Tolterodine tartrate tablets
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulation of standard release tablets containing tolterodine tartrate.
Symptomatic treatment of urinary urgency, frequency or urge incontinence
Symptomatic treatment of overactive bladder with urinary urgency, frequency or urge incontinence in adults.
Symptomatic treatment of overactive bladder with urinary urgency, frequency, incontinence and nocturnal enuresis in children.
2mg twice daily.
If troublesome side-effects occur, the dose may be reduced to 1mg twice daily.
Effects of treatment should be re-evaluated after two to three months.
Safety and effectiveness in children under 18 have not been established. Therefore tolterodine is not recommended by the manufacturer for use in children.
Children stabilised on immediate-release tolterodine tartrate 2mg twice daily may be transferred to modified-release tolterodine tartrate 4mg once daily.
The following dosing schedules may be suitable:
Urinary frequency, incontinence and urgency (unlicensed)
Children aged 2 to 18 years: 1mg once daily, increasing according to response to a maximum of 2mg twice daily.
Nocturnal enuresis associated with over active bladder (unlicensed)
Children aged 5 to 18 years: 1mg once daily at bedtime, titrate to response to a maximum of 2mg twice daily.
Patients with Renal Impairment
Severe renal impairment (GFR less than or equal to 30ml/minute): 1mg twice daily.
Patients with Hepatic Impairment
1mg twice daily.
Children under 2 years
Long QT syndrome
Severe ulcerative colitis
Torsade de pointes
Uncontrolled narrow angle glaucoma
Precautions and Warnings
Children aged 2 to 18 years
Family history of long QT syndrome
Benign prostatic hyperplasia
Bladder outflow obstruction
Congestive cardiac failure
Decreased gastrointestinal motility
History of torsade de pointes
Ischaemic heart disease
Renal impairment - creatinine clearance below or equal to 30ml/minute
Correct electrolyte disorders before treatment
Reduce dose in patients with severe renal impairment
Reduce maintenance dose in hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Consider organic reasons for urinary urge and frequency before treatment
After 3 months consider if further treatment is needed
Consider monitoring ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Modify dose if adverse effects occur
Not licensed for all indications in all age groups
Advise patient grapefruit products may increase plasma level
Pregnancy and Lactation
Tolterodine is contraindicated during pregnancy.
The manufacturer does not recommend using tolterodine during pregnancy. There is no adequate information from the use of this agent in human pregnancy. The potential risk is unknown. It is not known if tolterodine or its active metabolite crosses the human placenta. Tolterodine molecular weight indicates such possibility.
The limited animal data suggest low risk although, studies in animals have shown reproductive toxicity.
The safest course is to avoid the first trimester, but the risk in early pregnancy appears to be low (Briggs 2015).
Tolterodine is contraindicated in breastfeeding.
Manufacturer advises to avoid during lactation. No information is available on the use of this agent during breastfeeding.
LactMed (2018) indicates that long-term use of tolterodine might reduce milk production or milk let-down therefore, sings of decrease lactation (like insatiety and poor weight gain) should be observed.
Difficulty in micturition
Disturbances in accommodation
Prolongation of QT interval
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 ).
Last Full Review Date: March 2020.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Detrusitol 1mg film-coated tablets. Pfizer Ltd. Revised July 2015.
Summary of Product Characteristics: Detrusitol 2mg film-coated tablets. Pfizer Ltd. Revised July 2015.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 March 2020.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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