Constipation

PICOLAX^®SACHETS, CITRAFLEET^®SACHETSOne sachet should be reconstituted with150mL (approx. half a glass) of cold water.

lPRESCRIBING AND DISPENSING INFORMATIONFlavours of oral powder formulations may include lemon.

PICOLAX^®SACHETSOne reconstituted sachet contains K⁺ 5mmol and Mg²⁺87^mmol.

CITRAFLEET^®SACHETSOne reconstituted sachet contains K⁺5mmol and Mg²⁺86^mmol.

lPATIENT AND CARER ADVICELow residue diet recommended on the day before procedure and copious intake of water or other clearfluids recommended during treatment. Patients and carers should be given advice on how to administer oral powder; they should be warned that heat is generated during reconstitution and that the solution should be allowed to cool before drinking.

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

Powder

CAUTIONARY AND ADVISORY LABELS10, 13 ELECTROLYTES:May contain Magnesium, potassium

▶CitraFleet(Casen Recordati S.L.)

Sodium picosulfate 10 mg, Magnesium oxide light 3.5 gram, Citric acid anhydrous 10.97 gramCitraFleet oral powder15.08g sachets sugar-free|2sachet^p£3.25

▶Picolax(Ferring Pharmaceuticals Ltd)

Sodium picosulfate 10 mg, Magnesium oxide 3.5 gram, Citric acid anhydrous 12 gramPicolax oral powder16.1g sachets sugar-free| 2sachet^p£3.39

chloride, sodium bicarbonate and sodium chloride p.52^, citric acid with magnesium carbonate p.50, magnesium citrate with sodium picosulfate p.52and sodium acid phosphate with sodium phosphate p.59. Bowel cleansing treatments are not treatments for constipation.

Management

Short-duration constipation

gIn the management of short-duration constipation (where dietary measures are ineffective) treatment should be started with a bulk-forming laxative, ensuring adequatefluid intake. If stools remain hard, add or switch to an osmotic laxative. If stools are soft but difficult to pass or the person complains of inadequate emptying, a stimulant laxative should be added.h

Opioid-induced constipation

See alsoConstipationunder Prescribing in palliative care p.25^.gIn patients with opioid-induced constipation, an osmotic laxative (or docusate sodium to soften the stools) and a stimulant laxative is recommended. Bulk-forming laxatives should be avoided.

Naloxegol p.65is recommended for the treatment of opioid-induced constipation when response to other laxatives is inadequate.h

Methylnaltrexone bromide p.64is licensed for the treatment of opioid-induced constipation when response to other laxatives is inadequate. Manufacturer advises that in patients receiving palliative care, methylnaltrexone bromide should be used as an adjunct to existing laxative therapy.

Faecal impaction

The treatment of faecal impaction depends on the stool consistency.gIn patients with hard stools, a high dose of an oral macrogol (such as macrogol3350with potassium chloride, sodium bicarbonate and sodium chloride) may be considered. In those with soft stools, or with hard stools after a few days treatment with a macrogol, an oral stimulant laxative should be started or added to the previous treatment. If the response to oral laxatives is inadequate, for soft stools consider rectal administration of bisacodyl, and for hard stools rectal administration of glycerol alone, or glycerol plus bisacodyl. Alternatively, a docusate sodium or sodium citrate enema p.789may be tried.

If the response is still insufficient, a sodium acid phosphate with sodium phosphate or arachis oil retention enema may be necessary. For hard faeces it can be helpful to give the arachis oil enema p.60overnight before giving a sodium acid phosphate with sodium phosphate p.59^or sodium citrate enema p.789the following day. Enemas may need to be repeated several times to clear hard impacted faeces.h

Chronic constipation

gIn the management of chronic constipation, treatment should be started with a bulk-forming laxative, whilst ensuring good hydration. If stools remain hard, add or change to an osmotic laxative such as a macrogol. Lactulose p.56is an alternative if macrogols are not effective, or not tolerated. If the response is inadequate, a stimulant laxative can be added. The dose of laxative should be adjusted gradually to produce one or two soft, formed stools per day.

