Uritol Tablet 1 mg
Uritol Tablet 1 mg Uses, Dosage, Side Effects, Food Interaction and all others data.
Trade Name | Uritol Tablet 1 mg |
Generic | Tolterodine Tartrate |
Weight | 1 mg |
Type | Tablet |
Therapeutic Class | BPH/ Urinary retention/ Urinary incontinence |
Manufacturer | Eskayef Pharmaceuticals Ltd. |
Available Country | Bangladesh |
Last Updated: | October 19, 2023 at 6:27 am |
Uses
Uritol Tablet 1 mg is indicated for the treatment of an overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.Dosage
Uritol Tablet 1 mg dosage
Extended-release capsule: The recommended dose is Uritol Tablet 1 mg 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 Uritol Tablet 1 mg 2 mg daily.Film-coated tablet: The recommended dose is Uritol Tablet 1 mg 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 Uritol Tablet 1 mg 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 youngerpatients treated with Tolterodine.Side Effects
The most common side effects reported by patients receiving Uritol Tablet 1 mg were dry mouth, headache, constipation, and abdominal pain. Dry mouth was the most frequently reported adverse event for patients treated with Uritol Tablet 1 mg tablets occurring in 23.4% of patients treated with Uritol Tablet 1 mg tablets and 7.7% of placebo-treated patients. Dry mouth, constipation, abnormal vision (accommodation abnormalities), urinary retention, and dry eyes are expected side effects of antimuscarinic agents. The adverse events were reported regardless of causality.Precaution
Uritol Tablet 1 mg 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. For patients with significantly reduced hepatic function or renal function, the recommended dose for Uritol Tablet 1 mg is 2 mg daily. In a study of the effect of Uritol Tablet 1 mg immediate release tablets on the QT interval, the effect on the QT interval appeared greater for 8 mg/day (two times the therapeutic dose) compared to 4 mg/day and was more pronounced in CYP2D6 poor metabolizers than extensive metabolizers. The effect of Tolterodine 8 mg/day was not as large as that observed after four days of therapeutic dosing with the active control moxifloxacin. However, the confidence intervals overlapped. These observations should be considered in clinical decisions to prescribe Uritol Tablet 1 mg tablets for patients with a known history of QT prolongation or patients who are taking Class I A (e.g., quinidine, procainamide) or Class III (e.g.,amiodarone, sotalol) antiarrhythmic medications. Patients should be informed that antimuscarinic agents such as Uritol Tablet 1 mg tablets may produce the following effects: blurred vision, dizziness, or drowsiness.Interaction
Ketoconazole, an inhibitor of the drug metabolizing enzyme CYP3A4, significantly increased plasma concentrations of Tolterodine when co-administered to subjects who were poor metabolizers. For patients receiving Ketoconazole or other potent CYP3A4 inhibitors such as other azole antifungals (eg, Itraconazole, Miconazole) or Macrolide antibiotics (eg, Erythromycin, Clarithromycin) or Cyclosporine or Vinblastine, the recommended dose of Uritol Tablet 1 mg is 2 mg daily.Pregnancy & Breastfeeding use
There are no studies of Tolterodine in pregnant women. Therefore, Uritol Tablet 1 mg 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, Uritol Tablet 1 mg tablets should not be administered during nursing. A decision should be made whether to discontinue nursing or to discontinue Uritol Tablet 1 mg tablets in nursing mothers.Contraindication
Uritol Tablet 1 mg is contra-indicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, or in patients who have demonstrated hypersensitivity to Uritol Tablet 1 mg.Acute Overdose
Overdosage with Uritol Tablet 1 mg capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. ECG monitoring is recommended in the event of overdosage.Storage Condition
Store in a cool and dry place. Protect from light. Keep out of the reach of children.Innovators Monograph
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