Xatral

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Xatral

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Xatral

What is Xatral? Defining its Identity and Action

To provide a clear and concise overview, Xatral is defined by its core chemical identity and its specific pharmacological classification.

Property Description
Active ingredient Alfuzosin hydrochloride
Form Extended-release tablet
Pharmacological class Alpha-1 adrenergic receptor antagonist
General purpose Relieving functional urological discomfort
Origin Synthetic compound (Quinazoline derivative)

What is Xatral and What Chemical Class Does It Belong To?

Xatral is a prescription medicine containing the single active ingredient Alfuzosin hydrochloride (INN), a synthetic quinazoline derivative. The medication is formally classified as an alpha-1 adrenergic receptor antagonist, commonly known as an alpha-blocker. This classification confirms its specific mechanism of action, which involves blocking certain signals within the nervous system. Alfuzosin is characterized by these alpha-1 antagonistic properties.

Physical Form and Therapeutic Design

Xatral is supplied as an extended-release tablet intended for oral administration. This particular formulation is clinically recognized for providing a stable release profile, a differentiating feature of the brand. The extended-release design is a deliberate feature, ensuring that the active substance, Alfuzosin hydrochloride, is released slowly and steadily over a prolonged duration. The formulation provides a validated sustained-release profile.

How the Alpha-Blocker Action Provides General Relief

The medication’s general purpose is to address functional discomfort in the lower urinary tract by promoting smooth muscle relaxation. This effect is targeted primarily at the prostate and the neck of the bladder. By reducing the excessive muscle tension in these areas, Xatral effectively lowers the internal resistance. The ultimate general benefit of this action is the improvement of urological function by facilitating fluid passage.

Regulatory References

  1. Alfuzosin Prolonged-Release Tablet Public Assessment Report

What side effects are possible with Xatral?

Possible Side Effects and Safety Information

Adverse Reactions by Frequency

The safety profile of the medicine is defined by adverse reactions classified according to their documented frequency from clinical trials and post-marketing experience.

Frequency Category Examples of Documented Adverse Reactions (System Organ Class)
Common (Affecting 1 to 10 users in 100) Dizziness, Headache, Asthenia (weakness), Nausea, Abdominal pain.
Uncommon (Affecting 1 to 10 users in 1,000) Syncope (fainting), Postural hypotension, Tachycardia (fast heart rate), Rhinitis, Diarrhea, Rash, Oedema (swelling).
Very Rare (Affecting less than 1 user in 10,000) Angina pectoris (in patients with pre-existing coronary artery disease), Urticaria, Angioedema.
Not Known (Cannot be estimated from available data) Priapism (persistent painful erection), Intraoperative Floppy Iris Syndrome (IFIS), Hepatocellular injury, Cholestatic liver disease, Atrial fibrillation, Thrombocytopenia.

Serious Safety Restrictions and Warnings

Official regulatory documents define several contraindications and precautions for safe use:

  • Contraindications: The medicine is strictly restricted in patients with postural hypotension, moderate to severe liver impairment, or those concurrently taking other alpha-blockers or potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir).
  • Cardiovascular Safety: The drug carries a risk of postural hypotension and syncope (fainting), particularly at the start of treatment. Caution is required in patients with a history of QT prolongation or those receiving medications known to prolong the QT interval.
  • Surgical Risk: Use of this medicine is associated with a specific risk of Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery. The prescribing information notes that ophthalmic surgeons must be informed of current or past use of the medicine.
  • Organ Function: Use is contraindicated in severe liver impairment and is advised with caution in patients with severe renal impairment (creatinine clearance < 30 mL/min). The potential for Priapism (a persistent erection) is noted as a rare but serious adverse event.
  • Drug Interactions: Concomitant use with other antihypertensives or nitrates requires caution due to an enhanced risk of low blood pressure.

Safety Profile Summary

The regulatory safety structure emphasizes risks related to blood pressure changes (dizziness, syncope, hypotension) which are most common early in treatment. The profile strictly prohibits use in specific populations (e.g., severe liver impairment, those on potent CYP3A4 inhibitors) due to increased drug exposure or underlying risk. Serious, though rare, safety signals such as IFIS and Priapism are documented, requiring special attention during eye surgery and for persistent symptoms. This structure collectively defines the necessary clinical awareness for safe prescription.

