Hyoscine Butylbromide

Registered South African indications:

• Conditions associated with gastrointestinal spasm

Contraindications 
South African recommendations

• Hypersensitivity to the active ingredient or any of its excipients 
• Closed angle glaucoma 
• Enlarged prostrate 
• Urinary retention due to any urethral or prostate disease 
• Mechanical stenoses 
• Obstruction of the gastrointestinal tract 
• Pyloric stenosis 
• Paralytic or obstructive ileus 
• Megacolon 
• Tachycardia 
• Myasthenia gravis 
• Porphyria 
• Fever 
• Intramuscular administration to patients being treated with anticoagulant medicines

Recommendations in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Narrow-angle glaucoma (See additional prescribing points)
• Prostate hypertrophy with urinary retention
• Mechanical stenosis in the gastrointestinal tract
• Paralytic or obstructive ileus
• Megacolon
• Tachycardia
• Myasthenia gravis
• Intramuscular injection to patients being treated with anticoagulant drugs

Cautions
South African recommendations

• Pregnancy
• Breastfeeding
• Renal impairment 
• Hepatic impairment
• Elderly 
• Pre-existing cardiac conditions
  - Cardiac failure
  - Coronary heart disease
  - Cardiac dysrhythmia
  - Cardiac surgery
• Impaired metabolic function
• May impair ability to drive and operate machinery

Recommendations in other jurisdictions

• Pregnancy
• Breastfeeding
• Renal impairment 
• Hepatic impairment
• Elderly 
• Pre-existing cardiac conditions
  - Cardiac failure
  - Coronary heart disease
  - Cardiac arrhythmia
  - Hypertension
  - Cardiac surgery
• Fever
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: inj

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Conditions associated with gastrointestinal spasm

• IV/IM/SC: 20mg, as a slow injection several times daily; Max: 100mg/24hrs

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Hyoscine butylbromide should not be given by intramuscular injection to patients being treated with anticoagulant medicines since intramuscular haematoma may occur. In these patients, it should be administered via the subcutaneous or intravenous routes

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After parenteral administration of hyoscine butylbromide, cases of anaphylaxis including episodes of shock have been observed. Patients receiving hyoscine butylbromide by injection should be kept under observation 

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Indications and dosages registered in other jurisdictions

Acute spasm
- Renal or biliary colic
Diagnostics
- In radiology for differential diagnosis for obstruction
- To reduce spasm and pain in pyelography
- In other diagnostic procedures where spasm may be a problem (e.g. gastroduodenal endoscopy)

• IV: 20mg as a slow injection; Repeat dose after 0.5hrs if needed; Max: 100mg/24hrs 
• IM: 20mg; Repeat dose after 0.5hrs if needed; Max: 100mg/24hrs

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

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Intravenous injection should be performed 'slowly' (in rare cases a marked drop in blood pressure and even shock may be produced by hyoscine injection)

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When used in endoscopy this dose may need to be repeated more frequently 

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Method of administration: For intravenous and intramuscular injection. Hyoscine butylbromide may be used diluted with glucose or with sodium chloride 0.9% solution for injection

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Hyoscine butylbromide injection should not be used on a continuous daily basis or for extended periods without investigating the cause of abdominal pain

Paed. forms avail. in SA and covered in this monograph: inj

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Conditions associated with gastrointestinal spasm

Younger than 12 years
In severe cases

• IV/IM/SC: 5mg, as a slow injection, 8hrly; Max: 1.5mg/kg/24hrs

Older than 12 years

• See adult dosage 

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Hyoscine butylbromide should not be given by intramuscular injection to patients being treated with anticoagulant medicines since intramuscular haematoma may occur. In these patients, it should be administered via the subcutaneous or intravenous routes

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After parenteral administration of hyoscine butylbromide, cases of anaphylaxis including episodes of shock have been observed. Patients receiving hyoscine butylbromide by injection should be kept under observation 

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Indications and dosages registered in other jurisdictions

Not recommended for use

Pregnancy

South African recommendations

• Caution; not recommended
• Hyoscine butylbromide should not be used during pregnancy

