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Lansoprazole 07-Jun-2017 l INDICATIONS AND DOSE

4.4 Helicobacter pylori diagnosis

DIAGNOSTIC AGENTS

Urea (13C)

lINDICATIONS AND DOSE

Diagnosis of gastro-duodenalHelicobacter pylori infection

▶BY MOUTH

Adult:(consult product literature)

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lMEDICINAL FORMS

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

Soluble tablet

Pylobactell(Torbet Laboratories Ltd)

Urea [13-C] 100 mgPylobactell breath test kit|1kitP£20.75 Powder

Helicobacter Test INFAI(INFAI UK Ltd)

Urea [13-C] 75 mgHelicobacter Test INFAI breath test kit sugar-free

|1kitP£21.70 Tablet

Diabact UBT(Seahorse Laboratories Ltd)

Urea [13-C] 50 mgdiabact UBT50mg tablets|1tabletP £21.25

|10tabletP no price available (Hospital only)

5 Food allergy

Food allergy

15-Dec-2016

Description of condition

Food allergy is an adverse immune response to a food, commonly associated with cutaneous and gastro-intestinal reactions, and less frequently associated with respiratory reactions and anaphylaxis. It is distinct from food intolerance which is non-immunological. Cow’s milk, hen’s eggs, soy, wheat, peanuts, tree nuts,fish, and shellfish are the most common allergens. Cross-reactivity between similar foods can occur (e.g. allergy to other mammalian milk in patients with cow’s milk allergy).

Management of food allergy

gAllergy caused by specific foods should be managed by strict avoidance of the causal food. Sodium cromoglicate p.260is licensed as an adjunct to dietary avoidance in patients with food allergy. Educating patients about appropriate nutrition, food preparation, and the risks of accidental exposure is recommended, such as food and drinks to avoid, ensuring adequate nutritional intake, and interpreting food labels.h

Drug treatment

gThere is low quality evidence to support the use of antihistamines to treat acute,non-life-threatening symptoms (such asflushing and urticaria) if accidental ingestion of allergenic food has occurred (seeAntihistamines, under Antihistamines, allergen immunotherapy and allergic emergencies p.265). Chlorphenamine maleate p.272is licensed for the symptomatic control of food allergy. In case of food-induced anaphylaxis, adrenaline/epinephrine p.216 is thefirst-line immediate treatment (see alsoAllergic emergencies, under Antihistamines, allergen immunotherapy and allergic emergencies p.265). Patients who are at risk of anaphylaxis should be trained to use self-injectable adrenaline/epinephrine.h

6 Gastro-intestinal smooth muscle spasm

Antispasmodics

Antimuscarinics

The intestinal smooth muscle relaxant properties of antimuscarinic and other antispasmodic drugs may be useful inirritable bowel syndrome.

Antimuscarinics (formerly termed‘anticholinergics’) reduce intestinal motility. They can be used for the management of irritable bowel syndrome.

Antimuscarinics that are used for gastro-intestinal smooth muscle spasm include the tertiary amines atropine sulfate p.1224and dicycloverine hydrochloride below and the quaternary ammonium compounds propantheline bromide p.84and hyoscine butylbromide p.83. The quaternary ammonium compounds are less lipid soluble than atropine sulfate and are less likely to cross the blood–brain barrier;

they are also less well absorbed from the gastro-intestinal tract.

Dicycloverine hydrochloride has a much less marked antimuscarinic action than atropine sulfate and may also have some direct action on smooth muscle. Hyoscine butylbromide is advocated as a gastro-intestinal antispasmodic, but it is poorly absorbed; the injection is useful in endoscopy and radiology. Atropine sulfate and the belladonna alkaloids are outmoded treatments, any clinical virtues being outweighed by atropinic side-effects.

Other indications for antimuscarinic drugs include arrhythmias, asthma and airways disease, motion sickness, parkinsonism, urinary incontinence, mydriasis and cycloplegia, premedication, and as an antidote to organophosphorus poisoning.

Other antispasmodics

Alverine citrate p.84, mebeverine hydrochloride p.84, and peppermint oil p.46are believed to be direct relaxants of intestinal smooth muscle and may relieve pain inirritable bowel syndrome. They have no serious adverse effects but, like all antispasmodics, should be avoided in paralytic ileus.

