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
• Myasthenia gravis
• Mechanical stenosis in the gastrointestinal tract
• Paralytic or obstructive ileus
• Megacolon
• Narrow-angle glaucoma (See additional prescribing points)
• Porphyria
• Enlarged prostate
• Fever
• Tachycardia

Recommendations in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Myasthenia gravis
• Mechanical stenosis in the gastrointestinal tract
• Paralytic or obstructive ileus
• Megacolon
• Narrow-angle glaucoma (See additional prescribing points)

Cautions
South African recommendations

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Patients susceptible to intestinal or urinary outlet obstructions
• Patients prone to narrow-angle glaucoma (See additional prescribing points)
• Patients inclined to tachyarrhythmia
• Impaired metabolic function
• Fructose intolerance (tab)
• Glucose-galactose malabsorption (tab)
• Sucrase-isomaltase insufficiency (tab)
• May impair ability to drive and operate machinery

Recommendations in other jurisdictions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Conditions characterised by tachycardia
  - Thyrotoxicosis
  - Cardiac insufficiency or failure 
  - Cardiac surgery 
• Patients susceptible to intestinal or urinary outlet obstructions
• Fever
• Fructose intolerance
• Glucose-galactose malabsorption
• Sucrase-isomaltase insufficiency
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: syr, tab

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

• Oral (tab): Initial: 10mg, 8hrly; Titrated up to 20mg if necessary, 6hrly
• Oral (syr): 20ml, 6hrly

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The tablets should be swallowed whole with adequate liquid and not be chewed

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

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Indications and dosages registered in other jurisdictions

Relief of gastro-intestinal tract spasm associated with medically confirmed irritable bowel syndrome

• Oral (tab): Initial: 10mg, 8hrly; Titrated up to 20mg if necessary, 6hrly

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Tablets should be swallowed whole with adequate water

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Hyoscine butylbromide should not be taken 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: syr, tab

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

Oral (syr)

• Younger than 1 month: No information available
• Between 1-3 months: 2.5ml, 8hrly
• Between 3 months - 1 year: 2.5-5ml, 8hrly
• Between 1-3 years: 5-10ml, 8hrly 
• Between 3-6 years: 10ml, 8hrly 
• Between 6-12 years: 10-20ml, 8hrly  
• Older than 12 years: See adult dosage

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The initial dose must be the lowest recommended for age. Do not exceed the maximum recommended dose for age (syr)

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

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Oral (tab)

• Younger than 6 years: Not recommended for use (syr available)
• Between 6-12 years: Oral (tab): 10mg, 8hrly
• Older than 12 years: See adult dosage

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The tablets should be swallowed whole with adequate liquid and not be chewed

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Indications and dosages registered in other jurisdictions

Relief of gastro-intestinal tract spasm associated with medically confirmed irritable bowel syndrome

Younger than 12 years

• Not recommended for use

Older than 12 years

• See adult dosage

Pregnancy

• 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

• 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

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

Renal Impairment
South African recommendations

• Caution; no dose adjustment recommended  
  Adverse central nervous system effects may be more likely in these patients

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  
  Adverse central nervous system effects may be more likely in these patients 

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

Cardiovascular Disorders 

• Tachycardia
• Bradycardia followed by tachycardia with palpitations and arrhythmias

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders 

• Dry mouth

Genitourinary Disorders 

•  Urinary retention

Skin and Subcutaneous Tissue Disorders 

• Abnormal sweating
• Skin reactions
  - Urticaria
  - Rash
  - Erythema
  - Pruritis

Immune, Blood and Lymphatic System Disorders 

• Anaphylactic shock
• Anaphylactic reactions
• Hypersensitivity 

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

• 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 whilst, or after taking, hyoscine butylbromide

Hyoscine butylbromide is a quaternary ammonium anticholinergic medicine that acts at the parasympathetic ganglia in the walls of the viscera where it exerts a specific antispasmodic action on the smooth muscle of the gastrointestinal, biliary and urinary tracts. As a quaternary ammonium derivative, hyoscine butylbromide does not readily pass the blood-brain barrier to enter the central nervous system.

Syrup (per 5ml) 5mg

• Buscopan 0.1% (Sanofi Aventis) originator 
• Hyospasmol syrup (Pharmacare)    
• Scopex (Adcock Ingram) 

Tablet 10mg

• Buscopan 10mg (Sanofi Aventis) originator
• Hyospasmol (Pharmacare) 
• Scopex (Adcock Ingram) 

Also available in the following forms: injection.