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TOLCORD 1 FILM COATED TABLET 1 MG [SIN16598P]
Active ingredients: TOLCORD 1 FILM COATED TABLET 1 MG
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Product Info
TOLCORD 1 FILM COATED TABLET 1 MG
[SIN16598P]
Product information
Active Ingredient and Strength | TOLTERODINE TARTRATE - 1 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | INTAS PHARMACEUTICALS LIMITED - INDIA |
Registration Number | SIN16598P |
Licence Holder | ACCORD HEALTHCARE PRIVATE LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | G04BD07 |
iv. Therapeutic Indication:
Tolterodine is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.
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.
vii. Contraindications:
Tolterodine is contraindicated in patients with:
Known hypersensitivity to tolterodine or any component of the product
Urinary retention
Uncontrolled narrow angle glaucoma
