Company: Glenmark Generics.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Trospium chloride 20mg.
Description: Brownish yellow to light brown round, biconvex film-coated tablets marked L on one side and l on reverse.
Presentation: 60, €9.86.
Indications: 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).
Pharmacology: Trospium chloride is a quaternary derivative of nortropane and therefore belongs to the class of parasympatholytics or anticholinergics. It competes concentration-dependently with acetylcholine, the body’s own transmitter at postsynaptic parasympathic binding sites. Trospium chloride binds with high affinity to muscarinic receptors of the so-called M1, M2 and M3 subtypes and demonstrates negligible affinity to nicotinic receptors. Consequently, the anticholinergic effect of trospium chloride exerts a relaxing action on smooth muscle tissue and organ functions mediated by muscarinic receptors. It diminishes the contractile tone of smooth muscle in the gastrointestinal and genito-urinary tract.
Dosage: Adult: One tablet twice daily. Severe renal impairment: One tablet once daily or every second day. Reassess every 3-6 months. Children: Under 12 years, contraindicated.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Urinary retention, severe gastrointestinal conditions (including toxic megacolon) myasthenia gravis, narrow-angle glaucoma, tachyarrhythmia.
Special precautions: Exclude organic causes of urinary frequency, urgency and urge incontinence (such as heart or kidney diseases, polydipsia or infections or tumours of urinary organs) before starting treatment. Not recommended: Severe hepatic impairment. Caution: Gastrointestinal tract obstructions (such as pyloric stenosis), urinary flow obstruction (with risk of formation of urine retention), autonomic neuropathy, hiatus hernia with reflux oesophagitis, hyperthyroidism, coronary artery disease, congestive heart failure, mild to moderate hepatic impairment, renal impairment. Pregnancy, lactation. Contains lactose and sucrose.
Drug interactions: Not recommended: Agents containing guar, cholestyramine and colestipol. Anticholinergics (such as amantadine, tricyclic antidepressants), ß-sympathomimetics, prokinetics (e.g. metoclopramide), agents eliminated by active tubular secretion.
Adverse drug reactions: GI disorders.
Full prescribing information and references available from Rowex Ltd. Telephone: 1800 304400. Fax: (027) 50417. E-mail: rowex@rowa-pharma.ie