If at least two laxatives (from different classes) have been tried at the highest tolerated recommended doses for at least 6months, the use of prucalopride p.60(in women only) should be considered. If treatment with prucalopride is not effective after4weeks, the patient should be re-examined and the benefit of continuing treatment reconsidered.

Laxatives can be slowly withdrawn when regular bowel movements occur without difficulty, according to the frequency and consistency of the stools. If a combination of laxatives has been used, reduce and stop one laxative at a time; if possible, the stimulant laxative should be reduced

first. However, it may be necessary to also adjust the dose of the osmotic laxative to compensate.h

Constipation in pregnancy and breast-feeding

gIf dietary and lifestyle changes fail to control constipation in pregnancy,fibre supplements in the form of bran or wheat are likely to help women experiencing constipation in pregnancy, and raise no serious concerns about side-effects to the mother or fetus.

A bulk-forming laxative is thefirst choice during pregnancy iffibre supplements fail. An osmotic laxative, such as lactulose, can also be used. Bisacodyl p.61^{or senna} p.63may be suitable if a stimulant effect is necessary but use of senna should be avoided near term or if there is a history of unstable pregnancy. Stimulant laxatives are more effective than bulk-forming laxatives but are more likely to cause side-effects (diarrhoea and abdominal discomfort), reducing their acceptability to patients. Docusate sodium p.61and glycerol suppositories p.63can also be used.

A bulk-forming laxative is thefirst choice during breast-feeding, if dietary measures fail. Lactulose or a macrogol may be used if stools remain hard. As an alternative, a short course of a stimulant laxative such as bisacodyl or senna can be considered.h

Constipation in children

Early identification of constipation and effective treatment can improve outcomes for children. Without early diagnosis and treatment, an acute episode of constipation can lead to analfissure and become chronic.

gThefirst-line treatment for children with constipation requires the use of a laxative in combination with dietary modification or with behavioural interventions.

Diet modification alone is not recommended asfirst-line treatment.

In children an increase in dietaryfibre, adequatefluid intake, and exercise is advised. Diet should be balanced and contain fruits, and vegetables, high-fibre bread, baked beans, and wholegrain breakfast cereals. Unprocessed bran (which may cause bloating andflatulence and reduces the absorption of micronutrients) isnotrecommended.

If faecal impaction is not present (or has been treated), the child should be treated promptly with a laxative. A macrogol (such as macrogol3350with potassium chloride, sodium bicarbonate and sodium chloride p.57) is preferred asfi rst-line management. If the response is inadequate, add a stimulant laxative or change to a stimulant laxative if the first-line therapy is not tolerated. If stools remain hard, lactulose or another laxative with softening effects, such as docusate sodium can be added.

In children with chronic constipation, laxatives should be continued for several weeks after a regular pattern of bowel movements or toilet training is established. The dose of laxatives should then be tapered gradually, over a period of months, according to response. Some children may require laxative therapy for several years.

A shorter duration of laxative treatment may be possible in some children with a short history of constipation.

Laxatives should be administered at a time that produces an effect that is likely tofit in with the child’s toilet routine.

h

Faecal impaction in children

gTreatment of faecal impaction may initially increase symptoms of soiling and abdominal pain. In children over 1year of age with faecal impaction, an oral preparation containing a macrogol (such as macrogol3350^with potassium chloride, sodium bicarbonate and sodium chloride) is used to clear faecal mass and to establish and maintain soft well-formed stools, using an escalating dose regimen depending on symptoms and response. If disimpaction does not occur after2weeks, a stimulant laxative can be added or if stools are hard, used in

54 Constipation and bowel cleansing

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combination with an osmotic laxative such as lactulose.

