Alfuzosin oral standard release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral standard release formulation of alfuzosin
Drugs List
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.
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.