DETRUSITOL TABLETS 2MG 56`S

DETRUSITOL contains tolterodine tartrate, a competitive muscarinic receptor antagonist with relative selectivity for the urinary bladder over salivary glands compared to oxybutynin. It reduces involuntary bladder contractions by blocking the action of acetylcholine on muscarinic receptors in the detrusor muscle of the bladder.

DETRUSITOL is indicated for the treatment of overactive bladder (OAB) syndrome with symptoms of:

·       Urge incontinence (involuntary leakage of urine accompanied by a sudden strong urge)

·       Urgency (sudden compelling desire to pass urine that is difficult to defer)

·       Urinary frequency (passing urine more than 8 times per day).

Tolterodine works by reducing bladder muscle overactivity, allowing the bladder to hold more urine and reducing the frequency and urgency of urination, thereby improving quality of life in patients with OAB.

The recommended dose is 2 mg twice daily, taken with water. It may be taken with or without food.

Dose Adjustment

•       Hepatic impairment: reduce to 1 mg twice daily — tolterodine is extensively metabolised by the liver.

•       Renal impairment (eGFR 10–30 mL/min): reduce to 1 mg twice daily.

•       Co-administration with strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): reduce to 1 mg twice daily.

A clinical response is typically seen within 4–8 weeks of starting treatment. Full assessment of benefit should be made at 3 months.

Very Common Side Effects (greater than 1 in 10 patients)

•       Dry mouth — the most common side effect; sipping water throughout the day and sugar-free gum may help.

Common Side Effects

•       Constipation — increase dietary fibre and fluid intake.

•       Headache.

•       Dry eyes, blurred vision.

•       Dyspepsia (indigestion) and abdominal discomfort.

•       Fatigue.

•       Dizziness — particularly on standing (orthostatic).

Serious Side Effects — Seek Medical Attention

•       Urinary retention — inability to pass urine; especially in men with an enlarged prostate.

•       Acute angle-closure glaucoma — sudden severe eye pain, redness, blurred vision.

•       QT interval prolongation — irregular heartbeat, palpitations.

•       Cognitive effects — memory problems, confusion (particularly in elderly patients; consider anticholinergic burden).

•       Angioedema — swelling of the face, lips, tongue, throat.

Bladder Outlet Obstruction

Use with caution in men with benign prostatic hypertrophy (BPH). Although DETRUSITOL can coexist with BPH treatment, there is a risk of acute urinary retention. Ensure absence of significant post-void residual urine (ideally, check bladder scan before prescribing).

Glaucoma

The anticholinergic action can raise intraocular pressure. Narrow-angle glaucoma is an absolute contraindication. In patients with open-angle glaucoma (controlled), use cautiously with ophthalmologist co-management.

Anticholinergic Burden in Elderly Patients

Tolterodine contributes to anticholinergic burden. In elderly patients already taking multiple anticholinergic medicines, the cumulative effect may impair cognition (delirium, memory impairment) and increase fall risk. Review overall anticholinergic burden before prescribing. Consider using darifenacin or a beta-3 agonist (mirabegron) as alternatives with lower central effects.

Cardiac Conditions

Tolterodine prolongs the QT interval. Use with caution in patients with bradycardia, pre-existing QT prolongation, hypokalaemia, or hypomagnesaemia. Correct electrolyte imbalances before initiating therapy.

•       Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin, erythromycin) — increase tolterodine plasma levels significantly; reduce DETRUSITOL dose to 1 mg twice daily.

•       QT-prolonging drugs (antiarrhythmics, certain antipsychotics, chloroquine, methadone) — additive QT prolongation risk; avoid combination where possible.

•       Other anticholinergic agents (oxybutynin, amitriptyline, antihistamines, procyclidine) — additive anticholinergic effects; increased risk of urinary retention, constipation, dry mouth, and cognitive impairment.

•       Metoclopramide, domperidone, and tolterodine may antagonise their prokinetic effects.

•       Warfarin — rare reports of increased INR; monitor anticoagulation.

•       Store below 25 degrees Celsius.

•       Keep in original packaging, protected from moisture.

•       Keep out of reach of children.

•       Do not use after the expiry date printed on the pack.

DETRUSITOL 2 mg tablets are a prescription-only medicine (POM) in Kenya, regulated by the Pharmacy and Poisons Board (PPB).

Available through authorised pharmacies, urology clinics, and primary care facilities with a valid prescription.

Before Prescribing

•       Assess and document post-void residual urine (bladder scan preferred) to exclude urinary retention before initiating.

•       Confirm diagnosis of overactive bladder (OAB) versus stress urinary incontinence (DETRUSITOL is not effective for stress incontinence).

•       Calculate anticholinergic cognitive burden score in elderly patients.

•       Exclude UTI (urinalysis/culture) as a cause of urgency frequency before prescribing.

Follow-up

•       Review at 4–8 weeks: assess symptom improvement using a 3-day bladder diary (episodes of urgency, incontinence, nocturia, daytime frequency).

•       Continue if clinically effective with acceptable tolerability. Reassess at 3 months and 6 months.

•       If inadequate response after dose optimisation, consider switching to another antimuscarinic or adding mirabegron (beta-3 agonist) — note: combination may increase urinary retention risk.

Alternative Agents

For patients with significant cognitive impairment concerns, consider darifenacin (M3-selective) or solifenacin with lower CNS penetration. Mirabegron (Betmiga) is anticholinergic-free and preferred in elderly patients with high anticholinergic burden.

How long before I see improvement in my bladder symptoms?

Most people notice an improvement in urgency and frequency within 2–4 weeks of starting DETRUSITOL. Maximum benefit is usually seen after 8 weeks of consistent treatment. If there is no improvement after 3 months, discuss with your doctor about alternative treatments.

Can I take DETRUSITOL long-term?

Yes, DETRUSITOL can be used long-term if it continues to be effective and well-tolerated. Your doctor will review the treatment periodically to ensure it remains appropriate. Lifelong treatment may be needed for chronic overactive bladder.

Will the dry mouth get better over time?

Dry mouth usually improves as your body adjusts to the medicine over the first few weeks. In the meantime, try sipping water frequently, using sugar-free sweets, or a saliva substitute spray. If it remains bothersome, ask your doctor about adjusting the dose or trying an alternative medicine.