- Approval Id
- f8b37fc4a061275d
- Drug Name
- DETRUSITOL TABLET 1 mg
- Product Name
- DETRUSITOL TABLET 1 mg
- Approval Number
- SIN09911P
- Approval Date
- 1998-07-28
- Registrant
- VIATRIS PRIVATE LIMITED
- Licence Holder
- VIATRIS PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **4.2 Posology And Method Of Administration**
Adults (including the Elderly)
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.
Use in Children
Safety and effectiveness in children have not yet been established.
Use in Impaired Renal Function
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients with impaired renal function **(see Section 4.4 – Special Warnings and Precautions for Use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ **).**
Use in Impaired Hepatic Function
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients with impaired hepatic function **(see Section 4.4 – Special Warnings and Precautions for Use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ **).**
Use with Potent CYP3A4 Inhibitors
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 4.4 – Special Warnings and Precautions for Use, CYP3A4 inhibitors, and Section 4.5 – Interactions with Other Medicinal Products and Other Forms of Interaction** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ **).**
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic Indications**
Tolterodine is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.
- Contraindications
- **4.3 Contraindications**
Tolterodine is contraindicated in patients with:
- Known hypersensitivity to tolterodine or any component of the product
- Urinary retention
- Uncontrolled narrow angle glaucoma
- Atc Code
- G04BD07
- Atc Item Name
- tolterodine
- Pharma Manufacturer Name
- VIATRIS PRIVATE LIMITED
- Company Detail Path
- /organization/viatris-private-limited
