Generic Uroxatral is used for treating symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. It may also be used for certain conditions.
Other names for this medication:
Also known as: Alfuzosin.
Generic Uroxatral is an alpha-blocker. It works by blocking receptors in the lower urinary tract, causing smooth muscles in the bladder neck and prostate to relax. This relaxation improves urine flow and reduces the symptoms of BPH.
Generic name of Generic Uroxatral is Alfuzosin.
Brand name of Generic Uroxatral is Uroxatral.
Take Generic Uroxatral by mouth with food. Take with meal every day.
Swallow Generic Uroxatral whole. Do not break, crush, or chew before swallowing.
Take Generic Uroxatral on a regular schedule to get the most benefit from it.
If you want to achieve most effective results do not stop taking Generic Uroxatral suddenly.
If you overdose Generic Uroxatral and you don't feel good you should visit your doctor or health care provider immediately.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) away from moisture, light and heat. Throw away any unused medicine after the expiration date. Keep out of the reach of children in a container that small children cannot open.
The most common side effects associated with Uroxatral are:
Side effect occurrence does not only depend on medication you are taking, but also on your overall health and other factors.
Do not take Generic Uroxatral if you are allergic to Generic Uroxatral components.
Do not take Generic Uroxatral if you're pregnant or you plan to have a baby, or you are a nursing mother. Generic Uroxatral can harm your baby.
Do not take Generic Uroxatral if you have moderate to severe liver disease.
Do not take Generic Uroxatral if you are taking an alpha-blocker (e.g., prazosin), an azole antifungal (e.g., ketoconazole), or an HIV protease inhibitor (eg, ritonavir).
Sit up or stand slowly, especially in the morning.
Avoid situations in which injury could occur due to fainting.
Keep Generic Uroxatral away from children and don't give it to other people for using.
Do not stop taking Generic Uroxatral suddenly.
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In men with LUTS who responded to alfuzosin, changing the dosing regimen from daily to once every other day resulted in similar efficacy and safety at 3 and 6 months. By contrast, complete cessation of alfuzosin resulted in recurrence of both symptoms and impaired urinary flow. These data provide evidence that in responding patients, intermittent alpha-blocker therapy may be a reasonable therapeutic regimen. The role of intermittent alpha-blocker therapy using other agents, as well as in a large cohort of men with LUTS, remains to be determined.
This study suggests that the use of prophylactic tamsulosin or alfuzosin can reduce the incidence of urinary retention and the need for catheterization after urologic surgical procedures under spinal anaesthesia.
α1-adrenergic receptors blockers (ABs) are recommended as first-line medical therapy in men with Lower Urinary Tract Symptoms suggestive of Benign Prostatic Enlargement (LUTS/BPE). Available ABs include: terazosin, doxazosin, tamsulosin, naftopidil, alfuzosin and silodosin. These agents have different profiles of selectivity for α1-adrenergic receptors subtypes. All these agents are efficacious in improving both storage and voiding LUTS. In recent years the efficacy of ABs in improving urodynamic parameters of bladder outlet obstruction (BOO) has been questioned. We reviewed literature evidences about the effects of available ABs on invasive urodynamic parameters of BOO in men with LUTS/BPE. The impact of ABs therapy on urodynamic parameters indicative of BOO has been evaluated for all currently approved drugs. Available data demonstrate improvements in terms of both free uroflowmetry and pressure-flow parameters. While the impact of ABs on maximum urinary flow is clinically modest, the improvement of detrusor pressure at maximum urinary flow is more robust. Only few studies exist that directly compare the urodynamic effects of a small number of ABs. According to these studies there are no differences among ABs in terms of urodynamic efficacy. Indirect comparison of ABs suggests greater effectiveness of silodosin in terms of detrusor pressure at maximum urinary flow reduction. Studies that stratified populations based upon the degree of obstruction at baseline demonstrated greater urodynamic changes in patients with baseline BOO with respect to the unobstructed patients. Globally, the quality of studies available is low and there is considerable heterogeneity among studies.
