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Alfuzosin modified-release tablets

Presentation

Modified-release tablets containing alfuzosin hydrochloride.

Drugs List

  • alfuzosin 10mg modified release tablet
  • BESAVAR XL 10mg tablets
  • FUZATAL XL 10mg tablets
  • VASRAN XL 10mg modified release tablet
  • XATRAL XL 10mg tablets
  • ZOCHEK 10mg prolonged release tablet
  • Therapeutic Indications

    Uses

    Acute urinary retention: adjunct to catheterisation in pts aged > 65 years
    Urinary obstruction due to benign prostatic hyperplasia

    Dosage

    Adults

    Treatment of the functional symptoms of benign prostatic hypertrophy.
    One 10mg modified-release tablet once daily.

    Elderly

    Treatment of the functional symptoms of benign prostatic hypertrophy.
    One 10mg modified-release tablet once daily.

    Over 65 years old: Treatment of acute urinary retention related to benign prostatic hypertrophy
    One 10mg modified-release tablet to be taken once daily.
    The first dose should be given from the first day of catheterisation. The treatment should continue for 3 - 4 days (2 - 3 days during catheterisation and 1 day following the removal of the catheter).
    No benefit has been established when treatment exceeds 4 days.

    Contraindications

    Children under 16 years
    Micturition syncope
    Hepatic impairment
    History of postural hypotension
    Long QT syndrome
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Acute cardiac failure
    Cerebrovascular disorder
    Electrolyte imbalance
    Galactosaemia
    Glucose-galactose malabsorption syndrome
    History of torsade de pointes
    Hypertension
    Lactose intolerance
    Peri-operative period in cataract surgery
    Renal impairment - creatinine clearance below 30 ml/minute

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Not all available brands are licensed for all indications
    Some formulations contain castor oil polyoxyl which may cause diarrhoea
    Some formulations contain lactose
    First dose should be taken at bed-time
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor blood pressure in hypertensive patients
    Monitor serum electrolytes
    Advise patient that postural hypotension may occur
    Advise patient to sit or lie down at first signs of orthostatic hypotension
    Intraoperative Floppy Iris Syndrome has been reported in cataract surgery
    Seek immediate medical attention if priapism occurs
    Discontinue treatment 24 hours prior to surgery
    Discontinue treatment if angina appears or worsens
    Advise patient grapefruit products may increase plasma level

    Counselling

    Advise patients that the tablets should be swallowed whole and taken after food. The tablets should not be crunched, crushed, chewed, or ground to powder as this may lead to inappropriate release of alfuzosin and consequently early adverse effects.

    The first dose should be given just before bedtime due to the potential first dose hypotensive effect.

    Postural hypotension (with or without symptoms such as dizziness, fatigue and sweating) may occur within a few hours of administration. Warn the patient that this effect may occur and advise them that, if affected, they should lie down until symptoms have completely resolved.

    Advise patients that if affected by such symptoms, they should not drive or perform skilled tasks until the symptoms have resolved.

    Advise patient to avoid grapefruit products.

    Side Effects

    Abdominal pain
    Abnormal vision
    Aggravation of angina
    Angina pectoris
    Angioedema
    Asthenia
    Atrial fibrillation
    Chest pain
    Cholestatic liver changes
    Diarrhoea
    Dizziness
    Drowsiness
    Dry mouth
    Dyspepsia
    Erectile disturbance
    Faintness
    Flushing
    Headache
    Hepatocellular damage
    Hypersensitivity reactions
    Hypotension
    Intraoperative floppy iris syndrome
    Malaise
    Nausea
    Neutropenia
    Oedema
    Palpitations
    Postural hypotension
    Priapism
    Pruritus
    Rash
    Recurrent ischaemia/angina
    Rhinitis
    Syncope
    Tachycardia
    Thrombocytopenia
    Urticaria
    Vertigo
    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: February 2018

    Reference Sources

    Summary of Product Characteristics: Besavar XL 10mg tablets. Winthrop Pharmaceuticals UK Limited. Revised June 2017.

    Summary of Product Characteristics: Vasran XL 10mg tablets. Ranbaxy. Revised July 2016.

    Summary of Product Characteristics: Xatral XL 10mg. Sanofi-Aventis. Revised June 2017.

    Summary of Product Characteristics: Zochek 10mg prolonged release tablets. Aurobindo Pharma. Revised October 2015.

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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.