therapy. Inﬂiximab should be used after ensuring that all sepsis is actively draining. Abscess drainage, ﬁstulotomy, and seton insertion may be appropriate, particularly before inﬂiximab treatment. Azathioprine, mercaptopurine, or inﬂiximab should be continued as maintenance treatment for at least one year. For the management of non-perianal ﬁstulating Crohn’s disease (including entero-gynaecological and enterovesical ﬁstulae) surgery is the only recommended approach. h Useful Resources Crohn’s disease: management. National Institute for Health and Care Excellence. Clinical guideline 129. May 2019. www.nice.org.uk/guidance/ng129 Ulcerative colitis 17-Jun-2022 Description of condition Ulcerative colitis is a chronic inﬂammatory condition, characterised by diffuse mucosal inﬂammation—it has a relapsing-remitting pattern. It is a life-long disease that is associated with signiﬁcant morbidity. It most commonly Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. 1 Gastro-intestinal system BNF 85 40 Chronic bowel disorders Gastro-intestinal system 1 presents between the ages of 15 and 25 years, although diagnosis can be made at any age. The pattern of inﬂammation is continuous, extending from the rectum upwards to a varying degree. Inﬂammation of the rectum is referred to as proctitis, and inﬂammation of the rectum and sigmoid colon as proctosigmoiditis. Leftsided colitis refers to disease involving the colon distal to the splenic ﬂexure. Extensive colitis affects the colon proximal to the splenic ﬂexure, and includes pan-colitis, where the whole colon is involved. Common symptoms of active disease or relapse include bloody diarrhoea, an urgent need to defaecate, and abdominal pain. Complications associated with ulcerative colitis include an increased risk of colorectal cancer, secondary osteoporosis, venous thromboembolism, and toxic megacolon. Aims of treatment Treatment is focused on treating active disease to manage symptoms and to induce and maintain remission. Copyright © 2023. Pharmaceutical Press. All rights reserved. Drug treatment Overview Management of ulcerative colitis is dependent on factors such as clinical severity, extent of disease, and patient preference. Clinical and laboratory investigations are used to determine the extent and severity of disease and to guide treatment. Severity is classiﬁed as mild, moderate or severe by using the Truelove and Witts’ Severity Index to assess bowel movements, heart rate, erythrocyte sedimentation rate and the presence of pyrexia, melaena or anaemia—see the NICE guideline for Ulcerative Colitis for further information (see Useful resources). g The extent of disease should be considered when choosing the route of administration for aminosalicylates and corticosteroids; whether oral treatment, topical treatment or both are to be used. If the inﬂammation is distal, a rectal preparation is adequate but if the inﬂammation is extended, systemic medication is required. Either suppositories or enemas can be offered, taking into account the patient’s preferences. h g Rectal foam preparations and suppositories can be used when patients have difﬁculty retaining liquid enemas. Diarrhoea associated with ulcerative colitis is sometimes treated with anti-diarrhoeal drugs (such as loperamide hydrochloride p. 69 or codeine phosphate p. 492) on the advice of a specialist; however their use is contra-indicated in acute ulcerative colitis as they can increase the risk of toxic megacolon. A macrogol-containing osmotic laxative (such as macrogol 3350 with potassium chloride, sodium bicarbonate and sodium chloride p. 58) may be useful for proximal faecal loading in proctitis. l Oral aminosalicylates for the treatment of ulcerative colitis are available in different preparations and release forms. g The preparation and dosing schedule should be chosen taking into account the delivery characteristics and suitability for the patient. When used to maintain remission, single daily doses of oral aminosalicylates can be more effective than multiple daily dosing, but may result in more side-effects. The duration of corticosteroid course (usually 4 to 8 weeks) depends on the corticosteroid chosen. h Treatment of acute mild-to-moderate ulcerative colitis Proctitis g A topical aminosalicylate is recommended as ﬁrst-line treatment for patients with a mild-to-moderate initial presentation or inﬂammatory exacerbation of proctitis. If remission is not achieved within 4 weeks, adding an oral aminosalicylate should be considered. If response remains inadequate, consider addition of a topical or an oral corticosteroid for 4 to 8 weeks. BNF 85 Monotherapy with an oral aminosalicylate can be considered for patients who prefer not to use enemas or suppositories, although this may not be as effective. If remission is not achieved within 4 weeks, adding a topical or an oral corticosteroid for 4 to 8 weeks should be considered. A topical or an oral corticosteroid for 4 to 8 weeks should be considered for patients in whom aminosalicylates are unsuitable. h Proctosigmoiditis and left-sided ulcerative colitis g A topical aminosalicylate is recommended as ﬁrst-line treatment for patients with a mild-to-moderate initial presentation or inﬂammatory exacerbation of proctosigmoiditis or left-sided ulcerative colitis. If remission is not achieved within 4 weeks, consider adding a high-dose oral aminosalicylate, or switching to a high-dose oral aminosalicylate and 4 to 8 weeks of a topical corticosteroid. If response remains inadequate, stop topical treatment and offer an oral aminosalicylate and 4 to 8 weeks of an oral corticosteroid. Monotherapy with a high-dose oral aminosalicylate can be considered for patients who prefer not to use enemas or suppositories, although this may not be as effective. If remission is not achieved within 4 weeks, an oral corticosteroid for 4 to 8 weeks in addition to the high-dose aminosalicylate should be offered. A topical or an oral corticosteroid for 4 to 8 weeks should be considered for patients in whom aminosalicylates are unsuitable. h Extensive ulcerative colitis g A topical aminosalicylate and a high-dose oral aminosalicylate are recommended as ﬁrst-line treatment for patients with a mild-to-moderate initial presentation or inﬂammatory exacerbation of extensive ulcerative colitis. If remission is not achieved within 4 weeks, stop topical aminosalicylate treatment and offer a high-dose oral aminosalicylate and 4 to 8 weeks of an oral corticosteroid. An oral corticosteroid for 4 to 8 weeks should be considered for patients in whom aminosalicylates are unsuitable. h Treatment of acute moderate-to-severe ulcerative colitis Under specialist care, Janus kinase inhibitors and biological drugs (such as anti-lymphocyte monoclonal antibodies, interleukin inhibitors, and tumor necrosis factor alpha (TNFa) inhibitors) may be used for the treatment of moderate-tosevere active ulcerative colitis. Treatment of acute severe ulcerative colitis Acute severe ulcerative colitis of any extent can be lifethreatening and is regarded as a medical emergency. g Immediate hospital admission is required for treatment. Intravenous corticosteroids (such as hydrocortisone p. 754 or methylprednisolone p. 755) should be given to induce remission in patients with acute severe ulcerative colitis (at ﬁrst presentation or an exacerbation) while assessing the need for surgery. If intravenous corticosteroids are contraindicated, declined or cannot be tolerated, then intravenous ciclosporin p. 917 [unlicensed indication] or surgery should be considered. A combination of intravenous ciclosporin with intravenous corticosteroids, or surgery is second line therapy for patients who have little or no improvement within 72 hours of starting intravenous corticosteroids or whose symptoms worsen despite treatment. Inﬂiximab p. 1232 can be used to treat acute exacerbations of severely active ulcerative colitis if ciclosporin is contraindicated or clinically inappropriate. h g In patients who experience an initial response to steroids followed by deterioration, stool cultures should be taken to exclude the presence of pathogens; cytomegalovirus activation should be considered. l Maintaining remission in mild, moderate or severe ulcerative colitis g To reduce the chances of relapse occurring, maintenance therapy with an aminosalicylate is Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. Inﬂammatory bowel disease 41 recommended in most patients. Corticosteroids are not suitable for maintenance treatment because of their sideeffects. After a mild-to-moderate inﬂammatory exacerbation of proctitis or proctosigmoiditis, a rectal aminosalicylate can be started alone or in combination with an oral aminosalicylate, administered daily or as part of an intermittent regimen (such as twice to three times weekly or the ﬁrst seven days of each month). An oral aminosalicylate can be used alone in patients who prefer not to use enemas or suppositories, although this may not be as effective. A low-dose of oral aminosalicylate is given to maintain remission in patients after a mild-to-moderate inﬂammatory exacerbation of left-sided or extensive ulcerative colitis. When used to maintain remission, single daily doses of oral aminosalicylates can be more effective than multiple daily dosing, but may result in more side-effects. Oral azathioprine p. 915 or mercaptopurine p. 1001 [unlicensed indications] can be considered to maintain remission, if there has been two or more inﬂammatory exacerbations in a 12-month period that required treatment with systemic corticosteroids, or if remission is not maintained by aminosalicylates, or following a