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Solifenacin succinate oral


Oral formulations of solifenacin succinate.

Drugs List

  • solifenacin 10mg tablets
  • solifenacin 1mg/ml oral suspension sugar-free
  • solifenacin 5mg tablets
  • solifenacin 5mg/5ml oral solution sugar-free
  • VESICARE 10mg tablets
  • VESICARE 1mg/ml oral suspension
  • VESICARE 5mg tablets
  • Therapeutic Indications


    Neurogenic detrusor overactivity in children
    Unstable bladder treatment.Symptoms of urgency/frequency/urge incontinence

    Treatment of urge incontinence and/or increased urinary frequency and urgency that may occur in patients with overactive bladder syndrome.

    Oral suspension indicated for treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 2 to 18 years.



    5mg once daily. Increased to 10mg once daily if required.


    Neurogenic detrusor overactivity
    Children aged 2 to 18 years

    Oral suspension (1mg/ml)

    9kg to 15kg: Starting dose 2ml. Maximum dose 4ml.
    Greater than 15kg to 30kg: Starting dose 3ml. Maximum dose 5ml.
    Greater than 30kg to 45kg: Starting dose 3ml. Maximum dose 6ml.
    Greater than 45kg to 60kg: Starting dose 4ml. Maximum dose 8ml.
    Greater than 60kg: Starting dose 5ml. Maximum dose 10ml.

    During long term therapy, patients should be periodically evaluated for treatment continuation and for potential dose adjustment, at least annually or more frequently if indicated.

    Patients with Renal Impairment

    Severe renal impairment (creatinine clearance equal to or less than 30ml/minute)
    Maximum 5mg once daily.

    Patients with Hepatic Impairment

    Moderate hepatic impairment (Child Pugh score of 7-9)
    Maximum 5mg once daily.


    Children under 2 years
    Long QT syndrome
    Myasthenia gravis
    Narrow angle glaucoma
    Severe gastrointestinal disorder
    Severe hepatic impairment
    Torsade de pointes
    Toxic megacolon
    Urinary retention - if treating overactive bladder

    Precautions and Warnings

    Children under 18 years
    Family history of long QT syndrome
    Autonomic neuropathy
    Bladder outflow obstruction
    Decreased gastrointestinal motility
    Electrolyte imbalance
    Gastroesophageal reflux
    Gastrointestinal obstruction
    Glucose-galactose malabsorption syndrome
    Hereditary fructose intolerance
    Hiatus hernia
    History of torsade de pointes
    Lactose intolerance
    Moderate hepatic impairment
    Renal impairment - creatinine clearance below or equal to 30ml/minute

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Consider organic reasons for urinary urge and frequency before treatment
    Not all presentations are licensed for all indications
    Some formulations contain hydroxybenzoate
    Some formulations contain lactose
    Some formulations contain propylene glycol
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor serum electrolytes
    Risk of narrow angle glaucoma
    Discontinue if angioedema occurs
    Discontinue if serious allergic or anaphylactic reaction occurs
    Not licensed for all indications in all age groups
    Full treatment effect achieved at least 4 weeks after initiation

    Pregnancy and Lactation


    Use solifenacin succinate with caution during pregnancy.

    The manufacturer advises caution if solifenacin succinate is used during pregnancy. Animal studies do not indicate direct harmful effects on fertility, embryo/foetal development or parturition. At the time of writing no clinical data exists regarding women who became pregnant whilst taking solifenacin. The potential risk for humans is unknown.


    Solifenacin succinate is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking solifenacin succinate. It is not known if solifenacin is excreted in human breast milk. Solifenacin and/or its metabolites were excreted into the milk of mice and caused a dose dependent failure to thrive in neonatal mice. LactMed states, milk production can reduce with long-term use of solifenacin and infants should be observed for signs of anticholinergic symptoms.

    Side Effects

    Abdominal discomfort
    Abdominal pain
    Abnormal liver function tests
    Anaphylactic reaction
    Anticholinergic effects
    Atrial fibrillation
    Blurred vision
    Confusion (transient)
    Decreased appetite
    Difficulty in micturition
    Dry eyes
    Dry mouth
    Dry skin
    Dry throat
    Erythema multiforme
    Exfoliative dermatitis
    Faecal impaction
    Gastroesophageal reflux disease
    Intestinal obstruction
    Liver damage
    Muscular fatigue
    Nasal dryness
    Prolongation of QT interval
    Renal impairment
    Torsades de pointes
    Urinary retention
    Urinary tract infections


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2020

    Reference Sources

    Summary of Product Characteristics: Giraxine 5mg & 10mg film-coated tablets. Medreich plc. Revised September 2017.

    Summary of Product Characteristics: Solifenacin succinate 1 mg/ml Oral Solution. Brill Pharma Ltd. Revised December 2018.

    Summary of Product Characteristics: Vesicare 5mg & 10mg film-coated tablets. Astellas Pharma Ltd. Revised November 2019.

    Summary of Product Characteristics: Vesicare oral suspension. Astellas Pharma Ltd. Revised November 2019.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Solifenacin Last revised: 03 December 2018
    Last accessed: 04 March 2020

    NICE Evidence Services Available at: Last accessed: 09 October 2020

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