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Tolterodine tartrate tablets

Presentation

Oral formulation of standard release tablets containing tolterodine tartrate.

Drugs List

  • DETRUSITOL 1mg tablets
  • DETRUSITOL 2mg tablets
  • tolterodine 1mg tablets
  • tolterodine 2mg tablets
  • Therapeutic Indications

    Uses

    Symptomatic treatment of urinary urgency, frequency or urge incontinence

    Symptomatic treatment of overactive bladder with urinary urgency, frequency or urge incontinence in adults.

    Unlicensed Uses

    Nocturnal enuresis

    Symptomatic treatment of overactive bladder with urinary urgency, frequency, incontinence and nocturnal enuresis in children.

    Dosage

    Adults

    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.

    Children

    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.

    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
    Elderly
    Family history of long QT syndrome
    Autonomic neuropathy
    Benign prostatic hyperplasia
    Bladder outflow obstruction
    Cardiac arrhythmias
    Cardiac failure
    Cardiac surgery
    Congestive cardiac failure
    Decreased gastrointestinal motility
    Electrolyte imbalance
    Gastroesophageal reflux
    Gastrointestinal obstruction
    Hepatic impairment
    Hiatus hernia
    History of torsade de pointes
    Hypertension
    Hyperthyroidism
    Ischaemic heart disease
    Pyloric stenosis
    Reflux oesophagitis
    Renal impairment - creatinine clearance below or equal to 30ml/minute
    Tachycardia

    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

    Pregnancy

    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).

    Lactation

    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.

    Side Effects

    Abdominal pain
    Abnormal vision
    Anaphylactoid reaction
    Angioedema
    Arrhythmias
    Blurred vision
    Bronchitis
    Cardiac failure
    Chest pain
    Confusion
    Constipation
    Diarrhoea
    Difficulty in micturition
    Disorientation
    Disturbances in accommodation
    Dizziness
    Drowsiness
    Dry eyes
    Dry mouth
    Dry skin
    Dyspepsia
    Dysuria
    Fatigue
    Flatulence
    Flushing
    Gastroesophageal reflux
    Hallucinations
    Headache
    Hypersensitivity reactions
    Impaired memory
    Nervousness
    Palpitations
    Paraesthesia
    Peripheral oedema
    Prolongation of QT interval
    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: March 2020.

    Reference Sources

    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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