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Detrusitol/Detrusitol SR

Detrusitol/Detrusitol SR Dosage/Direction for Use

tolterodine

Manufacturer:

Viatris

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Detrusitol: 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 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 Precautions).
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 Precautions).
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 Precautions and Interactions).
Detrusitol SR: The recommended dose of DETRUSITOL SR Capsules is 4 mg once daily with water and swallowed whole. The dose may be lowered to 2 mg daily based on individual response and tolerability; however, limited efficacy data are available for DETRUSITOL SR 2 mg [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
Dosage Adjustment in Specific Populations: Hepatic and Renal Impairment: For patients with mild to moderate hepatic impairment (Child-Pugh Class A or B) or severe renal impairment (CCr 10 - 30 mL/min), the recommended dose of DETRUSITOL SR is 2 mg once daily. DETRUSITOL SR is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Patients with CCr<10 mL/min have not been studied and use of DETRUSITOL SR in this population is not recommended [see Precautions and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions].
Pediatric Use: Efficacy in the pediatric population has not been demonstrated.
Geriatric Use: No overall differences in safety were observed between the older and younger patients treated with tolterodine.
Dosage Adjustment in Presence of Concomitant Drugs: For patients who are taking drugs that are potent inhibitors of CYP3A4 [e.g. ketoconazole, clarithromycin, ritonavir], the recommended dose of DETRUSITOL SR is 2 mg once daily [see Interactions].
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