Xatral SR

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Xatral SR

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 SR

Property Description
Active Ingredient Alfuzosin hydrochloride
Form Extended-release tablet (Sustained-Release or SR)
Pharmacological Class Alpha-1 adrenergic receptor antagonist (Alpha-blocker)
Common Use Improving urinary flow dynamics
Origin Synthetic compound

Defining Xatral SR: Chemical Identity and Pharmacological Class

Xatral SR is a specific brand of prescription-only medication containing the synthetic compound Alfuzosin hydrochloride. This active substance is classified as an alpha-1 adrenergic receptor antagonist, falling within the pharmacological group known as alpha-blockers.

Alfuzosin is recognized for its uroselectivity, meaning it primarily targets the receptors within the smooth muscle of the lower urinary tract, making it distinct among some alpha-blockers. This class of drug achieves its primary action by selectively inhibiting specific nerve receptors in the sympathetic nervous system.

The Sustained-Release (SR) Formulation

Xatral SR is administered orally as an extended-release tablet, the “SR” designation indicating a sustained-release formulation. This preparation is manufactured with a specialized solid matrix designed to strictly control the rate at which Alfuzosin hydrochloride is released over a full 24-hour period.

This extended-release kinetics is a key feature for maintaining steady therapeutic levels without significant fluctuations in the bloodstream. This formulation ensures the active substance is released slowly over time. This consistent delivery profile allows for simplified, once-daily administration, differentiating it from immediate-release formulations.

General Therapeutic Purpose of Alfuzosin

The overall function of Alfuzosin is to produce selective relaxation of smooth muscle tissue located in the prostate and the neck of the bladder. This action is a consequence of the drug blocking the signals that cause those muscles to constrict and tighten.

The primary general benefit of this pharmacological action is the mechanical reduction of urethral resistance and pressure in the lower urinary system. By easing this tension, the medication helps to improve the dynamics of urine flow, serving its purpose of alleviating discomfort associated with restricted voiding, a common scenario in adult men who are the primary patient group for this medication.

What side effects are possible with Xatral SR?

Possible Side Effects and Safety Information

The safety profile of Xatral SR (Alfuzosin hydrochloride) is structured according to official regulatory classifications, detailing adverse reactions by frequency and physiological system. As an alpha-blocker, the documented side effects primarily involve the Vascular and Nervous Systems.

Frequency-Classified Adverse Reactions

The most frequently reported effects, classified as Common (up to 1 in 10 people), include dizziness, headache, nausea, fatigue, and general malaise. Effects classified as Uncommon (up to 1 in 100 people) include postural hypotension, syncope (fainting), palpitations, and tachycardia, as well as various gastrointestinal and dermatological reactions.

Serious Adverse Reactions and Constraints

Official regulatory documents identify certain adverse reactions as serious, including syncope, angioedema (swelling of the face, lips, or tongue), Priapism (a painful, prolonged erection), and documented hepatocellular injury. The potential for postural hypotension is a key safety pattern, noted to occur most frequently at the start of treatment and is often transient.

Regulatory restrictions state that Xatral SR is contraindicated in individuals with a history of orthostatic hypotension or severe hepatic impairment. Furthermore, the extended-release tablet must not be crushed, chewed, or divided due to the safety risk of uncontrolled drug release.

Overdose and Emergency Response

Overdose and When to Seek Help

This section describes the officially documented manifestations of Xatral SR (Alfuzosin hydrochloride) overdose and the required actions as specified in government regulatory information, such as the FDA Prescribing Information and the European Medicines Agency (EMA) Summary of Product Characteristics.

Documented Overdose Manifestations

The principal clinical sign of Xatral SR overdosage is hypotension (severely low blood pressure). This can manifest as symptoms including dizziness, lightheadedness, and potential for syncope (fainting) or collapse. The risk of developing profound hypotension is the primary concern and is noted to be a specific consideration for patients of advanced age.

Required Emergency Actions

In the event of a suspected overdosage, it is mandatory to seek immediate medical assistance and attention. Regulatory guidance states that hospitalisation is required for continuous monitoring and management of the patient's condition due to the risk of profound hypotension.

Official Management and Treatment

Management Aspect Regulatory Statement
Antidote No specific antidote is documented in the official regulatory sources.
Supportive Measures Management is symptomatic and supportive, focused on treating hypotension. Measures include placing the patient in the supine position and, if needed, administering a vasoconstrictor that acts directly on vascular muscle fibers.

All overdose situations require urgent medical evaluation and hospital observation.

Therapeutic Uses of Xatral SR

What Xatral SR Treats: Main Uses and Benefits


Xatral SR is commonly used to address the signs and symptoms associated with an enlarged prostate, a condition medically known as Benign Prostatic Hyperplasia (BPH). This medicine is indicated for managing these symptomatic manifestations. It helps address symptom clusters that may become intense or disruptive, falling under the umbrella of lower urinary tract symptoms (LUTS).

