Drugs List

Therapeutic Indications

Uses

Acute spasm especially in diagnostic procedures
Biliary colic
In radiology for differential diagnosis of obstruction
Renal colic

Unlicensed Uses

Bowel colic in palliative care
Excessive respiratory secretions

Administration

For intramuscular or intravenous injection.

Intravenous injection should be slow, as rapid injection can cause rapid hypotension and shock. In children, administration should be over at least 1 minute.

Cases of anaphylaxis have been reported after parenteral administration of hyoscine butylbromide, and so patients should be carefully observed for adverse reactions following administration.

In children the injection solution may be used for oral administration (unlicensed). The contents of the ampoule may be stored in a refrigerator for up to 24 hours after opening.

Contraindications

Children under 2 years
Benign prostatic hyperplasia
Megacolon
Myasthenia gravis
Narrow angle glaucoma
Paralytic ileus
Pyloric stenosis
Tachycardia

Precautions and Warnings

Children aged 2 to 18 years
Diarrhoea
Down's syndrome
Elderly
Pyrexia
Breastfeeding
Cardiac arrhythmias
Cardiac failure
Cardiac surgery
Gastroesophageal reflux
Gastrointestinal obstruction
Hypertension
Hyperthyroidism
Ischaemic heart disease
Pregnancy
Thyrotoxicosis
Ulcerative colitis
Urinary obstruction

Advise ability to drive/operate machinery may be affected by side effects
Advise visual disturbances may affect ability to drive or operate machinery
Discard any unused portion
Resuscitation facilities must be immediately available
If visual disturbances occur, perform ophthalmic evaluation
Monitor patient closely for serious adverse events following administration
Advise patient to report unexplained nausea,vomiting,abdominal pain
Elderly: may be more susceptible to antimuscarinic side effects

Patients should seek immediate ophthalmological advice if they develop a painful, red eye with loss of vision whilst or after taking hyoscine butylbromide, as anticholinergic agents may elevate intraocular pressure in patients with undiagnosed, and therefore untreated narrow angle glaucoma.

Hyoscine butylbromide injection should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.

Pregnancy and Lactation

Pregnancy

Use with caution in pregnancy.

Hyoscine butylbromide has been in wide general use for many years, there is no definite evidence of ill consequence during human pregnancy and animal studies have shown no hazard.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Hyoscine butylbromide may be administered for appropriate indications and appears to be well tolerated by breastfed infants (Schaefer, 2007)

The manufacturer however advises that safety during breastfeeding has not yet been established.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Anaphylactic reaction
Anaphylactic shock
Arrhythmias
Bradycardia
Confusion
Constipation
Decreased bronchial secretions
Dilatation of pupils
Dry mouth
Dry skin
Dyshidrosis
Dyspnoea
Erythema
Flushing
Giddiness
Glaucoma (closed angle)
Hypersensitivity reactions
Hypotension
Increased intra-ocular pressure
Local pain (injection site)
Mydriasis
Nausea
Palpitations
Photophobia
Pruritus
Rash
Skin reactions
Tachycardia
Urinary retention
Urinary urgency
Urticaria
Visual disturbances
Vomiting

Presentation

Solution for injection containing hyoscine butylbromide.

Drugs List

Therapeutic Indications

Uses

Acute spasm especially in diagnostic procedures
Biliary colic
In radiology for differential diagnosis of obstruction
Renal colic

Unlicensed Uses

Bowel colic in palliative care
Excessive respiratory secretions

Dosage

Adults

Children

Administration

For intramuscular or intravenous injection.

Intravenous injection should be slow, as rapid injection can cause rapid hypotension and shock. In children, administration should be over at least 1 minute.

Cases of anaphylaxis have been reported after parenteral administration of hyoscine butylbromide, and so patients should be carefully observed for adverse reactions following administration.

In children the injection solution may be used for oral administration (unlicensed). The contents of the ampoule may be stored in a refrigerator for up to 24 hours after opening.

Contraindications

Children under 2 years
Benign prostatic hyperplasia
Megacolon
Myasthenia gravis
Narrow angle glaucoma
Paralytic ileus
Pyloric stenosis
Tachycardia

Precautions and Warnings

Children aged 2 to 18 years
Diarrhoea
Down's syndrome
Elderly
Pyrexia
Breastfeeding
Cardiac arrhythmias
Cardiac failure
Cardiac surgery
Gastroesophageal reflux
Gastrointestinal obstruction
Hypertension
Hyperthyroidism
Ischaemic heart disease
Pregnancy
Thyrotoxicosis
Ulcerative colitis
Urinary obstruction

Advise ability to drive/operate machinery may be affected by side effects
Advise visual disturbances may affect ability to drive or operate machinery
Discard any unused portion
Resuscitation facilities must be immediately available
If visual disturbances occur, perform ophthalmic evaluation
Monitor patient closely for serious adverse events following administration
Advise patient to report unexplained nausea,vomiting,abdominal pain
Elderly: may be more susceptible to antimuscarinic side effects

Patients should seek immediate ophthalmological advice if they develop a painful, red eye with loss of vision whilst or after taking hyoscine butylbromide, as anticholinergic agents may elevate intraocular pressure in patients with undiagnosed, and therefore untreated narrow angle glaucoma.

Hyoscine butylbromide injection should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.

Pregnancy and Lactation

Pregnancy

Use with caution in pregnancy.

Hyoscine butylbromide has been in wide general use for many years, there is no definite evidence of ill consequence during human pregnancy and animal studies have shown no hazard.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Hyoscine butylbromide may be administered for appropriate indications and appears to be well tolerated by breastfed infants (Schaefer, 2007)

The manufacturer however advises that safety during breastfeeding has not yet been established.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Anaphylactic reaction
Anaphylactic shock
Arrhythmias
Bradycardia
Confusion
Constipation
Decreased bronchial secretions
Dilatation of pupils
Dry mouth
Dry skin
Dyshidrosis
Dyspnoea
Erythema
Flushing
Giddiness
Glaucoma (closed angle)
Hypersensitivity reactions
Hypotension
Increased intra-ocular pressure
Local pain (injection site)
Mydriasis
Nausea
Palpitations
Photophobia
Pruritus
Rash
Skin reactions
Tachycardia
Urinary retention
Urinary urgency
Urticaria
Visual disturbances
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: May 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweet man, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Buscopan Ampoules. Boehringer Ingelheim Ltd. Revised August 2017.

The Norwegian Porphyria Centre (NAPOS) - The Drug Database for Acute Porphyria
Available at: https://www.drug-porphyria.org/index.php
Butylscopolamine. Last revised October 8, 2010
Last accessed: March 24, 2012

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 27 April 2021