What is Regurin XL?
Regurin XL is one of a group of medicines called ‘anticholinergics’. Each prolonged release capsule contains 60mg of trospium chloride.

What is Regurin XL used for?
Regurin XL is indicated for the 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).

How does Regurin XL work?
The active ingredient, 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. Both in preclinical as well as in clinical experiments, trospium chloride diminishes the contractile tone of smooth muscle in the gastro-intestinal and genito-urinary tract.

Why use Regurin XL?
Patient age is a key factor when prescribing an antimuscarinic. The prevalence of overactive bladder increases markedly with age in both men and women, and approximately 57% of overactive bladder sufferers are over 65 years of age. For this age group, Regurin XL has distinct clinical benefits over other antimuscarinic treatments. Trospium chloride is a quaternary ammonium salt, the antimuscarinics most commonly prescribed (e.g. oxybutynin and tolterodine) are tertiary amines. As a quaternary amine, Regurin XL is hydrophilic and hence has negligible penetration of the blood-brain barrier. In the elderly population, who tend to take many medicines, it may also be of value to prescribe an option with no MDIs (Multi Drug Interactions) expected

Effect on Cognitive function:
Trospium chloride has no known effect on cognitive function and has not been found to impair electrical activity within the brain. A recent study has shown that, across all age groups studied, trospium chloride does not increase daytime sleepiness or affect alertness as measured by the validated Stanford Sleepiness Scale (see reference 2). The lack of effect on these components of cognitive function in contrast to other antimuscarinics is an important benefit. This is highlighted by the National Service Framework (NSF) for Older People 2001. Within the NSF the prevention of falls is identified as a key area and cognitive impairment is cited as one of the intrinsic factors contributing to falls.

No known metabolic drug interactions:
Metabolism by the cytochrome P450 (CYP450) system is an important step in the activation or elimination of a large number of drugs. Trospium chloride is largely excreted unchanged by the kidneys and has been shown not to influence the metabolic activities of the cytochrome P450 enzymes in the liver. Metabolic drug interactions are not expected (see reference 3).

Interactions are of particular relevance to elderly patients given that 51% of patients aged over 65 receive four or more concurrent repeat prescriptions. Other factors, such as the declining activity of certain parts of the CYP450 system and the effect of decreased hepatic blood flow on first-pass metabolism, suggest prudence in this age group.

The prevention of adverse reactions is highlighted in the NSF for Older People. In light of this, the metabolic profile of Regurin XL makes it a prudent alternative for patients subject to polypharmacy.

Regurin XL is a once-daily form of Trospium chloride and has the benefit of increased convenience and a reduced pill burden for patients.

What are the common side effects with Regurin XL?
Along with its desirable effects, a medicine may have some unwanted effects. This product may cause a dry mouth, indigestion, constipation, abdominal pain, nausea and/or flatulence. Other effects known to occur rarely include urinary disorders, an increased heart rate, eye disorders (especially in patients with uncorrected farsightedness), diarrhoea, difficulty breathing, skin rashes, weakness, chest pain, muscle pain, skin swelling, joint pain, increase in liver enzyme levels, acute allergic reaction (rash, itching, shortness of breath), headache or dizziness.

The table below compares trospium's CNS side-effects with those of other antimuscarinic drugs (see reference 9).

	Tolterodine ER	Oxybutynin ER	Solifenacin	Regurin
Common (>1/100, <1/10)	Dizziness Somnolence Headache	Depression Somnolence Headache Dizziness Insomnia Nervousness Confusion
Uncommon (>1/1,000, <1/100)	Nervousness Parasthesia Memory impairment	Abnormal dreams Paraesthesia Vertigo Anxiety	Somnolence Dysgeusia
Rare (>1/10,000, <1/1,000)		Hypertonia Tremor Tinnitus
Very Rare (<1/10,000)	Confusion Disorientation Hallucinations	Hallucinations Night terror Convulsions Agitation Memory impairment	Dizziness Hallucinations Headache	Headache Dizziness

How is Regurin XL taken?
One prolonged release capsule, once daily (equivalent to 60mg of trospium chloride per day).

The prolonged release capsule 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.

Since no data are available, use in children under 12 years of age is contra-indicated.

 

References

1. Pietko et al, Eur J Clin Pharmacol (1994) 47: 337-343

2. Staskin and Harnett, Current Urology Reports (2004) 5: 423-426

3. Beckmann-Knopp et al, Pharmacol Toxicol (1999) 85: 299-304

4. Zinner N, et al, The Journal of Urology (2004) 171: 2311-2315

5. Rudy et al, Urology (2006) 67: 275-280

6. Staskin et al, The Journal of Urology (2007) 178: 978-984

7. Dmochowski et al, Urology (2007) 71: 449-454

8. NICE clinical guideline - Urinary incontinence - the management of urinary incontinence in women CG40, 2006

9. Summaries of Product Characteristics

 

The information on this page is intended for use by healthcare professionals only.