Alfuzosin Orion
Alpha-1 blocker for the treatment of benign prostatic hyperplasia (BPH)
Alfuzosin Orion contains the active substance alfuzosin hydrochloride and is used to treat moderate to severe urinary symptoms caused by benign prostatic hyperplasia (BPH) — an enlarged prostate. It works by relaxing the smooth muscle in the prostate and bladder neck, improving urinary flow and making it easier to empty the bladder. This page provides comprehensive information about alfuzosin, including its uses, correct dosage, potential side effects, drug interactions, and important warnings.
Quick Facts
Key Takeaways
- Alfuzosin Orion is a once-daily extended-release alpha-1 blocker prescribed for moderate to severe symptoms of benign prostatic hyperplasia (BPH).
- Take one 10 mg tablet after your evening meal — do not crush, chew, or split the tablet as this may affect how the medicine is released.
- Common side effects include dizziness, headache, nausea, and fatigue, which usually improve with continued use.
- Do not combine alfuzosin with other alpha-blockers or strong CYP3A4 inhibitors (such as ritonavir, ketoconazole, or itraconazole).
- Alfuzosin may cause low blood pressure when standing up — rise slowly from sitting or lying positions, especially during the first few days of treatment.
What Is Alfuzosin Orion and What Is It Used For?
Alfuzosin Orion belongs to a group of medicines known as alpha-1 adrenergic receptor antagonists (alpha-1 blockers). The active substance, alfuzosin hydrochloride, selectively targets alpha-1 receptors found predominantly in the smooth muscle of the prostate gland, the bladder base, and the prostatic urethra. By blocking these receptors, alfuzosin relaxes the smooth muscle in these areas, reducing the constriction of the urethra and thereby improving urinary flow.
Benign prostatic hyperplasia (BPH) is a common condition affecting men, particularly those over the age of 50. The prostate gland, which sits just below the bladder and surrounds the urethra, gradually enlarges with age. This growth is non-cancerous (benign), but as the prostate increases in size, it can press on the urethra and obstruct the normal flow of urine. This obstruction causes what clinicians refer to as lower urinary tract symptoms (LUTS), which can be divided into two categories.
Obstructive (voiding) symptoms include difficulty starting urination (hesitancy), a weak or interrupted urinary stream, straining to urinate, prolonged voiding, incomplete bladder emptying, and post-void dribbling. Irritative (storage) symptoms include urinary frequency, urgency, nocturia (waking up at night to urinate), and urge incontinence. These symptoms can significantly affect quality of life, sleep, and daily activities.
The European Association of Urology (EAU) guidelines recognize alpha-1 blockers, including alfuzosin, as first-line pharmacological therapy for moderate to severe BPH symptoms. Clinical trials have demonstrated that alfuzosin 10 mg once daily significantly improves the International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), and patient quality of life compared to placebo. The onset of symptomatic relief typically occurs within the first one to two weeks of treatment.
It is important to understand that alfuzosin does not reduce the size of the prostate gland. Unlike 5-alpha reductase inhibitors (such as finasteride or dutasteride), which work by shrinking the prostate over several months, alfuzosin provides rapid symptomatic relief by relaxing the muscular component of prostatic obstruction. In some cases, doctors may prescribe combination therapy with both an alpha-blocker and a 5-alpha reductase inhibitor for more comprehensive management of BPH.
Alfuzosin Orion is available as extended-release (depot) tablets containing 10 mg of alfuzosin hydrochloride. The extended-release formulation is designed to provide a steady release of the active substance over 24 hours, allowing for once-daily dosing and maintaining consistent plasma concentrations. Other brand names containing the same active ingredient include Alfuzosin Sandoz, Xatral OD, Alfuzosin Rivopharm, and Alfuzosin Teva. Always consult your doctor if your symptoms do not improve or if they worsen during treatment.
What Should You Know Before Taking Alfuzosin Orion?
Contraindications
There are several important situations where alfuzosin must not be used. You should not take Alfuzosin Orion if any of the following apply to you:
- Allergy to alfuzosin or any excipient: If you have a known allergy to alfuzosin hydrochloride or any of the other ingredients in the tablet (listed in the composition section below). Symptoms of an allergic reaction include skin rash, swelling of the lips, throat, or tongue, and difficulty swallowing or breathing.
- Orthostatic hypotension: If you have a history of, or currently experience, a significant drop in blood pressure upon standing from a sitting or lying position. This condition can cause dizziness, lightheadedness, or fainting.
