Regulatory Information
ACCORD HEALTHCARE PRIVATE LIMITED
ACCORD HEALTHCARE PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**v. 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 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 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 Special Warnings and Precautions for Use, CYP3A4 inhibitors, and Section 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_). **vi. Method of administration** Tolterodine Tablets should be taken orally.
ORAL
Medical Information
**iv. Therapeutic Indication:** Tolterodine is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.
**vii. 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
ACCORD HEALTHCARE PRIVATE LIMITED
INTAS PHARMACEUTICALS LIMITED
Intas Pharmaceuticals Limited
Active Ingredients
Documents
Package Inserts
Attachment 2 1.4.3 Package Insert_TOLCORD 1& 2_SNG_Clear Copy.pdf
Approved: September 7, 2022