Recommendations in other jurisdictions

• Caution; not recommended
• There are limited data from the use of hyoscine butylbromide in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. As a precautionary measure, hyoscine butylbromide is not recommended during pregnancy

Breastfeeding
South African recommendations

• Caution; not recommended
• Hyoscine butylbromide should not be used during lactation

Recommendations in other jurisdictions

• Caution; not recommended 
• There is insufficient information on the excretion of hyoscine butylbromide and its metabolites in human milk. A risk to the breastfeeding child cannot be excluded. Use of hyoscine butylbromide during breastfeeding is not recommended

Fertility
South African recommendations

• No information available

Recommendations in other jurisdictions

• No studies on the effects on human fertility have been conducted

Renal Impairment
South African recommendations

• Caution; no dose adjustment recommended 

Recommendations in other jurisdictions

• Caution; no information available 
  There is an increased risk of adverse events

Hepatic Impairment
South African recommendations

• Caution; no dose adjustment recommended  

Recommendations in other jurisdictions

• Caution; no information available 
  There is an increased risk of adverse events

Elderly
South African recommendations

• Caution; no information available

Recommendations in other jurisdictions

• Caution; no dose adjustment recommended 
  No specific information on the use of this medicine in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported

Porphyria Information

South African recommendations

• Contraindicated 

Recommendations in other jurisdictions

• Probably not porphyrinogenic (PNP)

Drugs in Sport

 Permitted - No warnings

Central Nervous System Disorders 

• Dizziness
• Psychiatric disorders 
• Confusion

Cardiovascular Disorders 

• Tachycardia
• Decreased blood pressure

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders 

• Dry mouth
• Constipation

Genitourinary Disorders 

•  Urinary retention

Skin and Subcutaneous Tissue Disorders 

• Abnormal sweating
• Injection site pain (particularly after intramuscular)
• Flushing
• Skin reactions
  - Urticaria
  - Rash
  - Erythema
  - Pruritis
• Dyshidrosis

Immune, Blood and Lymphatic System Disorders 

• Anaphylactic shock (including cases with fatal outcome)
• Anaphylactic reactions
• Hypersensitivity reactions  

Sensory Disorders 

• Accommodation disorders
• Mydriasis
• Increased intraocular pressure

• Tricyclic antidepressants
• Tetracyclic antidepressants
• Antihistamines
• Quinidine
• Amantadine
• Antipsychotics
• Phenothiazines
• Butyrophenones
• Disopyramide
• Other anticholinergics
• Tiotropium 
• Ipratropium
• Atropine-like compounds
• Dopamine antagonists
• Metoclopramide

• Body temperature
• Heart rate
• Urinary output
• Intraocular pressure

Additional observations

• Mental alertness

Narrow-angle glaucoma

• Narrow-angle glaucoma is a contraindication for use of hyoscine butylbromide. Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as hyoscine butylbromide in patients with undiagnosed and therefore untreated narrow-angle glaucoma
• Therefore, patients should seek urgent ophthalmological advice in case they should develop a painful, red eye with loss of vision after the injection of hyoscine butylbromide

Hyoscine butylbromide is an antispasmodic agent which relaxes smooth muscle of the organs of the abdominal and pelvic cavities. It is believed to act predominantly on the intramural parasympathetic ganglia of these organs. Hyoscine butylbromide, due to its chemical structure as a quaternary ammonium derivate, is not expected to enter the central nervous system. Hyoscine butylbromide does not readily pass the blood-brain barrier. However, it cannot totally be ruled out that under certain circumstances psychiatric disorders (e.g. confusion) may also occur after administration of hyoscine butylbromide.

Injection (per ml) 20mg

• A-Lennon hyoscine butylbromide 20mg/1ml injection (Pharmacare)
• Buscopan 20mg/1ml (Sanofi Aventis) originator
• Hyoscine butylbromide Fresenius 20mg/ml (Fresenius Kabi)
• Hyospasmol (Pharmacare)
• Pharma-Q hyoscine butylbromide injection 20mg/1ml (Pharma-Q Holdings)
• Scopaject (Mylan) (Discontinued: 01/04/2018)
• Scopex (Adcock Ingram)

Also available in the following forms: syrup and tablets.