Alfuzosin STADA

What Is Alfuzosin STADA and What Is It Used For?

Alfuzosin STADA 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. The drug demonstrates selectivity for the lower urinary tract, which means it has a relatively modest effect on blood pressure compared to non-selective alpha-blockers.

Benign prostatic hyperplasia (BPH) is one of the most common conditions 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 broad categories that often coexist in the same patient.

Obstructive (voiding) symptoms include difficulty starting urination (hesitancy), a weak or interrupted urinary stream, straining to urinate, prolonged voiding, a feeling of incomplete bladder emptying, and post-void dribbling. Irritative (storage) symptoms include increased urinary frequency during the day, urgency (a sudden compelling desire to urinate that is difficult to defer), nocturia (waking up at night to urinate), and urge incontinence. The combined impact of these symptoms can significantly affect quality of life, disrupt sleep, limit social activities, and cause considerable psychological distress.

The European Association of Urology (EAU) guidelines recognize alpha-1 blockers, including alfuzosin, as first-line pharmacological therapy for moderate to severe BPH symptoms. Multiple randomized controlled trials have demonstrated that alfuzosin 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, which is considerably faster than other BPH drug classes such as 5-alpha reductase inhibitors.

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 blocking the conversion of testosterone to dihydrotestosterone and thereby shrinking the prostate over several months, alfuzosin provides rapid symptomatic relief by relaxing the muscular component of prostatic obstruction. The prostate has both a static component (gland tissue bulk) and a dynamic component (smooth muscle tone), and alfuzosin acts on the dynamic component. In some cases, physicians may prescribe combination therapy with both an alpha-blocker and a 5-alpha reductase inhibitor for patients with large prostates and significant symptoms, as the MTOPS and CombAT trials have shown that this combination offers superior long-term outcomes compared to either drug alone.

Alfuzosin STADA is available as extended-release (depot) tablets containing 5 mg of alfuzosin hydrochloride. Unlike the 10 mg once-daily formulation available from some other manufacturers, the 5 mg extended-release tablet is designed to be taken twice daily — once after breakfast and once after the evening meal. Both regimens deliver the same total daily dose of 10 mg alfuzosin, and clinical studies have confirmed equivalent efficacy and tolerability between the two approaches. Other brand names containing the same active ingredient include Alfuzosin Orion, Alfuzosin Sandoz, Xatral, 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 STADA?

Contraindications

There are several important situations where alfuzosin must not be used. You should not take Alfuzosin STADA 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 moderate to severe liver problems should not take this medicine, as impaired liver function can lead to dangerously elevated blood levels of alfuzosin and an increased risk of adverse effects.
• 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 significantly 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 including severe hypotension.

Warnings and Precautions

Speak with your doctor or pharmacist before taking Alfuzosin STADA 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 (creatinine clearance below 30 mL/min) should use alfuzosin with caution, as limited clinical data are available for this population and alfuzosin blood levels may be elevated.
• Heart disease: If you have any form of cardiac disease, including coronary artery disease, heart failure, or valvular heart 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 unstable angina or recently worsening angina should be closely monitored, particularly if they are also taking nitrates or other vasodilators for chest pain. In rare cases, alfuzosin has been associated with new or worsening angina symptoms.
• QT prolongation: If you have a known abnormality on your electrocardiogram (ECG) called QT prolongation, a family history of long QT syndrome, or if you take medications known to prolong the QT interval (such as certain antiarrhythmics, antipsychotics, or antibiotics), discuss this with your doctor before starting alfuzosin.
• Concomitant antihypertensive treatment: If you are currently taking blood pressure-lowering medications, your doctor may wish to monitor your blood pressure more frequently, especially during the first days and weeks of alfuzosin treatment, due to the risk of additive hypotensive effects.

Before Surgery

If you are scheduled for any surgery requiring general anesthesia, inform your anesthesiologist and surgeon that you are taking alfuzosin. This is important because the medication can lower blood pressure, which may need to be managed during the procedure. Your medical team can then take appropriate precautions and adjust anesthetic protocols accordingly.

