Zatral

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Zatral

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Zatral

Property Description
Active ingredient Alfuzosin hydrochloride
Form Extended-release oral tablet
Pharmacological class Alpha-1 adrenergic receptor antagonist (alpha1-blocker)
Common use Relieving physical constraints caused by muscle tension in the lower urinary tract
Origin Synthetic organic compound

What is the Drug Zatral and its Pharmacological Class?

Zatral is a prescription-only medicine defined by its active ingredient, Alfuzosin hydrochloride, which belongs to the alpha-1 adrenergic receptor antagonist (alpha1-blocker) pharmacological class. This substance is a synthetic organic compound derived from the quinazoline chemical class. Alfuzosin is a single-ingredient product (monotherapy), ensuring its therapeutic effect derives exclusively from its principal component. The function of this class is established by its ability to antagonize (block) the alpha-1 receptors, which are vital communication points found on the smooth muscle tissue of the lower urinary tract. This therapeutic principle is clinically recognized for addressing conditions associated with excessive smooth muscle tone.

Composition and Form: The Extended-Release Nature of Alfuzosin

Alfuzosin is typically administered via the oral route as an extended-release tablet. This dosage form is a solid pharmaceutical preparation containing Alfuzosin hydrochloride embedded within a specialized matrix of excipients. This formulation is distinctive because it is engineered to be functionally uroselective, meaning the drug's effect is optimized to target the muscles of the urinary system. The extended-release design is a specific functional characteristic of the tablet, engineered to control the rate at which the active substance is released into the system over many hours. This sustained-release formulation helps maintain a stable, effective concentration in the body compared to immediate-release alternatives.

General Purpose of an alpha1-Blocker

The fundamental purpose of an alpha1-blocker like Zatral is to facilitate the relaxation of smooth muscle tissue through its core mechanism of selective antagonism. By easing muscle tension, the drug works to relieve the physical constraints or pressure caused by excessive muscle tone. The mechanism is characterized by functional uroselectivity, concentrating its relaxing action primarily on the smooth muscle structures of the bladder neck and prostate area. This targeted action supports the general biological function of the related channels by reducing resistance caused by muscle contraction.

Regulatory References

  1. Alfuzosin Drug Information - MedlinePlus

What side effects are possible with Zatral?

Official Safety Profile

This section outlines the adverse reactions and safety restrictions for Zatral (alfuzosin) as documented in authoritative government regulatory sources.

Serious and Clinically Significant Adverse Reactions

The following effects are highlighted in regulatory documents as serious or requiring special attention:

  • Orthostatic Hypotension and Syncope: A sudden drop in blood pressure when standing up, which may cause dizziness, lightheadedness, or fainting (syncope), particularly when treatment is initiated or re-started.
  • Priapism: A painful erection of the penis, unrelated to sexual activity, which requires immediate medical intervention.
  • Intraoperative Floppy Iris Syndrome (IFIS): A complication observed during cataract and glaucoma surgery in patients who are currently or were previously treated with alfuzosin. Patients must inform their surgeon of alfuzosin use.
  • QT Interval Prolongation: Caution is advised for patients with certain heart rhythm conditions or who are taking medications known to affect the heart's QT interval.
  • Angina: Angina pectoris (chest pain) may be precipitated or exacerbated in patients with pre-existing coronary artery disease (a very rare event).

Frequency-Classified Adverse Reactions

Classification Examples of Adverse Reactions
Common (occurring in ge 1% of patients) Dizziness, Headache, Fatigue/Asthenia, Nausea, Abdominal pain.
Uncommon (occurring in 0.1% to < 1% of patients) Hypotension, Palpitations, Tachycardia, Somnolence, Vertigo, Rash.
Very Rare (occurring in < 0.01% of patients) Angioedema, Urticaria.

Safety Restrictions and Limitations

Zatral is contraindicated (strictly forbidden) for use in the following circumstances, according to regulatory labels:

  • In patients with moderate or severe hepatic (liver) impairment.
  • Concomitant use with potent CYP3A4 inhibitors (such as certain medications for fungal infections or HIV) due to the risk of increased alfuzosin exposure.
  • Known hypersensitivity to the drug or other alpha1-blockers.
  • Concomitant use with other alpha1-adrenoceptor antagonists.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose Manifestations and Required Actions

An overdose of Alfuzosin hydrochloride, the active ingredient in Zatral, is formally documented to lead to hypotension (low blood pressure). Due to the high risk of severe compromise to the cardiovascular system, seeking immediate medical attention is required upon suspicion of excessive exposure. Regulatory instructions specify that support of the cardiovascular system is of first importance during management.

