Overview of Dalfaz SR

Quick Facts

Property	Description
Active ingredient	Alfuzosin hydrochloride
Form	Extended-release tablet (SR)
Pharmacological class	Alpha-1 adrenergic antagonist (alpha1-blocker)
Route of administration	Oral
Origin	Synthetic small molecule

What Type of Medicine is Dalfaz SR?

Dalfaz SR is an oral, prescription-only medication fundamentally classified as an Alpha-1 adrenergic antagonist, commonly known as an alpha1-blocker. Its active pharmaceutical ingredient is Alfuzosin, utilized as the hydrochloride salt. The SR designation indicates its specialized Sustained Release property, meaning the drug is contained within an extended-release tablet structure designed to deliver Alfuzosin gradually over a 24-hour period. This classification dictates the drug's fundamental function as an agent that modulates nerve signals responsible for muscle tone. This formulation is designed to maintain consistent drug levels.

Composition, Origin, and Action Principle

The composition relies on the synthetic small molecule Alfuzosin hydrochloride as the core therapeutic agent. This compound acts as a selective antagonist at the alpha-1 adrenergic receptors (alpha1-adrenoceptors), which are abundant in the smooth muscle of the bladder neck and prostate.

This antagonist action represents the core principle of Dalfaz SR: by blocking the signals transmitted through these receptors, the drug promotes the relaxation of smooth muscle tissue. Alfuzosin exhibits functional uroselectivity in comparison to other agents in the class. The medication thus works by directly addressing the physical constriction caused by muscle tightness.

What is the General Purpose of Dalfaz SR?

The primary general purpose of Dalfaz SR is to alleviate symptoms related to increased resistance within the urinary outflow tract, a situation often clinically recognized in adult males. By initiating targeted smooth muscle relaxation, the medication reduces involuntary tension in the bladder neck and prostate. The overall therapeutic aim is to reduce functional obstruction and facilitate the improved flow of urine. The once-daily administration supported by the Sustained Release form ensures continuous muscle relaxation throughout the entire day.

What side effects are possible with Dalfaz SR?

Possible Side Effects and Safety Information

The safety profile for Dalfaz SR (alfuzosin) is formally structured by government regulatory agencies based on the observed frequency and physiological impact of adverse reactions documented in clinical trials and post-marketing surveillance. This information strictly details the established risks and regulatory constraints.

Official Adverse Reactions by Frequency

Adverse reactions are classified by their likelihood of occurrence according to regulatory standards:

Common Reactions (occurring in 1/100 to < 1/10 treated patients): These typically include dizziness, headache, asthenia (fatigue), postural hypotension (drop in blood pressure upon standing), and certain gastrointestinal effects like nausea and dyspepsia.
Uncommon Reactions (occurring in 1/1000 to < 1/100 treated patients): Events such as syncope (fainting), vertigo, palpitations, tachycardia (increased heart rate), rhinitis, and rash are documented in this category.

Serious and Clinically Significant Events

Certain rare or clinically important events are explicitly noted in regulatory documents. These include Priapism (a prolonged, painful erection), Angioedema (severe allergic swelling), and Intraoperative Floppy Iris Syndrome (IFIS), which has been observed during cataract surgery. Syncope and Angina Pectoris (chest pain) are also listed as serious potential events, particularly the latter in patients with pre-existing coronary artery disease.

Population and Time-Related Safety Constraints

The medicine is contraindicated in patients with moderate or severe hepatic impairment. Caution is advised for patients with severe renal impairment and for older adults, where the risk of hypotension may be greater. The regulatory label notes that reactions related to low blood pressure, such as dizziness and postural hypotension, are often transient and are most likely to occur at the beginning of treatment or shortly after initial administration.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation states that the principal clinical consequence of a Dalfaz SR (Alfuzosin) overdose is a significant drop in blood pressure, known as severe hypotension, which may lead to syncope (fainting). This exaggerated cardiovascular response necessitates immediate intervention.

