Fesoterodine Dosage

Medically reviewed by Drugs.com. Last updated on Sep 16, 2024.

Applies to the following strengths: 4 mg; 8 mg

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.