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Alfuzosin oral standard release

Presentation

Oral standard release formulation of alfuzosin

Drugs List

  • alfuzosin 2.5mg tablets
  • Therapeutic Indications

    Uses

    Urinary obstruction due to benign prostatic hyperplasia

    Dosage

    Adults

    The usual dose is 2.5 mg three times daily. The dose may be increased to a maximum of 10 mg per day depending on the clinical response.

    Hypertensive patients receiving anti-hypertensive therapy
    Initially 2.5 mg to be taken twice daily (morning and evening) adjusted according to clinical response.

    Elderly

    Patients aged over 65 years
    Initially 2.5 mg to be taken twice daily (morning and evening) adjusted according to clinical response.

    Patients with Renal Impairment

    Dosing should be started at 2.5 mg twice daily adjusted according to clinical response.

    Patients with Hepatic Impairment

    Mild to moderate hepatic impairment
    Initially 2.5 mg once daily, increasing to 2.5 mg twice daily according to clinical response.

    Contraindications

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

    Precautions and Warnings

    Elderly
    Family history of long QT syndrome
    Acute cardiac failure
    Cerebrovascular disorder
    Electrolyte imbalance
    Glucose-galactose malabsorption syndrome
    History of torsade de pointes
    Hypertension
    Lactose intolerance
    Mild hepatic impairment
    Renal impairment

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Contains 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
    Discontinue treatment if angina appears or worsens
    Advise patient grapefruit products may increase plasma level

    In some patients, especially those taking antihypertensive medications, postural hypotension (with or without symptoms such as dizziness, fatigue and sweating) may occur within a few hours of administration. If this occurs, the patients should lie down until symptoms have completely resolved.

    These effects are transient and treatment may be continued after dosage adjustment. The patient should be warned of this effect.

    There is a risk of cerebral ischaemic disorders in patients with symptomatic or asymptomatic pre-existing cerebral circulatory disturbances, due to the fact that hypotension may develop following alfuzosin administration.

    Intraoperative Floppy Iris Syndrome (IFIS) has been observed during the cataract surgery of patients who were currently taking alpha-1 receptor blockers or who had previously taken alpha-1 receptor blockers. A class-effect may exist. It is therefore important that ophthalmic surgeons are informed if a patient has ever been treated with alfuzosin, as IFIS may lead to increased procedural complications.

    Pregnancy and Lactation

    Pregnancy

    Not indicated for use in women.

    The 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

    Not indicated for use in women.

    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
    Abnormal vision
    Aggravation of angina
    Angina pectoris
    Angioedema
    Asthenia
    Atrial fibrillation
    Chest pain
    Cholestatic liver changes
    Diarrhoea
    Dizziness
    Drowsiness
    Dry mouth
    Faintness
    Flushing
    Headache
    Hepatocellular damage
    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: September 2016

    Reference Sources

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed on 7 September 2016.

    Summary of Product Characteristics: Alfuzosin HCL 2.5mg Film-coated tablets. Aurobindo Pharma-Milpharm Ltd. Revised September 2011.

    Summary of Product Characteristics: Alfuzosin Hydrochloride 2.5mg tablets. Zentiva. Revised May 2014.

    Summary of Product Characteristics: Xatral 2.5mg film-coated tablets. Sanofi. Revised October 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.