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), first described in 2005, which can cause complications during cataract surgery. The iris may become flaccid and billowy during the procedure, the pupil may constrict progressively despite preoperative dilation, and iris prolapse may occur through surgical incisions. When the surgeon is aware of this possibility in advance, appropriate surgical techniques (such as iris retractors, intracameral phenylephrine, or modified phacoemulsification settings) can be used to manage the situation safely.

Pregnancy and Breastfeeding

Alfuzosin STADA 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 for advice. Animal reproductive studies have not shown direct teratogenic effects, but the relevance of these findings to humans is uncertain.

Driving and Operating Machinery

Alfuzosin can cause dizziness, drowsiness, and visual disturbances, particularly at the beginning of treatment or when the dose is changed. If you experience these effects, do not drive a vehicle, ride a bicycle, 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. The risk of impaired ability is highest during the first few days of treatment and may also occur if you miss doses and then restart the medication. Discuss any concerns with your doctor or pharmacist.

How Does Alfuzosin STADA Interact with Other Drugs?

Drug interactions are an important safety consideration when taking alfuzosin. Alfuzosin is primarily metabolized by the liver enzyme cytochrome P450 3A4 (CYP3A4). Drugs that inhibit this enzyme can slow the breakdown of alfuzosin, leading to higher blood concentrations and an increased risk of side effects. Conversely, drugs that induce CYP3A4 may reduce alfuzosin levels and potentially decrease its 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, herbal supplements (particularly St John’s wort, a CYP3A4 inducer), and dietary supplements.

Additionally, alfuzosin has intrinsic blood pressure-lowering properties due to its alpha-1 blocking mechanism. When combined with other medications that lower blood pressure, the effects can be additive, potentially leading to symptomatic hypotension, dizziness, or syncope (fainting). This is particularly relevant for patients taking multiple medications, a situation that is common in the elderly population most affected by BPH.

Major Interactions — Do Not Combine

Moderate Interactions — Use with Caution

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.

Regarding phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra), which are commonly used for erectile dysfunction — a condition that frequently coexists with BPH — caution is advised when taking these drugs together with alfuzosin. Both drug classes lower blood pressure through different mechanisms, and their combined use may cause symptomatic hypotension. Your doctor may recommend separating the doses by several hours and starting the PDE5 inhibitor at the lowest available dose.

What Is the Correct Dosage of Alfuzosin STADA?

Always take Alfuzosin STADA 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 approximately 12 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 including a sudden and potentially dangerous drop in blood pressure.

Adults

Elderly Patients (Over 65 Years)

Patients with Kidney Problems

Children and Adolescents

Alfuzosin STADA is not recommended for children and adolescents. The safety and efficacy of alfuzosin have not been established in the pediatric population. BPH is a condition that exclusively affects adult men, and there is no clinical indication for the use of this medicine in younger individuals.

Missed Dose

If you forget to take a dose of Alfuzosin STADA, take it as soon as you remember, provided it is still close to the scheduled time and you are about to eat or have recently eaten. However, if it is almost time for your next dose, skip the missed dose and return to your regular schedule. 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. If you frequently forget doses, consider setting a reminder alarm linked to your mealtimes.

Overdose

Stopping Treatment

Continue taking Alfuzosin STADA for as long as your doctor prescribes, even if your symptoms improve significantly. Do not stop the medication on your own without consulting your doctor first. BPH symptoms are managed rather than cured by alfuzosin, and they are likely to return if you discontinue treatment. If your doctor decides that it is appropriate to stop therapy, no gradual dose reduction (tapering) is generally necessary. If you have any further questions about your treatment, consult your doctor or pharmacist.

What Are the Side Effects of Alfuzosin STADA?