Overdose Manifestations	Required Emergency Actions
Severe Hypotension	Seek immediate medical attention.
Syncope (Fainting)	Hospitalization is required for observation and stabilization.

In the event of a known or suspected overdose, the patient must be immediately placed and kept in the supine position to help restore blood pressure. Regulatory guidance prioritizes support of the cardiovascular system. If positioning is insufficient, intravenous fluids should be considered, followed by the use of vasopressors (such as noradrenaline) if hypotension remains severe. It is also officially stated that renal function must be monitored and supported. Given the drug's high protein binding, regulatory information advises that dialysis is not expected to be effective in management.

Therapeutic Uses of Dalfaz SR

What Dalfaz SR Treats: Main Uses and Benefits

Dalfaz SR is used for managing the symptomatic discomfort of Benign Prostatic Hyperplasia (BPH), a condition in adult males that leads to lower urinary tract symptoms (LUTS). The medication is used in contexts marked by increased urinary discomfort or tension.

The medication helps address symptom clusters that may become intense or disruptive. These symptoms are primarily categorized as obstructive symptoms, such as a weak stream and hesitancy, and irritative symptoms, including increased urinary frequency, urgency, and the need to wake up at night to urinate (nocturia). The use of the medication contributes to improved comfort during periods of heightened symptoms and assists with easing the overall symptom burden.

“The therapy is applied to help manage symptom clusters that may become intense or disruptive, contributing to improved day-to-day comfort.”

Quick Fact: Symptomatic Support for BPH

The medication supports the patient during symptomatic phases by easing the overall symptom load associated with prostate enlargement. It is used for conditions characterized by periods of heightened symptoms to help manage the resulting physical discomfort.

Regulatory References

NIH MedlinePlus overview

Eligibility and Restrictions for Use

Dalfaz SR (alfuzosin extended-release) is officially indicated for use exclusively in adult male patients for the management of BPH symptoms. The medication is not indicated for use in women or the pediatric population, as efficacy has not been demonstrated in children.

Contraindicated Populations

Alfuzosin 10 mg prolonged-release tablets are contraindicated and must not be used in the following populations or conditions, as per regulatory labeling:

Patients with moderate or severe hepatic impairment (liver insufficiency).
Patients with known hypersensitivity to alfuzosin or any component of the formulation.
Patients with a history of orthostatic hypotension.
Patients taking potent CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole).
Patients using other alpha-1 receptor blockers concomitantly.

Restrictions and Limitations

Caution is required when administering Dalfaz SR to patients with severe renal impairment (creatinine clearance < 30 mL/min), as clinical safety data are limited or lacking for this group. Caution is also advised in patients with a history of congenital or acquired QT prolongation. If signs of angina pectoris appear or worsen, the medication should be discontinued.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Dalfaz SR (alfuzosin) is defined by pharmacokinetic changes related to its metabolism and pharmacodynamic effects that influence blood pressure.

Combinations that are Contraindicated

Co-administration with potent inhibitors of the CYP3A4 enzyme is contraindicated. This is because CYP3A4 is the principal enzyme responsible for alfuzosin's metabolism, and inhibition significantly increases alfuzosin concentration (exposure), raising safety concerns. Examples include certain antifungal agents (e.g., ketoconazole, itraconazole) and some HIV protease inhibitors (e.g., ritonavir).

This medication is an alpha-adrenergic antagonist, and its use is strictly prohibited in combination with other alpha-adrenergic antagonists (alpha-blockers) due to the potential for excessive hypotensive effects.

Combinations Requiring Caution or Monitoring

Caution is required when Dalfaz SR is used with medications that may lower blood pressure, such as antihypertensive agents or nitrates, as this combination may cause symptomatic hypotension or fainting (syncope). This includes co-administration with Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil), which also have vasodilatory properties.

