Usual Adult Dose for Urinary Incontinence

4 mg orally once a day; based on individual response and tolerability, the dose may be escalated to 8 mg orally once a day

Maximum dose: 8 mg once a day

Comments:

• This drug can be administered with or without food.
• This drug should be taken with liquid and swallowed whole (not chewed, divided, or crushed).
• Full effect is usually observed between 2 and 8 weeks; therefore, it is recommended to reevaluate efficacy after 8 weeks of therapy.

Use: For overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency

Usual Adult Dose for Urinary Frequency

4 mg orally once a day; based on individual response and tolerability, the dose may be escalated to 8 mg orally once a day

Maximum dose: 8 mg once a day

Comments:

• This drug can be administered with or without food.
• This drug should be taken with liquid and swallowed whole (not chewed, divided, or crushed).
• Full effect is usually observed between 2 and 8 weeks; therefore, it is recommended to reevaluate efficacy after 8 weeks of therapy.

Use: For overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency

Usual Pediatric Dose for Neurogenic Bladder

6 Years and Older:
Weighing greater than 25 kg and up to 35 kg:
4 mg orally once a day, the dose may be increased to 8 mg orally once a day

Weighing greater than 35 kg:
4 mg orally once a day, increase the dose to 8 mg orally once a day, after one week

Comments:

• This drug can be taken with or without food.
• This drug should be taken with liquid and swallowed whole (not chewed, divided, or crushed).

Use: For the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older with a body weight greater than 25 kg

Renal Dose Adjustments

Adults (OAB):

• Mild to moderate renal impairment (CrCl 30 to 89 mL/min): No adjustment recommended.
• Severe renal impairment (CrCl less than 30 mL/min): Do not exceed 4 mg daily.

Pediatric (NDO):
Weighing Greater than 25 kg and up to 35 kg:

• Mild to moderate renal impairment: No adjustment recommended.
• Severe renal impairment: Use is not recommended.

Weighing greater than 35 kg:

• Mild to moderate renal impairment: No adjustment recommended.
• Severe renal impairment: Use is not recommended.

Liver Dose Adjustments

Adults (OAB):

• Mild to moderate hepatic impairment (Child Pugh A or B): No adjustment recommended.
• Severe hepatic impairment (Child Pugh C): Use is not recommended.

Pediatric (NDO):

• Mild to moderate hepatic impairment (Child Pugh A or B): No adjustment recommended.
• Severe hepatic impairment (Child Pugh C): Use is not recommended.

Dose Adjustments

Adults taking strong CYP3A4 inhibitors (OAB):
The daily dose should not exceed 4 mg in patients taking potent CYP450 3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin).

Pediatric weighing greater than 25 kg and up to 35 kg with NDO:
Use of this drug is not recommended in pediatric patients taking strong CYP3A4 inhibitors.

Pediatric weighing greater than 35 kg with NDO:
The daily dose should not exceed 4 mg in patients taking potent CYP450 3A4 inhibitors.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredient, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules
• Urinary retention
• Gastric retention
• Uncontrolled narrow-angle glaucoma

• Safety and efficacy have not been established for the treatment of overactive bladder syndrome (OAB) in patients younger than 18 years of age.
• Safety and efficacy have not been established for the treatment of neurogenic detrusor overactivity (NDO) in patients younger than 6 years of age or weighing 25 kg or less.

Consult WARNINGS section for additional precautions.

Dialysis

Use is not recommended.

Other Comments

Administration advice:

• This drug may be taken with or without food.
• Swallow whole with liquid and not chewed, crushed, or divided.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F), protected from moisture.

Monitoring:
Nervous system: Anticholinergic CNS effects

Patient advice:

• Patients should be instructed to read the approved patient labeling (Patient Information).
• Patients should be advised to avoid driving or operating machinery until they know how this drug affects them.