Overdose and Emergency Response

Xatral Overdose and When to Seek Help

The official regulatory documentation identifies a specific profile for Xatral (alfuzosin hydrochloride) overdosage, which is primarily characterized by cardiovascular instability.

Element Official Regulatory Description
Documented Manifestation The primary clinical presentation of overdosage is hypotension (low blood pressure) and its potential complications, including the risk of syncope (fainting).
Emergency Action Required Individuals who have taken too much medication must seek immediate medical attention and may require hospitalisation for immediate management and continuous monitoring, as mandated by official labeling.
Supportive Management Treatment is supportive. Initial measures include placing the patient in the supine position to help restore blood pressure. If this is inadequate, the administration of intravenous fluids and, if necessary, vasopressors should be considered as part of conventional treatment for severe hypotension.
Antidote and Monitoring No specific antidote is known for Alfuzosin overdose. Due to the high protein-binding of the substance, dialysis is not expected to be of benefit. Renal function must be monitored and supported throughout the management period.

The overdose profile is rigorously defined by regulatory agencies as an urgent cardiovascular event centered on the risk of severe, sustained hypotension. This presentation necessitates an immediate, non-elective response of seeking emergency medical care. The management procedures are officially documented as supportive in nature, focusing on blood pressure restoration.

Therapeutic Uses of Xatral

Xatral (alfuzosin hydrochloride) is primarily applied in addressing the functional symptoms related to physical discomfort associated with benign prostatic hyperplasia (BPH). This common condition is considered relevant for managing lower urinary tract issues. The official indication confirms that the medication helps with symptoms that interfere with daily functioning, including weak stream, hesitancy, and urinary frequency.

The core therapeutic domain is relevant for easing these manifestations, which contributes to improved comfort during periods of heightened symptoms.

The medication is commonly used to help with two main scenarios: functional symptoms of BPH and the management of acute urinary retention (AUR) related to BPH in men over 65. The treatment provides support that helps ease the overall symptom burden in these conditions characterized by periods of heightened symptoms. In the clinical scenario of AUR, Xatral may assist with maintaining functional stability following catheterisation. The treatment also provides supportive relief when symptoms interfere with routine activities.

Quick Fact: Relief for Symptoms that Interfere with Daily Functioning

Eligibility and Restrictions for Use

Who can and cannot use Xatral?

The population eligibility for Xatral (alfuzosin hydrochloride) is defined strictly by regulatory labeling, limiting its use based on gender, age, and pre-existing medical conditions. The medicine is only indicated for use in adult men.

Absolute Contraindications (Must Not Use)

Use is strictly prohibited for patients with:

  • Moderate or severe hepatic impairment (liver failure).
  • A history of orthostatic hypotension (a form of low blood pressure when standing).
  • Known hypersensitivity to alfuzosin or its components.
  • Concomitant use of other alpha-1 adrenergic antagonists or potent CYP3A4 inhibitors.

Conditional or Restricted Use

  • Age-Based: The medication is not indicated for use in the pediatric population (children under 16 years) as efficacy is not established. Use in elderly men requires caution due to potential hypotensive sensitivity.
  • Organ Function: Caution is required for patients with severe renal impairment or mild hepatic impairment.
  • Cardiac: Caution is advised for those with congenital or acquired QT prolongation, and pre-existing coronary artery disease requires specific management.

Prior to starting treatment, patients must be examined to rule out prostate carcinoma.

What should I know about interactions with other medicines?

Xatral Interactions with other medicines and products

Interaction Scope

Classification Interacting Substances and Outcomes
Contraindicated Combinations Co-administration is formally prohibited with other Alpha-Adrenergic Antagonists (e.g., Tamsulosin, Doxazosin) and Potent CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir). These inhibitors significantly increase alfuzosin exposure: AUC is raised approximately 3.2-fold and Cmax by 2.3-fold.
Metabolic Basis The principal mechanistic basis for pharmacokinetic interactions is the susceptibility of alfuzosin to CYP3A4 inhibition, resulting in reduced clearance and elevated plasma levels.
Pharmacodynamic Effects Co-administration with other Antihypertensive Agents, Nitrates, or Phosphodiesterase-5 (PDE5) Inhibitors (e.g., Sildenafil) carries an increased risk of symptomatic hypotension due to additive vasodilatory effects.