Increased monitoring is also necessary when this product is combined with other medicinal products known to prolong the QT interval, due to the potential for an additive effect on cardiac conduction.

Mechanism of Action

Targeted Blockade of alpha1-Adrenoceptors

Dalfaz SR's mechanism centers on the active ingredient, Alfuzosin, a selective antagonist that binds to the post-synaptic alpha1-adrenoceptors. These receptors are abundantly expressed on the smooth muscle cells within the prostate, prostatic capsule, and bladder neck. By blocking these molecular targets, Alfuzosin prevents the binding of the neurotransmitter norepinephrine, which inhibits the sympathetic nervous system's signal for muscle contraction.

Modulation of Autonomic Smooth Muscle Tone

The molecular blockade initiates a cascade that leads to the modulation of autonomic smooth muscle tone in the lower urinary tract. This action reduces the involuntary, ongoing tension—known as the dynamic component of resistance—in the prostatic stroma and bladder neck. The molecular blockade results in the inhibition of alpha1-adrenoceptor-mediated sympathetic signaling, resulting in the relaxation of the smooth muscle tissue.

Reduction of Bladder Outlet Resistance

The physiological consequence of sustained smooth muscle relaxation is a continuous decrease in the resistance at the bladder outlet. This mechanism functionally widens the urethral passage by adjusting activity within the key regulatory systems that control muscle tension, leading to predictable physiological adjustments, which is the physiological mechanism for reducing resistance at the bladder outlet.

Dosage and Administration Information

How to use Dalfaz SR

The administration of Dalfaz SR (Alfuzosin Extended-Release) is guided by a specific protocol established to ensure the medicine’s sustained-release properties function correctly.

Instruction Entity	Detail
Route of administration	Oral
Dosing schedule	10 mg once daily. This is the standard and maximum recommended dose for the extended-release formulation.
Timing in relation to meals	Must be taken immediately after a meal (not on an empty stomach). The dose should be taken with the same meal each day.
Preparation requirements	The tablet must be swallowed whole. Do not chew, crush, or divide the tablet.
Missed-dose rules	Skip the missed dose and take the next tablet at the regularly scheduled time. Do not take a double dose.

Special Procedural Conditions

Classification	Detail
Administration method type	Oral
Frequency pattern	Daily (Once a day)
Use-context constraints	Food-dependent administration and tablet integrity protection.
Population-specific rules	Use is contraindicated in moderate or severe hepatic impairment and requires caution in patients with severe renal impairment. Use is not indicated for the pediatric population.

Connection to the Overall Use Protocol

The administration protocol for Dalfaz SR is fundamentally structured around maintaining the integrity of the extended-release formulation and ensuring consistent absorption. The established protocol indicates this fixed 10 mg regimen is continuous and defines restrictions for specific patient populations, such as those with liver or severe kidney conditions, to outline the appropriate boundaries of use. Consistent timing with a full meal is a required component of the use protocol.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Dalfaz SR

The available research provides context on how this medication has been studied for its approved uses. The studies examined the drug's effect in groups of patients under specific, controlled conditions, and the findings describe the patterns observed in those particular trials.

Evidence for use in Symptomatic Benign Prostatic Hyperplasia (BPH)

This section summarizes the clinical research that has been conducted to evaluate the use of alfuzosin extended-release in adult men managing the symptoms of an enlarged prostate. Research has explored how symptoms and physical measurements change over defined study periods.

The evidence for the use of Dalfaz SR in BPH is primarily based on short-term, double-blind randomized controlled trials (RCTs). These studies were used in research exploring how symptoms change over time, typically monitoring patients for a few months.

Primary Measures Examined in BPH Studies

Researchers applied in studies examining patient-reported experiences to gauge outcomes related to physical discomfort. The primary outcomes measured included: 1) Symptom Measurement using standardized scores (e.g., I-PSS) for perceived discomfort like urinary frequency and nocturia, and 2) Functional Measurement of urine flow, such as the Maximum Urinary Flow Rate (Qmax). Findings describe patterns observed in these functional measures over the course of the study period, with measurements evolving differently in the alfuzosin groups compared to the placebo groups in short-term trials.

