- Approval Id
- 8dbbefd466c4c64e
- Drug Name
- TOLTERODINE MEVON SR CAPSULE 4 MG
- Product Name
- TOLTERODINE MEVON SR CAPSULE 4 MG
- Approval Number
- SIN16432P
- Approval Date
- 2022-02-28
- Registrant
- NOVEM PHARMA PRIVATE LIMITED
- Licence Holder
- NOVEM PHARMA PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Dosage
- **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_ **).**
- 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:
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_
- Urinary retention
- Uncontrolled narrow angle glaucoma
- Atc Code
- G04BD07
- Atc Item Name
- tolterodine
- Pharma Manufacturer Name
- NOVEM PHARMA PRIVATE LIMITED
- Company Detail Path
- /organization/66db3ea384434852/novem-pharma-private-limited
