Chemical formula: C₂₅H₃₀NO₃+ Molecular mass: 392.518 g/mol PubChem compound: 5284632
Trospium interacts in the following cases:
Co-administration of tropium with β-sympathomimetics may enhance the tachycardic action of β-sympathomimetics.
Co-administration of tropium with other anticholinergic agents may potentiate of the effect of drugs with anticholinergic action (such as amantadine, tricyclic antidepressants).
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.
In patients with mild to moderate liver impairment caution should be exercised.
As there are no data in patients with severe hepatic impairment, treatment of these patients with trospium chloride is not recommended.
Co-administration of tropium with pro-kinetic agents may decrease in efficacy of pro-kinetic agents (e.g. metoclopramide).
Trospium chloride should be used with caution by patients:
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.
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 of trospium chloride occurs. For trospium chloride, no clinical data on exposed pregnancies are available.
In rats, passage into the maternal milk of trospium chloride occurs. Caution should be exercised when prescribing to pregnant or breastfeeding women.
Principally, disorders of accommodation can lower the ability to actively participate in road traffic and to use machines. However, examinations of parameters characterising the ability to participate in road traffic (visual orientation, general ability to react, reaction under stress, concentration and motor coordination) have not revealed any effects of trospium chloride.
Undesirable effects observed with trospium chloride such as dry mouth, dyspepsia and constipation mainly reflect the typical anticholinergic properties of the active ingredient.
In Phase-III clinical studies, dry mouth was very common and occurred in approximately 18% of patients treated with trospium chloride and in approximately 6% treated with placebo (total of 1931 patients of which 911 received placebo).
The following list includes possibly related drug reactions reported for patients treated with trospium chloride immediate-release formulation:
Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very Rare (<1/10,000), Not known (cannot be estimated from the available data).
Uncommon: Tachycardia
Not known: Tachyarrhythmia
Uncommon: Headache
Rare: Dizziness
Not known: Hallucination*, Confusion*, Agitation*
Rare: Vision disorders
Not known: Dyspnoea
Very common: Dry mouth
Common: Dyspepsia, Constipation, Abdominal pain, Nausea
Uncommon: Flatulence, Diarrhoea
Rare: Micturition disorders, Urinary retention
Rare: Rash
Very Rare: Angio-oedema
Not known: Pruritus, Urticaria, Stevens-Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN)
Rare: Myalgia, Arthralgia
Uncommon: Chest pain
Not known: Asthenia
Not known: Anaphylaxis
Not known: Mild to moderate increase in serum transaminase levels
* These adverse effects occurred mostly in elderly patients and can be facilitated by neurological diseases and/or concomitant intake of other anticholinergic drugs.
Undesirable effects observed with trospium chloride are caused mainly by typical anticholinergic effects such as dry mouth, dyspepsia and constipation.
In two Phase 3, placebo-controlled, double-blind clinical studies 1165 patients were treated for 12 weeks with either trospium chloride 60 mg prolonged release formulation or placebo.
The following table lists possibly related adverse events reported for patients treated with trospium chloride prolonged release formulation:
Very common (>1/10), Common (≥1/100,<1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10.000, <1/1000), Very Rare (<1/10.000), Not known (cannot be estimated from the available data)
Rare: Tachycardia
Common: Dry eye
Rare: Vision disorders
Very common: Dry mouth
Common: Dyspepsia, Constipation, Constipation aggravated, Abdominal pain, Abdominal distension, Nausea
Uncommon: Flatulence
Rare: Asthenia
Very Rare: Urinary tract infection
Very Rare: Headache
Not known: Hallucination*, Confusion*, Agitation*
Rare: Micturition disorders, Urinary retention
Common: Nasal dryness
Rare: Rash
* These adverse effects occurred mostly in elderly patients and can be facilitated by neurological diseases and/or concomitant intake of other anticholinergic drugs.
In ensuing open-label phases of the two Phase 3 clinical studies the most common adverse events constipation (6.8%) and dry mouth (6.5%) were reported less frequently.
For immediate-release formulations of trospium chloride the following undesirable effects have been observed in post-marketing surveillance:
Cardiac disorders: tachyarrhythmia; Gastrointestinal disorders: diarrhoea; General disorders and administration site conditions: chest pain; Immune system disorders: anaphylaxis; Investigations: mild to moderate increase in serum transaminase levels; Muscoloskeletal and connective tissue disorders: myalgia, arthralgia; Nervous system disorders: dizziness; Respiratory, thoracic and mediastinal disorders: dyspnoea; Skin and subcutaneous tissue disorders: angio-oedema, Stevens-Johnson Syndrom (SJS)/Toxic Epidermal Necrolysis (TEN).
The frequencies for the prolonged-release capsule are not known.
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