Long-term regular use of laxatives is essential to maintain well-formed stools and prevent recurrence of faecal impaction; intermittent use may provoke relapses.h

LAXATIVES

›

BULK-FORMING LAXATIVES

Ispaghula husk

24-Feb-2016 lDRUG ACTIONBulk-forming laxatives relieve constipation

by increasing faecal mass which stimulates peristalsis.

lINDICATIONS AND DOSE Constipation

▶BY MOUTH

▶Child 1 month–5 years:2^.5–5mL twice daily, dose to be taken only when prescribed by a doctor, as half or whole level spoonful in water, preferably after meals, morning and evening

▶Child 6–11 years:2^.5–5mL twice daily, dose to be given as a half or whole level spoonful in water, preferably after meals, morning and evening

▶Child 12–17 years:1sachet twice daily, dose to be given in water preferably after meals, morning and evening

▶Adult:1sachet twice daily, dose to be given in water preferably taken after food, morning and evening DOSE EQUIVALENCE AND CONVERSION

▶1sachet equivalent to2^level5ml spoonfuls.

lCONTRA-INDICATIONSColonic atony

.

faecal impaction

.

intestinal obstruction

.

reduced gut motility

lCAUTIONSAdequatefluid intake should be maintained to avoid intestinal obstruction

lSIDE-EFFECTSAbdominal distension

.

bronchospasm

.

conjunctivitis

.

gastrointestinal disorders

.

hypersensitivity

.

rhinitis

.

skin reactions

lDIRECTIONS FOR ADMINISTRATIONDose to be taken with at least150^{mL liquid.}

lPRESCRIBING AND DISPENSING INFORMATIONFlavours of soluble granules formulations may include plain, lemon, or orange.

lHANDLING AND STORAGEIspaghula husk contains potent allergens. Individuals exposed to the product (including those handling the product) can develop hypersensitivity reactions such as rhinitis, conjunctivitis, bronchospasm and in some cases, anaphylaxis.

lPATIENT AND CARER ADVICEManufacturer advises that preparations that swell in contact with liquid should always be carefully swallowed with water and should not be taken immediately before going to bed. Patients and their carers should be advised that the full effect may take some days to develop and should be given advice on how to administer ispaghula husk.

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

Effervescent granules

CAUTIONARY AND ADVISORY LABELS13 EXCIPIENTS:May contain Aspartame

▶Fybogel(Reckitt Benckiser Healthcare (UK) Ltd)

Ispaghula husk 3.5 gramFybogel3.5g effervescent granules sachets plain SF sugar-free|30sachet^G£2.83DT = £2.83

Fybogel Orange3.5g effervescent granules sachets SF sugar-free| 30sachet^G £2.83DT = £2.83

Fybogel Lemon3.5g effervescent granules sachets SF sugar-free| 30sachet^G £2.83DT = £2.83

▶Fybogel Hi-Fibre(Reckitt Benckiser Healthcare (UK) Ltd) Ispaghula husk 3.5 gramFybogel Hi-Fibre Orange3.5g effervescent granules sachets sugar-free|10sachet^G£2.26sugar-free| 30sachet^G £4.85DT = £2.83

Fybogel Hi-Fibre Lemon3.5g effervescent granules sachets sugar-free

|10sachet^G £2.26

▶Ispagel(Bristol Laboratories Ltd)

Ispaghula husk 3.5 gramIspagel Orange3.5g effervescent granules sachets sugar-free|10sachet^G£1.92sugar-free| 30sachet^G£2.45DT = £2.83

Granules

CAUTIONARY AND ADVISORY LABELS13 EXCIPIENTS:May contain Aspartame

▶Ispaghula husk (Non-proprietary)

Ispaghula husk 3.5 gramIspaghula husk3.5g granules sachets gluten free|30sachet^G£2.83

Combinations available:Senna with ispaghula husk,p.63

Methylcellulose

lDRUG ACTIONBulk-forming laxatives relieve constipation by increasing faecal mass which stimulates peristalsis.

lINDICATIONS AND DOSE Constipation|Diarrhoea

▶BY MOUTH USING TABLETS

▶Adult:3–6tablets twice daily

lCONTRA-INDICATIONSColonic atony

.

difficulty in swallowing

.

faecal impaction

.

infective bowel disease

.

intestinal obstruction

lCAUTIONSAdequatefluid intake should be maintained to avoid intestinal obstruction

CAUTIONS, FURTHER INFORMATIONIt may be necessary to supervise elderly or debilitated patients or those with intestinal narrowing or decreased motility to ensure adequatefluid intake.

lSIDE-EFFECTSAbdominal distension

.

gastrointestinal disorders

lDIRECTIONS FOR ADMINISTRATIONIn constipation the dose should be taken with at least300mL liquid. In diarrhoea, ileostomy, and colostomy control, avoid liquid intake for30minutes before and after dose.

lPATIENT AND CARER ADVICEPatients and their carers should be advised that the full effect may take some days to develop. Preparations that swell in contact with liquid should always be carefully swallowed with water and should not be taken immediately before going to bed.