This medication is generally applied across domains where additional symptomatic support is needed, particularly during phases when LUTS become more noticeable. It is used in areas where short-term symptom management is appropriate and contributes to easing the overall symptom load.

Key symptomatic areas include hesitancy, a weak urinary stream, incomplete bladder emptying, and the increased frequency and urgency of urination. By helping to manage these issues, Xatral SR assists with maintaining functional stability when symptoms interfere with routine activities.

Quick Fact: Relief for Lower Urinary Tract Symptoms (LUTS)

Eligibility and Restrictions for Use

Xatral SR (alfuzosin) is an alpha-blocker primarily used to treat symptoms of Benign Prostatic Hyperplasia (BPH), or enlarged prostate, in adult men. It is not indicated for use in women or in the pediatric population (those under 16 years of age).


Contraindications (Who Should Not Use Xatral SR)

This medication should generally not be used by individuals with:

  • Known allergy or hypersensitivity to alfuzosin or any other component of the tablet.
  • Moderate to severe liver impairment (hepatic insufficiency).
  • A history of orthostatic hypotension (a significant drop in blood pressure upon standing, leading to dizziness or fainting).
  • Severe kidney impairment (creatinine clearance <30 ml/min) in some formulations.
  • Concurrent use of other alpha-blockers (such as prazosin, tamsulosin, or doxazosin).
  • Concurrent use of potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or ritonavir), as these can dangerously increase alfuzosin levels.

Precautions (Use with Caution)

Patients with certain other health conditions require careful medical assessment before starting treatment, including those with pre-existing heart conditions (e.g., angina, severe heart failure, or prolonged QT interval) or a history of marked hypotensive response to other alpha-blockers. Consultation is vital to ensure safe use, especially for elderly patients who may be more susceptible to the hypotensive effects.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Xatral SR (Alfuzosin hydrochloride) establishes two main interaction risks: increased drug exposure and enhanced blood pressure lowering (hypotension).


Contraindicated Combinations

Co-administration is strictly contraindicated with two classes of products:

  • Other Alpha-1 Adrenergic Antagonists (e.g., doxazosin, tamsulosin), due to the expected, significant risk of additive blood pressure lowering and postural hypotension.
  • Potent CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir), because they block the metabolism of Alfuzosin, resulting in a clinically significant increase in its blood levels (Cmax and AUC).

Other Documented Interactions and Restrictions

Classification Official Regulatory Statement
Pharmacodynamic Use with caution when taken with antihypertensive agents, nitrates, or PDE5 inhibitors (e.g., sildenafil), as the risk of symptomatic hypotension is increased.
Procedural Restriction Alfuzosin treatment must be withdrawn 24 hours prior to surgery involving General Anaesthetics to manage the risk of profound blood pressure instability.
Exposure Modification Co-administration with Moderate CYP3A4 Inhibitors (e.g., diltiazem) increases Alfuzosin exposure. Cimetidine has also been documented to increase plasma concentrations.
Population-Specific The drug is contraindicated in patients with Moderate or Severe Hepatic Impairment due to impaired clearance leading to high Alfuzosin blood levels.
Product-Food Restriction The tablet must be taken immediately after the same meal each day to ensure consistent absorption, as taking it in a fasting state reduces absorption significantly.

Mechanism of Action

Alpha-1 Adrenergic Receptor Antagonism

Alfuzosin is an alpha-1 mathbfalpha1 adrenoceptor antagonist that acts within the sympathetic nervous system pathways to modulate smooth muscle tone. This selective binding process inhibits the activation of these receptors by natural signaling molecules like norepinephrine.


Smooth Muscle Tone Modulation

By inhibiting alpha1-adrenoceptors on smooth muscle cells, the compound engages mechanisms that modulate contractile force. The resulting physiological effect is a reduction in smooth muscle tone in the bladder neck, prostate, and prostatic urethra.


Altered Pressure Gradient

This reduction in smooth muscle tone leads to a cascade effect: it lowers the effective resistance at the bladder outlet. This contributes to a shift in basal tone within the affected pathway, resulting in an altered pressure gradient across the prostatic urethra.

Dosage and Administration Information

How to Use Xatral SR: Official Administration Guidelines

Xatral SR (10 mg prolonged-release tablets) must be used strictly according to the established administration rules. This section outlines the standard protocols, encompassing dosing, frequency, and critical handling instructions.


Dosing and Administration Schedule

Feature Official Instruction
Route of Administration Oral administration only.
Standard Adult Dose One 10 mg tablet once daily.
Dosing Frequency Once daily (q.d.).
Timing Relative to Meals Must be taken immediately after the same meal each day (e.g., after dinner) to ensure consistent drug absorption.

