- Approval Id
- 415d7efee5330b18
- Drug Name
- TOLCORD 1 FILM COATED TABLET 1 MG
- Product Name
- TOLCORD 1 FILM COATED TABLET 1 MG
- Approval Number
- SIN16598P
- Approval Date
- 2022-09-07
- Registrant
- ACCORD HEALTHCARE PRIVATE LIMITED
- Licence Holder
- ACCORD HEALTHCARE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>v. Posology and Method of Administration:</strong></p>
<p><u>Adults (including the Elderly)</u><br>
The recommended total daily dose is 4 mg. Dosage with tolterodine tablets is 2 mg twice daily. The total daily dose may be reduced to 2 mg, based on individual tolerability.</p>
<p><u>Use in Children</u><br>
Safety and effectiveness in children have not yet been established.</p>
<p><u>Use in Impaired Renal Function</u><br>
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients with impaired renal function (see Section Special Warnings and Precautions for Use – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Use in Impaired Hepatic Function</u><br>
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients with impaired hepatic function (see Section Special Warnings and Precautions for Use – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Use with Potent CYP3A4 Inhibitors</strong><br>
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients receiving concomitant ketoconazole or other potent CYP3A4 inhibitors (see Section Special Warnings and Precautions for Use, CYP3A4 inhibitors, and Section Interactions with Other Medicinal Products and Other Forms of Interaction – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>vi. Method of administration</strong></p>
<p>Tolterodine Tablets should be taken orally.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>iv. Therapeutic Indication:</strong></p>
<p>Tolterodine is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.</p>
- Contraindications
- <p><strong>vii. Contraindications:</strong></p>
<p>Tolterodine is contraindicated in patients with:</p>
<ul class="dash">
<li>Known hypersensitivity to tolterodine or any component of the product</li>
<li>Urinary retention</li>
<li>Uncontrolled narrow angle glaucoma</li>
</ul>
- Atc Code
- G04BD07
- Atc Item Name
- tolterodine
- Pharma Manufacturer Name
- ACCORD HEALTHCARE PRIVATE LIMITED
