Ucol 2mg Tablet

Ucol 2mg Tablet

Ucol is indicated for the treatment of an overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Pharmacology

Tolterodine is a competitive, specific muscarinic receptor antagonist which exhibits a selectivity for the urinary bladder over salivary glands, which have been demonstrated in non clinical pharmacological in vivo studies. Tolterodine has a high specificity for muscarinic receptors.

Dosage & Administration

Extended-release capsule: The recommended dose is Tolterodine Tartrate 4 mg once daily. The dose may be lowered to 2 mg once daily based on individual response and tolerability. For patients with significantly reduced hepatic or renal function or who are currently taking drugs that are potent inhibitors of CYP3A4, the recommended dose is Tolterodine Tartrate 2 mg daily.

Film-coated tablet: The recommended dose is Tolterodine Tartrate 2 mg twice daily except in patients with impaired liver function or severely impaired renal function (GFR<30 ml/min) for whom the recommended dose is one Tolterodine Tartrate 1 mg tablet twice daily. In case of troublesome side effects, the dose may be reduced from 2 mg to 1 mg twice daily. The effect of treatment should be re-evaluated after 2-3 months.

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

Geriatric use: No overall differences in safety were observed between the older and younger patients treated with Tolterodine.

Interaction

Ketoconazole, an inhibitor of the drug metabolizing enzyme CYP3A4, significantly increased plasma concentrations of Ucol when co-administered to subjects who were poor metabolizers.

Contraindications

Tolterodine Tartrate is contra-indicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, or in patients who have demonstrated hypersensitivity to Tolterodine Tartrate.

Side Effects

The most common side effects reported by patients receiving Ucol were dry mouth, headache, constipation, and abdominal pain. Dry mouth was the most frequently reported adverse event for patients treated with Ucol tablets occurring in 23.4% of patients treated with Ucol tablets and 7.7% of placebo-treated patients.

Pregnancy & Lactation

There are no studies of Tolterodine in pregnant women. Therefore, Tolterodine Tartrate tablets should be used during pregnancy only if the potential benefit for the mother justifies the potential risk to the fetus. It is not known whether Tolterodine is excreted in human milk. Therefore, Tolterodine Tartrate tablets should not be administered during nursing. 

Precautions & Warnings

Ucol should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention and to patients with gastrointestinal obstructive disorders, such as pyloric stenosis, because of the risk of gastric retention and in patients being treated for narrow-angle glaucoma.

Overdose Effects

Overdosage with Ucol capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. ECG monitoring is recommended in the event of overdosage.

Therapeutic Class

BPH/ Urinary retention/ Urinary incontinence

Storage Conditions

Store in a cool and dry place. Protect from light. Keep out of the reach of children.