- Hepatic (liver) impairment: Alfuzosin is extensively metabolized by the liver. Patients with liver problems should not take this medicine, as impaired liver function can lead to dangerously elevated blood levels of alfuzosin.
- Concurrent use of other alpha-1 blockers: Do not take alfuzosin if you are already taking another alpha-blocker such as tamsulosin, doxazosin, terazosin, prazosin, indoramin, or phenoxybenzamine, as this combination increases the risk of severe hypotension.
- Potent CYP3A4 inhibitors: Do not take alfuzosin with ritonavir (alone or in combination with ombitasvir/paritaprevir, lopinavir, or nirmatrelvir), as these drugs significantly increase alfuzosin plasma concentrations, raising the risk of serious side effects.
Warnings and Precautions
Speak with your doctor or pharmacist before taking Alfuzosin Orion if you have any of the following conditions or circumstances:
- Severe kidney problems: Although no dose adjustment is needed for mild to moderate renal impairment, patients with severe kidney disease should use alfuzosin with caution, as limited clinical data are available for this population.
- Heart disease: If you have any form of cardiac disease, your doctor should evaluate the risks and benefits before prescribing alfuzosin, as the drug can affect blood pressure and heart rate.
- Angina pectoris (chest pain): Patients with angina should be closely monitored, particularly if they are also taking nitrates or other vasodilators for chest pain.
- QT prolongation: If you have a known abnormality on your electrocardiogram (ECG) called QT prolongation, or if you take medications known to prolong the QT interval, discuss this with your doctor before starting alfuzosin.
Some patients, particularly those concurrently taking blood pressure-lowering medications or medicines for angina, may experience dizziness, weakness, or sweating within a few hours of taking their first dose. If this occurs, lie down immediately until the symptoms completely resolve. Inform your doctor, as a dose adjustment may be necessary.
In rare cases, alfuzosin may cause priapism — a prolonged, often painful erection not related to sexual activity. If you experience an erection lasting longer than 4 hours, seek emergency medical attention immediately, as untreated priapism can result in permanent erectile dysfunction.
Before Surgery
If you are scheduled for any surgery requiring general anesthesia, inform your anesthesiologist that you are taking alfuzosin. This is important because the medication can lower blood pressure, which may need to be managed during the procedure.
If you are planning cataract surgery, tell your eye specialist (ophthalmologist) before the operation that you are taking or have previously taken alfuzosin. Alpha-1 blockers have been associated with a condition called Intraoperative Floppy Iris Syndrome (IFIS), which can cause complications during cataract surgery. When the surgeon is aware of this possibility in advance, appropriate surgical techniques can be used to manage the situation safely.
Pregnancy and Breastfeeding
Alfuzosin Orion is intended for use in adult men only. It is not indicated for use in women. There are no adequate data on the use of alfuzosin in pregnant or breastfeeding women. If a female partner accidentally takes this medication, she should contact a healthcare professional immediately.
Driving and Operating Machinery
Alfuzosin can cause dizziness and drowsiness, particularly at the beginning of treatment. If you experience these effects, do not drive a vehicle or operate machinery until you know how the medicine affects you. You are personally responsible for assessing whether you are fit to drive or perform tasks that require alertness. Discuss any concerns with your doctor or pharmacist.
Alfuzosin Orion should always be taken immediately after a meal. Food significantly increases the absorption of alfuzosin, ensuring consistent and effective blood levels throughout the day.
How Does Alfuzosin Orion Interact with Other Drugs?
Drug interactions are an important safety consideration when taking alfuzosin. Alfuzosin is primarily metabolized by the liver enzyme CYP3A4. Drugs that inhibit or induce this enzyme can alter alfuzosin blood levels, potentially leading to increased side effects or reduced effectiveness. Always inform your doctor or pharmacist about all medications you are currently taking, have recently taken, or plan to take, including over-the-counter medicines and herbal supplements.
