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HSA Approval

DETRUSITOL TABLET 1 mg

SIN09911P

DETRUSITOL TABLET 1 mg

DETRUSITOL TABLET 1 mg

July 28, 1998

VIATRIS PRIVATE LIMITED

VIATRIS PRIVATE LIMITED

Regulatory Information

VIATRIS PRIVATE LIMITED

VIATRIS PRIVATE LIMITED

Therapeutic

Prescription Only

Formulation Information

TABLET, FILM COATED

**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_ **).**

ORAL

Medical Information

**4.1 Therapeutic Indications** Tolterodine is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.

**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

G04BD07

tolterodine

Manufacturer Information

VIATRIS PRIVATE LIMITED

Pfizer Italia S.r.l.

Active Ingredients

TOLTERODINE TARTRATE EQV TOLTERODINE

1 mg

Tolterodine

Documents

Package Inserts

Detrusitol Tablet PI.pdf

Approved: April 29, 2008

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