Retained Kenya · PPB

TROSIGLEN 20

Trospium Chloride

H2026/CTD8031/16186 Film-Coated Tablet INN generic

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Registration & product details

Registration no.
H2026/CTD8031/16186
Registration date
2026 October 22
Expiry date
2031 October 22
Status
Retained
Active ingredient
Trospium Chloride
Dosage form
Film-Coated Tablet
Strength
-
Pack size
-
Therapeutic class
-
Country of origin
Kenya
Manufacturer location
4V64+XGF Glenmark House, BD Sawant Marg, Parshiwada, Sai Wadi, Andheri East, Mumbai, Maharashtra 400099, India

Source: Pharmacy and Poisons Board · fetched 2026-11-06 02:03:30 · updated 2026-11-06 02:03:30

Drug Interactions

2
Check interactions

Pharmacodynamic Warnings

Trospium appears in TABLE 10: Drugs with antimuscarinic effects

Unknown (2)

Trospium - additive effect

Clozapinecancauseconstipation,ascantrospium;concurrent usemightincreasetheriskofdevelopingintestinal obstruction.rTheoretical →AlsoseeTABLE10p.1519

Unknown Theoretical

Trospium - additive effect

Antipsychotics, second generation (clozapine) can cause constipation, as can trospium; concurrent use might increase the risk of developing intestinal obstruction. Also see TABLE 10 p. 1519 Tryptophan

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

Clinical monograph: Trospiumchloride

BNF-referenced

Trospium chloride is an antimuscarinic agent primarily used to manage symptoms of overactive bladder, including urinary urgency, frequency, and urge incontinence. It works by inhibiting muscarinic receptors in the bladder, leading to reduced bladder contractions and increased bladder capacity. This results in a decrease in urinary frequency and urgency.

Indications

  • Urinary frequency
  • Urinary urgency
  • Urge incontinence

Dosage

Children: For children, dosing information should be referred to the BNF for Children. Specific dosing details are not provided in the current BNF text.

Adults: For adults, the recommended dose is 60 mg once daily for modified-release formulations. For immediate-release formulations, the dose is reduced to 20 mg twice daily.

Mechanism of action

Trospium chloride acts as a competitive antagonist of muscarinic receptors (M1, M2, and M3 subtypes) in the bladder. By blocking these receptors, it reduces the involuntary contractions of the bladder muscle, thereby increasing bladder capacity and decreasing the sensation of urgency.

Pharmacodynamics

Trospium chloride exhibits its pharmacological effects through the inhibition of acetylcholine binding to muscarinic receptors, which leads to decreased smooth muscle tone in the bladder. This reduction in bladder activity helps alleviate symptoms associated with overactive bladder disorders.

Pharmacokinetics

Trospium chloride has a bioavailability of approximately 10-20% due to extensive first-pass metabolism. It is primarily excreted unchanged in the urine, with a half-life of about 20 hours. Peak plasma concentrations are typically reached within 5-6 hours after oral administration. Adjustments in dosing may be necessary for patients with renal impairment due to altered clearance.

Adverse effects

  • Abdominal pain
  • Bronchitis
  • Chest pain
  • Diarrhoea
  • Dry eye
  • Fatigue
  • Gastrointestinal disorders
  • Paraesthesia
  • Peripheral oedema
  • Vertigo
  • Hallucination
  • Memory loss
  • Nervousness
  • Rash
  • Dyspepsia
  • Dry mouth
  • Constipation

Precautions

  • History of QT-interval prolongation
  • Caution in hepatic impairment
  • Caution in renal impairment
  • Caution advised during pregnancy and breastfeeding

Pregnancy

Manufacturer advises to avoid due to toxicity in animal studies.

Breast-feeding

Manufacturer advises to avoid; no information available.

Storage

Store in a cool, dry place away from direct sunlight.

Formulations

  • Trospium chloride 60 mg modified-release capsules
  • Trospium chloride 20 mg tablets
BNF 85 (British National Formulary) p.874 BNF for Children 2019-2020 p.530 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: trospium

PubChem CID 5284632

Molecular formula: C25H30NO3+

Mechanism of action

Trospium antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder.

Pharmacodynamics

Trospium is an antispasmodic, antimuscarinic agent indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. According to receptor assays, it displays higher affinity towards muscarininc receptors compared to nicotinic receptors at therapeutic concentrations.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.