Propiverine hydrochloride oral modified release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Modified release capsules containing propiverine hydrochloride
Drugs List
Therapeutic Indications
Uses
Neurogenic bladder disorder
Overactive bladder syndrome
Treatment of urinary incontinence and/or urinary urgency and urinary frequency in patients with overactive bladder syndrome or neurogenic detrusor overactivity (detrusor hyperreflexia) from spinal cord injuries.
Dosage
Adults
Overactive bladder syndrome
30 mg to 45 mg daily.
Neurogenic bladder disorder
45 mg daily.
Patients may be transferred from standard-release tablets to the modified-release capsule which provides the same total daily dose.
Elderly
Overactive bladder syndrome
30 mg to 45 mg daily.
Neurogenic bladder disorder
45 mg daily.
Patients may be transferred from standard-release tablets to the modified-release capsule which provides the same total daily dose.
Patients with Renal Impairment
Creatinine clearance of less than 30 ml/minute
Maximum dose of 30 mg daily.
Contraindications
Children under 18 years
Bladder outflow obstruction
Breastfeeding
Galactosaemia
Gastrointestinal atony
Gastrointestinal obstruction
Moderate hepatic impairment
Myasthenia gravis
Narrow angle glaucoma
Pregnancy
Severe ulcerative colitis
Tachyarrhythmia
Toxic megacolon
Urinary retention
Precautions and Warnings
Predisposition to narrow angle glaucoma
Autonomic neuropathy
Benign prostatic hyperplasia
Cardiac arrhythmias
Glucose-galactose malabsorption syndrome
Hiatus hernia
Hypertension
Hyperthyroidism
Ischaemic heart disease
Lactose intolerance
Mild hepatic impairment
New York Heart Association class IV failure
Reflux oesophagitis
Renal impairment - creatinine clearance below 30 ml/minute
Tachycardia
Advise patient blurred vision may affect ability to drive/operate machinery
Advise patient drowsiness may affect ability to drive or operate machinery
Not all available strengths are licensed for all indications
Contains lactose
Consider residual urinary volume, in patients with urinary tract infections
Monitor hepatic function on long term therapy
Monitor patients at risk of glaucoma for increases in intraocular pressure
Pregnancy and Lactation
Pregnancy
Propiverine is contraindicated in pregnancy.
At the time of writing there no adequate reports of its use in pregnant women.
Skeletal retardation has occurred in animal studies with high doses of propiverine.
he use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Propiverine is contraindicated in breastfeeding.
Propiverine is secreted in the breast milk of mammals.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abdominal pain
Alterations in hepatic enzymes
Blurred vision
Confusion
Constipation
Decrease in blood pressure
Difficulty in micturition
Disturbances in accommodation
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Dyspepsia
Fatigue
Flushing
Hallucinations
Headache
Hypersensitivity reactions
Mydriasis
Nausea
Palpitations
Rash
Restlessness
Tremor
Urinary retention
Visual disturbances
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: October 2014
Reference Sources
Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 22 October 2014.
Summary of Product Characteristics: Detrunorm XL 30 mg modified release capsules. AMCo. Revised August 2014.
Summary of Product Characteristics: Detrunorm XL 45 mg modified release capsules. AMCo. Revised February 2014.
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