Evidence for use in Acute Urinary Retention (AUR) related to BPH

Research examined the use of the medication as part of a Trial Without a Catheter (TWOC) procedure following an acute event. The core research involved dedicated placebo-controlled trials conducted during periods of increased symptom activity.

Outcomes Monitored in Acute Retention Trials

In these trials, the main outcome measured was the success rate of the Trial Without Catheter—the ability of patients to urinate successfully after the catheter was removed. Findings describe patterns observed in the studies, reporting the measured percentage of patients who achieved this outcome compared to those receiving placebo.

What is Still Uncertain About Dalfaz SR Research

Research provides context but not individual predictions, and the evidence highlights what is known and what is still uncertain. The most definitive evidence is concentrated in studies of only a few months; follow-up durations were limited. Data for the sustained effects of treatment beyond one year are still emerging and often come from less rigorous, open-label studies. Furthermore, comparative evidence is lacking for all possible comparisons against every other similar medication available, meaning findings describe group patterns, not personal outcomes.

Frequently Asked Questions (FAQ)

Common questions about Dalfaz SR (FAQ)

Q: Is Dalfaz SR the same type of medicine as Flomax?

Dalfaz SR (Alfuzosin) and Flomax (Tamsulosin) both belong to the same broad pharmacological category. According to official product information, they are both classified as alpha-1 adrenergic antagonists (commonly known as alpha-blockers). This means they act on similar targets in the body to help manage symptoms related to BPH.

Q: How long does it typically take to see the effects of Dalfaz SR?

Studies and official information indicate that this type of medication begins working quickly. Objective measures of effect, such as improvements in urinary flow rate, have been observed in clinical trials within 24 hours after the first dose. Symptom relief is generally reported as occurring quickly with this class of medication in clinical settings.

Q: What is the difference between Dalfaz and Dalfaz SR?

The difference lies in how the medicine is delivered in the body. Dalfaz SR is an extended-release or sustained-release formulation of the active ingredient, Alfuzosin. This specialized formulation is designed to release the medication slowly and continuously over a 24-hour period.

Q: Are there any common over-the-counter medicines that interact with Dalfaz SR?

Regulatory warnings cover medication classes that should be avoided or used with caution. Specifically, Dalfaz SR should be used cautiously with common over-the-counter products that contain ingredients that could lower blood pressure or affect heart rhythm, such as specific decongestants or antacids. Official guidance emphasizes the importance of discussing all products, including over-the-counter medicines, with a healthcare professional.

Q: What kind of monitoring is recommended when taking Dalfaz SR?

Regulatory documents indicate that monitoring is necessary when Dalfaz SR is used with certain other medicines that could affect the heart’s electrical activity, known as the QT interval. Caution is also advised for patients who have existing cardiac or kidney conditions, where the official prescribing information advises increased caution.

Q: How does Dalfaz SR differ from immediate-release versions of the drug?

The key difference is the administration schedule and drug concentration. The extended-release formulation of Dalfaz SR allows for once-daily dosing, which is designed to maintain a consistent level of the drug over 24 hours. Immediate-release versions typically require multiple doses throughout the day to achieve a similar effect.

Q: Do you have to change your diet while taking Dalfaz SR?

The official administration protocol requires the medication to be taken immediately after a meal to support proper absorption. Additionally, regulatory documents advise against consuming grapefruit or grapefruit juice while taking this medication. This is because grapefruit can increase the amount of medicine in the blood and raise the risk of side effects like low blood pressure.

Q: Is Dalfaz SR considered a long-term medication?

Dalfaz SR is officially indicated for the management of symptoms associated with Benign Prostatic Hyperplasia (BPH). Since BPH is a chronic (long-lasting) condition, the medication is often used as part of a continuous, long-term treatment plan to manage symptoms.

