Trospium Chloride 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 blocks the action of acetylcholine on muscarinic receptors in cholinergically innervated organs, including the bladder. Its parasympatholytic effect reduces the tone of smooth muscle in the bladder. Receptor studies show that trospium chloride has very low affinity for nicotinic receptors compared to muscarinic receptors at therapeutic doses.

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

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

In geriatric patients: In patients ≥75 years of age, the dose may be reduced to 20 mg once daily based on tolerability.

Pediatric use: The safety and efficacy of Trospium Chloride 20 mg film-coated tablets in children under 12 years of age have 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-sympathomimetics
• Decrease in efficacy of pro-kinetic agents (e.g. metoclopramide)

Since Trospium Chloride may influence gastrointestinal motility and secretion, it may alter the absorption of other concurrently administered medicines.

Pharmacokinetic interactions: Absorption of Trospium Chloride may be reduced by drugs such as guar, cholestyramine, and colestipol. Therefore, concurrent use is not recommended. In vitro studies show no significant interaction with cytochrome P450 enzymes (1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4). Since Trospium Chloride undergoes minimal metabolism, clinically relevant metabolic interactions are unlikely. Although it does not affect the pharmacokinetics of digoxin, interaction with drugs eliminated by active tubular secretion cannot be completely excluded.

Trospium Chloride is contraindicated in patients with: Urinary retention , Severe gastrointestinal conditions (including toxic megacolon), Myasthenia gravis, Narrow-angle glaucoma, Tachyarrhythmia. It is also contraindicated in patients hypersensitive to the active substance or any excipients.

Reported adverse reactions include:

• Gastritis
• Palpitations, supraventricular tachycardia, chest pain, syncope, hypertensive crisis
• Stevens-Johnson syndrome, anaphylactic reactions, angioedema
• Dizziness, confusion, visual disturbances, hallucinations, somnolence, delirium
• Rhabdomyolysis
• Skin rash

Animal studies do not indicate direct or indirect harmful effects on pregnancy, fetal development, or postnatal development. Placental transfer and excretion into breast milk have been observed in animals. No clinical data are available in pregnant or breastfeeding women. Therefore, caution should be exercised when prescribing.

Use with caution in patients with:

• Gastrointestinal obstruction (e.g. pyloric stenosis)
• Urinary outflow obstruction or risk of urinary retention
• Autonomic neuropathy
• Hiatus hernia with reflux oesophagitis
• Conditions where tachycardia is undesirable (e.g. hyperthyroidism, coronary artery disease, congestive heart failure)

Hepatic impairment: Not recommended in severe hepatic impairment; caution in mild to moderate cases.
Renal impairment: Use with caution due to increased plasma levels in severe renal impairment.

Organic causes of urinary symptoms (e.g. infections, tumors, cardiac or renal disease) should be excluded before treatment.

Symptoms of overdose may include dry mouth, tachycardia, and urinary disorders. Severe toxicity has not been reported.

Management includes:

• Gastric lavage and activated charcoal
• Pilocarpine for glaucoma symptoms
• Catheterization for urinary retention
• Parasympathomimetic agents (e.g. neostigmine) in severe cases
• Beta-blockers for severe tachycardia or circulatory instability

Other genito-urinary preparations

Store below 30°C in a dry place, protected from light.