Major Interactions — Do Not Combine
| Drug / Class | Examples | Risk |
|---|---|---|
| Other alpha-blockers | Doxazosin, tamsulosin, terazosin, prazosin, indoramin, phenoxybenzamine | Severe hypotension, fainting, cardiovascular collapse |
| HIV protease inhibitors | Ritonavir (alone or in combination with ombitasvir/paritaprevir, lopinavir, or nirmatrelvir) | Markedly increased alfuzosin plasma levels; risk of severe hypotension and toxicity |
Moderate Interactions — Use with Caution
| Drug / Class | Examples | Risk |
|---|---|---|
| Antihypertensives | ACE inhibitors, ARBs, calcium channel blockers, beta-blockers, diuretics | Additive blood pressure-lowering effect; increased risk of dizziness, weakness, and postural hypotension |
| Nitrates (anti-angina) | Nitroglycerin, isosorbide mononitrate, isosorbide dinitrate | Additive vasodilation; significant blood pressure drop, especially upon standing |
| Azole antifungals | Itraconazole, ketoconazole | CYP3A4 inhibition; increased alfuzosin plasma concentrations |
| Macrolide antibiotics | Clarithromycin, telithromycin | CYP3A4 inhibition; potential for elevated alfuzosin levels |
| Antidepressants | Nefazodone | CYP3A4 inhibition; increased alfuzosin exposure |
| Ketoconazole tablets | Ketoconazole (for Cushing’s syndrome) | Strong CYP3A4 inhibition; substantially elevated alfuzosin concentrations |
If you have previously experienced a significant drop in blood pressure when taking another alpha-blocker, inform your doctor before starting alfuzosin. Your doctor may decide to start with careful monitoring or consider alternative treatment options. Additionally, if you are taking any blood pressure-lowering medication and experience dizziness, weakness, or sweating after taking alfuzosin, lie down until the symptoms have completely resolved and contact your doctor, as your medication doses may need to be adjusted.
What Is the Correct Dosage of Alfuzosin Orion?
Always take Alfuzosin Orion exactly as your doctor has prescribed. Consult your doctor or pharmacist if you are uncertain about any aspect of your treatment. The extended-release tablet is specifically formulated to release alfuzosin gradually over 24 hours, which is why it must be swallowed whole with plenty of water (for example, a full glass). Crushing, splitting, or chewing the tablet will damage the extended-release mechanism and may cause too much of the drug to be released at once, increasing the risk of side effects.
Adults
Standard Adult Dose
10 mg once daily, taken immediately after the evening meal. The tablet should be swallowed whole with a sufficient amount of liquid.
Elderly Patients (Over 65 Years)
Elderly Dose
10 mg once daily — no dose adjustment is required for patients over 65 years of age. However, elderly patients may be more susceptible to postural hypotension (dizziness on standing), so particular caution is advised at the start of treatment.
Patients with Kidney Problems
Renal Impairment Dose
10 mg once daily for mild to moderate renal impairment — no dose adjustment required. Alfuzosin should be used with caution in patients with severe renal impairment, as clinical data in this population are limited.
Children and Adolescents
Alfuzosin Orion is not recommended for children and adolescents aged 16 years or younger. The safety and efficacy of alfuzosin have not been established in this age group.
| Patient Group | Dose | Frequency | Notes |
|---|---|---|---|
| Adults | 10 mg | Once daily | Take after evening meal |
| Elderly (>65 years) | 10 mg | Once daily | No adjustment; monitor for hypotension |
| Mild-moderate kidney impairment | 10 mg | Once daily | No adjustment needed |
| Severe kidney impairment | 10 mg | Once daily | Use with caution; limited data |
| Children (≤16 years) | N/A | N/A | Not recommended |
Missed Dose
If you forget to take your daily dose of Alfuzosin Orion, simply skip the missed dose and take your next dose as usual after your evening meal the following day. Do not take a double dose to make up for the one you missed. Taking two tablets at once increases the risk of side effects, particularly a dangerous drop in blood pressure.
Overdose
If you take more alfuzosin than prescribed, or if a child accidentally ingests the medicine, contact your local poison control center or emergency services immediately. Inform the medical team how many tablets were taken. Lie down as much as possible to minimize the effects of low blood pressure. Do not attempt to drive yourself to the hospital.
Stopping Treatment
Continue taking Alfuzosin Orion even if your symptoms improve. Do not stop the medication unless your doctor advises you to do so. Your symptoms are better controlled when you maintain a consistent daily dose. If you have any further questions about your treatment, consult your doctor or pharmacist.
What Are the Side Effects of Alfuzosin Orion?
Like all medicines, Alfuzosin Orion can cause side effects, although not everyone experiences them. Side effects are more likely to occur at the beginning of treatment as your body adjusts to the medication. The following list groups side effects by how often they occur, based on data from clinical trials and post-marketing surveillance.
- Chest pain (angina): especially if you have a history of angina. Stop the medication and seek emergency care.
- Severe allergic reaction (angioedema): including skin rash, swelling of the face, eyelids, lips, mouth, or tongue, or difficulty breathing or swallowing.
