Tolterodine Tartrate is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.
BPH/ Urinary retention/ Urinary incontinence
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. A major active metabolite (5-hydroxymethyl derivative) of tolterodine exhibits a pharmacological profile which is similar to that of the parent compound. In extensive metabolisers this metabolite contributes significantly to the therapeutic effect of tolterodine. The effect of treatment can be expected within 4 weeks.
The recommended dose for tolterodine is 2 mg twice daily. In case of troublesome side effects the dose may be reduced from 2 mg to 1 mg twice daily. The recommended total daily dose of tolterodine is 2 mg (1 mg b.i.d.) for patients with impaired renal function, impaired liver function, or receiving concomitant medication with potent CYP3A inhibitors, such as macrolide antibiotics (e.g. erythromycin and clarithromycin) or azole antifungal agents (e.g. ketoconazole, itraconazole and miconazole). After six months the need for further treatment should be considered.
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 Tolterodine Tartrate is 2 mg daily.
Tolterodine is contraindicated in those patients with urinary retention, uncontrolled narrow angle glaucoma, known hypersensitivity to tolterodine or any other component of the drug. Tolterodine should be used with caution in the following patients: at risk for urinary retention at risk for decreased gastrointestinal motility with impaired renal function with impaired hepatic function Organic reasons for urge and frequency should be considered before treatment.
Tolterodine may cause mild to moderate antimuscarinic effects, like dryness of mouth, dyspepsia and/or reduced lacrimation.
There are no studies in pregnant women. Therefore, tolterodine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Use of tolterodine during lactation should be avoided since no data on excretion of the drug into breast milk in humans is available.
Overdosage with Tolterodine Tartrate capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. ECG monitoring is recommended in the event of overdosage.
Store in a cool and dry place. Protect from light. Keep out of the reach of children.
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