Official Management Protocol

Since no specific antidote is known, official management is strictly symptomatic and supportive. The documented procedural steps to address the hypotension include keeping the patient in the supine position and considering the administration of intravenous fluids. If these steps are insufficient, the use of vasopressors is directed to restore blood pressure. Furthermore, continuous monitoring of renal function is required. A specific procedural note in the official documentation states that due to the drug being highly protein bound, dialysis may not be of benefit in the management of this overdose.

Summary of Regulatory Guidance

The regulatory profile strictly classifies the overdose scenario as an acute, severe hypotensive event. This classification dictates that medical help must be sought urgently to initiate the specific supportive measures defined in the prescribing information, which are designed solely to counteract the profound drop in blood pressure and manage potential complications.

Therapeutic Uses of Zatral

What Zatral treats: main uses and benefits

Zatral (alfuzosin) is commonly used in the therapeutic domains for conditions involving episodic or fluctuating manifestations. Its primary role is considered relevant for the symptomatic management of benign prostatic hyperplasia (BPH), a condition where functional stability becomes affected by lower urinary tract symptoms (LUTS). This medication is applied in addressing symptoms that interfere with daily functioning.

Quick Fact: May assist with relief for Urinary Symptoms

It is particularly relevant when supportive symptom management is appropriate for symptoms related to physical discomfort, specifically those concerning micturition. These symptoms, which may escalate temporarily, include urinary frequency, urgency, nocturia (waking up at night to urinate), a weak or interrupted urinary stream, and the sensation of incomplete bladder emptying. This support is often provided in clinical settings when short-term symptomatic assistance is needed. Zatral contributes to improved comfort during periods of heightened symptoms and supports patients during difficult episodes by easing distress. It may help patients cope more steadily with symptom fluctuations.

“Supports the patient during difficult episodes by easing distress.”

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Official Population Eligibility for Zatral (Alfuzosin)

The use of Zatral is governed by official regulatory documentation detailing specific eligibility and exclusionary criteria. The medicine is indicated exclusively for adult men for the management of symptoms associated with benign prostatic hyperplasia (BPH).

Contraindicated Populations (Must Not Use)

Use is absolutely contraindicated in patients who meet the following criteria:

  • Presence of moderate or severe hepatic impairment (liver function disease).
  • Known hypersensitivity or allergic reaction to alfuzosin hydrochloride or any tablet component.
  • Co-administration with certain potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir).

Population Exclusions and Restrictions

The regulatory profile includes the following restrictions:

  • Pediatric Population: Use is not indicated in those under 18 years of age, as safety and efficacy have not been established.
  • Women: The medication is not recommended for women, including those who are pregnant or nursing.

Conditional Use and Caution

Special caution is required for specific conditions:

  • Severe Renal Impairment (creatinine clearance leq 30 mL/min) due to limited clinical data.
  • History of symptomatic hypotension or conditions like Congenital or Acquired QT Prolongation.
  • Patients with Angina Pectoris must discontinue treatment if symptoms appear or worsen. Additionally, patients should be examined to rule out prostatic carcinoma prior to initiating treatment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory interaction profile for alfuzosin hydrochloride is defined by strict pharmacokinetic and pharmacodynamic constraints documented in official labeling.

Restrictions on Combination Use

  • Co-administration with Potent CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, ritonavir) is formally contraindicated. This restriction stems from a documented pharmacokinetic interaction where CYP3A4 inhibition significantly increases alfuzosin plasma exposure, resulting in an AUC increase of over three-fold.
  • The combination with other Alpha-1 Adrenergic Antagonists is also prohibited, as interactions are expected due to the shared pharmacological classification.
  • Use is contraindicated in patients with moderate or severe hepatic impairment (Childs-Pugh B and C), as regulatory documents cite increased drug blood levels due to altered clearance in this population.

Pharmacodynamic and Administration Constraints

  • Caution is required when alfuzosin is co-administered with other vasodilatory agents, including antihypertensive medications, nitrates, and PDE5 inhibitors (e.g., sildenafil), due to the documented risk of symptomatic hypotension from additive effects.
  • Caution is also advised regarding drugs that prolong the QT interval due to the risk of an increased cardiac effect.
  • A mandatory administration constraint requires the extended-release tablet must be taken with food and with the same meal each day to prevent the significant 50% reduction in absorption observed under fasting conditions.

Mechanism of Action

Selective Blockade of Alpha-1 Adrenergic Receptors

Zatral's primary action is the competitive antagonism of post-synaptic alpha1-adrenergic receptors, particularly the alpha1A subtype, on the smooth muscle cells of the lower urinary tract. This molecular event inhibits the signal that would typically lead to sympathetic-mediated muscle contraction.


Physiological Consequences: Dynamic Urethral Resistance

The core mechanistic consequence is the direct relaxation of smooth muscle tone in the prostate, prostatic capsule, and bladder neck. This physiological change results in a reduction of smooth muscle tension in the prostatic urethra. This reduction constitutes a decrease in the dynamic component of urethral resistance.