Like all medicines, Alfuzosin STADA can cause side effects, although not everyone experiences them. The majority of side effects are mild, occur at the beginning of treatment as your body adjusts to the medication, and often diminish or resolve entirely with continued use. The following list groups side effects by how often they occur, based on data from clinical trials and post-marketing pharmacovigilance reports from regulatory authorities worldwide.

Cataract Surgery and Intraoperative Floppy Iris Syndrome

If you are taking or have previously taken Alfuzosin STADA 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 and prone to prolapse through surgical incisions. This condition, known as Intraoperative Floppy Iris Syndrome (IFIS), was first reported in association with tamsulosin but has since been observed with all alpha-1 blockers, including alfuzosin. 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, even if you stopped taking the medication months or years ago.

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 at yellowcard.mhra.gov.uk. In the United States, report to the FDA MedWatch program at fda.gov/medwatch. In the European Union, you can report through the national pharmacovigilance system of your member state. By reporting side effects, you help provide valuable information about the safety of medicines and contribute to ongoing post-market surveillance.

How Should You Store Alfuzosin STADA?

Proper storage of your medication is essential to ensure that it remains safe and effective throughout its shelf life. Alfuzosin STADA should be stored at room temperature, below 25°C (77°F), protected from moisture and direct sunlight. Keep the medicine in its original packaging (blister pack or bottle) to protect it from environmental factors that could degrade the active substance or damage the extended-release formulation.

• Keep out of sight and reach of children. Store the medication in a secure, elevated location where children cannot access it. Consider using a lockable medicine cabinet if children are present in the household.
• Check the expiry date printed on the blister pack, bottle, or outer 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, as the active substance may have degraded and the medicine may no longer be effective or safe.
• Do not store in the bathroom, as the humidity and temperature fluctuations from showers and baths can damage the tablets and their extended-release coating.
• Proper disposal: Do not dispose of unused or expired medicines by flushing them down the toilet or throwing them in household waste, as this can contaminate water supplies and harm the environment. Return unused medicines to your local pharmacy for safe disposal through an authorized pharmaceutical waste program.

What Does Alfuzosin STADA Contain?

Understanding the full composition of your medicine can be helpful, especially if you have known allergies or intolerances to specific excipients (inactive ingredients). If you are uncertain whether any ingredient may cause a problem for you, consult your doctor or pharmacist before taking the medicine.

Active Ingredient

Each extended-release tablet contains 5 mg of alfuzosin hydrochloride, which is the therapeutically active substance responsible for the medication’s pharmacological effects. Alfuzosin hydrochloride is a white to off-white crystalline powder that is freely soluble in water at acidic pH and sparingly soluble at neutral pH. The hydrochloride salt form was selected for its favorable dissolution and absorption characteristics.

Inactive Ingredients (Excipients)

The inactive ingredients in Alfuzosin STADA extended-release tablets serve various pharmaceutical functions, including forming the matrix that controls drug release, ensuring tablet integrity, and providing a protective film coating. Typical excipients in alfuzosin extended-release formulations include:

Tablet core: hypromellose (hydroxypropyl methylcellulose — the primary matrix-forming polymer that controls drug release), hydrogenated castor oil, povidone, ethylcellulose, colloidal anhydrous silica, magnesium stearate, and microcrystalline cellulose.

Film coating: hypromellose, macrogol (polyethylene glycol), and titanium dioxide (E171).

If you have a known allergy to any of these ingredients, do not take this medicine and discuss alternative medications with your doctor. In particular, patients with rare hereditary conditions affecting galactose tolerance, total lactase deficiency, or glucose-galactose malabsorption should check with their pharmacist whether this specific formulation contains lactose.

Appearance and Pack Sizes

Alfuzosin STADA 5 mg extended-release tablets are typically white to off-white, round, biconvex, film-coated tablets. The precise appearance, markings, and pack sizes may vary depending on the market. Available pack sizes may include blister packs of 20, 30, 50, 60, and 90 tablets. Not all pack sizes may be marketed in every country. Your pharmacist can confirm the specific packaging available in your region.