ANTIMUSCARINICS

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Dicycloverine hydrochloride

(Dicyclomine hydrochloride)

lINDICATIONS AND DOSE

Symptomatic relief of gastro-intestinal disorders characterised by smooth muscle spasm

▶BY MOUTH

Child 6–23 months:5–10mg3–4times a day, dose to be taken15minutes before feeds

Child 2–11 years: 10mg3times a day

Child 12–17 years:10–20mg3times a day

Adult:10–20mg3times a day

lCONTRA-INDICATIONSChild under6months lINTERACTIONS→Appendix1: dicycloverine lPREGNANCYNot known to be harmful; manufacturer

advises use only if essential.

lBREAST FEEDINGAvoid—present in milk; apnoea reported in infant.

lEXCEPTIONS TO LEGAL CATEGORYDicycloverine hydrochloride can be sold to the public provided that max.

single dose is10mg and max. daily dose is60mg.

lMEDICINAL FORMS

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

Oral solution

Dicycloverine hydrochloride (Non-proprietary) Dicycloverine hydrochloride 2 mg per 1 mlDicycloverine 10mg/5ml oral solution|100mlP no price available|120 mlP£196.36DT price = £178.79|300mlPno price available

Tablet

Dicycloverine hydrochloride (Non-proprietary)

Dicycloverine hydrochloride 10 mgDicycloverine10mg tablets| 100tabletP£201.22DT price = £184.25

82 Food allergy

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Dicycloverine hydrochloride 20 mgDicycloverine20mg tablets| 84tabletP £203.42DT price = £196.69

Dicycloverine hydrochloride with aluminium hydroxide, magnesium oxide and simeticone

The properties listed below are those particular to the combination only. For the properties of the components please consider, dicycloverine hydrochloride p.82, aluminium hydroxide p.964, simeticone p.70.

lINDICATIONS AND DOSE

Symptomatic relief of gastro-intestinal disorders characterised by smooth muscle spasm

▶BY MOUTH

Child 12–17 years:10–20mL every4hours as required

Adult:10–20mL every4hours as required lINTERACTIONS→Appendix1: antacids, dicycloverine lMEDICINAL FORMS

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

Oral suspension

Kolanticon(Peckforton Pharmaceuticals Ltd)

Dicycloverine hydrochloride 500 microgram per 1 ml, Simeticone 4 mg per 1 ml, Magnesium oxide light 20 mg per 1 ml, Aluminium hydroxide dried 40 mg per 1 mlKolanticon gel sugar-free|200 mlp £4.00sugar-free|500mlp £6.00

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Hyoscine butylbromide

13-Mar-2017 lINDICATIONS AND DOSE

Symptomatic relief of gastro-intestinal or genito-urinary disorders characterised by smooth muscle spasm

▶BY MOUTH

Child 6–11 years:10mg3times a day

Child 12–17 years:20mg4times a day

Adult:20mg4times a day Irritable bowel syndrome

▶BY MOUTH

Adult:10mg3times a day; increased if necessary up to 20mg4times a day

Acute spasm|Spasm in diagnostic procedures

▶INITIALLY BY INTRAMUSCULAR INJECTION, OR BY SLOW INTRAVENOUS INJECTION

Adult:20mg, then (by intramuscular injection or by slow intravenous injection)20mg after30minutes if required, dose may be repeated more frequently in endoscopy; maximum100mg per day

Excessive respiratory secretions in palliative care

▶BY MOUTH

Child 1 month–1 year:300–500micrograms/kg3–4times a day (max. per dose5mg)

Child 2–4 years:5mg3–4times a day

Child 5–11 years:10mg3–4times a day

Child 12–17 years:10–20mg3–4times a day

▶BY INTRAMUSCULAR INJECTION, OR BY INTRAVENOUS INJECTION

Child 1 month–4 years:300–500micrograms/kg 3–4times a day (max. per dose5mg)

Child 5–11 years:5–10mg3–4times a day

Child 12–17 years:10–20mg3–4times a day

▶BY SUBCUTANEOUS INJECTION

Adult:20mg every4hours if required, adjusted according to response to up to20mg every1hour

▶BY SUBCUTANEOUS INFUSION

Adult:20–120mg/24hours

Bowel colic (in palliative care)

▶BY MOUTH

Child 1 month–1 year:300–500micrograms/kg3–4times a day (max. per dose5mg)

Child 2–4 years:5mg3–4times a day

Child 5–11 years:10mg3–4times a day

Child 12–17 years:10–20mg3–4times a day

▶BY INTRAMUSCULAR INJECTION, OR BY INTRAVENOUS INJECTION

Child 1 month–4 years:300–500micrograms/kg 3–4times a day (max. per dose5mg)

Child 5–11 years:5–10mg3–4times a day

Child 12–17 years:10–20mg3–4times a day

▶BY SUBCUTANEOUS INJECTION

Adult:20mg every4hours if required, adjusted according to response to up to20mg every1hour

▶BY SUBCUTANEOUS INFUSION

Adult:60–300mg/24hours PHARMACOKINETICS

Administration by mouth is associated with poor absorption.

lUNLICENSED USETabletsnot licensed for use in children under6years.Injectionnot licensed for use in children (age range not specified by manufacturer).

