Trospi Tablet

Trospi is indicated for the 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).

Trospium is a muscarinic antagonist. Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder. Receptor assays showed that trospium chloride has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses.

20 mg Trospium Chloride tablet twice daily. The need for continued treatment should be reassessed at regular intervals of 3-6 months. The film-coated tablet should be swallowed whole with a glass of water before meals on an empty stomach.

Renal impairment: For patients with severe renal impairment (CrCl<30 mL/min), the recommended dose is 20 mg once daily at bedtime.

In geriatric patients: Greater than or equal to 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability.

Pediatric Use: The safety and efficacy of Trospium Chloride 20 mg film-coated tablets in children under 12 years of age has not been established. No data are available.

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 ß-sympathomi metics
• Decrease in efficacy of pro-kinetic agents (e.g. metoclopr amide)

Since Trospi may influence gastro-intestinal motility and secretion, the possibility cannot be excluded that the absorption of other concurrently administered medicinal products may be altered.

Pharmacokinetic interactions: An inhibition of the absorption of Trospi with drugs like guar, cholestyramine and colestipol cannot be excluded. Therefore, the simultaneous administration of these drugs with Trospi is not recommended. Metabolic interactions of Trospi have been investigated in vitro on cytochrome P450 enzymes involved in active substance metabolism (P450 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4). No influence on their metabolic activities was observed. Since Trospi is metabolised only to a low extent and since ester hydrolysis is the only relevant metabolic pathway, no metabolic interactions are expected. Though Trospi was shown not to affect pharmakinetics of digoxin, an interaction with other active substances eliminated by active tubular secretion cannot be excluded.

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.

The following adverse reactions have been identified during post-approval use of Trospi. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Gastrointestinal: gastritis
• Cardiovascular: palpitations, supraventricular tachycardia, chest pain, syncope,
• hypertensive crisis
• Immunological: Stevens-Johnson syndrome, anaphylactic reaction, angioedema
• Nervous System: dizziness, confusion, vision abnormal, hallucinations, somnolence and delirium
• Musculoskeletal: rhabdomyolysis
• General: rash

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. In rats, placental transfer and passage into the maternal milk of Trospium Chloride occurs. For Trospium Chloride 20mg film-coated tablets, no clinical data on exposed pregnancies are available. Caution should be exercised when prescribing to pregnant or breastfeeding women.

Trospi should be used with caution by patients:

• with obstructive conditions of the gastrointestinal 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.

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

Precautions: Renal impairment: Trospi 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.

After administration of a maximum single dose of 360 mg Trospi to healthy volunteers, dryness of the mouth, tachycardia and disorders of micturition were observed to an increased extent. No manifestations of severe overdose or intoxication in humans have been reported to date. Increased anticholinergic symptoms are to be expected as signs of intoxication.

In the case of intoxication the following measures should be taken:

• gastric lavage and reduction of absorption (e.g. activated charcoal)
• local administration of pilocarpine to glaucoma patients
• catheterisation in patients with urinary retention
• treatment with a parasympathomimetic agent (e.g. neostigmine) in the case of severe symptoms
• administration of beta blockers in the case of insufficient response, pronounced tachycardia and/or circulatory instability (e.g. initially 1 mg propranolol intravenously along with monitoring of ECG and blood pressure)

Other genito-urinary preparations

Store below 30ºC temperature in a dry place, protected from light.