Although these medications are frequently prescribed for functional bowel symptoms such as irritable bowel syndrome, their value in clinical trials has not been proved. Lifestyle changes and identifying food triggers are the mainstay of treating functional gut symptoms.
NICE CG61 (February 2008) gives advice on the pharmacological management of Irritable Bowel Syndrome (IBS). Antispasmodic agents should be considered alongside dietary and lifestyle advice. Laxatives (not lactulose) may be offered for constipation, and loperamide for diarrhoea. A low dose tricyclic antidepressant, unlicensed, (e.g. amitriptyline starting at 5-10mg at night) may be considered if first line treatments do not help.
Antimuscarinics
Hyoscine butylbromide
- Tablets 10mg (£16.08 = 20mg four times daily)
- Solution for injection 20mg/1ml (£0.41 = 1ml ampoule)
Indications and dose
- Symptomatic relief of gastro-intestinal or genito-urinary disorders characterised by smooth muscle spasm
- By mouth:
- Child 6–11 years: 10mg three times daily
- Child 12–17 years: 20 mg four times daily
- Adult: 20 mg four times a daily
- Irritable bowel syndrome
- By mouth:
- Adult: 10mg three times daily, increased if required up to 20mg four times daily
- Acute spasm and spasm in diagnostic procedures (specialist)
- By intramuscular or slow intravenous injection:
- Adult: 20mg repeated after 30 minutes if required (may be repeated more frequently in endoscopy), maximum 100mg daily
- Excessive respiratory secretions and bowel colic in palliative care (specialist)
- By mouth: (unlicensed under 6 years)
- Child 1 month–1 year: 300–500 micrograms/kg 3–4 times daily (max. per dose 5 mg)
- Child 2–4 years: 5 mg 3-4 times daily
- Child 5–11 years: 10 mg 3–4 times daily
- Child 12–17 years: 10–20 mg 3–4 times daily
- By intramuscular injection, or by intravenous injection (unlicensed)
- Child 1 month–4 years: 300–500 micrograms/kg 3–4 times daily (max. per dose 5 mg)
- Child 5–11 years: 5–10 mg 3–4 times daily
- Child 12–17 years: 10–20 mg 3–4 times a day
- By subcutaneous injection
- Adult: 20 mg every 4 hours if required, adjusted according to response to up to 20 mg every 1 hour.
- By subcutaneous infusion
- Adult:
- (Excessive respiratory secretions) 20–120 mg/24 hours
- (Bowel colic) 60–300 mg/24 hours
Notes
- MHRA Drug Safety Update (February 2017) Hyoscine butylbromide injection: risk of serious adverse effects in patients with underlying cardiac disease.
- hyoscine butylbromide injection can cause serious adverse effects including tachycardia, hypotension, and anaphylaxis
- these adverse effects can result in a fatal outcome in patients with underlying cardiac disease, such as those with heart failure, coronary heart disease, cardiac arrhythmia, or hypertension
- hyoscine butylbromide injection should be used with caution in patients with cardiac disease
- monitor these patients, and ensure that resuscitation equipment, and personnel who are trained how to use this equipment, are readily available
- hyoscine butylbromide injection remains contraindicated in patients with tachycardia
- Tablets not licensed for use in children under 6 years
- Injection not licensed for use in children (age range not specified by manufacturer)
- Hyoscine butylbromide may be useful in gastro-intestinal disorders characterised by smooth muscle spasm and in palliative care, but its anticholinergic side effects limit its use and administration by mouth is associated with poor absorption
Propantheline bromide
- Tablets 15mg (£25.93 = 28 days)
Indications
- Alternative to oxybutynin for hyperhidrosis which has not responded to a topical aluminium antiperspirant and self-care management strategies
Dose
- 15mg three times daily at least 1 hour before meals and 30mg at night, maximum 120mg daily
Notes
- Although it is an off-label use, specialists advise that for patients with hyperhidrosis, oxybutynin (see 7.4.2 Drugs for urinary frequency, enuresis, and incontinence) is considered ahead of the licensed alternative (propantheline bromide) owing to greater evidence of efficacy and lower cost.
Sialanar
(Glycopyrronium bromide)
- Oral solution SF 400micrograms/ml (320micrograms/ml glycopyrronium base) (£320.00 = 250ml)
Indications and dose
- Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders
Notes
- Prescribe by brand: Different formulations of glycopyrronium oral solution are not bioequivalent
- Unlicensed specials should not be prescribed.