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE: HYOSCINE BUTYLBROMIDE (BUSCOPAN®) INJECTION: RISK OF SERIOUS ADVERSE EFFECTS IN PATIENTS WITH UNDERLYING CARDIAC DISEASE (FEBRUARY 2017) The MHRA advises that hyoscine butylbromide injection can cause serious adverse effects including tachycardia, hypotension, and anaphylaxis; several reports have noted that anaphylaxis is more likely to be fatal in patients with underlying coronary heart disease.

Hyoscine butylbromide injection is contra-indicated in patients with tachycardia and should be used with caution in patients with cardiac disease; the MHRA recommends that these patients are monitored and that resuscitation equipment and trained personnel are readily available.

lCONTRA-INDICATIONS

With intramuscular use or intravenous use or subcutaneous useTachycardia

lINTERACTIONS→Appendix1: hyoscine lSIDE-EFFECTS

GENERAL SIDE-EFFECTS Anaphylaxis SPECIFIC SIDE-EFFECTS

▶Common or very common

With intramuscular use or intravenous use or subcutaneous useTachycardia

▶Uncommon

With oral useTachycardia

▶Frequency not known

With intramuscular use or intravenous use or subcutaneous useHypotension

lPREGNANCYManufacturer advises avoid.

lBREAST FEEDINGAmount too small to be harmful.

lDIRECTIONS FOR ADMINISTRATION

With oral use in childrenFor administration bymouth, injection solution may be used; content of ampoule may be stored in a refrigerator for up to24hours after opening.

With intravenous use in childrenForintravenous injection, may be diluted with Glucose5% or Sodium Chloride0.9%; give over at least1minute.

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lPRESCRIBING AND DISPENSING INFORMATION Palliative care

For further information on the use of hyoscine butylbromide in palliative care, see

www.palliativedrugs.com/formulary/en/hyoscine-butylbromide.

html.

lEXCEPTIONS TO LEGAL CATEGORYHyoscine butylbromide tablets can be sold to the public for medically confirmed irritable bowel syndrome, provided single dose does not exceed20mg, daily dose does not exceed80mg, and pack does not contain a total of more than240mg.

lMEDICINAL 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 Solution for injection

Buscopan(Boehringer Ingelheim Ltd)

Hyoscine butylbromide 20 mg per 1 mlBuscopan20mg/1ml solution for injection ampoules|10ampouleP £2.92DT price =

£2.92 Tablet

Buscopan(Boehringer Ingelheim Self-Medication Division, Boehringer Ingelheim Ltd)

Hyoscine butylbromide 10 mgBuscopan10mg tablets|56 tabletP £3.00DT price = £3.00

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Propantheline bromide

lINDICATIONS AND DOSE

Symptomatic relief of gastro-intestinal disorders characterised by smooth muscle spasm

▶BY MOUTH

Child 12–17 years:15mg3times a day, dose to be taken at least one hour before food and30mg, dose to be taken at night; maximum120mg per day

Adult:15mg3times a day, dose to be taken at least one hour before food and30mg, dose to be taken at night; maximum120mg per day

Adult enuresis

▶BY MOUTH

Adult:Initially15mg3times a day, dose to be taken at least one hour before food and30mg, dose to be taken at bedtime, subsequently adjusted according to response; maximum120mg per day

lUNLICENSED USETabletsnot licensed for use in children under12years.

lINTERACTIONS→Appendix1: propantheline lSIDE-EFFECTSFacialflushing

lPREGNANCYManufacturer advises avoid unless essential—no information available.

lBREAST FEEDINGMay suppress lactation.

lHEPATIC IMPAIRMENTManufacturer advises caution.

lRENAL IMPAIRMENT Manufacturer advises caution.

lMEDICINAL 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 LABELS23

Propantheline bromide (Non-proprietary)

Propantheline bromide 15 mgPropantheline bromide15mg tablets

|100tabletP no price available

Pro-Banthine(Kyowa Kirin Ltd)

Propantheline bromide 15 mgPro-Banthine15mg tablets|112 tabletP £20.74DT price = £20.74