Q: Can Dalfaz SR cause problems with ejaculation?

Official regulatory documents list the serious, but rare, side effect of priapism (a prolonged, painful erection). The official label reports a generally low incidence of common ejaculation-related side effects, such as a reduced amount of fluid.

Q: Is there a generic version of Dalfaz SR available?

Yes, regulatory records confirm that generic versions of the active ingredient, Alfuzosin hydrochloride extended-release, are approved and available. Generic versions contain the same active ingredient as the brand-name product.

Q: Can Dalfaz SR be taken with antacids?

Official warnings suggest caution when combining Dalfaz SR with certain antacids. Some antacids contain ingredients like magnesium hydroxide which may interact, potentially increasing the risk of an irregular heart rhythm. Consultation is recommended regarding the use of specific antacid products.

Q: Are there dietary restrictions specifically for Dalfaz SR?

Yes. Beyond the requirement to take the tablet immediately after a meal, regulatory documents specifically advise against consuming grapefruit or grapefruit juice. These products can interfere with the way the body processes the medication, which could raise the risk of side effects like low blood pressure.

Q: Is Dalfaz SR an antibiotic?

No. Dalfaz SR is classified as an Alpha-1 adrenergic antagonist (α1-blocker). This class of medicine is designed to relax smooth muscle in the urinary tract to improve urine flow, and it is not used to treat bacterial infections.

Q: What are the typical signs that Dalfaz SR is working for the intended condition?

Studies and official information indicate that when the medication has a therapeutic effect for BPH symptoms, improvements may include changes in standardized symptom scores, such as reduced urinary frequency and urgency. Researchers also measure objective increases in the maximum urinary flow rate (Qmax).

Q: Are there specific safety warnings related to driving or operating machinery with Dalfaz SR?

Yes. Official product information contains warnings that because side effects like dizziness, vertigo, or fainting (syncope) may occur. Official warnings state that caution should be exercised regarding activities that require full alertness, such as driving or operating heavy machinery.

Q: Is it true that Dalfaz SR is not meant to treat cancer?

Yes, this is correct. Dalfaz SR is formally indicated only for the management of symptoms associated with benign prostatic hyperplasia (BPH). It does not treat or prevent prostate cancer.

Q: Can Dalfaz SR affect the results of lab tests?

Official regulatory information notes that Alfuzosin may cause a small decrease in the measured levels of Prostate-Specific Antigen (PSA). This is a factor that should be considered when interpreting the results of PSA blood tests used for prostate cancer screening.

Q: Why is Dalfaz SR only available in one strength?

The extended-release formulation is typically available in a single strength of 10 mg. This single dosage is the established standard dose intended to provide continuous, sustained release over 24 hours to manage BPH symptoms effectively.

Q: Is it okay to drink alcohol in moderation while on Dalfaz SR?

Regulatory warnings specifically indicate that drinking alcohol while taking Dalfaz SR can increase the risk of hypotension (low blood pressure), which may lead to dizziness or fainting. For this reason, regulatory guidance suggests limiting or avoiding alcohol consumption.

How should Dalfaz SR be stored and disposed of?

How to Store and Dispose of Dalfaz SR?

Storage Requirements

Dalfaz SR (Alfuzosin Prolonged-Release) must be stored in alignment with official regulatory requirements to maintain its stability. The medication requires storage at room temperature, typically between 20 C and 25 C. It is mandatory to keep the tablets away from light, excess heat, and moisture. Storing in places like a bathroom is prohibited, and the product must be kept from freezing.

Tablets must remain in the original container, which should be kept tightly closed. A critical instruction is to keep the medicine out of the sight and reach of children.

Disposal Instructions

Expired or unused Dalfaz SR must be disposed of according to local requirements and guidance from a healthcare professional. The preferred method is typically a drug take-back program. The medicine must not be accessible to children or pets during disposal.

Dalfaz SR