single acute severe episode. h There is no evidence to support the use of methotrexate p. 1001 to induce or maintain remission in ulcerative colitis, though its use is common in clinical practice. Biological drugs and Janus kinase inhibitors for maintaining remission of ulcerative colitis Treatment with these agents may be continued into the maintenance phase. Non-drug treatment l l eiii i F above Balsalazide sodium INDICATIONS AND DOSE Treatment of mild to moderate ulcerative colitis, acute attack ▶ BY MOUTH Adult: 2.25 g 3 times a day until remission occurs or for up to maximum of 12 weeks Maintenance of remission of ulcerative colitis ▶ ▶ BY MOUTH ▶ l l l l l g Useful Resources l l Adult: 1.5 g twice daily (max. per dose 3 g), adjusted according to response; maximum 6 g per day CAUTIONS History of asthma INTERACTIONS → Appendix 1: balsalazide SIDE-EFFECTS Blood disorder. cholelithiasis. lupus-like syndrome PREGNANCY Manufacturer advises avoid. BREAST FEEDING Diarrhoea may develop in the infant. Monitoring Monitor breast-fed infants for diarrhoea. HEPATIC IMPAIRMENT Manufacturer advises caution; avoid in severe impairment (no information available). RENAL IMPAIRMENT g Use with caution in mild impairment; avoid in moderate to severe impairment. M MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Capsule Ulcerative colitis: management. National Institute for Health and Care Excellence. Clinical guideline 130. May 2019. www.nice.org.uk/guidance/NG130 Other drugs used for Inflammatory bowel disease Filgotinib, p. 1221. Golimumab, p. 1230. Ozanimod, p. 936. Tofacitinib, p. 1222. Upadacitinib, p. 1224 Copyright © 2023. Pharmaceutical Press. All rights reserved. 24-Jun-2021 l l Surgery may be necessary as emergency treatment for severe ulcerative colitis that does not respond to drug treatment. Patients can also choose to have elective surgery for unresponsive or frequently relapsing disease that is affecting their quality of life. h MONITORING REQUIREMENTS Renal function should be monitored before starting an oral aminosalicylate, at 3 months of treatment, and then annually during treatment. PATIENT AND CARER ADVICE Blood disorders Patients receiving aminosalicylates, and their carers, should be advised to report any unexplained bleeding, bruising, purpura, sore throat, fever or malaise that occurs during treatment. CAUTIONARY AND ADVISORY LABELS 21, 25 ▶ Colazide (Almirall Ltd) Balsalazide disodium 750 mg Colazide 750mg capsules | 130 capsule P £30.42 DT = £30.42 eiii i F above Mesalazine 10-Feb-2022 l AMINOSALICYLATES Aminosalicylates l ▶ ▶ ▶ ▶ l f SIDE-EFFECTS Common or very common Arthralgia. cough. diarrhoea. dizziness. fever. gastrointestinal discomfort. headache. leucopenia. nausea. skin reactions. vomiting Uncommon Alopecia. depression. dyspnoea. myalgia. photosensitivity reaction. thrombocytopenia Rare or very rare Agranulocytosis. bone marrow disorders. cardiac inﬂammation. hepatitis. neutropenia. pancreatitis. peripheral neuropathy. renal impairment. respiratory disorders Frequency not known Angioedema. eosinophilia. haemolytic anaemia. nephritis tubulointerstitial. oligozoospermia (reversible). ulcerative colitis aggravated SIDE-EFFECTS, FURTHER INFORMATION A blood count should be performed and the drug stopped immediately if there is suspicion of a blood dyscrasia. ALLERGY AND CROSS-SENSITIVITY g Contra-indicated in salicylate hypersensitivity M. INDICATIONS AND DOSE DOSE EQUIVALENCE AND CONVERSION There is no evidence to show that any one oral preparation of mesalazine is more effective than another; however, the delivery characteristics of oral mesalazine preparations may vary. ASACOL ® MR 400MG TABLETS Treatment of mild to moderate ulcerative colitis, acute attack ▶ BY MOUTH Child 12–17 years: 800 mg 3 times a day Adult: 2.4 g daily in divided doses Maintenance of remission of ulcerative colitis and Crohn’s ileo-colitis ▶ ▶ ▶ BY MOUTH ▶ ▶ Child 12–17 years: 400–800 mg 2–3 times a day Adult: 1.2–2.4 g daily in divided doses ASACOL ® MR 800MG TABLETS Treatment of mild to moderate ulcerative colitis, acute attack ▶ BY MOUTH ▶ Adult: 2.4–4.8 g daily in divided doses Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. continued → 1 Gastro-intestinal system BNF 85 1 Maintenance of remission of ulcerative colitis Gastro-intestinal system 42 Chronic bowel disorders ▶ ▶ BY MOUTH Adult: Up to 2.4 g once daily, alternatively up to 2.4 g daily in divided doses Maintenance of remission of Crohn’s ileo-colitis ▶ BY MOUTH ▶ Adult: Up to 2.4 g daily in divided doses ASACOL ® FOAM ENEMA Treatment of acute attack of mild to moderate ulcerative colitis affecting the rectosigmoid region ▶ BY RECTUM Adult: 1 g daily for 4–6 weeks, to be administered into the rectum Treatment of acute attack of mild to moderate ulcerative colitis, affecting the descending colon ▶ PENTASA ® RETENTION ENEMA Treatment of acute attack of mild to moderate ulcerative colitis or maintenance of remission ▶ BY RECTUM Adult: 1 g once daily, dose to be administered at bedtime Treatment of acute attack of mild to moderate ulcerative colitis affecting the rectosigmoid region ▶ ▶ BY RECTUM ▶ Child 12–17 years: 1 g once daily, dose to be administered at bedtime PENTASA ® SUPPOSITORIES Treatment of acute attack, ulcerative proctitis ▶ BY RECTUM ▶ BY RECTUM Adult: 1 g daily for 2–4 weeks Maintenance, ulcerative proctitis ▶ ▶ BY RECTUM Adult: 2 g once daily for 4–6 weeks, to be administered into the rectum ▶ ▶ Adult: 1 g daily ASACOL ® SUPPOSITORIES Treatment of acute attack of mild to moderate ulcerative colitis and maintenance of remission PENTASA ® TABLETS Treatment of mild to moderate ulcerative colitis, acute attack ▶ BY RECTUM ▶ BY MOUTH ▶ ▶ Adult: 0.75–1.5 g daily in divided doses, last dose to be administered at bedtime MEZAVANT ® XL Treatment of mild to moderate ulcerative colitis, acute attack ▶ BY MOUTH Adult: 2.4 g once daily, increased if necessary to 4.8 g once daily, review treatment at 8 weeks Maintenance of remission of ulcerative colitis ▶ ▶ BY MOUTH ▶ Adult: 2.4 g once daily Adult: Up to 4 g once daily, alternatively up to 4 g daily in 2–3 divided doses Maintenance of remission of ulcerative colitis ▶ BY MOUTH ▶ Adult: 2 g once daily SALOFALK ® ENEMA Treatment of acute attack of mild to moderate ulcerative colitis or maintenance of remission ▶ BY RECTUM ▶ Adult: 2 g once daily, dose to be administered at bedtime OCTASA ® Treatment of mild to moderate ulcerative colitis, acute attack SALOFALK ® GRANULES Treatment of mild to moderate ulcerative colitis, acute attack ▶ BY MOUTH ▶ BY MOUTH ▶ ▶ Adult: 2.4–4.8 g once daily, alternatively 2.4–4.8 g daily in divided doses, dose over 2.4 g daily in divided doses only Maintenance of remission of ulcerative colitis and Crohn’s ileo-colitis ▶ BY MOUTH ▶ Copyright © 2023. Pharmaceutical Press. All rights reserved. BNF 85 Adult: 1.2–2.4 g once daily, alternatively daily in divided doses PENTASA ® GRANULES Treatment of mild to moderate ulcerative colitis, acute attack Child 5–17 years (body-weight up to 40 kg): 30–50 mg/kg once daily, dose preferably given in the morning, alternatively 10–20 mg/kg 3 times a day ▶ Child 5–17 years (body-weight 40 kg and above): 1.5–3 g once daily, dose preferably given in the morning, alternatively 0.5–1 g 3 times a day ▶ Adult: 1.5–3 g once daily, dose preferably taken in the morning, alternatively 0.5–1 g 3 times a day Maintenance of remission of ulcerative colitis ▶ BY MOUTH ▶ ▶ BY MOUTH Child 5–17 years (body-weight up to 40 kg): 10–20 mg/kg 3 times a day ▶ Child 5–17 years (body-weight 40 kg and above): 1–2 g twice daily, total daily dose may alternatively be given in 3–4 divided doses ▶ Adult: Up to 4 g once daily, alternatively up to 4 g daily in 2–4 divided doses Maintenance of remission of ulcerative colitis ▶ ▶ BY MOUTH ▶ ▶ ▶ Child 5–17 years (body-weight up to 40 kg): 7.5–15 mg/kg twice daily, total daily dose may alternatively be given in 3 divided doses Child 5–17 years (body-weight 40 kg and above): 2 g once daily Adult: 2 g once daily ▶ ▶ Child 5–17 years (body-weight up to 40 kg): 7.5–15 mg/kg twice daily, total daily dose may alternatively be given in 3 divided doses Child 5–17 years (body-weight 40 kg and above): 500 mg 3 times a day Adult: 500 mg 3 times a day SALOFALK ® RECTAL FOAM Treatment of mild ulcerative colitis affecting sigmoid colon and rectum ▶ BY RECTUM ▶ ▶ Child 12–17 years: 2 g once daily, dose to be administered into the rectum at bedtime, alternatively 2 g daily in 2 divided doses Adult: 2 g once daily, dose to be administered into the rectum at bedtime, alternatively 2 g daily in 2 divided doses Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. Inﬂammatory bowel disease 43 SALOFALK ® SUPPOSITORIES Treatment of acute attack of mild to moderate ulcerative colitis affecting the rectum l ▶ BY RECTUM ▶ Adult: 0.5–1 g 2–3 times a day, adjusted according to response, dose to be given using 500 mg suppositories, alternatively 1 g once daily, preferably at bedtime, dose to be given using 1 g suppositories l SALOFALK ® TABLETS Treatment of mild to moderate ulcerative colitis, acute attack ▶ BY MOUTH Child 5–17 years (body-weight up to 40 kg): 10–20 mg/kg 3 times a day ▶ Child 5–17 years (body-weight 40 kg and above): 0.5–1 g 3 times a day ▶ Adult: 0.5–1 g 3 times a day Maintenance of remission of ulcerative colitis ▶ ▶ BY MOUTH ▶ ▶ ▶ Copyright © 2023. Pharmaceutical Press. All rights reserved. l Child 5–17 years (body-weight up to 40 kg): 7.5–15 mg/kg twice daily, total daily dose may alternatively be given in 3 divided doses Child 5–17 years (body-weight 40 kg and above): 500 mg 3 times a day Adult: 500 mg 3 times a day UNLICENSED