Solifenacin succinate with tamsulosin hydrochloride oral modified release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of solifenacin succinate with tamsulosin hydrochloride.
Drugs List
Therapeutic Indications
Uses
Benign prostatic hyperplasia
Treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia (BPH) in men who are not adequately responding to treatment with monotherapy.
Dosage
Adults
One tablet taken once daily.
Contraindications
Children under 18 years
Females
Haemodialysis
History of postural hypotension
Long QT syndrome
Myasthenia gravis
Narrow angle glaucoma
Severe gastrointestinal disorder
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Torsade de pointes
Toxic megacolon
Precautions and Warnings
Family history of long QT syndrome
Autonomic neuropathy
Decreased gastrointestinal motility
Electrolyte imbalance
Gastroesophageal reflux
Gastrointestinal obstruction
Hepatic impairment - Child-Pugh score between 7 and 9
Hiatus hernia
History of torsade de pointes
Hypokalaemia
Renal impairment - creatinine clearance below 30 ml/minute
Urinary retention
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Advise hypotension/syncope may affect ability to drive/operate machinery
Consider organic reasons for urinary urge and frequency before treatment
Avoid anticholinergics within 1 week of stopping treatment
Consider monitoring ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Advise patient to sit or lie down at first signs of orthostatic hypotension
Intraoperative Floppy Iris Syndrome has been reported in cataract surgery
Intraoperative Floppy Iris Syndrome has been reported in glaucoma surgery
Discontinue 1 to 2 weeks prior to cataract surgery
Discontinue 1 to 2 weeks prior to glaucoma surgery
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue immediately if angioedema of the tongue/glottis/larynx occurs
Advise patient grapefruit products may increase plasma level
Pregnancy and Lactation
Pregnancy
Solifenacin succinate and tamsulosin hydrochloride is not indicated in females.
Lactation
Solifenacin succinate and tamsulosin hydrochloride is not indicated in females.
Side Effects
Abdominal discomfort
Abdominal pain
Abnormal liver function tests
Anaphylactic reaction
Angioedema
Arrhythmias
Asthenia
Atrial fibrillation
Blurred vision
Confusion
Constipation
Cystitis
Decreased appetite
Delirium
Diarrhoea
Difficulty in micturition
Dizziness
Dry eyes
Dry mouth
Dry skin
Dry throat
Dysgeusia
Dyspepsia
Dysphonia
Dyspnoea
Ejaculation disorders
Epistaxis
Erythema multiforme
Exfoliative dermatitis
Faecal impaction
Failure of ejaculation
Fatigue
Gastroesophageal reflux disease
Glaucoma
Hallucinations
Headache
Hepatic disorders
Hyperkalaemia
Ileus
Intestinal obstruction
Intraoperative floppy iris syndrome
Muscle weakness
Nasal dryness
Nausea
Orthostatic hypotension
Palpitations
Peripheral oedema
Priapism
Prolongation of QT interval
Pruritus
Rash
Renal impairment
Retrograde ejaculation
Rhinitis
Somnolence
Stevens-Johnson syndrome
Syncope
Tachycardia
Torsades de pointes
Urinary retention
Urinary tract infections
Urticaria
Visual impairment (irreversible)
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: September 2019
Reference Sources
Summary of Product Characteristics: Vesomni 6mg/0.4mg modified release tablets. Astellas Pharma Ltd. Revised March 2018.
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.