Mechanistically-Linked Peripheral Vascular Effects

While the primary function is focused on the urinary system, the same alpha1-receptor blockade mechanism also applies to receptors in the walls of blood vessels. This results in an accompanying physiological change of vasodilation (widening of blood vessels), a peripheral effect linked to the action on vascular alpha1-adrenergic receptors.

Dosage and Administration Information

How to Use Zatral (Alfuzosin Extended-Release)

Zatral, which contains Alfuzosin hydrochloride, is administered exclusively via the oral route as a 10 mg extended-release tablet. The administration protocol is designed to ensure a consistent release of the active substance over a 24-hour period, which is essential for the drug's mechanism.


Official Administration Guidelines

Instruction Detail
Route of Administration Oral route only
Standard Dosing Schedule One 10 mg extended-release tablet taken once daily
Timing in Relation to Meals Must be taken immediately after the same meal each day
Tablet Integrity The tablet must be swallowed whole; it is strictly prohibited to crush, chew, split, or divide the tablet

Procedural and Population Constraints

The standard adult dose is one 10 mg tablet per day, which is also the maximum recommended dose for this formulation. This fixed once-daily frequency and mandatory meal dependence are key components of the official use protocol, ensuring reliable absorption and adherence to the release profile. The dose should be administered consistently at the same time relative to a meal.

For older adults (over 65 years), the standard 10 mg daily dose is generally appropriate, with no routine dose adjustment required. However, the 10 mg prolonged-release tablet is contraindicated in patients with moderate to severe hepatic impairment. Patients with severe renal impairment (creatinine clearance less than 30 mL/min) should generally not be given the 10 mg tablet due to limited safety data available for this group.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Zatral

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

Research exploring the effects of Alfuzosin (Zatral) for men with Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) primarily involves multiple short-term, placebo-controlled clinical trials. These studies focused on understanding symptom patterns and changes over defined time intervals. Researchers monitored outcomes related to physical discomfort and daily functioning. They often used standardized instruments like the International Prostate Symptom Score (IPSS) and objective functional measures, including Peak Urinary Flow Rate ( Q max), to evaluate the study participants. Findings describe patterns observed in the study groups relative to the patterns observed in the placebo groups.

However, the main body of initial efficacy research relied on short follow-up durations, typically around three months. Therefore, while short-term changes were studied, long-term outcomes are not fully established based on extended placebo-controlled designs. Data for long-term periods often comes from open-label extension studies, where patients knew they were receiving the agent. Individuals with severe renal impairment were excluded from the core research, meaning data for this specific group remains insufficient.

Long-Term Studies and Durability of Response

Research has explored what happens beyond the initial three-month treatment period through open-label extension studies that monitored responses over defined time intervals. Findings from this research describe the observed patterns in functional measures and symptom reports in the study populations over the extended periods they were monitored. Longer-term reports provide data for observed patterns over the periods they were monitored. It is important to note that because the follow-up durations were limited in the core, highly controlled trials, the research provides limited information for long-term outcomes regarding the risk of needing BPH-related surgery or experiencing acute episodes over many years.

Exploratory Studies on Ureteral Stone Passage

Alfuzosin was also studied for a different clinical context: its use in Medical Expulsive Therapy (MET) to explore whether it facilitates the passage of ureteral stones. The research examined outcomes like the Stone-Free Rate and the Stone Expulsion Time. Findings were mixed across some studies, although data show patterns related to faster expulsion times and higher stone-free rates when compared to controls in some studies, particularly for smaller, more distally located stones. This specific use is considered exploratory, and the evidence quality varies across studies, leading to low certainty for generalized application.

Key Studies & References

  1. Alfuzosin: MedlinePlus Drug Information

Frequently Asked Questions (FAQ)

Common questions about Zatral (FAQ)

Q: Why is Zatral sometimes prescribed for something other than its main use?

A: Official information indicates that Zatral was investigated in exploratory research for other clinical contexts, such as the passage of ureteral stones. However, the primary approved use, according to regulatory documents, remains the management of symptoms related to benign prostatic hyperplasia (BPH).


Q: Is it typical to experience minor side effects when first starting Zatral?

A: Regulatory documents note that adverse reactions, such as dizziness, light-headedness (vertigo), and fatigue (asthenia), may be observed essentially at the beginning of treatment. This initial presentation of effects is related to the way the medication works within the body.


Q: Does official information about Zatral include warnings about drowsiness or driving?

A: Yes, official regulatory documents advise caution regarding activities like driving or operating machinery. Adverse reactions such as dizziness, vertigo, or fainting (syncope) may occur, and regulatory documents advise that the risk should be assessed prior to performing activities that require full attention.


Q: What is known about Zatral's potential impact on mood or mental status?

