Fesoterodine Fumarate
Generic Name: fesoterodine fumarate
Brand Names:
Fesoterodine Fumarate
11 DESCRIPTION Fesoterodine fumarate extended-release tablets contains fesoterodine fumarate. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate.
Overview
11 DESCRIPTION Fesoterodine fumarate extended-release tablets contains fesoterodine fumarate. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate.
Uses
1 INDICATIONS AND USAGE Fesoterodine fumarate extended-release are indicated for the treatment of: • Overactive bladder(OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) • Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. ( 1.2) 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.
Dosage
2 DOSAGE AND ADMINISTRATION • OAB in Adults:The recommended starting dosage is 4 mg orally once daily. Based upon individual response and tolerability, increase the maximum dosage of 8 mg once daily. ( 2.1 ) • NDO 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. (2.2) 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. (2.2) • Adult or Pediatric Patients with Renal Impairment : Refer to the full prescribing information for recommended dosage.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Angioedema [ see Warnings and Precautions ( 5.1 ) ] Urinary Retention [ see Warnings and Precautions ( 5.2 ) ] Decreased Gastrointestinal Motility [ see Warnings and Precautions ( 5.3 ) ] Most frequently reported adverse events with fesoterodine fumarate extended-release tablets in adult patients with OAB (≥4%) were: dry mouth (placebo, 7%; fesoterodine fumarate extended-release tablets 4 mg, 19%; fesoterodine fumarate extended-release tablets 8 mg, 35%) and constipation (placebo, 2%; fesoterodine fumarate extended-release tablets 4 mg, 4%; fesoterodine fumarate extended-release tablets 8 mg, 6%).
Interactions
7 DRUG INTERACTIONS 7.1 Antimuscarinic Drugs Coadministration of fesoterodine fumarate with other antimuscarinic agents that produce dry mouth, constipation, urinary retention, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. 7.2 CYP3A4 Inhibitors Doses of fesoterodine fumarate extended-release tablets greater than 4 mg are not recommended in adult patients taking strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin [see Dosage and Administration (2.5)].
Warnings
5 WARNINGS AND PRECAUTIONS Angioedema : Promptly discontinue fesoterodine fumarate and provide appropriate therapy. ( 5.1 ). Urinary Retention : Fesoterodine fumarate extended-release tablets are not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention. ( 5.2 ) Decreased Gastrointestinal Motility : Fesoterodine fumarate extended-release tablets are not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation. ( 5.3 ) Worsening of Narrow Angle Glaucoma : Use fesoterodine fumarate with caution in patients being treated for narrow-angle glaucoma. ( 5.4 ) Central Nervous System Effects: Somnolence has been reported with fesoterodine fumarate extended-release tablets. 4 CONTRAINDICATIONS Fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following, known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [s ee Clinical Pharmacology ( 12.1 ) ].
Pregnancy
8.1 Pregnancy Risk Summary There are no available data with the use of fesoterodine fumarate extended-release tablets in pregnant women and adolescents to evaluate for a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times, respectively the maximum recommended human dose (MRHD) of 8 mg/day based on AUC (see Data) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Fesoterodine fumarate extended-release tablets, 4 mg are light blue colored, oval shaped, biconvex, film-coated, debossed with ‘ ’ on one side and 'FS' on the other side and are supplied in bottles of 30's, and 90’s.
Frequently Asked Questions
What is Fesoterodine Fumarate used for?▼
1 INDICATIONS AND USAGE Fesoterodine fumarate extended-release are indicated for the treatment of: • Overactive bladder(OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) • Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. ( 1.2) 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.
What are the side effects of Fesoterodine Fumarate?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Angioedema [ see Warnings and Precautions ( 5.1 ) ] Urinary Retention [ see Warnings and Precautions ( 5.2 ) ] Decreased Gastrointestinal Motility [ see Warnings and Precautions ( 5.3 ) ] Most frequently reported adverse events with fesoterodine fumarate extended-release tablets in adult patients with OAB (≥4%) were: dry mouth (placebo, 7%; fesoterodine fumarate extended-release tablets 4 mg, 19%; fesoterodine fumarate extended-release tablets 8 mg, 35%) and constipation (placebo, 2%; fesoterodine fumarate extended-release tablets 4 mg, 4%; fesoterodine fumarate extended-release tablets 8 mg, 6%).
Can I take Fesoterodine Fumarate during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data with the use of fesoterodine fumarate extended-release tablets in pregnant women and adolescents to evaluate for a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times, respectively the maximum recommended human dose (MRHD) of 8 mg/day based on AUC (see Data) .
What are the important warnings for Fesoterodine Fumarate?▼
5 WARNINGS AND PRECAUTIONS Angioedema : Promptly discontinue fesoterodine fumarate and provide appropriate therapy. ( 5.1 ). Urinary Retention : Fesoterodine fumarate extended-release tablets are not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention. ( 5.2 ) Decreased Gastrointestinal Motility : Fesoterodine fumarate extended-release tablets are not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation. ( 5.3 ) Worsening of Narrow Angle Glaucoma : Use fesoterodine fumarate with caution in patients being treated for narrow-angle glaucoma. ( 5.4 ) Central Nervous System Effects: Somnolence has been reported with fesoterodine fumarate extended-release tablets. 4 CONTRAINDICATIONS Fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following, known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [s ee Clinical Pharmacology ( 12.1 ) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.