USE ® ▶ With oral use in children Asacol (all preparations) not licensed for use in children under 18 years. Pentasa ® granules and Salofalk ® tablets and granules not licensed for use in children under 6 years. ® ▶ With rectal use in children Salofalk rectal foam no dose recommendations for children (age range not speciﬁed by manufacturer). l CONTRA-INDICATIONS ▶ With oral use Blood clotting abnormalities l CAUTIONS Elderly. maintain adequate ﬂuid intake. pulmonary disease l INTERACTIONS → Appendix 1: mesalazine l SIDE-EFFECTS GENERAL SIDE-EFFECTS ▶ Rare or very rare Cholestasis exacerbated. drug fever. ﬂatulence. nephritis SPECIFIC SIDE-EFFECTS ▶ Rare or very rare ▶ With rectal use Constipation l PREGNANCY Negligible quantities cross placenta. l BREAST FEEDING Diarrhoea reported in breast-fed infants, but negligible amounts of mesalazine detected in breast milk. Monitoring Monitor breast-fed infant for diarrhoea. l HEPATIC IMPAIRMENT Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment. l RENAL IMPAIRMENT g Use with caution in mild to moderate impairment (risk of toxicity including crystalluria); avoid in severe impairment. M l DIRECTIONS FOR ADMINISTRATION PENTASA ® TABLETS Manufacturer advises tablets may be halved, quartered, or dispersed in water, but should not be chewed. PENTASA ® GRANULES Manufacturer advises granules should be placed on tongue and washed down with water or orange juice without chewing. ▶ In children Expert sources advise contents of one sachet should be weighed and divided immediately before use; discard any remaining granules. SALOFALK ® GRANULES Manufacturer advises granules should be placed on tongue and washed down with water without chewing. l PRESCRIBING AND DISPENSING INFORMATION There is no evidence to show that any one oral preparation of mesalazine is more effective than another; however, the delivery characteristics of oral mesalazine preparations may vary. Flavours of granule formulations of Salofalk ® may include vanilla. PATIENT AND CARER ADVICE If it is necessary to switch a patient to a different brand of mesalazine, the patient should be advised to report any changes in symptoms. Some products may require special administration advice; patients and carers should be informed. Medicines for Children leaflet: Mesalazine (oral) for inflammatory bowel disease www.medicinesforchildren.org.uk/medicines/ mesalazine-oral-for-inﬂammatory-bowel-disease/ Medicines for Children leaflet: Mesalazine foam enema for inflammatory bowel disease www.medicinesforchildren.org.uk/ medicines/mesalazine-foam-enema-for-inﬂammatory-boweldisease/ Medicines for Children leaflet: Mesalazine liquid enema for inflammatory bowel disease www.medicinesforchildren.org.uk/ medicines/mesalazine-liquid-enema-for-inﬂammatory-boweldisease/ MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Modified-release tablet CAUTIONARY AND ADVISORY LABELS 21(does not apply to Pentasa ® ▶ ▶ tablets), 25 (does not apply to Pentasa ® tablets) Mezavant XL (Takeda UK Ltd) Mesalazine 1.2 gram Mezavant XL 1200mg tablets | 60 tablet P £42.95 DT = £42.95 Pentasa (Ferring Pharmaceuticals Ltd) Mesalazine 500 mg Pentasa 500mg modified-release tablets | 100 tablet P £30.74 DT = £30.74 Mesalazine 1 gram Pentasa 1g modified-release tablets | 60 tablet P £36.89 DT = £36.89 Foam EXCIPIENTS: May contain Cetostearyl alcohol (including cetyl and stearyl alcohol), disodium edetate, hydroxybenzoates (parabens), polysorbates, propylene glycol, sodium metabisulfite Salofalk (Dr. Falk Pharma UK Ltd) Mesalazine 1 gram per 1 application Salofalk 1g/application foam enema | 14 actuation P £30.17 DT = £30.17 ▶ Gastro-resistant tablet CAUTIONARY AND ADVISORY LABELS 5(does not apply to Octasa ®), 25 ▶ ▶ ▶ Asacol (AbbVie Ltd) Mesalazine 400 mg Asacol 400mg MR gastro-resistant tablets | 84 tablet P £27.45 DT = £27.45 | 168 tablet P £54.90 Mesalazine 800 mg Asacol 800mg MR gastro-resistant tablets | 84 tablet P £54.90 DT = £54.90 Octasa MR (Tillotts Pharma UK Ltd) Mesalazine 400 mg Octasa 400mg MR gastro-resistant tablets | 90 tablet P £16.58 DT = £16.58 | 120 tablet P £22.10 Mesalazine 800 mg Octasa 800mg MR gastro-resistant tablets | 90 tablet P £40.38 | 180 tablet P £80.75 DT = £80.75 Salofalk (Dr. Falk Pharma UK Ltd) Mesalazine 250 mg Salofalk 250mg gastro-resistant tablets | 100 tablet P £16.19 DT = £16.19 Mesalazine 500 mg Salofalk 500mg gastro-resistant tablets | 100 tablet P £32.38 DT = £32.38 Suppository ▶ ▶ Pentasa (Ferring Pharmaceuticals Ltd) Mesalazine 1 gram Pentasa 1g suppositories | 28 suppository £40.01 DT = £40.01 Salofalk (Dr. Falk Pharma UK Ltd) Mesalazine 500 mg Salofalk 500mg suppositories | 30 suppository P £14.81 DT = £14.81 Mesalazine 1 gram Salofalk 1g suppositories | 30 suppository £29.62 Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. P P 1 Gastro-intestinal system BNF 85 44 Chronic bowel disorders BNF 85 eiii i F 41 Modified-release granules 1 CAUTIONARY AND ADVISORY LABELS 25 (does not apply to Pentasa ® Sulfasalazine Gastro-intestinal system granules) EXCIPIENTS: May contain Aspartame ▶ ▶ Pentasa (Ferring Pharmaceuticals Ltd) Mesalazine 1 gram Pentasa 1g modified-release granules sachets sugar-free | 50 sachet P £30.74 DT = £30.74 Mesalazine 2 gram Pentasa 2g modified-release granules sachets sugar-free | 60 sachet P £73.78 DT = £73.78 Salofalk (Dr. Falk Pharma UK Ltd) Mesalazine 1 gram Salofalk 1g gastro-resistant modified-release granules sachets sugar-free | 50 sachet P £28.74 DT = £28.74 Mesalazine 1.5 gram Salofalk 1.5g gastro-resistant modified-release granules sachets sugar-free | 60 sachet P £48.85 DT = £48.85 Mesalazine 3 gram Salofalk 3g gastro-resistant modified-release granules sachets sugar-free | 60 sachet P £97.70 DT = £97.70 l INDICATIONS AND DOSE Treatment of acute attack of mild to moderate and severe ulcerative colitis | Active Crohn’s disease ▶ BY MOUTH ▶ ▶ Adult: 0.5–1 g twice daily, administered alone or in conjunction with oral therapy, morning and night after a bowel movement Maintenance of remission of mild to moderate and severe ulcerative colitis ▶ Pentasa (Ferring Pharmaceuticals Ltd) Mesalazine 10 mg per 1 ml Pentasa Mesalazine 1g/100ml enema | 7 enema P £17.73 DT = £17.73 Salofalk (Dr. Falk Pharma UK Ltd) Mesalazine 33.9 mg per 1 ml Salofalk 2g/59ml enema | 7 enema P £29.92 DT = £29.92 ▶ BY MOUTH ▶ Adult: 0.5–1 g twice daily, administered alone or in conjunction with oral therapy, morning and night after a bowel movement Active rheumatoid arthritis (administered on expert advice) ▶ 24-Jun-2021 l INDICATIONS AND DOSE Treatment of acute attack of mild ulcerative colitis ▶ BY MOUTH ▶ ▶ BY MOUTH Adult: 1 g daily in divided doses, doses to be taken after meals, then increased if necessary up to 3 g daily in divided doses (max. per dose 1 g), dose to be increased over 1 week Maintenance of remission of mild ulcerative colitis ▶ l SAFE PRACTICE Sulfasalazine has been confused with sulfadiazine; care must be taken to ensure the correct drug is prescribed and dispensed. Adult: Maintenance 500 mg twice daily, dose to be taken after food SIDE-EFFECTS. l Copyright © 2023. Pharmaceutical Press. All rights reserved. l. PREGNANCY Manufacturer advises avoid unless potential beneﬁt outweighs risk. BREAST FEEDING Monitoring Monitor breast-fed infants for diarrhoea. RENAL IMPAIRMENT g Use with caution in mild to moderate impairment; avoid in signiﬁcant impairment. M l DIRECTIONS FOR ADMINISTRATION Expert sources advise capsules can be opened and contents sprinkled on food. l MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension, oral solution Tablet CAUTIONARY AND ADVISORY LABELS 21 ▶ Olsalazine sodium (Non-proprietary) Olsalazine sodium 500 mg Olsalazine 500mg tablets | 60 tablet P £161.00 DT = £161.00 Capsule CAUTIONARY AND ADVISORY LABELS 21 ▶ CAUTIONS Acute porphyrias p. 1171. G6PD deﬁciency. history of allergy. history of asthma. maintain adequate ﬂuid intake. risk of haematological toxicity. risk of hepatic toxicity. slow acetylator status l INTERACTIONS → Appendix 1: sulfasalazine l SIDE-EFFECTS GENERAL SIDE-EFFECTS ▶ Common or very common Insomnia. stomatitis. taste altered. tinnitus. urine abnormalities ▶ Uncommon Face oedema. seizure. vasculitis. vertigo ▶ Frequency not known Anaemia. appetite decreased. ataxia. cyanosis. encephalopathy. haematuria. hallucination. hepatic failure. hypoprothrombinaemia. lymphadenopathy. macrocytosis. meningitis aseptic. methaemoglobinaemia. nephrotic syndrome. parotitis. periorbital oedema. pseudomembranous enterocolitis. serum sickness. severe cutaneous adverse reactions (SCARs). smell disorders. systemic lupus erythematosus (SLE). yellow discolouration of body ﬂuids SPECIFIC SIDE-EFFECTS ▶ With oral use Urine discolouration SIDE-EFFECTS, FURTHER INFORMATION Incidence of sideeffects increases with higher doses. Blood disorders Haematological abnormalities occur usually in the ﬁrst 3 to 6 months of treatment— discontinue if these occur. l PREGNANCY Theoretical risk of neonatal haemolysis in third trimester; adequate folate supplements should be given to mother. l BREAST FEEDING Small amounts in milk (1 report of bloody diarrhoea); theoretical risk of neonatal haemolysis especially in G6PD-deﬁcient infants. l HEPATIC IMPAIRMENT Manufacturer advises caution. l ▶ Uncommon Paraesthesia tachycardia ▶ Frequency not known Palpitations vision blurred l Adult: Initially 500 mg daily, increased in steps of 500 mg every week, increased to 2–3 g daily in divided doses, enteric coated tablets to be administered IMPORTANT SAFETY INFORMATION ▶ BY MOUTH ▶ Adult: 500 mg 4 times a day ▶ BY RECTUM eiii i F 41 Olsalazine sodium Adult: 1–2 g 4 times a day until