- Priapism: a persistent, painful erection lasting more than 4 hours and unrelated to sexual activity. This is a medical emergency.
Common
May affect up to 1 in 10 people
- Dizziness
- Headache
- Nausea (feeling sick)
- Abdominal discomfort and indigestion (dyspepsia)
- Abdominal pain
- Weakness or fatigue (asthenia)
- General malaise
Uncommon
May affect up to 1 in 100 people
- Orthostatic hypotension (dizziness or faintness when standing up)
- Rapid heartbeat (tachycardia)
- Drowsiness or somnolence
- Rhinitis (runny or stuffy nose, sneezing)
- Diarrhea and vomiting
- Dry mouth
- Skin rash and itching (pruritus)
- Peripheral edema (swelling of arms or legs)
- Chest pain
- Flushing (hot flushes)
Rare
May affect up to 1 in 10,000 people
- Angina pectoris (chest pain related to the heart)
- Angioedema (severe allergic reaction with swelling)
Frequency Not Known
Cannot be estimated from available data
- Irregular or rapid heartbeat (arrhythmia, atrial fibrillation)
- Decreased white blood cell count (neutropenia) — may present as frequent infections, sore throat, or mouth sores
- Low platelet count (thrombocytopenia) — may present as unusual bleeding or bruising, prolonged bleeding from cuts, petechiae (tiny red spots on the skin)
- Abnormal liver function (hepatotoxicity) — may present as yellowing of the skin or whites of the eyes (jaundice)
- Priapism (prolonged, painful erection unrelated to sexual activity)
- Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery
Cataract Surgery and Intraoperative Floppy Iris Syndrome
If you are taking or have previously taken Alfuzosin Orion and you are scheduled for cataract surgery (removal of a cloudy lens in the eye), the pupil may not dilate properly during the procedure, and the iris (the colored part of the eye) may become floppy. This condition, known as Intraoperative Floppy Iris Syndrome (IFIS), can complicate the surgery but can be managed safely if the ophthalmologist is informed in advance. Always tell your eye specialist about your current and past use of alpha-blockers before any eye surgery.
Reporting Side Effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this page. You can also report side effects directly to your national medicines regulatory authority. In the United Kingdom, report to the Medicines and Healthcare products Regulatory Agency (MHRA) via the Yellow Card Scheme. In the United States, report to the FDA MedWatch program. By reporting side effects, you help provide valuable information about the safety of medicines.
How Should You Store Alfuzosin Orion?
Alfuzosin Orion does not require any special storage conditions. Store the tablets at room temperature, away from excessive heat and moisture. Keep the medicine in its original packaging to protect it from light and environmental factors.
- Keep out of sight and reach of children. Store the medication in a secure location where children cannot access it.
- Check the expiry date printed on the blister pack, bottle, or carton before taking the medicine. The expiry date refers to the last day of the stated month. Do not take the medicine after this date.
- Silica gel desiccant: The bottle packaging may contain a silica gel desiccant. This is included to absorb moisture and keep the tablets dry. Do not ingest the desiccant.
- Proper disposal: Do not dispose of unused or expired medicines by flushing them down the toilet or throwing them in household waste. Return unused medicines to your local pharmacy for safe disposal. This helps protect the environment.
What Does Alfuzosin Orion Contain?
Understanding the full composition of your medicine can be helpful, especially if you have known allergies or intolerances to specific excipients (inactive ingredients).
Active Ingredient
Each extended-release tablet contains 10 mg of alfuzosin hydrochloride, which is the therapeutically active substance responsible for the medication’s pharmacological effects.
Inactive Ingredients (Excipients)
Tablet core: hypromellose, hydrogenated vegetable oil, povidone (K-30), calcium hydrogen phosphate, carbomer, colloidal anhydrous silica, and magnesium stearate.
Film coating: hypromellose, propylene glycol, and titanium dioxide (E171).
Appearance and Pack Sizes
Alfuzosin Orion 10 mg extended-release tablets are white to off-white, round, biconvex, film-coated tablets marked with “X” on one side and “47” on the other. The tablets are approximately 8.1 mm in diameter.
Available pack sizes include blister packs of 10, 20, 30, 50, 60, and 90 tablets, as well as bottle packs of 30 and 90 tablets. Not all pack sizes may be marketed in every country.
