Anticholinergics.

Trospium

The active ingredient is trospium chloride. Each coated tablet contains 20mg trospium chloride.

Coated tablet. Brownish-yellow, glossy coated, biconvex tablets.

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (e.g. idiopathic or neurologic detrusor overactivity).

One coated tablet twice daily (equivalent to 40mg of trospium chloride per day).

In patients with severe renal impairment (creatinine clearance between 10 and 30 ml/min/1.73 m²) the recommended dosage is: One coated tablet per day or every second day (equivalent to 20mg of trospium chloride per day or every second day).

The coated tablet should be swallowed whole with a glass of water before meals on an empty stomach.

The need for continued treatment should be reassessed at regular intervals of 3-6 months.

Since no data are available, use in children under 12 years of age is contra-indicated.

Under 12 years, contraindicated.

Trospium chloride is contra-indicated in patients with urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis, narrow-angle glaucoma and tachyarrhythmia.

Trospium chloride is also contra-indicated in patients who have demonstrated hypersensitivity to the active substance or to any of the excipients.

Trospium chloride should be used with caution by patients:

- with obstructive conditions of the gastro-intestinal tract such as pyloric stenosis

- with obstruction of the urinary flow with the risk of formation of urinary retention

- with autonomic neuropathy

- with hiatus hernia associated with reflux oesophagitis

- in whom fast heart rates are undesirable e.g. those with hyperthyroidism, coronary artery disease and congestive heart failure.

As there are no data in patients with severe hepatic impairment, treatment of these patients with trospium chloride is not recommended. In patients with mild to moderate liver impairment caution should be exercised.

Trospium chloride is mainly eliminated by renal excretion. Marked elevations in the plasma levels have been observed in patients with severe renal impairment. Therefore in this population but also in patients with mild to moderate renal impairment caution should be exercised.

Before commencing therapy organic causes of urinary frequency, urgency, and urge incontinence,such as heart diseases, diseases of the kidneys, polydipsia, or infections, or tumours of urinary organs should be excluded.

Regurin contains lactose monohydrate, sucrose and wheat starach. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Patients with rare hereditary problems of fructose intolerance or sucrase-isomaltase insufficiency should not take this medicine.

Patients with wheat allergy (different from coeliac disease) should not take this medicine. Apart from that, trospium chloride is suitable for people with coeliac disease.

Trospium chloride should be used with caution by patients:

- with obstructive conditions of the gastro-intestinal tract such as pyloric stenosis

- with obstruction of the urinary flow with the risk of formation of urinary retention

- with autonomic neuropathy

- with hiatus hernia associated with reflux oesophagitis

- in whom fast heart rates are undesirable e.g. those with hyperthyroidism, coronary artery disease and congestive heart failure.

As there are no data in patients with severe hepatic impairment, treatment of these patients with trospium chloride is not recommended. In patients with mild to moderate liver impairment caution should be exercised.

Trospium chloride is mainly eliminated by renal excretion. Marked elevations in the plasma levels have been observed in patients with severe renal impairment. Therefore in this population but also in patients with mild to moderate renal impairment caution should be exercised.

Before commencing therapy organic causes of urinary frequency, urgency, and urge incontinence,such as heart diseases, diseases of the kidneys, polydipsia, or infections, or tumours of urinary organs should be excluded.

Regurin contains lactose monohydrate, sucrose and wheat starach. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Patients with rare hereditary problems of fructose intolerance or sucrase-isomaltase insufficiency should not take this medicine.

Patients with wheat allergy (different from coeliac disease) should not take this medicine. Apart from that, trospium chloride is suitable for people with coeliac disease.

Pharmacodynamic interactions:

The following potential pharmacodynamic interactions may occur: Potentiation of the effect of drugs with anticholinergic action (such as amantadine, tricyclic antidepressants), enhancement of the tachycardic action of β-sympathomimetics; decrease in efficacy of pro-kinetic agents (e.g. metoclopramide).

Since trospium chloride may influence gastro-intestinal motility and secretion, the possibility cannot be excluded that the absorption of other concurrently administered drugs may be altered.

Pharmacokinetic interactions:

An inhibition of the absorption of trospium chloride with drugs like guar, cholestyramine and colestipol cannot be excluded. Therefore the simultaneous administration of these drugs with trospium chloride is not recommended.

Metabolic interactions of trospium chloride have been investigated in vitro on cytochrome P450 enzymes involved in drug metabolism (P450 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4). No influence on their metabolic activities were observed. Since trospium chloride is metabolised only to a low extent and since ester hydrolysis is the only relevant metabolic pathway, no metabolic interactions are expected.

Anticholinergic effects such as dry mouth, dyspepsia and constipation may occur during treatment with trospium chloride.

Very common (> 10%):

gastro-intestinal system: dry mouth

Common (> 1%):

gastro-intestinal system: dyspepsia, constipation, abdominal pain, nausea

Uncommon (< 1%):

gastro-intestinal system: flatulence

Rare (< 0.1%):

urinary system: micturition disorders (e.g. formation of residual urine)

cardiovascular system: tachycardia

vision disorders: disorders of accommodation (this applies in particular to patients who are hypermetropic and whose vision has not been adequately corrected)

gastro-intestinal system: diarrhoea

respiratory sytem: dyspnoea

skin: rash

body as a whole: asthenia, chest pain

Very rare (< 0.01%):

urinary system: urinary retention

cardiovascular system: tachyarrhythmia

musculoskeletal system: myalgia, arthralgia

skin: angio-oedema

liver and biliary system: mild to moderate increase in serum transaminase levels

body as a whole: anaphylaxis

central nervous system: headache, dizziness.

Galen

(POM)

21 May 2009