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alpha(1)-Adrenoceptor antagonists such as alfuzosin, doxazosin, tamsulosin and terazosin are first-line agents for the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH), but are only second-line agents (doxazosin and terazosin only) for the treatment of arterial hypertension. Sexual function is complex and includes multiple domains such as sexual desire (libido), erectile function and ejaculatory function. Erectile and ejaculatory functions are frequently reduced in patients with BPH and can impact on their quality of life. Therefore, the treatment of BPH should aim to maintain or even restore sexual function.alpha(1)-Adrenoceptor antagonists lack major effects on sexual desire in placebo-controlled studies. Reports on erectile function are inconsistent, with both beneficial and adverse effects being reported, but impotence can occur in some patients without clear differences between drugs. Ejaculatory dysfunction during treatment may represent (relative) an ejaculation. It occurs more frequently with tamsulosin than with other drugs of this class, but the differences are not big enough to be consistently detectable in directly comparative studies. We propose that such differences between drugs should be weighed against differences in cardiovascular tolerability when choosing the optimal treatment for each patient.
Bromocresol purple (BCP), bromophenol blue (BPB) and bromothymol blue (BTB) were used to determine alfuzosin hydrochloride either in pure form or in pharmaceutical formulations. Alfuzosin was extracted as an ion-pair complex from sample solution containing KCl-HCl buffer pH2.2, 2.4 and 2.6 into CHCl3 and the absorbance was measured at 407, 413 and 412nm with use of the cited reagents, respectively. The analytical parameters and their effects on the reported systems are investigated. The reactions were extremely rapid at room temperature and the absorbance values remains unchanged up to 24 h. Beer's law was obeyed in the concentration ranges 1.20-38.3, 0.85-46.0 and 0.63-34.0 μg/ml and detection limits were 0.28, 0.24 and 0.18 μg/ml with BCP, BPB and BTB, respectively. Recoveries were 98.80-101.33%. Interferences of the other ingredients and excipients were not observed. The proposed method is simple, fast and sensitive, and the first reported extractive method for the determination of alfuzosin in commercial tablets.
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Penile erectile tissue was obtained from male New Zealand White rabbits (22-26 weeks old). The CC was cut into longitudinal strips and mounted under 2 g resting tension in 5-mL jacketed organ baths containing a modified Krebs solution bubbled with 95% O2, 5% CO2 and maintained at 37 degrees C. Tissue strips were pre-contracted by 60 mmol/L KCl or 10 micro mol/L phenylephrine. After obtaining a stable plateau of contractions, test compounds were added to the organ bath. The relaxant potencies were expressed as the percentage of inhibition of the plateau of contraction induced by 10 micro mol/L phenylephrine.
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Alfuzosin 10 mg OD is an effective treatment for symptomatic BPH for at least 12 months, with a better cardiovascular safety profile than the immediate release formulation.
Over the past years new formulations of several α1-adrenoceptor blockers were introduced to the market. Five long-acting α1-blockers are currently approved by the Food and Drug Administration for treatment of symptomatic LUTS/BPH: terazosin, doxazosin, tamsulosin, alfuzosin and silodosin. Silodosin is the only adrenoceptor blocker that exhibits true selectivity for the α1-adrenoceptor subtypes. This unique adrenoceptor selectivity profile likely accounts for the very favorable cardiovascular safety profile.
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The mean (SD) maximum stone dimension was 7.8 (1.5), 8.1 (1.3), 7.9 (1.6) and 8.0 (1.4) mm in Groups I, II, III and IV, respectively. Groups II and IV had significantly higher stone-free rates than Groups I and III (P < 0.05), whilst there were no statistically significant differences between Groups I and III or between Groups II and IV. There was no statistical difference among the four groups for the time to stone expulsion. Three patients in Group II and two patients in Group IV developed transient hyperglycaemia, which resolved after cessation of methylprednisolone.
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PSA and IPSS (total and voiding subscore) showed significant correlations with IPP (P<0.05). Comparison of parameters before and after 8 weeks showed that alfuzosin improved the total IPSS and all subscores (P<0.001), QoL (P<0.001), Qmax (P<0.001), and PVR (P=0.030) in the non-IPP group.
The coefficient of repeatability of maximum flow after detection and correction of artifacts by the computer (0.38 ml/s) was slightly better when compared with the coefficient of repeatability between 2 observations by 1 expert (1.12 ml/s). The interobserver variation for the quantitative assessment of maximum flow appeared to be great. A total of 51% of the maximum flow values assessed by expert 2 was 1 ml/s or more greater than those assessed by expert 1. When comparing the results of the computer with those of the experts, the mean value of maximum flow from expert 1 was 0.71 ml/s smaller than the computer value (p < 0.01), the mean value from expert 2 was 0.53 ml/s greater (p < 0.01) and the mean value from expert 3 was not significantly different (0.25 ml/s greater). The SD of maximum flow after correction by the computer was 0.3 ml/s smaller than the SD of the raw data from the flowmeter and the corrected values by 2 experts.
