Propiverine Hydrochloride

Registered South African indications

Adults

• Idiopathic bladder instability
• Neurogenic bladder
• Unstable bladder conditions

Paediatrics

• Symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency in patients with overactive bladder or neurogenic detrusor overactivity from spinal cord injuries

Contraindications

5mg Tablet

• Hypersensitivity to the active ingredient or any of its excipients
• Obstruction of the bowel
• Significant degree of bladder outflow obstruction where urinary retention may be anticipated
• Myasthenia gravis
• Intestinal atony
• Severe ulcerative colitis
• Toxic megacolon
• Uncontrolled angle closure glaucoma
• Moderate or severe hepatic impairment
• Tachyarrhythmias

15mg Tablet

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Obstruction of the bowel
• Significant degree of bladder outflow obstruction where urinary retention may be anticipated
• Myasthenia gravis
• Intestinal atony
• Severe ulcerative colitis
• Toxic megacolon
• Glaucoma
• Hepatic disorders
• Renal impairment
• Tachyarrhythmias
• Cardiac failure / dysrhythmias
• Diabetes mellitus with autonomic dysfunction
• Due to lack of data propiverine hydrochloride should not be used in children

Capsule

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Obstruction or suspected obstruction of the bowel
• Bladder outflow obstruction where urinary retention may be anticipated
• Myasthenia gravis
• Paralytic ileus
• Ulcerative colitis
• Toxic megacolon
• Glaucoma
• Renal impairment
• Hepatic impairment
• Tachydysrhythmias
• Due to lack of data propiverine hydrochloride should not be used in children

Cautions

• Pregnancy (5mg tab)
• Breastfeeding (5mg tab)
• Renal impairment (5mg tab)
• Mild hepatic impairment (5mg tab)
• Autonomic neuropathy
• Severe congestive cardiac failure (NYHA IV)
• Prostatic hypertrophy
• Hiatus hernia with reflux oesophagitis
• Cardiac arrhythmia
• Tachycardia
• Closed angle glaucoma
• Organic bladder diseases
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption
• Fructose intolerance
• Sucrase-isomaltase insufficiency

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

Overactive bladder syndrome
Idiopathic bladder instablility
Unstable bladder conditions

• Oral (cap): 30mg, dly
• Oral (tab): 15mg, 8-12hrly

Neurogenic detrusor overactivity

• Oral (tab): 15mg, 8hrly; Max: 45mg/24hrs

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

Symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency in patients with overactive bladder or neurogenic detrusor overactivity from spinal cord injuries

Younger than 1 year

• Not established for use

Older than 1 year

• Oral (tab): Daily average: 0.8mg/kg body weight, in 2-3 single doses (see below table)

Body weight (kg)	Propiverine Hydrochloride (5mg) per day
12 – 16	1 – 0 - 1
17 – 22	1 – 1 - 1
23 – 28	2 – 0 – 2
29 – 34	2 – 1 - 2
≥ 35	2 – 2 – 2 OR 3 – 0 – 3

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In children with a body weight ≥ 35kg, the maximum dose is the same as the standard dose in adults of 15mg twice daily

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Treatment of overactive bladder should not start before 5 years of age, as organic development is still not complete in many cases. However, treatment of neurogenic detrusor overactivity due to spinal cord injuries can be started even before 5 years of age. Administration of propiverine hydrochloride to children below 1 year of age is not recommended due to a lack of data

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Treatment of children should be administered only within the framework of an overall therapeutic approach (e.g. so-called “urotherapy” in cases of idiopathic detrusor overactivity)

Pregnancy

Capsule 30mg and Tablet 15mg

• Contraindicated

Tablet 5mg

• Caution; not recommended

Breastfeeding

Capsule 30mg and Tablet 15mg

• Contraindicated

Tablet 5mg

• Caution; not recommended

Renal Impairment

Capsule 30mg and Tablet 15mg

• Contraindicated

Tablet 5mg

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Caution; dose adjustment recommended
  Max: 30mg/24hrs

Hepatic Impairment

Capsule 30mg and Tablet 15mg

• Contraindicated

Tablet 5mg

• Mild: Caution; no dose adjustment recommended
• Moderate to severe: Contraindicated

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness
• Tremor
• Dysgeusia
• Restlessness
• Confusion
• Hallucinations
• Fatigue

Cardiovascular Disorders

• Palpitations
• Decreased blood pressure
• Flushing

Gastrointestinal Disorders

• Dry mouth
• Constipation
• Abdominal pain
• Dyspepsia
• Nausea and vomiting

Genitourinary Disorders

• Urinary retention

Skin and Subcutaneous Tissue Disorders

• Rash 

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity

Sensory Disorders

• Abnormal accommodation 
• Accommodation disturbances
• Abnormal vision 

• CYP3A4 inhibitors 
• Tricyclic antidepressants 
• Tranquillisers 
• Anticholinergics 
• Amantadine
• Neuroleptics
• Beta-agonists 
• Cholinergic agents
• Isoniazid
• Metoclopramide

• Hepatic function
• Renal function

Specific cases may require

• Intraocular pressure
• ECG

Propiverine is antispasmodic and anticholinergic. Inhibition of calcium influx causes musculotropic spasmolysis. Animal models show a decrease in the intravesical pressure and increase in bladder capacity.

Tablet 15mg

• Detrunorm (Acino Pharma)

Capsule 30mg

• Detrunorm XL (Acino Pharma)