remission occurs, corticosteroids may also be given, if necessary ▶ BY RECTUM Enema ▶ Olsalazine sodium (Non-proprietary) Olsalazine sodium 250 mg Olsalazine 250mg capsules | 112 capsule P £144.00 DT = £144.00 24-Jun-2021 (Sulphasalazine) Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. Inﬂammatory bowel disease 45 RENAL IMPAIRMENT g Use with caution in mild to moderate impairment (risk of toxicity including crystalluria); avoid in severe impairment. M l MONITORING REQUIREMENTS ▶ Blood disorders Close monitoring of full blood counts (including differential white cell count and platelet count) is necessary initially, and at monthly intervals during the ﬁrst 3 months. ▶ Renal function Although the manufacturer recommends renal function tests in rheumatic diseases, evidence of practical value is unsatisfactory. ▶ Liver function Liver function tests should be performed at monthly intervals for ﬁrst 3 months. l PATIENT AND CARER ADVICE Contact lenses Some soft contact lenses may be stained. l l MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension Oral suspension CAUTIONARY AND ADVISORY LABELS 14 EXCIPIENTS: May contain Alcohol ▶ Sulfasalazine (Non-proprietary) Sulfasalazine 50 mg per 1 ml Sulfasalazine 250mg/5ml oral suspension sugar free sugar-free | 500 ml P £125.00 DT = £125.00 Sulfasalazine (Non-proprietary) Sulfasalazine 500 mg Sulfasalazine 500mg gastro-resistant tablets | 112 tablet P £84.00 DT = £62.66 Salazopyrin EN (Pfizer Ltd) Sulfasalazine 500 mg Salazopyrin EN-Tabs 500mg | 112 tablet P £8.43 DT = £62.66 Tablet CAUTIONARY AND ADVISORY LABELS 14 ▶ ▶ Sulfasalazine (Non-proprietary) Sulfasalazine 500 mg Sulfasalazine 500mg tablets | 112 tablet P £78.00 DT = £55.59 Salazopyrin (Pfizer Ltd) Sulfasalazine 500 mg Salazopyrin 500mg tablets | 112 tablet £6.97 DT = £55.59 P Suppository CAUTIONARY AND ADVISORY LABELS 14 ▶ Salazopyrin (Pfizer Ltd) Sulfasalazine 500 mg Salazopyrin 500mg suppositories | 10 suppository P £3.30 DT = £3.30 Copyright © 2023. Pharmaceutical Press. All rights reserved. CORTICOSTEROIDS Beclometasone dipropionate 1 Modified-release tablet CAUTIONARY AND ADVISORY LABELS 25 ▶ eiii i F 749 Budesonide l l eiii i F 749 08-Mar-2022 INDICATIONS AND DOSE Adjunct to aminosalicylates in acute mild to moderate ulcerative colitis ▶ BY MOUTH Adult: 9 mg once daily for up to 8 weeks, to be taken in the morning, alternatively 3 mg 3 times a day for up to 8 weeks, reduce dose gradually over 2 weeks following treatment course before stopping Microscopic colitis, induction of remission ▶ Adult: 9 mg once daily for up to 8 weeks, to be taken in the morning, reduce dose gradually over 2 weeks following treatment course before stopping Microscopic colitis, maintenance ▶ BY MOUTH Adult: 6 mg once daily, to be taken in the morning, alternatively 6 mg once daily and 3 mg once daily, to be taken on alternate mornings, review treatment regularly and no later than 12 months after initiation of maintenance treatment, treatment may be extended to beyond 12 months if required, when stopping treatment, reduce dose gradually over 2 weeks Autoimmune hepatitis, induction of remission ▶ ▶ BY MOUTH Adult: 3 mg 3 times a day until remission is achieved, reduce dose gradually over 2 weeks following treatment course before stopping Autoimmune hepatitis, maintenance ▶ Adult: 5 mg daily maximum duration of treatment of 4 weeks, dose to be taken in the morning INTERACTIONS → Appendix 1: corticosteroids SIDE-EFFECTS ▶ Uncommon Constipation. idiopathic intracranial hypertension. muscle cramps l HEPATIC IMPAIRMENT Manufacturer advises avoid in severe impairment (no information available). Adult: 3 mg twice daily for at least 24 months, when stopping treatment, reduce dose gradually over 2 weeks BUDENOFALK ® GRANULES Mild to moderate Crohn’s disease affecting the ileum and/or ascending colon | Microscopic colitis, induction of remission ▶ BY MOUTH ▶ ▶ BY MOUTH l INDICATIONS AND DOSE BUDENOFALK ® CAPSULES Mild to moderate Crohn’s disease affecting the ileum and/or ascending colon ▶ l l 10-Nov-2022 DRUG ACTION Budesonide is a glucocorticoid, which exerts signiﬁcant local anti-inﬂammatory effects. ▶ BY MOUTH (Beclomethasone dipropionate) ▶ Clipper (Chiesi Ltd) Beclometasone dipropionate 5 mg Clipper 5mg gastro-resistant modified-release tablets | 30 tablet P £56.56 DT = £56.56 ▶ CAUTIONARY AND ADVISORY LABELS 5, 14, 25 ▶ MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. ▶ BY MOUTH Gastro-resistant tablet ▶ l Gastro-intestinal system BNF 85 Adult: 9 mg once daily for up to 8 weeks, to be taken in the morning, reduce dose over 2 weeks by giving doses on alternate days following treatment course before stopping BUDENOFALK ® RECTAL FOAM Ulcerative colitis affecting sigmoid colon and rectum ▶ BY RECTUM Adult: 1 metered application once daily for up to 8 weeks DOSE EQUIVALENCE AND CONVERSION ® ▶ For Budenofalk rectal foam: 1 metered application is equivalent to budesonide 2 mg. continued → ▶ Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. 46 Chronic bowel disorders CORTIMENT ® Induction of remission of mild to moderate active ulcerative colitis | Induction of remission of active microscopic colitis Gastro-intestinal system 1 BNF 85 l ▶ ▶ BY MOUTH ▶ Adult: 9 mg once daily for up to 8 weeks, dose to be taken in the morning ENTOCORT ® CAPSULES Microscopic colitis, induction of remission ▶ BY MOUTH Adult: 9 mg once daily, to be taken in the morning, when stopping treatment, reduce dose for the last 2–4 weeks of therapy Microscopic colitis, maintenance ▶ ▶ BY MOUTH l Adult: 6 mg once daily, or the lowest effective dose, to be taken in the morning, when stopping treatment, reduce dose for the last 2–4 weeks of therapy Mild to moderate Crohn’s disease affecting the ileum and/or ascending colon l ▶ BY MOUTH ▶ ▶ ▶ Adult: 9 mg once daily for up to 8 weeks, to be taken in the morning, when stopping treatment, reduce dose for the last 2–4 weeks of therapy ENTOCORT ® ENEMA Ulcerative colitis involving rectal and recto-sigmoid disease l ▶ BY RECTUM ▶ Adult: 1 enema daily for 4 weeks, to be administered at bedtime ▶ ® JORVEZA Eosinophilic oesophagitis, induction of remission (initiated by a specialist) ▶ ▶ BY MOUTH USING ORODISPERSIBLE TABLET Adult: 1 mg twice daily for 6 weeks; treatment may be extended to up to 12 weeks if required, to be taken after food Eosinophilic oesophagitis, maintenance (initiated by a specialist) ▶ ▶ INITIALLY BY MOUTH USING ORODISPERSIBLE TABLET Copyright © 2023. Pharmaceutical Press. All rights reserved. ▶ Adult: 0.5 mg twice daily, to be taken after food, alternatively (by mouth) 1 mg twice daily, to be taken after food, use higher dose option for patients with long-term disease and/or with extensive oesophageal inﬂammation in the acute phase INTERACTIONS → Appendix 1: corticosteroids SIDE-EFFECTS ▶ Common or very common ▶ With oral use Dry mouth. muscle complaints. oedema. oral disorders ▶ With rectal use Diarrhoea. gastrointestinal disorders ▶ Uncommon ▶ With oral use Back pain. dizziness. ﬂatulence l ALLERGY AND CROSS-SENSITIVITY CORTIMENT ® g Avoid in patients with hypersensitivity to peanuts or soya (contains soya lecithin). M ® l HEPATIC IMPAIRMENT For Budenofalk manufacturer advises avoid in cirrhosis (risk of increased exposure, limited information available). JORVEZA ® Manufacturer advises avoid (no information available). l RENAL IMPAIRMENT JORVEZA ® Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (no information available). l MONITORING REQUIREMENTS g When used in autoimmune hepatitis, liver-function tests should be l ▶ ▶ ▶ l l monitored every 2 weeks for ﬁrst month, then at least every 3 months. M DIRECTIONS FOR ADMINISTRATION With oral use Manufacturer advises granules should be placed on tongue and washed down with water without chewing. JORVEZA ® Manufacturer advises the tablet should be placed on the tip of the tongue, gently pressed against the roof of the mouth to dissolve, and the dissolved material swallowed with saliva as the tablet disintegrates. Patients should avoid eating, drinking or performing oral hygiene for at least 30 minutes after taking the tablet. Oral solutions, sprays or chewable tablets should be avoided for at least 30 minutes before and after taking the tablet. PRESCRIBING AND DISPENSING INFORMATION ENTOCORT ® CAPSULES Dispense modiﬁed-release capsules in original container (contains desiccant). BUDENOFALK ® GRANULES Flavours of granule formulations may include lemon. PATIENT AND CARER ADVICE With oral use Patients or carers should be given advice on how to administer budesonide granules. JORVEZA ® Manufacturer advises patients or carers should be given advice on how to administer orodispersible tablets. NATIONAL FUNDING/ACCESS DECISIONS For full details see funding body website NICE decisions Budesonide orodispersible tablet for inducing remission of eosinophilic oesophagitis (June 2021) NICE TA708 Recommended Scottish Medicines Consortium (SMC) decisions Budesonide (Cortiment ®) in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where aminosalicylate (5-ASA) treatment is not sufficient (October 2016) SMC No. 1093/15 Recommended with restrictions Budesonide (Jorveza ®) for the treatment of eosinophilic oesophagitis in adults (October 2020) SMC No. SMC2158 Recommended with restrictions Budesonide (Cortiment ®) for induction of remission in patients with active microscopic colitis (January 2022) SMC No. SMC2448 Recommended BUDENOFALK ® CAPSULES For full details see funding body website Scottish Medicines Consortium (SMC) decisions Budesonide 3 mg gastro-resistant capsules (Budenofalk ®) for autoimmune hepatitis (May 2015) SMC No. 1043/15 Recommended with