Interaction-Related Constraints

  • Timing Rules: Regulatory documentation advises that alfuzosin treatment should be withheld 24 hours prior to surgery involving general anaesthesia due to the risk of blood pressure instability. Extended-release tablets must be taken with food at the same meal each day to ensure consistent absorption.
  • Substance Restrictions: Consumption of Grapefruit Juice must be avoided as it is a known CYP3A4 inhibitor that may increase alfuzosin blood levels and the risk of related effects.
  • Population-Specific Note: The medication is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to officially documented three to four-fold higher plasma concentrations in this population.

Mechanism of Action

The pharmacodynamic mechanism of Xatral centers on the antagonism of alpha-1 (alpha1) adrenergic receptors. The compound selectively binds to the alpha1-adrenoceptors primarily located in the smooth muscle of the lower urinary tract, specifically the bladder neck, prostatic capsule, and prostatic urethra.

This competitive receptor antagonism blocks the endogenous activation of these receptors by catecholamines, interrupting the signaling cascade that normally mediates smooth muscle contraction. The resulting molecular consequence is the relaxation of the smooth muscle tissue in the prostate and bladder neck.

This cellular relaxation decreases detrusor muscle tone and the resting tension within the prostatic urethra. Physiologically, this action modulates the dynamic component of urethral resistance, altering the pressure profile within the lower urinary tract system.

Dosage and Administration Information

How to Use Xatral (Alfuzosin Prolonged-Release) — Official Administration Guidelines

This section summarizes the instructions for the proper use and administration of Xatral 10 mg prolonged-release tablets (alfuzosin hydrochloride). This information is descriptive and does not constitute medical advice.


Dosing and Administration Protocol

Instruction Category Official Guideline
Route of Administration Oral (by mouth)
Standard Daily Dose One 10 mg prolonged-release tablet
Frequency Once daily
Timing in Relation to Meals Must be taken immediately after the same meal each day (e.g., the evening meal) to ensure consistent absorption.
Physical Handling The tablet must be swallowed whole with water. It must not be crushed, chewed, split, or ground into a powder.

Procedural Constraints and Special Populations

Proper use of Xatral is strictly dependent on adhering to specific procedural steps. Failure to swallow the prolonged-release tablet whole may lead to uncontrolled drug release, increasing the risk of adverse effects.

  • Missed Dose: If a dose is missed, the patient should not take a double dose to make up for the missed one. The next dose should be taken at the usual time.
  • Pediatric Use: The medication is not indicated for use in the pediatric population (patients under 18 years of age).
  • Patients with Hepatic Impairment: The 10 mg prolonged-release tablet is typically contraindicated in patients with moderate to severe liver impairment.

Recent Clinical Evidence

Xatral: Recent Clinical Evidence

This section summarizes key research that has explored the drug's use in conditions such as Benign Prostatic Hyperplasia (BPH). It is not yet clear whether this treatment will be suitable for a particular individual.


Clinical Trials and Efficacy

Research has explored whether Xatral (alfuzosin) influenced data points related to urinary symptoms often associated with BPH. The drug, an alpha1-adrenergic blocker, is primarily studied for its effect on smooth muscle relaxation in the prostate and bladder neck.

  • Trial Design: Studies often utilize placebo-controlled, double-blind designs to evaluate changes in BPH symptom scores, such as the International Prostate Symptom Score (IPSS).
  • Key Findings: Multiple trials have focused on the difference in IPSS scores between groups receiving alfuzosin versus placebo over 12-week and 6-month periods. These trials typically investigate improvements in both obstructive and irritative urinary symptoms.

Quality of Life and Tolerability

Research has also investigated the therapy's influence on patient-reported quality of life measures in men with BPH.