Essential Administration Rules

  • Tablet Integrity: The prolonged-release tablet must be swallowed whole with a sufficient amount of liquid. It is a critical restriction that the tablet must not be crushed, chewed, divided, or otherwise altered to prevent improper release of the active substance, Alfuzosin hydrochloride.
  • Missed Dose: If a dose is missed, the patient should skip the missed dose and take the next dose at the regularly scheduled time after the next meal. A double dose should never be taken to compensate for a missed dose.
  • Age-Specific Rules: For older adults (patients 65 years and older), the standard 10 mg once-daily dose does not typically require adjustment. The medication is not indicated for use in the pediatric population.

Recent Clinical Evidence

Research evidence / Overview of studies for Xatral SR


Evidence for Use in Lower Urinary Tract Symptoms (LUTS) related to BPH

The primary research for Xatral SR (Alfuzosin Extended-Release) has been short-term, placebo-controlled randomized clinical trials (RCTs). These studies were designed to evaluate measurements related to the substance over periods typically lasting 4 to 12 weeks. Researchers used these trials to examine patient experiences related to research endpoints related to symptom severity and measurements reflecting quality of life. This included monitoring changes in the International Prostate Symptom Score (IPSS), a tool used to track symptom intensity and perceived discomfort.

The research also explored functional changes in the lower urinary system, monitoring Peak Urinary Flow Rate and Post-Void Residual (PVR) urine volume in adult men with LUTS that suggested Benign Prostatic Hyperplasia (BPH). These research efforts describe findings reported in the study documents regarding subjective symptom scores and objective measurements of flow. Subsequent systematic reviews and meta-analyses have synthesized the findings from these initial RCTs, reporting variations in the measurement of functional flow rate across the trials.

Evidence Regarding BPH Progression and Long-Term Outcomes

Studies have explored research questions related to the overall clinical course of BPH, known as BPH progression. This area was evaluated primarily through one large, long-term Randomized Controlled Trial that monitored responses over a period of up to two years. The study was designed to monitor the incidence of major BPH-related events, such as the incidence of Acute Urinary Retention (AUR) requiring medical help or the need for BPH-related surgery.

In this long-term study, when the researchers specifically analyzed the AUR incidence alone, no discernible difference in incidence was observed between the active substance and the placebo. However, the same study described patterns in the tracked incidence rates when analyzing a composite endpoint of overall clinical progression. The research for progression tracking is limited as it rests largely on the findings of a single major study.

Frequently Asked Questions (FAQ)

Common questions about Xatral SR (FAQ)

Q: What is the active ingredient in Xatral SR and what is it used for?

According to the official product information, the active ingredient in Xatral SR is alfuzosin hydrochloride. This medicine is indicated for the treatment of moderate to severe symptoms associated with benign prostatic hyperplasia (BPH) in men. BPH is a non-cancerous enlargement of the prostate gland that can cause urinary problems.

Q: Can I take Xatral SR if I have severe kidney problems?

Regulatory documents state that Xatral SR is generally contraindicated in patients who have severe kidney insufficiency. Severe kidney problems are defined in official information as having a creatinine clearance of less than 30 ml/min. For individuals with severe kidney issues, official guidance states that use of this medicine is contraindicated.

Q: Is Xatral SR suitable for women?

Official information indicates that Xatral SR is not intended for use by women. This medicine is specifically indicated and studied for the treatment of benign prostatic hyperplasia (BPH), which is a condition that affects men.

Q: Will this drug cure my enlarged prostate forever?

Studies and official information indicate that Xatral SR works by managing the symptoms of BPH, such as difficulty or frequent urination. It belongs to a class of drugs that help relax the muscle in the prostate and bladder neck. However, the medicine does not provide a permanent cure for the underlying enlarged prostate condition itself.

Q: Is it safe to drive after taking Xatral SR?

According to the official product information, caution is advised regarding driving or operating machinery. This is because Xatral SR may cause side effects such as dizziness, vertigo, or fatigue (asthenia). Official information advises that extra caution may be necessary when these effects are more likely, such as during the initial phase of treatment.

How should Xatral SR be stored and disposed of?

Official Storage and Disposal Requirements

The storage and disposal of Xatral SR (alfuzosin hydrochloride) tablets must strictly adhere to regulatory labeling to maintain safety and efficacy.

Storage & Disposal Scope Official Regulatory Requirement
Labeled Storage Temperature Controlled room temperature: 20 C to 25 C (68 F to 77 F).
Light/Moisture Protection Must be protected from light, excess heat, and moisture; do not store in the bathroom.
Packaging-Related Rules Keep the medicine in its original container or blister pack and tightly closed.
Child-Protection Storage Must be kept out of the sight and reach of children.
Disposal Instructions Utilize an authorized drug take-back program. If unavailable, the medicine must be mixed with an undesirable substance (e.g., dirt) before being placed in the trash; do not flush down the toilet.

These constraints define how the product must be protected from environmental factors and handled post-use, in alignment with public safety standards and local regulations.

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

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