Tolterodine tartrate oral modified release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Modified release capsules containing tolterodine tartrate.
Drugs List
Therapeutic Indications
Uses
Symptomatic treatment of urinary urgency, frequency or urge incontinence
Dosage
Adults
4mg once daily.
Reduce to 2mg once daily if 4mg not tolerated.
Effects of treatment should be re-evaluated after two to three months.
Children
Children aged 2 to 18 years (unlicensed)
Children stabilised on standard release tolterodine 2mg twice daily may be transferred to modified release tolterodine 4mg once daily.
Patients with Renal Impairment
Glomerular filtration rate equal or less than 30ml/minute: 2mg once daily.
Patients with Hepatic Impairment
2mg once daily.
Contraindications
Children under 2 years
Breastfeeding
Long QT syndrome
Myasthenia gravis
Pregnancy
Severe ulcerative colitis
Torsade de pointes
Toxic megacolon
Uncontrolled narrow angle glaucoma
Urinary retention
Precautions and Warnings
Children aged 2 to 18 years
Family history of long QT syndrome
Autonomic neuropathy
Bladder outflow obstruction
Cardiac arrhythmias
Cardiomyopathy
Congestive cardiac failure
Decreased gastrointestinal motility
Electrolyte imbalance
Galactosaemia
Gastrointestinal obstruction
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
Hiatus hernia
History of torsade de pointes
Hypertension
Hyperthyroidism
Ischaemic heart disease
Lactose intolerance
Pyloric stenosis
Renal impairment - glomerular filtration rate below 31ml/minute
Correct electrolyte disorders before treatment
Reduce dose in patients with hepatic impairment
Reduce dose in patients with severe renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Contains propylene glycol
Some formulations contain lactose
Some formulations contain sucrose
After 3 months consider if further treatment is needed
Consider monitoring ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Not licensed for use in children under 18 years
Advise patient grapefruit products may increase plasma level
Pregnancy and Lactation
Pregnancy
Tolterodine is contraindicated during pregnancy.
The manufacturer does not recommend using tolterodine during pregnancy. Animal studies have shown reproductive toxicity. There is no adequate data from the use of tolterodine in human pregnancy and as such a potential risk cannot be ruled out.
Lactation
Tolterodine is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking tolterodine. At the time if writing, there is no data regarding the presence of tolterodine into human breast milk.
Side Effects
Abdominal pain
Abnormal vision
Anaphylactoid reaction
Angioedema
Arrhythmias
Bronchitis
Cardiac failure
Chest pain
Confusion
Constipation
Delusions
Diarrhoea
Disorientation
Disturbances in accommodation
Dizziness
Dry eyes
Dry mouth
Dry skin
Dyspepsia
Dysuria
Fatigue
Flatulence
Flushing
Gastroesophageal reflux
Hallucinations
Headache
Hypersensitivity reactions
Impaired memory
Nervousness
Palpitations
Paraesthesia
Peripheral oedema
Sinusitis
Somnolence
Tachycardia
Urinary retention
Vertigo
Vomiting
Weight gain
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: November 2015
Reference Sources
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Blerone XL 2mg, prolonged release capsules. Zentiva. Revised June 2015.
Summary of Product Characteristics: Blerone XL 4mg, prolonged release capsules. Zentiva. Revised June 2015.
Summary of Product Characteristics: Detrusitol XL 4mg capsules. Pfizer Ltd. Revised July 2015.
Summary of Product Characteristics: Efflosomyl XL 2mg, prolonged-release capsules, hard. Mylan. Revised December 2012.
Summary of Product Characteristics: Efflosomyl XL 4mg, prolonged-release capsules, hard. Mylan. Revised August 2012.
Summary of Product Characteristics: Inconex XL 4mg, prolonged-release capsules. Sandoz Ltd. Revised August 2015.
Summary of Product Characteristics: Mariosea XL 2mg, prolonged release capsules. Teva UK Ltd. Revised July 2015.
Summary of Product Characteristics: Mariosea XL 4mg, prolonged release capsules. Teva UK Ltd. Revised July 2015.
Summary of Product Characteristics: Neditol XL 4mg, prolonged release capsules. Aspire. Revised May 2012.
Summary of Product Characteristics: Neditol XL 2mg, prolonged release capsules. Aspire. Revised May 2012.
Summary of Product Characteristics: Preblacon XL 4mg, prolonged release capsules. Actavis UK Ltd. Revised February 2015.
Summary of Product Characteristics: Santizor XL 4mg, prolonged-release capsules, hard. Pfizer Ltd. Revised July 2015.
Summary of Product Characteristics: Toldelo XL 2mg, prolonged-release capsules. Morningside Healthcare Ltd. Revised January 2022.
Summary of Product Characteristics: Toldelo XL 4mg, prolonged-release capsules. Morningside Healthcare Ltd. Revised January 2022.
Summary of Product Characteristics: Tolterma XL 2mg, prolonged-release capsules, hard. Macleods Pharma UK Ltd. Revised May 2018.
Summary of Product Characteristics: Tolterma XL 4mg, prolonged-release capsules, hard. Macleods Pharma UK Ltd. Revised May 2018.
Summary of Product Characteristics: Tolthen XL 2 mg, prolonged-release capsules, hard. Northumbria Pharma Ltd. Revised August 2019.
Summary of Product Characteristics: Tolthen XL 4 mg, prolonged-release capsules, hard. Northumbria Pharma Ltd. Revised August 2019.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 September 2022
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