restrictions MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Modified-release tablet CAUTIONARY AND ADVISORY LABELS 10, 25 EXCIPIENTS: May contain Lecithin ▶ Cortiment (Ferring Pharmaceuticals Ltd) Budesonide 9 mg Cortiment 9mg modified-release tablets | 30 tablet P £75.00 DT = £75.00 Gastro-resistant capsule CAUTIONARY AND ADVISORY LABELS 5, 10, 22, 25 ▶ Budenofalk (Dr. Falk Pharma UK Ltd) Budesonide 3 mg Budenofalk 3mg gastro-resistant capsules | 100 capsule P £75.05 DT = £75.05 Foam EXCIPIENTS: May contain Cetostearyl alcohol (including cetyl and stearyl alcohol), disodium edetate, propylene glycol, sorbic acid ▶ Budenofalk (Dr. Falk Pharma UK Ltd) Budesonide 2 mg per 1 actuation Budenofalk 2mg foam enema | 14 dose P £57.11 DT = £57.11 Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. Inﬂammatory bowel disease 47 Modified-release capsule CAUTIONARY AND ADVISORY LABELS 5, 10, 25 ▶ Entocort CR (Tillotts Pharma UK Ltd) Budesonide 3 mg Entocort CR 3mg capsules | 50 capsule £37.53 | 100 capsule P £75.05 DT = £75.05 P Gastro-resistant granules CAUTIONARY AND ADVISORY LABELS 5, 10, 22, 25 ▶ Budenofalk (Dr. Falk Pharma UK Ltd) Budesonide 9 mg Budenofalk 9mg gastro-resistant granules sachets | 60 sachet P £135.00 DT = £135.00 l l ▶ Orodispersible tablet CAUTIONARY AND ADVISORY LABELS 10 ELECTROLYTES: May contain Sodium ▶ Jorveza (Dr. Falk Pharma UK Ltd) Budesonide 500 microgram Jorveza 0.5mg orodispersible tablets sugar-free | 60 tablet P £214.80 Budesonide 1 mg Jorveza 1mg orodispersible tablets sugar-free | 90 tablet P £323.00 DT = £323.00 Enema ▶ ▶ ▶ ▶ Entocort (Tillotts Pharma UK Ltd) Budesonide 20 microgram per 1 ml Entocort 2mg/100ml enema | 7 enema P £33.66 DT = £33.66 IMMUNOSUPPRESSANTS › MONOCLONAL ANTIBODIES, ANTI-LYMPHOCYTE Vedolizumab l 24-Mar-2021 DRUG ACTION Vedolizumab is a monoclonal antibody that binds speciﬁcally to the a4b7 integrin, which is expressed on gut homing T helper lymphocytes and causes a reduction in gastrointestinal inﬂammation. l INDICATIONS AND DOSE Ulcerative colitis (under expert supervision) ▶ BY INTRAVENOUS INFUSION Copyright © 2023. Pharmaceutical Press. All rights reserved. ▶ Adult: Initially 300 mg, then 300 mg after 2 weeks, followed by 300 mg after 4 weeks, followed by 300 mg every 8 weeks, dose to be given over 30 minutes, if treatment is interrupted or response decreases, dosing frequency may be increased—consult product literature; review treatment if no response within 10 weeks of initial dose l l l ▶ BY SUBCUTANEOUS INJECTION l ▶ ▶ Adult: Maintenance 108 mg every 2 weeks, following at least 2 intravenous infusions; the ﬁrst subcutaneous dose should be administered in place of the next scheduled intravenous dose Crohn’s disease (under expert supervision) ▶ ▶ BY INTRAVENOUS INFUSION ▶ Adult: Initially 300 mg, then 300 mg after 2 weeks, followed by 300 mg after 4 weeks, followed by 300 mg every 8 weeks, dose to be given over 30 minutes, if no response is observed, an additional dose of 300 mg may be given 10 weeks after initial dose; if treatment is interrupted or response decreases, dosing frequency may be increased—consult product literature; review treatment if no response within 14 weeks of initial dose l ▶ BY SUBCUTANEOUS INJECTION ▶ l l ▶ Adult: Maintenance 108 mg every 2 weeks, following at least 2 intravenous infusions; the ﬁrst subcutaneous dose should be administered in place of the next scheduled intravenous dose CONTRA-INDICATIONS Severe active infection CAUTIONS Controlled chronic severe infection. history of recurring severe infection. previous treatment with natalizumab (wait at least 12 weeks between natalizumab use and initiation of vedolizumab unless potential beneﬁt outweighs risk). previous treatment with rituximab CAUTIONS, FURTHER INFORMATION Risk of infection g Patients must be screened for tuberculosis before starting treatment; if latent l tuberculosis is diagnosed, appropriate treatment must be initiated prior to vedolizumab treatment; if tuberculosis is diagnosed during treatment, discontinue vedolizumab until infection is resolved. Patients should be brought up to date with current immunisation schedule before initiating treatment. M INTERACTIONS → Appendix 1: monoclonal antibodies SIDE-EFFECTS Common or very common Arthralgia. constipation. cough. fatigue. fever. gastrointestinal discomfort. gastrointestinal disorders. headache. hypertension. increased risk of infection. muscle spasms. muscle weakness. nasal congestion. nausea. night sweats. oropharyngeal pain. pain. paraesthesia. skin reactions Uncommon Chills. feeling cold. infusion related reaction Rare or very rare Hypersensitivity. vision blurred Frequency not known Meningitis listeria. sepsis SIDE-EFFECTS, FURTHER INFORMATION Infusion-related and hypersensitivity reactions have been reported. Patients should be observed continuously during each infusion for signs and symptoms of acute hypersensitivity reactions; they should also be observed for 2 hours after the initial two infusions, and for 1 hour after subsequent infusions. Discontinue treatment if a severe infusionrelated or other severe reaction occurs and initiate appropriate treatment (e.g. adrenaline and antihistamines); if a mild to moderate infusion-related reaction occurs, interrupt infusion or reduce infusion rate and initiate appropriate treatment (if reaction subsides the infusion may be continued)—consider pretreatment with an antihistamine, hydrocortisone, and/or paracetamol prior to subsequent infusions in patients who experience mild to moderate infusion-related reactions. CONCEPTION AND CONTRACEPTION Manufacturer advises effective contraception required during and for at least 18 weeks after treatment. PREGNANCY Manufacturer advises use only if potential beneﬁt outweighs risk. BREAST FEEDING g Specialist sources indicate use with caution—present in milk. k MONITORING REQUIREMENTS Manufacturer advises monitor closely for infection before, during and after treatment—potential increased risk of opportunistic infection. Manufacturer advises monitor for new onset or worsening neurological signs and symptoms (withhold treatment if progressive multifocal leukoencephalopathy (PML) is suspected). DIRECTIONS FOR ADMINISTRATION For intravenous infusion (Entyvio ®), manufacturer advises give intermittently in Sodium chloride 0.9%; allow vial to reach room temperature then reconstitute with 4.8 mL of water for injection (using a syringe with a 21–25 gauge needle); gently swirl vial for at least 15 seconds, do not shake vigorously or invert; allow to stand for up to 20 minutes (gently swirl vial if needed), leave for an additional 10 minutes if not dissolved; gently invert vial three times, withdraw 5 mL of reconstituted solution (using a syringe with a 21–25 gauge needle), and add to 250 mL of infusion ﬂuid; gently mix and give over 30 minutes. PRESCRIBING AND DISPENSING INFORMATION Vedolizumab is a biological medicine. Biological medicines must be prescribed and dispensed by brand name, see Biological medicines and Biosimilar medicines, under Guidance on prescribing p. 1; manufacturer advises to record the brand name and batch number after each administration. Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. 1 Gastro-intestinal system BNF 85 1 l Gastro-intestinal system 48 Chronic bowel disorders ▶ l BNF 85 PATIENT AND CARER ADVICE Self-administration With subcutaneous use Manufacturer advises patients and their carers should be given training in subcutaneous injection technique if appropriate. Alert card Patients should be provided with a patient alert card. NATIONAL FUNDING/ACCESS DECISIONS For full details see funding body website disordered defaecation (either diarrhoea, or constipation with straining, urgency, and incomplete evacuation), passage of mucus, and bloating. Symptoms are usually relieved by defaecation. Obtaining an accurate clinical diagnosis of IBS prior to treatment is crucial. NICE decisions Non-drug treatment ▶ Vedolizumab for treating moderately to severely active ▶ ▶ ▶ ▶ ▶ l Crohn’s disease after prior therapy (August 2015) NICE TA352 Recommended with restrictions Vedolizumab for treating moderately to severely active ulcerative colitis (June 2015) NICE TA342 Recommended Scottish Medicines Consortium (SMC) decisions Vedolizumab powder for concentrate for solution for infusion (Entyvio ®) for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha antagonist (July 2015) SMC No. 1064/15 Recommended with restrictions Vedolizumab solution for injection (Entyvio ®) for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha antagonist (August 2020) SMC No. SMC2277 Recommended with restrictions Vedolizumab powder for concentrate for solution for infusion (Entyvio ®) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha antagonist (May 2015) SMC No. 1045/15 Recommended Vedolizumab solution for injection (Entyvio ®) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha antagonist (August 2020) SMC No. SMC2276 Recommended MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Copyright © 2023. Pharmaceutical Press. All rights reserved. Solution for injection CAUTIONARY AND ADVISORY LABELS 10 EXCIPIENTS: May contain Polysorbates ▶ Entyvio (Takeda UK Ltd) Vedolizumab 158.82 mg per 1 ml Entyvio 108mg/0.68ml solution for injection pre-filled pens | 1 pre-filled disposable injection P £512.50 (Hospital only) | 2 pre-filled disposable injection P £1,025.00 (Hospital only) Entyvio 108mg/0.68ml solution for injection pre-filled syringes | 2 pre-filled disposable injection P £1,025.00 (Hospital only) Powder for solution for infusion CAUTIONARY AND ADVISORY LABELS 10 EXCIPIENTS: May contain Polysorbates ▶ Entyvio (Takeda UK Ltd) Vedolizumab 300 mg Entyvio 300mg powder for concentrate for solution for infusion vials | 1 vial P £2,050.00 (Hospital only) 1.4 Irritable bowel syndrome Irritable bowel syndrome 02-May-2020 Description of condition Irritable bowel syndrome (IBS) is a common, chronic, relapsing, and often life-long condition, mainly affecting people aged between 20 and 30 years. It is more common in women. Symptoms include abdominal pain or discomfort, Aims of treatment The treatment of IBS is focused on symptom control, in order to improve quality of life. Diet and lifestyle changes are important for effective self-management of IBS. Patients should be encouraged to increase physical activity, and advised to eat regularly, without missing meals or leaving long gaps between meals. Dietary advice should also include, limiting fresh fruit consumption to no more than 3 portions per day. The ﬁbre intake of patients with IBS should be reviewed. If an increase in dietary ﬁbre is required, soluble ﬁbre such as ispaghula husk p. 56, or foods high in soluble ﬁbre such as oats, are recommended. Intake of insoluble ﬁbre (e.g. bran) and ‘resistant starch’ should be reduced or discouraged as they may exacerbate symptoms. Fluid intake (mostly water) should be increased to at least 8 cups each day and the intake of caffeine, alcohol and ﬁzzy drinks reduced. The artiﬁcial sweetener sorbitol should be avoided in patients with diarrhoea. Where probiotics are being used, continue for at least 4 weeks while monitoring the effect. If a patient’s symptoms persist following lifestyle and dietary advice, single food avoidance and exclusion diets may be an option under the supervision of a dietitian or medical specialist. h g Drug treatment The choice of drug treatment depends on the nature and severity of the symptoms. Many drug treatment options for IBS are available over-the-counter. Antispasmodic drugs (such as alverine citrate p. 92, mebeverine hydrochloride p. 93 and peppermint oil p. 49) can be taken in addition to dietary and lifestyle changes. A laxative (excluding lactulose p. 57 as it may cause bloating) can be used to treat constipation. Patients who have not responded to laxatives from the different classes and who have had constipation for at least 12 months, can be treated with linaclotide p. 49. Loperamide hydrochloride p. 69 is the ﬁrst-line choice of anti-motility drug for relief of diarrhoea. Patients with IBS should be advised how on to adjust their dose of laxative or anti-motility drug according to stool consistency, with the aim of achieving a soft, well-formed stool. h See Constipation p. 54, for information on other drugs used for chronic constipation. g A low-dose tricyclic antidepressant, such as amitriptyline hydrochloride p. 410 [unlicensed indication], can be used for abdominal pain or discomfort as a secondline option in patients who have not responded to antispasmodics, anti-motility drugs, or laxatives. A selective serotonin reuptake inhibitor may be considered in those who do not respond to a tricyclic antidepressant [unlicensed indication]. Psychological intervention can be offered to patients who have no relief of IBS symptoms after 12 months of drug treatment. h g Useful Resources Irritable bowel syndrome in adults: diagnosis and management. National Institute for Health and Care Excellence. Clinical guideline 61. February 2008 (updated April 2017). www.nice.org.uk/guidance/cg61 Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. Irritable bowel syndrome 49 ANTISPASMODICS l DIRECTIONS FOR ADMINISTRATION Manufacturer advises capsules should not be broken or chewed because peppermint oil may irritate mouth or oesophagus. l MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Mebeverine with ispaghula husk 09-Nov-2020 The properties listed below are those particular to the combination only. For the properties of the components please consider, mebeverine hydrochloride p. 93, ispaghula husk p. 56. Gastro-resistant capsule CAUTIONARY AND ADVISORY LABELS 5, 22, 25 ▶ l INDICATIONS AND DOSE Irritable bowel syndrome Modified-release capsule CAUTIONARY AND ADVISORY LABELS 5, 22, 25 EXCIPIENTS: May contain Arachis (peanut) oil ▶ BY MOUTH ▶ ▶ l l l Child 12–17 years: 1 sachet twice daily, in water, morning and evening, 30 minutes before food and 1 sachet daily if required, taken 30 minutes before midday meal Adult: 1 sachet twice daily, in water, morning and evening, 30 minutes before food and 1 sachet daily if required, taken 30 minutes before midday meal CAUTIONARY AND ADVISORY LABELS 13, 22 EXCIPIENTS: May contain Aspartame ELECTROLYTES: May contain Potassium l 19-Nov-2020 INDICATIONS AND DOSE COLPERMIN ® Relief of abdominal colic and distension, particularly in irritable bowel syndrome Copyright © 2023. Pharmaceutical Press. All rights reserved. ▶ BY MOUTH ▶ ▶ Child 15–17 years: 1–2 capsules 3 times a day for up to 3 months if necessary, capsule to be swallowed whole with water Adult: 1–2 capsules 3 times a day for up to 3 months if necessary, capsule to be swallowed whole with water MINTEC ® Relief of abdominal colic and distension, particularly in irritable bowel syndrome ▶ BY MOUTH ▶ l l l l Linaclotide 10-Nov-2020 l INDICATIONS AND DOSE Moderate to severe irritable bowel syndrome with constipation ▶ BY MOUTH ▶ Adult: 290 micrograms once daily, dose to be taken at least 30 minutes before meals, review treatment if no response after 4 weeks CONTRA-INDICATIONS Gastro-intestinal obstruction. inﬂammatory bowel disease l CAUTIONS Predisposition to ﬂuid and electrolyte disturbances l SIDE-EFFECTS ▶ Common or very common Diarrhoea. dizziness. gastrointestinal discomfort. gastrointestinal disorders ▶ Uncommon Appetite decreased. dehydration. haemorrhage. hypokalaemia. nausea. postural hypotension. vomiting ▶ Frequency not known Rash SIDE-EFFECTS, FURTHER INFORMATION Manufacturer advises if diarrhoea severe or prolonged, consider suspending treatment. l PREGNANCY Manufacturer advises avoid. l BREAST FEEDING Unlikely to be present in milk in signiﬁcant amounts, but manufacturer advises avoid. l PRESCRIBING AND DISPENSING INFORMATION Dispense capsules in original container (contains desiccant); discard any capsules remaining 18 weeks after opening. l NATIONAL FUNDING/ACCESS DECISIONS For full details see funding body website l Fybogel Mebeverine (Reckitt Benckiser Healthcare (UK) Ltd) Mebeverine hydrochloride 135 mg, Ispaghula husk 3.5 gram Fybogel Mebeverine effervescent granules sachets orange sugar-free | 10 sachet p £7.67 DT = £7.67 Peppermint oil Colpermin (Johnson & Johnson Ltd) Peppermint oil 200 microlitre Colpermin IBS Relief gastro-resistant modified-release capsules | 20 capsule G £4.19 | 100 capsule G £15.99 DT = £14.97 LAXATIVES › GUANYLATE CYCLASE-C RECEPTOR AGONISTS MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Effervescent granules l ▶ DIRECTIONS FOR ADMINISTRATION Manufacturer advises contents of one sachet should be stirred into a glass (approx. 150 mL) of cold water and drunk immediately. PATIENT AND CARER ADVICE Patients or carers should be given advice on how to administer ispaghula husk with mebeverine granules. ▶ Mintec (Almirall Ltd) Peppermint oil 200 microlitre Mintec 0.2ml gastro-resistant capsules | 84 capsule G £7.04 DT = £7.04 Adult: 1–2 capsules 3 times a day for up to 2–3 months if necessary, dose to be taken before meals, swallowed whole with water CAUTIONS Sensitivity to menthol INTERACTIONS → Appendix 1: peppermint SIDE-EFFECTS Ataxia. bradycardia. gastrointestinal discomfort. gastrooesophageal reﬂux disease. headache. nausea. paraesthesia. rash erythematous. tremor. vomiting PREGNANCY Not known to be harmful. BREAST FEEDING Signiﬁcant levels of menthol in breast milk unlikely. Scottish Medicines Consortium (SMC) decisions ® ▶ Linaclotide (Constella ) for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults (June 2013) SMC No. 869/13 Recommended with restrictions l MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 22 ▶ Constella (AbbVie Ltd) Linaclotide 290 microgram Constella 290microgram capsules | 28 capsule P £37.56 DT = £37.56 Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. 1 Gastro-intestinal system BNF 85 50 Chronic bowel disorders Gastro-intestinal system 1 BNF 85 1.5 Short bowel syndrome Short bowel syndrome 31-Aug-2016 Description of condition Patients with a shortened bowel due to large surgical resection (with or without stoma formation) may require medical management to ensure adequate absorption of nutrients and ﬂuid. Absorption of oral medication is also often impaired. Aims of treatment The management of short bowel syndrome focuses on ensuring adequate nutrition and drug absorption, thereby reducing the risk of complications resulting from these effects. Drug treatment Copyright © 2023. Pharmaceutical Press. All rights reserved. Nutritional deficiencies g Patients with a short bowel may require replacement of vitamins and minerals depending on the extent and position of the bowel resection. Deﬁciencies in vitamins A, B12, D, E, and K, essential fatty acids, zinc, and selenium can occur. Hypomagnesaemia is common and is treated with oral or intravenous magnesium supplementation (see Magnesium imbalance p. 1162), though administration of oral magnesium may cause diarrhoea. Occasionally the use of oral alfacalcidol p. 1199 and correction of sodium depletion may be useful. Nutritional support can range from oral supplements to parenteral nutrition, depending on the severity of intestinal failure. h Diarrhoea and high output stomas Diarrhoea is common in short bowel syndrome and can be due to multiple factors. g The use of oral rehydration