Trospium Chloride

Registered South African indications:

• Detrusor overactivity

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Urinary retention, including urinary retention due to prostatic disease (e.g. benign prostatic hyperplasia)
• Bladder neck and/or urethral stenosis
• Narrow-angle glaucoma
• Tachyarrhythmia
• Myasthenia gravis
• Severe ulcerative colitis
• Toxic megacolon
• Dialysed renal insufficiency (creatinine clearance <10ml/min/1.73m²)
• Mechanical stenosis or obstructive lesions of the gastrointestinal tract
• Severe impairment of hepatic function

Cautions

• Pregnancy
• Breastfeeding
• Mild to moderate renal impairment
• Mild to moderate hepatic impairment
• Elderly
• Gastrointestinal tract obstruction
• Urinary obstruction
• Autonomous neuropathy
• Hiatus hernia
• Reflux oesophagitis
• Hyperthyroidism
• Coronary disease
• Congestive cardiac failure
• Organic causes of frequency, urgency and urge incontinence
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption
• May impair ability to drive and operate machinery

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

Detrusor instability or overactivity

• Oral (tab): 20mg, 12hrly

To be taken whole on an empty stomach with a glass of water

Not recommended for use in children under 18 years of age as insufficient data is available

Pregnancy

• Caution; not recommended
• 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
• No clinical data on exposed pregnancies are available, so caution should be exercised when prescribing to pregnant women

Breastfeeding

• Caution; not recommended
• Caution should be exercised when prescribing to breastfeeding women

Renal Impairment

• Mild: Caution; no dose adjustment recommended
• Moderate: Caution; dose adjustment recommended
  Oral (tab): 20mg, dly
• Dialysed renal insufficiency (CrCl<10ml/min/1.73m²): Contraindicated

Hepatic Impairment

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Contraindicated

Elderly

• Caution; dose adjustment recommended

Porphyrinogenic information

• Not porphyrinogenic (NP)

Central Nervous System Disorders

• Headache
• Dizziness
• Asthenia

Cardiovascular Disorders

• Tachycardia
• Tachyarrhythmia
• Chest pain

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders

• Dry mouth
• Dyspepsia
• Constipation
• Abdominal pain
• Nausea
• Flatulence
• Diarrhoea

Hepatobiliary Disorders

• Increased serum transaminases

Genitourinary Disorders

• Micturition disorders
• Urinary retention

Musculoskeletal Disorders

• Myalgia
• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Rash
• Angioedema

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis

Sensory Disorders

• Disorders of accommodation

• Anticholinergics
• Sympathomimetics
• Prokinetics
• Guar
• Cholestyramine
• Colestipol

Renal function

Trospium chloride binds antagonistically to M1, M2 and M3muscarinic receptors. This has an anticholinergic effect which results in relaxation of genitourinary and gastrointestinal smooth muscle. In addition, trospium can inhibit bronchial secretion, the secretion of saliva and sweat, as well as the accommodation ability of the eyes. No central effects have so far been observed.

Tablet 20mg

• Uricon (Takeda) originator