- Sialanar description on packaging and on GP prescribing systems is 320micrograms/ml – this is the amount of glycopyrronium BASE per ml and is equivalent to 400micrograms/ml of the SALT, glycopyrronium bromide
- Specify doses as glycopyrronium bromide (not glycopyrronium base)
- The routine commissioning of glycopyrronium bromide oral solution is accepted in Devon for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders (see Commissioning Policy for more details)
- NICE NG62 recommends both glycopyrronium bromide oral solution and hyoscine hydrobromide transdermal patches (off-label, see section 4.6) as options to reduce the severity and frequency of drooling in children and young people with cerebral palsy. Glycopyrronium bromide is licensed for this indication but is available at significantly increased cost, and there is a lack of evidence of clinical benefit of glycopyrronium over hyoscine. Local specialists may indicate a preference for either drug as the first line treatment
- The choice of treatment will be made by the specialist, taking into account the preferences of the child or young person and their parents or carers, and the age range and indication covered by the marketing authorisations.
Glycopyrronium bromide
- Tablets 1mg, 2mg (click here for preferred brand)
- Solution for injection 200micrograms/1ml ampoule (£17.85 = 10 ampoules)
- Solution for injection 600micrograms/3ml ampoule (£21.12 = 10 ampoules)
Indications and dose
- Treatment of severe sialorrhoea (chronic pathological drooling) in patients with chronic neurological disorders (see notes):
- By mouth: as advised by specialists, titrated depending on weight and according to therapeutic response and tolerability; up to 0.1mg/kg, not to exceed 1.5mg to 3mg three times daily (refer to SmPC for further information).
- Mild to moderate renal impairment (eGFR ≥ 30 and <90 ml/min/1.73m2): reduce dose by 30%.
- Contraindicated in severe renal impairment (eGFR <30 ml/min/1.73m2, including end stage renal disease requiring dialysis).
- Reduction of respiratory tract secretions (Just in case bags)
- Premedication at induction (Hospital Only)
- Control of muscarinic side-effects of neostigmine in reversal of non-depolarising neuromuscular block (Hospital Only)
Notes
- Treatment of severe sialorrhoea may be started in primary care on the advice of a specialist.
- Different formulations of glycopyrronium differ in bioavailability and should not be regarded as interchangeable.
- There is variation in licensing between brands. For adults, glycopyrronium tablets are only licensed for initiation in patients with chronic neurological disorders of childhood onset. Use in other conditions is off-label.
- Use in elderly: The elderly have a longer elimination half-life and reduced medicinal product clearance as well as limited data to support efficacy in short-term use; for this reason, SmPCs for glycopyrronium tablets state these should not be used in patients over 65 years, however local specialists routinely use glycopyrronium bromide in elderly patients due to its limited ability to cross the blood brain barrier.
- NICE NG71 recommends considering glycopyrronium bromide for Parkinson’s disease if non-pharmacological management (e.g. speech and language therapy) is not available or has not been effective (off-label).
- NICE NG42 recommends considering a trial of an antimuscarinic medicine as a first line treatment for sialorrhoea in people with motor neurone disease, and to consider glycopyrronium bromide as first-line for people who have cognitive impairment (off-label).
- NICE NG62 includes glycopyrronium bromide (oral or by enteral tube) as one of a several anticholinergic medicines recommended for drooling in children and young people with cerebral palsy.
- Co-administration with food results in a marked decrease in systemic medicinal product exposure. SmPCs include advice for managing administration with respect to food intake.
- Where a preferred brand is recommended for a particular presentation, prescribing by brand helps ensure cost-efficient use of local NHS resources (see preferred brand link above).
Antispasmodics
Mebeverine
- Tablets 135mg (£2.77 = 135mg three times daily)
- Oral suspension sugar free 50mg/5ml (£205.70 = 300ml)
Indications
- Adjunct in gastro-intestinal disorders characterised by smooth muscle spasm
Dose
- 135-150mg three times daily preferably 20 minutes before meals
Notes
- Mebeverine liquid should only be prescribed for people unable to swallow tablets as there is approximately a 30 fold difference in cost compared to tablets
Peppermint oil
- Gastro-resistant capsules 0.2ml (£7.04 - £14.08)
Indications
- Relief of abdominal colic and distension, particularly in irritable bowel syndrome
Dose
- 1-2 capsules swallowed whole with water, three times daily before meals for up to 2-3 months if necessary