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

Tablet

▶Celevac(Advanz Pharma)

Methylcellulose "450" 500 mgCelevac500mg tablets| 112tablet^G£3.22DT = £3.22

Sterculia

19-Feb-2016

lDRUG ACTIONSterculia is a bulk-forming laxative. It relieves constipation by increasing faecal mass which stimulates peristalsis.

lINDICATIONS AND DOSE Constipation

▶BY MOUTH

▶Child 6–11 years: 0^.5–1^sachet1–2times a day, alternatively, half to one heaped5-mL spoonful once or twice a day; washed down without chewing with plenty of liquid after meals

▶Child 12–17 years:1–2^sachets1–2times a day, alternatively, one to two heaped5-mL spoonfuls once or twice a day; washed down without chewing with plenty of liquid after meals

▶Adult:1–2^sachets1–2times a day, alternatively, one to two heaped5-mL spoonfuls once or twice a day;

washed down without chewing with plenty of liquid after meals

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1

lCONTRA-INDICATIONSColonic atony

.

difficulty in swallowing

.

faecal impaction

.

intestinal obstruction lCAUTIONSAdequatefluid intake should be maintained to

avoid intestinal obstruction CAUTIONS, FURTHER INFORMATION

▶In adultsIt may be necessary to supervise elderly or debilitated patients or those with intestinal narrowing or decreased motility to ensure adequatefluid intake.

lSIDE-EFFECTSDiarrhoea

.

gastrointestinal discomfort

.

gastrointestinal disorders

.

nausea

lDIRECTIONS FOR ADMINISTRATIONMay be mixed with soft food (e.g. yoghurt) before swallowing, followed by plenty of liquid.

lPATIENT AND CARER ADVICEPatients and their carers should be advised that the full effect may take some days to develop. Preparations that swell in contact with liquid should always be carefully swallowed with water and should not be taken immediately before going to bed.

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

Granules

CAUTIONARY AND ADVISORY LABELS25, 27

▶Normacol(Forum Health Products Ltd)

Sterculia 620 mg per 1 gramNormacol granules7g sachets| 60sachet^G£6.67DT = £6.67

Normacol granules|500gram^G£7.92DT = £7.92

Sterculia with frangula

The properties listed below are those particular to the combination only. For the properties of the components please consider, sterculia p.55^.

lINDICATIONS AND DOSE After haemorrhoidectomy

▶BY MOUTH

▶Adult:1–2^sachets1–2times a day, alternatively, 1–2^heaped5mL spoonfuls once or twice a day;

washed down without chewing with plenty of liquid after meals

Constipation

▶BY MOUTH

▶Adult:1–2^sachets1–2times a day, alternatively, 1–2^heaped5mL spoonfuls once or twice a day;

washed down without chewing with plenty of liquid after meals

lPREGNANCYManufacturer advises avoid.

lBREAST FEEDINGManufacturer advises avoid.

lPATIENT AND CARER ADVICEPatients and their carers should be advised that the full effect may take some days to develop. Preparations that swell in contact with liquid should always be carefully swallowed with water and should not be taken immediately before going to bed.

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

Granules

▶Normacol Plus(Forum Health Products Ltd) Frangula 80 mg per 1 gram, Sterculia 620 mg per

1 gramNormacol Plus granules7g sachets|60sachet^G £7.12 DT = £7.12

Normacol Plus granules|500gram^G £8.45DT = £8.45

LAXATIVES

›

OSMOTIC LAXATIVES

Lactulose

lINDICATIONS AND DOSE Constipation

▶BY MOUTH

▶Child 1–11 months: 2^.5mL twice daily, adjusted according to response

▶Child 1–4 years:2^.5–10mL twice daily, adjusted according to response

▶Child 5–17 years:5–20mL twice daily, adjusted according to response

▶Adult:Initially15mL twice daily, adjusted according to response

Hepatic encephalopathy (portal systemic encephalopathy)