A: The official safety profile lists several effects related to the central nervous system, including dizziness, somnolence (drowsiness), and vertigo. These effects are primarily related to changes in blood pressure and alertness. Direct information about impacts on mood, such as depression or anxiety, is not typically detailed in the official warnings.


Q: Are there specific food types or beverages that interact with Zatral?

A: Regulatory documents do not strictly prohibit specific food types, but official regulatory constraints specify that the medication is required to be taken immediately after the same meal each day. This administration constraint is crucial because studies show that absorption of the active ingredient is significantly reduced if the tablet is taken without food.


Q: Is the use of Zatral with herbal supplements like St. John's Wort described as an interaction risk?

A: Official drug labels state that taking Zatral with certain potent CYP3A4 inhibitors is strictly prohibited. While St. John's Wort is a substance known to affect the CYP3A4 system, its specific interaction with Zatral is not detailed in the core official warnings. Given the absence of a specific interaction detail, the official profile focuses on the general prohibition of potent CYP3A4 inhibitors.


Q: Is Zatral categorized as safe for older adult patients?

A: Official information indicates that the standard dosage is generally considered appropriate for older adults, defined as those over 65 years of age. Routine dose adjustments are not typically required for this population.


Q: What is the current status of research examining the long-term safety of Zatral?

A: Initial research supporting the drug’s effectiveness primarily involved short clinical trial durations, often around three months. Long-term data for both safety and effectiveness frequently come from less restrictive open-label extension studies, where patients knew they were receiving the medication.


Q: How reliable is the evidence base supporting the use of Zatral?

A: The evidence base for the approved use includes multiple short-term, placebo-controlled clinical trials, which is considered a high standard for initial efficacy. Official documents note limitations, such as limited data available for patients with severe kidney impairment and the short duration of the most controlled studies.


Q: What type of clinical trials (Phase 3, observational, etc.) support Zatral's approval?

A: The drug's approval is primarily supported by data from randomized, placebo-controlled, double-blind trials, which are typically Phase 3 studies. Research has also included subsequent open-label extension studies to monitor observed patterns over longer periods.


Q: What is the general timeline for Zatral to start showing its expected effects?

A: Studies on the drug’s movement in the body indicate that the highest concentration of the active substance in the bloodstream is reached about eight hours after a mealtime dose. Urodynamically measurable effects have been observed within hours of the first dose, and symptom improvement is generally evaluated over several weeks.


Q: What happens in the body when Zatral is broken down?

A: According to official pharmacokinetic data, the drug undergoes extensive processing by the liver through a process called metabolism, primarily through oxidation. The substances produced after this breakdown (metabolites) are described as having no pharmacological activity.


Q: How long does a single dose of Zatral generally stay in the system?

A: Following oral administration, the apparent elimination half-life of the drug is approximately 10 hours. The drug is primarily removed from the body through excretion in the feces, with a smaller amount removed through the urine.


Q: What are the official warnings about consuming alcohol while using Zatral?

A: Official information notes that consuming alcohol can contribute to a lowering of blood pressure. Since Zatral works by relaxing blood vessels, combining it with alcohol may increase the risk of orthostatic hypotension (a sudden drop in blood pressure when standing), which could cause dizziness or fainting.


Q: What types of activities should potentially be limited or avoided while using Zatral?

A: Due to the risk of a sudden drop in blood pressure, certain activities that can exacerbate this effect, such as extensive periods of standing, prolonged or intense exercise, and exposure to heat, are noted in regulatory documents as those that may need to be minimized, especially when treatment is first initiated.


Q: Is Zatral considered a narcotic or controlled substance?

A: No. The active ingredient, alfuzosin hydrochloride, is classified as an alpha-1 blocker based on its mechanism of action. Official government agencies do not classify Zatral as a federally controlled substance.


Q: Does Zatral typically treat symptoms or the underlying cause of a condition?

A: Regulatory indications state that Zatral is prescribed for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Its mechanism is to relieve physical constraints by relaxing the muscles of the lower urinary tract.

How should Zatral be stored and disposed of?

How to Store and Dispose of Zatral?

To ensure product stability and safety, the storage and handling of Zatral must adhere strictly to official regulatory guidelines.

Storage and Handling Requirement Official Instruction
Temperature Constraint Store below 30 C (86 F).
Protection Keep in the original container to protect from light and moisture.
Safety Precaution Keep out of the reach of children.
Disposal No special disposal precautions are required; dispose according to local regulations.

Store Zatral in a cool, dry place within the temperature limit specified. Maintaining the medicine in its original packaging is required to safeguard it from environmental factors like light and moisture. As with all medications, it must be kept out of the reach of children. When discarding, no specific environmental or controlled-waste disposal instructions are documented; the medication may be disposed of without special handling.

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

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