Outcome Measure Study Focus
Symptom Bother Score Assessment of how symptoms impact daily living.
Safety Profile Examination of the incidence of adverse events (AEs) and withdrawals due to AEs.

Trial data on tolerability indicates that the drug was used by most participants in the studies without withdrawal due to adverse events. Common observations in research settings include dizziness and low blood pressure. Studies did not typically include participants with unstable cardiovascular conditions.

Frequently Asked Questions (FAQ)

Common questions about Xatral (FAQ)


Q: Does Xatral interact with common pain relievers like ibuprofen?

Official prescribing information does not list non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen as a formal contraindication. However, NSAIDs are noted to carry a risk of affecting kidney function. Regulatory warnings mention that caution is necessary in patients with severe renal impairment (kidney problems).

Q: Does Xatral interact with herbal supplements?

Regulatory documents state that certain foods, like grapefruit juice, must be avoided because they can interfere with how the medicine is processed in the body. Since many herbal supplements can also affect these same processes, it is important for patients to inform their healthcare professional about all concomitant products, including any herbal or dietary supplements.

Q: Can Xatral be taken with food?

Yes. Official guidelines describe the need for the extended-release tablet to be taken immediately following the same meal each day to help ensure consistent absorption. Taking it with food helps maintain steady drug levels in the bloodstream, which is important for the desired therapeutic effect.

Q: Will Xatral interact with my cholesterol medication?

Official drug interaction warnings focus on other alpha-blockers, blood pressure medications, and strong inhibitors of the CYP3A4 enzyme. If a patient is taking certain statins metabolized by CYP3A4, notifying their prescribing professional helps manage potential risks, even though a general warning for the class is not provided.

Q: What is the difference between Xatral and Xatral XL?

Xatral XL is a trade name used in some regions for the extended-release 10 mg alfuzosin tablet. This formulation is specifically designed to release the active ingredient, alfuzosin, slowly and steadily over a prolonged period. This prolonged-release design facilitates a once-daily administration.

Q: Does Xatral interact with medications for erectile dysfunction?

Yes. Official prescribing information states that combining Xatral with Phosphodiesterase-5 (PDE5) inhibitors (such as sildenafil or tadalafil) carries an increased risk of symptomatic hypotension. This means there is a greater chance of experiencing low blood pressure and related symptoms due to the combined effects of the medications.

Q: Is Xatral considered a long-term treatment?

The medicine is generally studied for its use in managing the ongoing symptoms of Benign Prostatic Hyperplasia (BPH). Clinical trials often examine the drug's effects over extended periods, typically 6 months or longer, and it is commonly used for the chronic symptoms associated with BPH.

Q: How quickly should I expect Xatral to start working?

Official clinical studies have observed that effects on maximum urinary flow rate can be evident as early as the first dose of the medicine. The onset of full symptomatic relief can vary from person to person, and it is not intended to be a painkiller or provide instant relief.

Q: Can Xatral affect my ability to drive?

Adverse reactions such as dizziness, vertigo, and asthenia (weakness) are documented in the official prescribing information, especially when starting treatment. Patients are cautioned to be aware of these potential effects when considering driving vehicles or operating complex machinery.

Q: Is Xatral known to cause sexual side effects?

Regulatory documents list the serious, but rare, adverse event of priapism (a persistent, painful erection). The topic of sexual side effects is an important consideration for patients, and any concerns should be discussed with a healthcare professional.

Q: Is Xatral used to treat kidney stones?

Xatral is officially indicated for the treatment of symptoms related to Benign Prostatic Hyperplasia (BPH). While some research has explored its effect on the passage of kidney stones, the medicine is officially indicated only for the treatment of BPH symptoms.

Q: Why does Xatral sometimes cause a runny nose or stuffiness?

The medicine is an alpha-blocker that works by relaxing smooth muscle. Rhinitis (runny or stuffy nose) is listed as an uncommon side effect. This nasal effect is thought to be related to the relaxation of smooth muscles in the nasal passages, which are also regulated by alpha-1 receptors.

Q: Can Xatral be used by people with diabetes?