▶BY MOUTH

▶Adult:Adjusted according to response to30–50^mL 3times a day, subsequently adjusted to produce2–3 soft stools per day

PHARMACOKINETICS

▶Lactulose may take up to48hours to act.

lUNLICENSED USE

▶In adultsLactulose doses in the BNF may differ from those in product literature.

lCONTRA-INDICATIONSGalactosaemia

.

intestinal obstruction

lCAUTIONSLactose intolerance lSIDE-EFFECTS

▶Common or very commonAbdominal pain

.

diarrhoea

.

flatulence

.

nausea

.

vomiting

▶UncommonElectrolyte imbalance lPREGNANCYNot known to be harmful.

lPATIENT AND CARER ADVICE

Medicines for Children leaflet: Lactulose for constipation www.medicinesforchildren.org.uk/lactulose-constipation lMEDICINAL FORMSThere can be variation in the licensing of

different medicines containing the same drug.

Oral solution

▶Lactulose (Non-proprietary)

Lactulose 666.667 mg per 1 mlLactulose10g/15ml oral solution 15ml sachets sugar free sugar-free|10sachet^p£2.51DT = £2.51 Lactulose10g/15ml oral solution15ml sachets sugar free unflavoured sugar-free|10sachet^p£2.50DT = £2.51

Lactulose10g/15ml oral solution15ml sachets sugar free plum sugar-free|10sachet^p £2.60DT = £2.51

Lactulose 680 mg per 1 mlLactulose3.1-3.7g/5ml oral solution| 300ml^p£1.44–£2.73|500ml^p£4.55DT = £2.40

▶Duphalac(Mylan)

Lactulose 680 mg per 1 mlDuphalac3.35g/5ml oral solution| 200ml^p£1.92|300ml^p £2.88|500ml^p £4.80DT = £2.40

Macrogol 3350

21-Aug-2017 lINDICATIONS AND DOSE

Chronic constipation

▶BY MOUTH

▶Adult:2sachets once daily usually for up to2^weeks, dose to be taken preferably in the morning PHARMACOKINETICS

▶Onset of action24–48^hours.

lCONTRA-INDICATIONSIleus

.

intestinal obstruction

.

intestinal perforation

.

risk of intestinal perforation

.

severe inflammatory bowel disease

.

toxic megacolon lSIDE-EFFECTS

▶Common or very commonFlatulence

.

gastrointestinal discomfort

.

nausea

.

vomiting

56 Constipation and bowel cleansing

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▶UncommonAnaemia

.

angioedema

.

appetite disorder

.

dehydration

.

dizziness

.

fatigue

.

hiccups

.

hypertension

.

hypoglycaemia

.

hypothyroidism

.

increased risk of infection

.

local swelling

.

migraine

.

muscle twitching

.

neuritis

.

oedema

.

pain

.

pelvic pain

.

sinus congestion

.

skin reactions

.

tachycardia

.

taste altered

lPREGNANCYLimited data, but manufacturer advises no effects anticipated as systemic exposure is negligible.

lDIRECTIONS FOR ADMINISTRATIONManufacturer advises contents of each sachet to be dissolved in half a glass (approx.100mL) of water just before administration.

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

Powder

CAUTIONARY AND ADVISORY LABELS13

▶TransiSoft(HFA Healthcare Products Ltd)

Macrogol’3350’85 gram per 1 litreTransiSoft oral powder8.5g sachets sugar-free|28sachet^p £29.85DT = £29.85

Macrogol 3350 with potassium chloride, sodium bicarbonate and sodium chloride

18-Apr-2018 lINDICATIONS AND DOSE

Chronic constipation (dose for’paediatric’sachets)| Prevention of faecal impaction (dose for’paediatric’ sachets)

▶BY MOUTH

▶Child 2–5 years:1sachet daily, adjust dose to produce regular soft stools; maximum4sachets per day

▶Child 6–11 years:2sachets daily, adjust dose to produce regular soft stools; maximum4sachets per day Faecal impaction (dose for’paediatric’sachets)

