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HSA Approval

DETRUSITOL SR CAPSULE 2 mg

SIN11859P

DETRUSITOL SR CAPSULE 2 mg

DETRUSITOL SR CAPSULE 2 mg

April 1, 2002

VIATRIS PRIVATE LIMITED

VIATRIS PRIVATE LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantVIATRIS PRIVATE LIMITED
Licence HolderVIATRIS PRIVATE LIMITED

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

CAPSULE, EXTENDED RELEASE

**4.2 Posology and Method of Administration** The extended-release capsules can be taken with or without food and must be swallowed whole **(see Section 5.2 – Pharmacokinetic Properties, _Pharmacokinetic characteristics_** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ **)**. Adults (including the Elderly) The recommended total daily dose is 4 mg. Dosage with tolterodine capsules is 4 mg once 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 capsules 2 mg once 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 capsules 2 mg once 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 capsules 2 mg once 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 other component of the product - Urinary retention - Uncontrolled narrow angle glaucoma

G04BD07

tolterodine

Manufacturer Information

VIATRIS PRIVATE LIMITED

Catalent Pharma Solutions, LLC

Active Ingredients

TOLTERODINE TARTRATE

2 mg

Tolterodine

Documents

Package Inserts

Detrusitol SR capsules PI.pdf

Approved: January 31, 2023

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DETRUSITOL SR CAPSULE 2 mg - HSA Approval | MedPath