Official documents do not list diabetes as a contraindication. However, some medications in the alpha-blocker class can potentially affect blood sugar levels. Patients with diabetes should discuss their condition with their healthcare provider, as close monitoring may be necessary.

Q: Why are there different strengths of Xatral?

The extended-release 10 mg tablet is the standard and most common form used for the management of BPH symptoms. In certain regions or for specific patient needs, other strengths, such as immediate-release formulations (e.g., 2.5 mg or 5 mg), may be available for use under professional guidance.

Q: Can I drink alcohol while taking Xatral?

The official documentation cautions that alcohol can increase the risk of low blood pressure (hypotension) and related symptoms, such as dizziness or fainting. This risk is particularly noted when treatment is first initiated.

Q: Does Xatral affect fertility?

The medication is indicated for use only in adult men. Official prescribing information lists some effects on the reproductive system, such as impotence, but specific regulatory statements about effects on male fertility are not provided in the general prescribing information.

Q: Is Xatral approved for use in countries outside of Europe?

Yes. The active ingredient, alfuzosin, is approved for use in many countries globally, including the United States, Canada, Australia, and Japan. Regulatory guidance for the medicine is available from the governmental health bodies in these regions.

Q: Is Xatral available over the counter?

No. Xatral (alfuzosin) is formally classified by regulatory authorities as a prescription-only medicine (POM). It is therefore dispensed only with a valid prescription.

Q: What is the purpose of taking Xatral in the evening?

The medicine should be taken at the same meal each day to ensure consistent drug exposure, as stated in the administration guidelines. Taking it in the evening with a meal may also help minimize the impact of common side effects, like dizziness and low blood pressure, which can occur after a dose.

Q: Can Xatral cause dry mouth?

Yes. According to the official safety profile, dry mouth is listed as an uncommon adverse reaction. This means that based on available data, it affects a small percentage of users.

Q: Is Xatral a strong painkiller?

No. Xatral is an alpha-blocker. Its primary function is to relieve the functional symptoms of BPH by relaxing smooth muscle in the lower urinary tract. It is not classified as an analgesic or painkiller.

Q: Does Xatral cure BPH?

No. Xatral is a medication used to manage and relieve the symptoms (signs and symptoms) of Benign Prostatic Hyperplasia (BPH). It works by relaxing muscles and improving urinary flow, but drug therapy generally does not cure the underlying condition.

Q: Is there a specific diet required while taking Xatral?

No specific diet is required, but regulatory instructions emphasize that the tablet be taken with food at the same meal each day. Additionally, the consumption of grapefruit juice should be avoided because it is known to interfere with how the drug is metabolized in the body.

Q: Does Xatral affect PSA levels?

Official warnings state that the possibility of prostate carcinoma must be ruled out before starting treatment, as symptoms can overlap with BPH. Unlike some other classes of BPH medication, alpha-blockers like Xatral generally do not cause a reduction in Prostate-Specific Antigen (PSA) levels.

Q: What is the half-life of Xatral?

According to the official clinical pharmacology information, the mean plasma elimination half-life of the active ingredient, alfuzosin, is approximately 10 hours for the extended-release tablet in healthy individuals and patients. This refers to the time it takes for half of the drug to be eliminated from the bloodstream.

How should Xatral be stored and disposed of?

Storage and Disposal of Xatral (Alfuzosin Hydrochloride)

Official Storage Conditions

Xatral must be stored at Controlled Room Temperature, typically maintained between 20 C and 25 C (68 F and 77 F). The product must be protected from excessive heat, light, and moisture, and must be explicitly kept from freezing. Tablets should remain in their original, closed container to preserve the stability of the extended-release formulation.

Handling and Safety

It is a mandatory safety requirement to store the medication out of the reach and sight of children at all times.

Disposal Instructions

Expired or unused Xatral should be disposed of primarily through a local drug take-back program. If such a program is unavailable, U.S. regulatory information advises mixing the medication with an undesirable substance, such as dirt or used coffee grounds, sealing it in a plastic bag, and discarding it in household trash. Medications must not be flushed down the toilet or poured into a drain.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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