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3,228 patients suffering from BPH were included by 812 centers in a 3-year open prospective study and were treated with alfuzosin (immediate release) at the recommended dosage. A symptom score (modified Boyarsky) and a specific HRQL score, comprising 20 items including 3 questions on sexuality (Urolifetm BPH Qol20) were self-administered on inclusion and after 3, 6, 12, 18, 24, 30 and 36 months.
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ABs improve BOOI in patients with LUTS/BPE mainly by reducing PdetQmax, and this effect is higher in patients presenting with urodynamic obstruction at baseline. The free Qmax variation underestimates the real effect of ABs on benign prostatic obstruction.
Throughout the study year, 193 different physicians wrote 341 prescriptions that matched the drug inclusion criteria for 210 different patients. The most frequently observed scenario involved the prescription for women of selective alpha-blockers, including alfuzosin hydrochloride, tamsulosin hydrochloride, and terazosin hydrochloride, that are indicated exclusively for the treatment of benign prostatic hyperplasia.
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Alfuzosin, a quinazoline derivative, is a selective and competitive alpha(1)-adrenoceptor antagonist. It distributes preferentially in the prostate, compared with plasma, and decreases the sympathetically controlled tone of prostatic smooth muscle. As a result lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH) are improved. The once-daily formulation of alfuzosin contains inactive barrier layers which have been added to the planar surfaces of compressed tablets. Drug release is sustained over 20 hours with a near constant dissolution rate between 2 and 12 hours. Mean values for area under the plasma concentration-time curve over 24 hours (AUC(24)) were similar after administration of prolonged-release alfuzosin 10mg once daily and immediate-release alfuzosin 2.5mg three times daily. Likewise, similar AUC(24) values were reported when prolonged-release alfuzosin 10mg once daily and sustained-release alfuzosin 5mg twice daily were compared. These data suggest that these alfuzosin regimens provide similar average systemic exposure. Data from short- (3 months) and long-term (up to 12 months) clinical trials show that the prolonged-release formulation of alfuzosin controls the symptoms associated with BPH as effectively as immediate-release alfuzosin 2.5mg three times daily and clinical improvement is maintained for up to 1 year. Improvements in International Prostate Symptom Score, maximum urinary flow rate and quality-of-life index were improved to a similar extent in patients treated with immediate- or prolonged-release alfuzosin and improvements were statistically significant compared with placebo. Prolonged-release alfuzosin 10mg is well tolerated and the overall incidence of adverse events is similar to that seen with placebo. The once-daily formulation of alfuzosin 10mg caused fewer vasodilatory adverse events than immediate-release alfuzosin 2.5mg three times daily and caused only slight decreases in systolic and diastolic blood pressure which were not clinically significant and did not differ significantly from those with placebo. No dosage titration is required. The incidence of ejaculatory disorders was <1%.
This report focuses on cardiovascular and ocular AEs of α-blockers as related to their mechanism of action and subtype selectivity.
Addition of flurbiprofen increased the therapeutic effectiveness of alfuzosin by further improving symptoms in patients with LUTS/BPO. Combination therapy also improved urine flow compared to baseline. Monotherapy with flurbiprofen was not superior to alfuzosin.
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To establish new methods for the chiral separation and preparation of three new drugs, alfuzosin, terazosin and doxazosin.
In healthy volunteers who completed the study (48), tamsulosin resulted in significantly decreased ejaculate volume (-2.4 +/- 0.17 ml) compared to alfuzosin (+0.3 +/- 0.18 ml, p < 0.0001 vs tamsulosin) or placebo (+0.4 +/- 0.18 ml, p < 0.0001 vs tamsulosin, p = nonsignificant vs alfuzosin). Among completers the incidence of more than 20% decreased ejaculate volume was significantly greater with tamsulosin (89.6%) compared to alfuzosin (20.8%, p < 0.0001 vs tamsulosin) or placebo (12.5%, p < 0.0001 vs tamsulosin, p = nonsignificant vs alfuzosin). While on tamsulosin 35.4% of 48 completers had complete lack of ejaculation (anejaculation) and no subjects experienced anejaculation while on alfuzosin or placebo.