▶BY MOUTH

▶Child 5–11 years:4^{sachets on}first day, then increased in steps of2sachets daily, total daily dose to be taken over a12-hour period, after disimpaction, switch to maintenance laxative therapy; maximum12^sachets per day

Chronic constipation (dose for’half-strength’sachets)

▶BY MOUTH

▶Child 12–17 years:2–6sachets daily in divided doses usually for up to2weeks; maintenance2–4^sachets daily

▶Adult:2–6sachets daily in divided doses usually for up to2weeks; maintenance2–4sachets daily

Faecal impaction (dose for’half-strength’sachets)

▶BY MOUTH

▶Child 12–17 years:8^{sachets on}first day, then increased in steps of4sachets daily, total daily dose to be drunk within a6hour period, after disimpaction, switch to maintenance laxative therapy if required; maximum 16sachets per day

▶Adult:8^{sachets on}first day, then increased in steps of 4sachets daily, total daily dose to be drunk within a 6hour period, after disimpaction, switch to maintenance laxative therapy if required; maximum 16sachets per day

Chronic constipation (dose for’full-strength’sachets)

▶BY MOUTH

▶Child 12–17 years:1–3sachets daily in divided doses usually for up to2weeks; maintenance1–2^sachets daily

▶Adult:1–3sachets daily in divided doses usually for up to2weeks; maintenance1–2sachets daily

Faecal impaction (dose for’full-strength’sachets)

▶BY MOUTH

▶Child 12–17 years:4^{sachets on}first day, then increased in steps of2sachets daily, total daily dose to be drunk within a6hour period, after disimpaction, switch to maintenance laxative therapy if required; maximum 8sachets per day

▶Adult:4^{sachets on}first day, then increased in steps of 2sachets daily, total daily dose to be drunk within a 6hour period, after disimpaction, switch to maintenance laxative therapy if required; maximum 8sachets per day

DOSE EQUIVALENCE AND CONVERSION

▶Each‘paediatric’sachet contains6^.563g of macrogol 3350^{; each}‘half-strength’sachet contains6^.563^{g of} macrogol3350^{; each}‘full-strength’sachet contains 13^.125g of macrogol3350^.

MOVICOL^®READY TO TAKE SACHETS Chronic constipation

▶BY MOUTH

▶Child 12–17 years:1–3sachets daily in divided doses usually for up to2weeks; maintenance1–2^sachets daily

▶Adult:1–3sachets daily in divided doses usually for up to2weeks; maintenance1–2sachets daily

Faecal impaction

▶BY MOUTH

▶Child 12–17 years:4^{sachets on}first day, then increased in steps of2sachets daily, total daily dose to be drunk within a6hour period; patients should also take an additional1^{litre of}fluid daily, after disimpaction, switch to maintenance laxative therapy if required;

maximum8sachets per day

▶Adult:4^{sachets on}first day, then increased in steps of 2sachets daily, total daily dose to be drunk within a 6hour period; patients should also take an additional 1^{litre of}fluid daily, after disimpaction, switch to maintenance laxative therapy if required; maximum 8sachets per day

MOVICOL^®LIQUID Chronic constipation

▶BY MOUTH

▶Child 12–17 years:25^mL1–3times a day usually for up to2weeks; maintenance25^mL1–2times a day

▶Adult:25^mL1–3times a day usually for up to2^weeks;

maintenance25^mL1–2times a day VISTAPREP^®ORAL POWDER Bowel cleansing before colonoscopy

▶BY MOUTH

▶Adult:3–4litres, reconstituted solution taken over 4hours, generally on the day of procedure;

alternatively, it can be taken on the evening before procedureorstarted on the evening before procedure and completed on the morning of procedure

lUNLICENSED USE

▶In childrenMacrogol3350with potassium chloride, sodium bicarbonate and sodium chloride may be used as detailed below, although these situations are considered outside the scope of its licence:

.^gdose for chronic constipation/prevention of faecal impaction in children aged6^years;

.dose titration schedule for faecal impaction in children aged12–17^yearsh.

▶In adultsMacrogol3350with potassium chloride, sodium bicarbonate and sodium chloride may be used as detailed below, although this is considered outside the scope of its licence:gdose titration schedule for faecal impaction l

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Gastro-intestinalsystem

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