Frequently Asked Questions About Alfuzosin Orion
Alfuzosin is used to treat moderate to severe symptoms of benign prostatic hyperplasia (BPH), commonly known as an enlarged prostate. BPH is a non-cancerous condition where the prostate gland grows larger with age and presses on the urethra, causing urinary difficulties. Alfuzosin belongs to a class of medicines called alpha-1 blockers, which relax the smooth muscle in the prostate and bladder neck. This reduces urethral constriction and makes it easier to start urinating, improves urinary flow, and reduces the frequency of nighttime urination. Alfuzosin does not shrink the prostate but provides symptomatic relief.
Take one 10 mg extended-release tablet once daily, immediately after your evening meal. Swallow the tablet whole with a full glass of water. Do not crush, chew, or split the tablet, as this will destroy the extended-release mechanism and may cause the entire dose to be released at once, increasing side effects. Taking the tablet with food is essential because it improves the absorption of alfuzosin and helps maintain steady blood levels throughout the day and night.
The most common side effects of alfuzosin include dizziness, headache, nausea, abdominal discomfort or indigestion, abdominal pain, and weakness or fatigue. These side effects typically occur during the initial days of treatment and tend to diminish as your body adjusts to the medication. Less common side effects include drowsiness, rapid heartbeat, runny nose, diarrhea, dry mouth, skin rash, and swelling of the ankles or feet. If any side effect becomes severe or persistent, or if you experience chest pain, difficulty breathing, or a prolonged erection, seek medical attention immediately.
Yes, alfuzosin can cause orthostatic hypotension, which is a sudden drop in blood pressure when you stand up from a sitting or lying position. This can lead to dizziness, lightheadedness, blurred vision, or even fainting. The risk is highest at the beginning of treatment and is increased if you are also taking blood pressure-lowering medications or nitrates for chest pain. To reduce this risk, stand up slowly, sit on the edge of the bed for a moment before standing, and avoid prolonged standing in hot weather. If you feel dizzy, lie down immediately until the symptoms pass and inform your doctor.
Alfuzosin must not be taken with other alpha-1 blockers (such as tamsulosin, doxazosin, terazosin, or prazosin), as combining them can cause dangerous drops in blood pressure. It is also contraindicated with potent CYP3A4 inhibitors such as ritonavir, ketoconazole, and itraconazole, which can dramatically increase alfuzosin blood levels. Use caution when combining alfuzosin with antihypertensives, nitrates for angina, certain macrolide antibiotics (clarithromycin, telithromycin), and the antidepressant nefazodone. Always provide your doctor with a complete list of all medications and supplements you are taking.
Yes, alfuzosin 10 mg once daily is generally well tolerated in elderly patients over 65 years of age. No dose adjustment is required for this age group. However, older adults may be more susceptible to orthostatic hypotension, especially if they are taking multiple medications that lower blood pressure. Extra caution is therefore recommended at the start of treatment. Your doctor may wish to monitor your blood pressure more closely during the initial period. Elderly patients should also rise slowly from sitting or lying positions and report any persistent dizziness to their doctor.
References
- European Medicines Agency (EMA). Alfuzosin hydrochloride — Summary of Product Characteristics (SmPC). www.ema.europa.eu.
- Gravas S, Cornu JN, Gacci M, et al. EAU Guidelines on Management of Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS), incl. Benign Prostatic Obstruction (BPO). European Association of Urology; 2024. uroweb.org/guidelines.
- Roehrborn CG. Benign prostatic hyperplasia: an overview. Rev Urol. 2005;7(Suppl 9):S3–S14.
- van Kerrebroeck P, Jardin A, Laval KU, van Cangh P. Efficacy and safety of a new prolonged release formulation of alfuzosin 10 mg once daily versus alfuzosin 2.5 mg thrice daily and placebo in patients with symptomatic benign prostatic hyperplasia. Eur Urol. 2000;37(3):306–313. doi:10.1159/000020154.
- MacDonald R, Wilt TJ. Alfuzosin for treatment of lower urinary tract symptoms compatible with benign prostatic hyperplasia: a systematic review of efficacy and adverse effects. Urology. 2005;66(4):780–788. doi:10.1016/j.urology.2005.05.001.
- Joint Formulary Committee. British National Formulary (BNF). Alfuzosin hydrochloride monograph. bnf.nice.org.uk.
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List. Geneva: WHO; 2023. www.who.int.
- Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with tamsulosin. J Cataract Refract Surg. 2005;31(4):664–673. doi:10.1016/j.jcrs.2005.02.027.
- U.S. Food and Drug Administration (FDA). Alfuzosin hydrochloride — Prescribing Information. www.accessdata.fda.gov.
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