Ucol

Description

Indications

Ucol is used to treat an overactive bladder, presenting symptoms such as urge urinary incontinence, urgency, and increased frequency of urination.

Use under the supervision of a registered medical professional.

Pharmacology

Tolterodine, the active ingredient in Ucol, is a competitive muscarinic receptor antagonist. It primarily targets the muscarinic receptors in the urinary bladder, showing selectivity for the bladder over the salivary glands, as demonstrated in clinical pharmacological studies.

Tolterodine’s primary active metabolite, a 5-hydroxymethyl derivative, mirrors the pharmacological profile of the parent compound. In extensive metabolizers, this metabolite plays a significant role in the therapeutic effects of tolterodine. The benefits of treatment typically begin to manifest within 4 weeks.

Dosage & Administration

• Extended-release capsules: The recommended dosage is Tolterodine Tartrate 4 mg once daily. The dose may be reduced to 2 mg daily, depending on individual response and tolerability. In patients with severe hepatic or renal dysfunction, or those taking potent CYP3A4 inhibitors, the recommended dose is Tolterodine Tartrate 2 mg daily.

• Film-coated tablets: The recommended dosage is Tolterodine Tartrate 2 mg twice daily. For patients with impaired liver function or severely impaired renal function (GFR <30 ml/min), the dosage should be reduced to one Tolterodine Tartrate 1 mg tablet twice daily. In cases of troublesome side effects, the dose may be further reduced to 1 mg twice daily. Treatment effectiveness should be re-evaluated after 2-3 months.

• Pediatric use: The safety and efficacy of tolterodine in children have not been established.

• Geriatric use: No significant differences in safety were observed between older and younger patients receiving Tolterodine.

Use under the guidance of a registered medical professional.

Interaction

The concomitant use of Ucol with Ketoconazole, a potent CYP3A4 inhibitor, significantly increases plasma concentrations of Tolterodine, particularly in poor metabolizers. In such cases, or when other potent CYP3A4 inhibitors (such as Itraconazole, Miconazole, Erythromycin, Clarithromycin, Cyclosporine, or Vinblastine) are used, the recommended dosage of Ucol is 2 mg daily.

Contraindications

Ucol is contraindicated in the following conditions:

• Urinary retention
• Gastric retention
• Uncontrolled narrow-angle glaucoma
• Hypersensitivity to Tolterodine Tartrate

Side Effects

The most commonly reported side effects include:

• Dry mouth
• Headache
• Constipation
• Abdominal pain

Dry mouth is the most frequently observed side effect, occurring in 23.4% of patients treated with Ucol tablets compared to 7.7% in placebo-treated patients. Other possible side effects include dry eyes, abnormal vision (accommodation abnormalities), urinary retention, and constipation. These effects are commonly associated with antimuscarinic agents and may occur regardless of causality.

Pregnancy & Lactation

There are no studies available on the use of Tolterodine in pregnant women. Therefore, Tolterodine Tartrate tablets should only be used during pregnancy if the potential benefit to the mother justifies the potential risk to the fetus. It is not known whether Tolterodine is excreted in human milk. As such, it should not be used during breastfeeding. A decision should be made whether to discontinue breastfeeding or discontinue Tolterodine Tartrate tablets in nursing mothers.

Precautions & Warnings

Caution is advised when administering Ucol to patients with:

• Clinically significant bladder outflow obstruction, due to the risk of urinary retention
• Gastrointestinal obstructive disorders (e.g., pyloric stenosis), as there is a risk of gastric retention
• Narrow-angle glaucoma For patients with severely impaired hepatic or renal function, the recommended dosage of Ucol is 2 mg daily.

In a study of Ucol’s effect on the QT interval, a higher dose of 8 mg/day (double the therapeutic dose) appeared to affect the QT interval more significantly compared to 4 mg/day, particularly in CYP2D6 poor metabolizers. These findings should be taken into account when prescribing Ucol to patients with a history of QT prolongation or those taking antiarrhythmic medications.

Patients should be informed that antimuscarinic agents like Ucol can cause blurred vision, dizziness, and drowsiness.

Overdose Effects

An overdose of Ucol may result in severe central anticholinergic effects. In case of overdose, ECG monitoring is recommended, and treatment should address the symptoms accordingly.

Therapeutic Class

BPH / Urinary retention / Urinary incontinence

Storage Conditions

Store in a cool, dry place, protected from light. Keep out of the reach of children.