Solifenacin succinate oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of solifenacin succinate.
Drugs List
Therapeutic Indications
Uses
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.
Dosage
Adults
5mg once daily. Increased to 10mg once daily if required.
Children
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.
Contraindications
Children under 2 years
Breastfeeding
Haemodialysis
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
Galactosaemia
Gastroesophageal reflux
Gastrointestinal obstruction
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Hiatus hernia
History of torsade de pointes
Lactose intolerance
Moderate hepatic impairment
Pregnancy
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
Pregnancy
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.
Lactation
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
Angioedema
Anticholinergic effects
Atrial fibrillation
Blurred vision
Confusion (transient)
Constipation
Cystitis
Decreased appetite
Delirium
Difficulty in micturition
Dizziness
Dry eyes
Dry mouth
Dry skin
Dry throat
Dysgeusia
Dyspepsia
Dysphonia
Erythema multiforme
Exfoliative dermatitis
Faecal impaction
Fatigue
Gastroesophageal reflux disease
Glaucoma
Hallucinations
Headache
Hyperkalaemia
Ileus
Intestinal obstruction
Liver damage
Muscular fatigue
Nasal dryness
Nausea
Oedema
Palpitations
Prolongation of QT interval
Pruritus
Rash
Renal impairment
Somnolence
Tachycardia
Torsades de pointes
Urinary retention
Urinary tract infections
Urticaria
Vomiting
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
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: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Solifenacin Last revised: 03 December 2018
Last accessed: 04 March 2020
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 09 October 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.