Composition: Trospium chloride 20mg.
Presentation: Brownish-yellow tablets.
Action: Anticholinergic.
Indications:
For the treatment of detrusor instability or detrusor hyperreflexia with the
symptoms of urinary frequency, urgency and urge incontinence.
Contraindications: Urinary retention, narrow angle glaucoma, tachyarrhythmia,
myasthenia gravis, severe ulcerative colitis, toxic megacolon, dialysed renal
insufficiency (creatinine clearance <10ml/min/1.73m2).
Dosage and administration: 20mg twice daily. The tablets 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.
Renal impairment, use with caution. Severe renal impairment (creatinine clearance
between 10 and 30ml/min/1.73m2), recommended dose 20mg per day or every second
day.
Liver impairment, no data available. Not recommended.
Children under 12 years of age, no data available. Contraindicated.
Pregnancy and lactation, use with caution.
Overdosage: Increased anticholinergic symptoms expected as signs of intoxication.
See SPC for treatment of intoxication.
Precautions: Use with caution: obstructive conditions of the gastro-intestinal
tract such as pyloric stenosis; obstruction of urinary flow with the risk of
developing urinary retention; autonomic neuropathy; hiatus hernia associated
with reflux oesophagitis; patients in whom fast heart rates are undesirable
eg, those with hyperthyroidism, coronary artery disease and congestive heart
failure. Organic causes of urinary frequency, urgency and urge incontinence
such as heart diseases, kidney diseases, polydipsia, infections or tumours of
urinary organs should be excluded. Regurin contains wheat starch as an excipient.
Drug interactions: Potentiation of the effects of drugs with anticholinergic
action such as amantadine, tricyclic antidepressants, quinidine, antihistamines
and disopyramide; enhancement of the tachycardic action of b-sympathomimetics;
decrease in efficacy of metoclopramide and cisapride. Absorption of concurrently
administered drugs may be altered. Simultaneous administration of trospium with
guar, cholestyramine and cholestipol is not recommended.
Side effects: Anticholinergic effects. Common undesirable effects (>1 per
cent) are dry mouth, dyspepsia, constipation, abdominal pain, nausea. Rare effects
(<1 per cent) are micturition disorders, tachycardia, disorders of accommodation,
diarrhoea, flatu-
lence, dyspnoea, rash, asthenia and chest pain.
Net price: 60 £25.
Supplier: Galen, Seagoe Industrial Estate, Craigavon, Northern Ireland BT63
5UA. Tel 028 3833 4974, fax 028 3835 0206.
Legal class: POM.