salts can be considered in order to promote adequate hydration. Oral intake inﬂuences the volume of stool passed, so reducing food intake will lessen diarrhoea, but will also exacerbate the problems of undernutrition. A patient may require parenteral nutrition to allow them to eat less, if the extent of diarrhoea is unacceptable. Pharmacological treatment may be necessary, with the choice of drug depending on the potential for side-effects and the degree of resection. h Antimotility drugs g Loperamide hydrochloride p. 69 and codeine phosphate p. 492 reduce intestinal motility and thus exert antidiarrhoeal actions. Loperamide hydrochloride is preferred as it is not sedative and does not cause dependence or fat malabsorption. High doses of loperamide hydrochloride [unlicensed] may be required in patients with a short bowel due to disrupted enterohepatic circulation and rapid gastrointestinal transit time. If the desired response is not obtained with loperamide hydrochloride, codeine phosphate may be added to therapy. Co-phenotrope p. 69 has traditionally been used alone or in combination with other medications to help decrease faecal output. Co-phenotrope crosses the blood–brain barrier and can produce central nervous system side-effects, which may limit its use; the potential for dependence and anticholinergic effects may also restrict its use. h Colestyramine g In patients with an intact colon and less than 100 cm of ileum resected, colestyramine p. 216 can be used to bind the unabsorbed bile salts and reduce diarrhoea. When colestyramine is given to these patients, it is important to monitor for evidence of fat malabsorption (steatorrhoea) or fat-soluble vitamin deﬁciencies. h Antisecretory drugs g Drugs that reduce gastric acid secretion reduce jejunostomy output. Omeprazole p. 85 is readily absorbed in the duodenum and upper small bowel, but if less than 50 cm of jejunum remains, it may need to be given intravenously. Use of a proton pump inhibitor alone does not eliminate the need for further intervention for ﬂuid control (such as antimotility agents, intravenous ﬂuids, or oral rehydration salts). Octreotide [unlicensed indication] reduces ileostomy diarrhoea and large volume jejunostomy output by inhibiting multiple pro-secretory substances. There is insufﬁcient evidence to establish its role in the management of short bowel syndrome. h Growth factors Growth factors can be used to facilitate intestinal adaptation after surgery in patients with short bowel syndrome, thus enhancing ﬂuid, electrolyte, and micronutrient absorption. Teduglutide p. 51 is an analogue of endogenous human glucagon-like peptide 2 (GLP-2) which is licensed for use in the management of short bowel syndrome. It may be considered after a period of stabilisation following surgery, during which intravenous ﬂuids and nutritional support should have been optimised. Drug absorption For Prescribing in patients with stoma, see Stoma care p. 105. g Many drugs are incompletely absorbed by patients with a short bowel and may need to be prescribed in much higher doses than usual (such as levothyroxine, warfarin, oral contraceptives, and digoxin) or may need to be given intravenously. h Several factors can alter the absorption of drugs taken by mouth in patients with a compromised gastrointestinal system. The most important factors are the length of intestine available for drug absorption, and which section has been removed. The small intestine, with its large surface area and high blood ﬂow, is the most important site of drug absorption. The larger the amount of the small intestine that has been removed, the higher the possibility that drug absorption will be affected. Other factors, such as gastric emptying and gastric transit time, also affect drug handling. g Enteric-coated and modiﬁed-release preparations are unsuitable for use in patients with short bowel syndrome, particularly in patients with an ileostomy, as there may not be sufﬁcient release of the active ingredient. Dosage forms with quick dissolution (soluble tablets) should be used. Uncoated tablets and liquid formulations may also be suitable. hg Before prescribing liquid formulations, prescribers should consider the osmolarity, excipient content and volume required. Hyperosmolar liquids and some excipients (such as sorbitol) can result in ﬂuid loss. The calorie density of oral supplements should also be considered, as it will inﬂuence the volume to be taken. l Other drugs used for Short bowel syndrome Cimetidine, p. 79 Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. Bowel cleansing 51 AMINO ACIDS AND DERIVATIVES Teduglutide l 07-Jul-2022 DRUG ACTION Teduglutide is an analogue of human glucagon-like peptide-2 (GLP-2), which preserves mucosal integrity by promoting growth and repair of the intestine. 2 Constipation and bowel cleansing 2.1 Bowel cleansing Other drugs used for Bowel cleansing Bisacodyl, p. 62. Docusate sodium, p. 62. Magnesium sulfate, p. 1164 l INDICATIONS AND DOSE Short bowel syndrome (initiated under specialist supervision) ▶ BY SUBCUTANEOUS INJECTION ▶ Adult: 0.05 mg/kg once daily, dose to be administered to alternating quadrants of the abdomen; alternatively the thigh can be used, for optimal injection volume per body weight, consult product literature. Review treatment after 6 months CONTRA-INDICATIONS Active or suspected malignancy. history of gastro-intestinal malignancy (in previous 5 years) l CAUTIONS Abrupt withdrawal of parenteral support (reduce gradually with concomitant monitoring of ﬂuid status). cardiac insufﬁciency. cardiovascular disease. colo-rectal polyps. hypertension l SIDE-EFFECTS ▶ Common or very common Anxiety. appetite decreased. congestive heart failure. cough. dyspnoea. ﬂuid imbalance. gallbladder disorders. gastrointestinal discomfort. gastrointestinal disorders. gastrointestinal stoma complication. headache. inﬂuenza like illness. insomnia. nausea. pancreatitis. peripheral oedema. respiratory tract infection. vomiting ▶ Uncommon Syncope l ALLERGY AND CROSS-SENSITIVITY Manufacturer advises caution in patients with tetracycline hypersensitivity. l PREGNANCY g Specialist sources indicate use if necessary—no human data available. k l BREAST FEEDING Manufacturer advises avoid—toxicity in animal studies. l RENAL IMPAIRMENT Dose adjustments g Use half the daily dose if creatinine clearance is less than 50 mL/minute, M see p. 20. l MONITORING REQUIREMENTS Manufacturer advises monitoring of small bowel function, gall bladder, bile ducts and pancreas during treatment. l TREATMENT CESSATION Caution when discontinuing treatment—risk of dehydration. l PATIENT AND CARER ADVICE Patients with cardiovascular disease should seek medical attention if they notice sudden weight gain, swollen ankles or dyspnoea—may indicate increased ﬂuid absorption. l NATIONAL FUNDING/ACCESS DECISIONS For full details see funding body website LAXATIVES › OSMOTIC LAXATIVES Citric acid with magnesium carbonate 19-Aug-2021 (Formulated as a bowel cleansing preparation) Copyright © 2023. Pharmaceutical Press. All rights reserved. l NICE decisions ▶ Teduglutide for treating short bowel syndrome (June 2022) NICE TA804 Recommended Scottish Medicines Consortium (SMC) decisions ® ▶ Teduglutide (Revestive ) for the treatment of adults with short bowel syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery (February 2020) SMC No. SMC2225 Recommended l MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Powder and solvent for solution for injection ▶ Revestive (Takeda UK Ltd) A Teduglutide 1.25 mg Revestive 1.25mg powder and solvent for solution for injection vials | 28 vial P £7,307.70 (Hospital only) Teduglutide 5 mg Revestive 5mg powder and solvent for solution for injection vials | 28 vial P £14,615.39 (Hospital only) l INDICATIONS AND DOSE Bowel evacuation for surgery, colonoscopy or radiological examination ▶ BY MOUTH ▶ ▶ ▶ Child 5–9 years: One-third of a sachet to be given at 8 a.m. the day before the procedure and, one-third of a sachet to be given between 2 and 4 p.m. the day before the procedure Child 10–17 years: 0.5–1 sachet, given at 8 a.m. the day before the procedure and 0.5–1 sachet, given between 2 and 4 p.m. the day before the procedure Adult: 1 sachet, given 8 a.m. the day before the procedure and 1 sachet, given between 2 and 4 p.m. the day before the procedure, use half the dose in frail elderly patients CONTRA-INDICATIONS Acute intestinal or gastric ulceration. acute severe colitis. gastric retention. gastrointestinal obstruction. gastro-intestinal perforation. toxic megacolon l CAUTIONS Debilitated. elderly. hypovolaemia (should be corrected before administration of bowel cleansing preparations). patients with ﬂuid and electrolyte disturbances CAUTIONS, FURTHER INFORMATION Adequate hydration should be maintained during treatment. l INTERACTIONS → Appendix 1: bowel cleansing preparations l SIDE-EFFECTS ▶ Common or very common Gastrointestinal discomfort. nausea. vomiting ▶ Uncommon Dehydration. dizziness. electrolyte imbalance. headache SIDE-EFFECTS, FURTHER INFORMATION Abdominal pain is usually transient and can be reduced by taking preparation more slowly. l PREGNANCY Use with caution. l BREAST FEEDING Use with caution. l RENAL IMPAIRMENT g Caution in mild to moderate impairment; avoid in severe impairment (risk of hypermagnesaemia). M l MONITORING REQUIREMENTS Renal function should be measured before starting treatment in patients at risk of ﬂuid and electrolyte disturbances. l DIRECTIONS FOR ADMINISTRATION Manufacturer advises one sachet should be reconstituted with 200 mL of hot water; the solution should be allowed to cool for approx. 