Fesoterodine fumarate oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of fesoterodine fumarate.
Drugs List
Therapeutic Indications
Uses
Symptomatic treatment of urinary urgency, frequency or urge incontinence
Dosage
Adults
The recommended starting dose is 4mg once daily.
Dosage may be increased up to 8mg once daily. Individual response and tolerability should be evaluated prior to increasing the daily dose to 8mg.
The maximum daily dose is 8mg.
Full treatment efficacy has been observed between 2 and 8 weeks. It is therefore recommended to review the efficacy of therapy after 8 weeks of fesoterodine treatment.
Patients with Renal Impairment
Glomerular Filtration Rate (GFR) 30 to 80ml/min
4mg to 8mg once daily. Exercise caution if dose increase required.
Glomerular Filtration Rate (GFR) less than 30ml/min
4mg once daily.
Patients with Hepatic Impairment
Mild hepatic impairment
4mg to 8mg once daily. Exercise caution if dose increase required.
Moderate hepatic impairment
4mg once daily.
Additional Dosage Information
Fesoterodine is metabolised by CYP3A4.
See coded interactions, but the manufacturer's advice for concurrent use with CYP3A4 inhibitors is as follows:
Concurrent potent CYP3A4 inhibitors
Patients with normal renal and hepatic function - The maximum daily dose in these patients is 4mg.
Patients with mild renal impairment (GFR 50 to 80ml/min) - fesoterodine should be avoided.
Patients with moderate to severe renal impairment (GFR less than 50ml/min) - fesoterodine is contraindicated.
Patients with mild hepatic impairment - fesoterodine should be avoided.
Patients with moderate hepatic impairment - fesoterodine is contraindicated.
Concurrent moderate CYP3A4 inhibitors
Patients with mild to moderate renal impairment (GFR 30 to 80ml/min) - 4mg once daily.
Patients with severe renal impairment (GFR less than 30ml/min) - fesoterodine should be avoided.
Patients with mild hepatic impairment - 4mg once daily.
Patients with moderate hepatic impairment - fesoterodine should be avoided.
Contraindications
Children under 18 years
Breastfeeding
Delayed gastric emptying
Galactosaemia
Myasthenia gravis
Pregnancy
Severe hepatic impairment
Severe ulcerative colitis
Toxic megacolon
Uncontrolled narrow angle glaucoma
Urinary retention
Precautions and Warnings
Predisposition to prolongation of QT interval
Autonomic neuropathy
Benign prostatic hyperplasia
Bladder outflow obstruction
Bradycardia
Cardiac arrhythmias
Cardiac disorder
Congestive cardiac failure
Decreased gastrointestinal motility
Gastroesophageal reflux
Gastrointestinal obstruction
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hiatus hernia
Hypertension
Hyperthyroidism
Hypokalaemia
Ischaemic heart disease
Lactose intolerance
Long QT syndrome
Narrow angle glaucoma
Pyloric stenosis
Renal impairment
Tachycardia
Advise ability to drive/operate machinery may be affected by side effects
Consider organic reasons for urinary urge and frequency before treatment
Contains lactose
Some products contain arachis (peanut) oil, soya or soya derivative
After 8 weeks consider if further treatment is required
Discontinue if angioedema occurs
Advise patient not to take St John's wort concurrently
Advise patient grapefruit products may increase plasma level
Safety and efficacy of fesoterodine has not been established in patients with a neurogenic cause of detrusor overactivity.
Other causes of frequent urination (e.g. treatment of heart failure or renal disease) should be considered before therapy with fesoterodine commences. Treat urinary tract infections before commencing fesoterodine treatment.
Pregnancy and Lactation
Pregnancy
Fesoterodine is contraindicated during pregnancy.
The manufacturer does not recommend using fesoterodine during pregnancy. Animal studies have shown reproductive toxicity. At the time of writing there are no adequate data on the use of fesoterodine during human pregnancy. Potential risks are unknown.
Lactation
Fesoterodine is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking fesoterodine. At the time of writing it is unknown if fesoterodine or it's metabolites are excreted into human milk. A risk to neonates cannot be excluded.
Side Effects
Abdominal discomfort
Abdominal pain
Angioedema
Blurred vision
Confusion
Constipation
Cough
Diarrhoea
Dizziness
Dry eyes
Dry mouth
Dry skin
Dry throat
Dysgeusia
Dyspepsia
Dysuria
Fatigue
Flatulence
Gamma glutamyl transferase (GGT) increased
Gastroesophageal reflux
Headache
Increase in ALT level
Insomnia
Nasal dryness
Nausea
Palpitations
Pharyngolaryngeal pain
Pruritus
Rash
Somnolence
Tachycardia
Urinary hesitancy
Urinary retention
Urinary tract infections
Urticaria
Vertigo
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2022
Reference Sources
Summary of Product Characteristics: Teraleve 4mg prolonged-release tablets. Dr Reddy's Laboratories (UK) Limited. Revised December 2021.
Summary of Product Characteristics: Teraleve 8mg prolonged-release tablets. Dr Reddy's Laboratories (UK) Limited. Revised December 2021.
Summary of Product Characteristics: Toviaz 4mg prolonged-release tablets. Pfizer Limited. Revised February 2021.
Summary of Product Characteristics: Toviaz 8mg prolonged-release tablets. Pfizer Limited. Revised February 2021.
Summary of Product Characteristics: Zecatrin 4mg prolonged-release tablets. Zentiva Pharma UK Limited. Revised November 2021.
Summary of Product Characteristics: Zecatrin 8mg prolonged-release tablets. Zentiva Pharma UK Limited. Revised November 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 June 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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