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Propiverine hydrochloride oral modified release

Presentation

Modified release capsules containing propiverine hydrochloride

Drugs List

  • DETRUNORM XL 30mg modified release capsules
  • DETRUNORM XL 45mg modified release capsules
  • propiverine 30mg modified release capsules
  • propiverine 45mg modified release capsules
  • 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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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    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.