Fesotrex ER

Adult Overactive Bladder
: Fesotrex ER is indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.
Pediatric Neurogenic Detrusor Overactivity
: Fesotrex ER is indicated 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.

Dosage & Administration

Overactive Bladder in adults: The recommended starting dosage is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of 8 mg once daily.
Neurogenic Detrusor Overactivity in pediatric patients 6 years and older:
Pediatric Patients Weighing Greater than 25 kg and up to 35 kg: The recommended dosage is 4 mg orally once daily. If needed, dosage may be increased to 8 mg orally once daily.
Pediatric Patients Weighing Greater than 35 kg: The recommended starting dosage is 4 mg orally once daily. After one week, increase to 8 mg orally once daily.
Administration: Swallow whole with liquid. Do not chew, divide, or crush. Take with or without food.
Pediatric Use
: The safety and effectiveness of Toviaz have been established for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 6 years and older and weighing greater than 25 kg.
Geriatric Use
: No dose adjustment is recommended for the elderly. The pharmacokinetics of fesoterodine are not significantly influenced by age.

Most frequently reported adverse events with Fesotrex ER in adult patients with OAB (≥4%) were: dry mouth (placebo, 7%; Fesotrex ER 4 mg, 19%; Fesotrex ER 8 mg, 35%) and constipation (placebo, 2%; Fesotrex ER 4 mg, 4%; Fesotrex ER 8 mg, 6%).
Most frequently reported adverse reactions with Fesotrex ER in pediatric patients (≥2%) with NDO were: diarrhea, urinary tract infection (UTI), dry mouth, constipation, abdominal pain, nausea, weight increased, and headache.

Angioedema
: Promptly discontinue Fesotrex ER and provide appropriate therapy.
Urinary Retention
: Fesotrex ER is not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention.
Decreased Gastrointestinal Motility
: Fesotrex ER is not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation.
Worsening of Narrow-Angle Glaucoma
: Use Fesotrex ER with caution in patients being treated for narrow-angle glaucoma.
Central Nervous System Effects
: Somnolence has been reported with Fesotrex ER. Advise patients not to drive or operate heavy machinery until they know how Fesotrex ER affects them.
Worsening of Myasthenia Gravis Symptoms
: Use Fesotrex ER with caution in patients with myasthenia gravis.

Fesoterodine is a competitive muscarinic receptor antagonist. After oral administration, fesoterodine is rapidly and extensively hydrolyzed by nonspecific esterases to its active metabolite, 5-hydroxymethyl tolterodine, which is responsible for the antimuscarinic activity of fesoterodine. Muscarinic receptors play a role in contractions of urinary bladder smooth muscle. Inhibition of these receptors in the bladder is presumed to be the mechanism by which fesoterodine produces its effects.
In a urodynamic study involving patients with involuntary detrusor contractions, the effects after the administration of fesoterodine on the volume at first detrusor contraction and bladder capacity were assessed. Administration of fesoterodine increased the volume at first detrusor contraction and bladder capacity in a dose-dependent manner. These findings are consistent with an antimuscarinic effect on the bladder.