ANTISPASMODICS

Alverine citrate

24-Feb-2016 lINDICATIONS AND DOSE

Symptomatic relief of gastro-intestinal disorders characterised by smooth muscle spasm|Dysmenorrhoea

▶BY MOUTH

Child 12–17 years:60–120mg1–3times a day

Adult:60–120mg1–3times a day

lCONTRA-INDICATIONSIntestinal obstruction

.

paralytic ileus

lSIDE-EFFECTSDizziness

.

dyspnoea

.

headache

.

hepatitis

.

jaundice (resolves with cessation)

.

nausea

.

pruritus

.

wheezing

lPREGNANCYManufacturer advises avoid—limited information available

lBREAST FEEDINGManufacturer advises avoid—limited information available.

lPATIENT AND CARER ADVICE Driving and skilled tasks

Dizziness may affect performance of skilled tasks (e.g.

driving).

lMEDICINAL FORMS

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

Capsule

Alverine citrate (Non-proprietary)

Alverine citrate 60 mgAlverine60mg capsules|100capsulep

£19.49DT price = £19.48

Alverine citrate 120 mgAlverine120mg capsules|60capsulep

£23.28DT price = £23.28

Audmonal(Teva UK Ltd)

Alverine citrate 60 mgAudmonal60mg capsules|100capsulep

£14.80DT price = £19.48

Alverine citrate 120 mgAudmonal Forte120mg capsules|60 capsulep£17.75DT price = £23.28

Gielism(HFA Healthcare Products Ltd)

Alverine citrate 60 mgGielism60mg capsules|100capsulep

£19.48DT price = £19.48

Spasmonal(Meda Pharmaceuticals Ltd)

Alverine citrate 60 mgSpasmonal60mg capsules|100capsulep

£16.45DT price = £19.48

Alverine citrate 120 mgSpasmonal Forte120mg capsules|60 capsulep£19.42DT price = £23.28

Mebeverine hydrochloride

lINDICATIONS AND DOSE

Adjunct in gastro-intestinal disorders characterised by smooth muscle spasm

▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES

Child 10–17 years:135–150mg3times a day, dose preferably taken20minutes before meals

Adult:135–150mg3times a day, dose preferably taken 20minutes before meals

Irritable bowel syndrome

▶BY MOUTH USING MODIFIED-RELEASE MEDICINES

Child 12–17 years:200mg twice daily

Adult:200mg twice daily

lUNLICENSED USETablets and liquidnot licensed for use in children under10years.Granulesnot licensed for use in children under12years.Modified-release capsulesnot licensed for use in children under18years.

lCONTRA-INDICATIONSParalytic ileus

lSIDE-EFFECTSAllergic reactions

.

angioedema

.

rash

.

urticaria

84 Gastro-intestinal smooth muscle spasm

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lPREGNANCYNot known to be harmful—manufacturers advise avoid.

lBREAST FEEDINGManufacturers advise avoid—no information available.

lPATIENT AND CARER ADVICE

Patients or carers should be given advice on the timing of administration of mebeverine hydrochloride tablets and oral suspension.

Medicines for Children leaflet: Mebeverine for intestinal spasm www.medicinesforchildren.org.uk/mebeverine-for-intestinal-spasms

lEXCEPTIONS TO LEGAL CATEGORY

In adultsMebeverine hydrochloride can be sold to the public for symptomatic relief of irritable bowel syndrome provided that max. single dose is135mg and max. daily dose is405mg; for uses other than symptomatic relief of irritable bowel syndrome provided that max. single dose is 100mg and max. daily dose is300mg.

lMEDICINAL FORMS

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

Oral suspension

Mebeverine hydrochloride (Non-proprietary)

Mebeverine hydrochloride (as Mebeverine pamoate) 10 mg per 1 mlMebeverine50mg/5ml oral suspension sugar free sugar-free| 300mlP £187.00DT price = £187.00

Modified-release capsule CAUTIONARY AND ADVISORY LABELS25

Colofac MR(Mylan Ltd)

Mebeverine hydrochloride 200 mgColofac MR200mg capsules| 60capsuleP£6.92DT price = £6.92

Tablet

Mebeverine hydrochloride (Non-proprietary)

Mebeverine hydrochloride 135 mgMebeverine135mg tablets| 100tabletP £20.00DT price = £5.22

Colofac(Mylan Ltd)

Mebeverine hydrochloride 135 mgColofac135mg tablets|100 tabletP £9.02DT price = £5.22

7 Liver disorders and related

conditions