30 minutes before drinking. l PRESCRIBING AND DISPENSING INFORMATION Reconstitution of one sachet containing 11.57 g magnesium carbonate and 17.79 g anhydrous citric acid l Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. 1 Gastro-intestinal system BNF 85 52 Constipation and bowel cleansing Gastro-intestinal system 1 l l produces a solution containing magnesium citrate with 118 mmol Mg2+. Flavours of oral powders may include lemon and lime. PATIENT AND CARER ADVICE Low residue or ﬂuid only diet (e.g. water, fruit squash, clear soup, black tea or coffee) recommended before procedure (according to prescriber’s advice) and copious intake of clear ﬂuids recommended until procedure. Patient or carers should be given advice on how to administer oral powder. MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Effervescent powder CAUTIONARY AND ADVISORY LABELS 13, 10 ELECTROLYTES: May contain Magnesium ▶ Citramag (Cambridge Healthcare Supplies Ltd) Magnesium carbonate heavy 11.57 gram, Citric acid anhydrous 17.79 gram Citramag effervescent powder sachets sugar-free | 10 sachet p £20.50 DT = £20.50 Macrogol 3350 with anhydrous sodium sulfate, ascorbic acid, potassium chloride, sodium ascorbate 17-Aug-2021 and sodium chloride (Polyethylene glycols) l INDICATIONS AND DOSE MOVIPREP ® Bowel cleansing [before any procedure requiring a clean bowel] ▶ BY MOUTH Copyright © 2023. Pharmaceutical Press. All rights reserved. ▶ Adult: 1 litre daily for 2 doses; ﬁrst dose of reconstituted solution taken on the evening before procedure and the second dose on the morning of procedure, alternatively 2 litres daily for 1 dose; reconstituted solution to be taken on the evening before the procedure, or on the morning of the procedure, treatment should be completed at least 1 hour before clinical procedures conducted without general anaesthesia, and at least 2 hours before clinical procedures conducted under general anaesthesia PLENVU ® Bowel cleansing [before any procedure requiring a clean bowel] ▶ BY MOUTH ▶ Adult: 500 mL daily for 2 doses; ﬁrst dose of reconstituted solution taken on the evening before procedure and the second dose on the morning of procedure, alternatively 1 litre daily in 2 divided doses, reconstituted solution to be taken either on the evening before the procedure, or in the morning of the procedure—separate doses by at least 1 hour, treatment should be completed at least 1 hour before clinical procedures conducted without general anaesthesia, and at least 2 hours before clinical procedures conducted under general anaesthesia IMPORTANT SAFETY INFORMATION MHRA/CHM ADVICE: POLYETHYLENE GLYCOL (PEG) LAXATIVES AND STARCH-BASED THICKENERS: POTENTIAL INTERACTIVE EFFECT WHEN MIXED, LEADING TO AN INCREASED RISK OF ASPIRATION (APRIL 2021) Addition of a macrogol (PEG)-based laxative to a liquid that has been thickened with a starch-based thickener may counteract the thickening action, resulting in a thin watery liquid that, when swallowed, increases the risk of potentially fatal aspiration in patients with dysphagia. Healthcare professionals are advised to avoid directly mixing macrogol-based laxatives with starch-based BNF 85 thickeners, especially for patients with dysphagia who are considered at risk of aspiration. CONTRA-INDICATIONS Disorders of gastric emptying. G6PD deﬁciency. gastro-intestinal obstruction. gastrointestinal perforation. ileus. toxic megacolon l CAUTIONS Debilitated patients. dehydration (correct before administration). impaired consciousness. impaired gag reﬂex or possibility of regurgitation or aspiration. moderate-to-severe cardiac impairment. patients at risk of arrhythmia (including those with thyroid disease or electrolyte imbalance). severe acute inﬂammatory bowel disease l INTERACTIONS → Appendix 1: bowel cleansing preparations l SIDE-EFFECTS ▶ Common or very common Chills. dehydration. dizziness. fever. gastrointestinal discomfort. headaches. hunger. malaise. nausea. sleep disorder. thirst. vomiting ▶ Uncommon Arrhythmias. asthenia. drowsiness. dry mouth. dry throat. dysphagia. electrolyte imbalance. hot ﬂush. pain. palpitations. temperature sensation altered ▶ Frequency not known Flatulence. hyponatraemic seizure SIDE-EFFECTS, FURTHER INFORMATION Abdominal pain is usually transient and can be reduced by taking preparation more slowly. l PREGNANCY Manufacturer advises use only if essential— no or limited information available. l BREAST FEEDING Manufacturer advises use only if essential—no information available. l RENAL IMPAIRMENT Manufacturer advises caution if creatinine clearance less than 30 mL/minute. See p. 20. l MONITORING REQUIREMENTS Manufacturer advises consider monitoring baseline and post-treatment electrolytes, renal function and ECG as appropriate, in debilitated patients, those with signiﬁcant renal impairment, arrhythmia, or at risk of electrolyte imbalance. l DIRECTIONS FOR ADMINISTRATION PLENVU ® Manufacturer advises the contents of the single sachet for Dose 1 should be made up to 500 mL with water and taken over 30 minutes; the contents of the 2 sachets (A and B) for Dose 2 should be made up to 500 mL with water and taken over 30 minutes. Each dose should be followed by 500 mL of clear ﬂuid taken over 30 minutes. MOVIPREP ® Manufacturer advises one pair of sachets (A and B) should be made up to 1 litre with water and taken over 1–2 hours; 1 litre of other clear ﬂuid should also be taken during treatment. l PRESCRIBING AND DISPENSING INFORMATION PLENVU ® Dose 1 (single sachet) when reconstituted up to 500 mL with water provides Na+ 160.9 mmol, K+ 13.3 mmol, Cl- 47.6 mmol; Dose 2 (sachets A and B) when reconstituted up to 500 mL with water provides Na+ 297.6 mmol, K+ 16.1 mmol, Cl- 70.9 mmol. MOVIPREP ® 1 pair of sachets (A+B) when reconstituted up to 1 litre with water provides Na+ 181.6 mmol (Na+ 56.2 mmol absorbable), K+ 14.2 mmol, Cl– 59.8 mmol. l PATIENT AND CARER ADVICE Manufacturer advises solid food should not be taken during treatment until procedure completed. l l MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Form unstated CAUTIONARY AND ADVISORY LABELS 10, 13 EXCIPIENTS: May contain Aspartame ELECTROLYTES: May contain Chloride, potassium, sodium ▶ Moviprep (Forum Health Products Ltd) Moviprep oral powder sachets sugar-free | 4 sachet Joint, Formulary Committee. BNF 85 (British National Formulary) March 2023, Pharmaceutical Press, 2023. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/rps/detail.action?docID=30613100. Created from rps on 2024-02-25 12:21:29. p £10.36 Bowel cleansing 53 ▶ Plenvu (Forum Health Products Ltd) Plenvu oral powder sachets sugar-free | 3 sachet p £12.43 Macrogol 3350 with anhydrous sodium sulfate, potassium chloride, sodium bicarbonate and sodium 05-May-2021 chloride (Formulated as a bowel cleansing preparation) l l l l INDICATIONS AND DOSE Bowel cleansing before radiological examination, colonoscopy, or surgery Adult: Initially 2 litres daily for 2 doses: ﬁrst dose of reconstituted solution taken on the evening before procedure and the second dose on the morning of procedure, alternatively (by mouth) initially 250 mL every 10–15 minutes, reconstituted solution to be administered, alternatively (by nasogastric tube) initially 20–30 mL/minute, starting on the day before procedure until 4 litres have been consumed CAUTIONARY AND ADVISORY LABELS 10, 13 EXCIPIENTS: May contain Aspartame ELECTROLYTES: May contain Bicarbonate, chloride, potassium, sodium ▶ Magnesium citrate with sodium picosulfate l Copyright © 2023. Pharmaceutical Press. All rights reserved. l l l l l l INDICATIONS AND DOSE CITRAFLEET ® SACHETS Bowel evacuation on day before radiological examination, endoscopy, or surgery Addition of a macrogol (PEG)-based laxative to a liquid that has been thickened with a starch-based thickener may counteract the thickening action, resulting in a thin watery liquid that, when swallowed, increases the risk of potentially fatal aspiration in patients with dysphagia. Healthcare professionals are advised to avoid directly mixing macrogol-based laxatives with starch-based thickeners, especially for patients with dysphagia who are considered at risk of aspiration. l 19-Aug-2021 (Formulated as a bowel cleansing preparation) MHRA/CHM ADVICE: POLYETHYLENE GLYCOL (PEG) LAXATIVES AND STARCH-BASED THICKENERS: POTENTIAL INTERACTIVE EFFECT WHEN MIXED, LEADING TO AN INCREASED RISK OF ASPIRATION (APRIL 2021) CONTRA-INDICATIONS Acute severe colitis. gastric retention. gastro-intestinal obstruction. gastro-intestinal perforation. toxic megacolon CAUTIONS Colitis. debilitated patients. ﬂuid and electrolyte disturbances. heart failure (avoid if moderate to severe). hypovolaemia (should be corrected before administration of bowel cleansing preparations). impaired gag reﬂex or possibility of regurgitation or aspiration INTERACTIONS → Appendix 1: bowel cleansing preparations SIDE-EFFECTS Angioedema. arrhythmia. chills. confusion. dehydration. dizziness. dyspnoea. electrolyte imbalance. fever. ﬂatulence. gastrointestinal discomfort. headache. malaise. nausea. palpitations. seizure. skin reactions. thirst. vomiting SIDE-EFFECTS, FURTHER INFORMATION Abdominal pain is usually transient and can be reduced by taking preparation more slowly. PREGNANCY Manufacturers advise use only if essential— no information available. BREAST FEEDING Manufacturers advise use only if essential—no information available. MONITORING REQUIREMENTS Renal function should be measured before starting treatment in patients at risk of ﬂuid and electrolyte disturbances. DIRECTIONS FOR ADMINISTRATION g 1 sachet should be reconstituted w

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