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The construction and characterization of potentiometric membrane electrodes are described for the quantification of alfuzosin, a drug used in a mono- and combined therapy of benign prostatic hyperplasia (BPH). The membranes of these electrodes consist of alfuzosin hydrochloride-tetraphenyl borate, (Az-TPB), chlorophenyl borate (Az-ClPB), and phosphotungstate (Az(3)-PT) ion associations as molecular recognition reagent dispersed in PVC matrix with dioctylpthalate as plasticizer. The performance characteristics of these electrodes, which were evaluated according to IUPAC recommendations, revealed a fast, stable and liner response for alfuzosin over the concentration ranges of 8.3 x 10(-6) to 1.0 x 10(-2) M, 3.8 x 10(-6) to 1.0 x 10(-2) M, 7.5 x 10(-7) to 1.0 x 10(-2) M AzCl with cationic slopes of 57.0, 56.0 and 58.5 mV/decade, respectively. The solubility product of the ion-pair and the formation constant of the precipitation reaction leading to the ion-pair formation were determined conductometrically. The electrodes, fully characterized in terms of composition, life span and usable pH range, were applied to the potentiometric determination of alfuzosin hydrochloride ion in different pharmaceutical preparations and biological fluids without any interference from excipients or diluents commonly used in drug formulations. The potentiometric method was also used in the determination of alfuzosin hydrochloride in pharmaceutical preparations in four batches with different expiration dates. Validation of the method showed suitability of the proposed electrodes for use in the quality control assessment of alfuzosin hydrochloride. This potentiometric method offers the advantages of high-throughput determination, simplicity, accuracy, automation feasibility, and applicability to turbid and colored sample solutions.
With alfuzosin, IPSS improved by 6.4 points (-33.4%) from baseline (P < 0.001), reaching >or=3 points and >6 points in 71.3% and 47.2% of men, respectively. There were also significant (P < 0.001) improvements from baseline in nocturia (-0.8, -25.5%), bother score (-1.7, -40.7%) and DAN-PSSsex weighted scores with treatment. Symptom relief was rapid and maintained over 3 years. Overall, 78 men (12.4%) had an IPSS worsening of >or=4 points, 16 (2.6%) had AUR, and 36 (5.7%) required BPH-related surgery. Symptom deterioration during treatment and high baseline PSA values were the best predictors of AUR and BPH-related surgery. Alfuzosin was well tolerated, dizziness being the most frequent adverse event (4.5%) possibly related to vasodilatation. Ejaculatory disorders were uncommon (0.4%). Changes in blood pressure remained marginal, including in men aged >or=65 years and those receiving antihypertensive agents.
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We determined the binding affinity of tamsulosin, a selective α(1)-adrenoceptor antagonist, for human α(1)-adrenoceptor subtypes in comparison with those of other α(1)-adrenoceptor antagonists including silodosin, prazosin, 5-methylurapidil, terazosin, alfuzosin, nafopidil, urapidil and BMY7378. The association and dissociation kinetics of [(3)H]tamsulosin for recombinant human α(1)-adrenoceptor subtypes were compared with those of [(3)H]prazosin. Tamsulosin competitively inhibited [(3)H]prazosin binding to human α(1A)-, α(1B)- and α(1D)-adrenoceptors (pK(i) values were 10.38, 9.33, 9.85) indicating 11 and 3.4-fold higher affinities for human α(1A)-adrenoceptor than those for α(1B)- and α(1D)-adrenoceptors, respectively. The affinity of tamsulosin for the human α(1A)-adrenoceptor was, respectively, 5, 9.9, 38, 120, 280, 400, 1200 and 10000 fold higher than those of silodosin, prazosin, 5-methylurapidil, terazosin, alfuzosin, naftopidil, urapidil and BMY7378, respectively. [(3)H]Tamsulosin dissociated from the α(1A)-adrenoceptor slower than from the α(1B)- and α(1D)-adrenoceptors (α(1B)>α(1D)>α(1A)). Moreover, [(3)H]tamsulosin dissociated slower than [(3)H]prazosin from the α(1A)-adrenoceptor and faster from the α(1B)- and α(1D)-adrenoceptors. In conclusion, tamsulosin potently and selectively antagonized α(1A/1D)-adrenoceptor ligand binding, and slowly dissociated from the α(1A)-adrenoceptor subtype.
A pharmacokinetic bioequivalence study was conducted in Asian subjects, to compare a fixed dose combination capsule single oral dose of alpha adrenoceptor blocker-Alfuzosin hydrochloride 10mg extended release and muscarinic antagonists-Solifenacin succinate 5mg against individually administered Xatral XL 10mg tablets (Alfuzosin) of Sanofi Synthelabo Limited, United Kingdom (UK) and Vesicare 5mg tablets (Solifenacin) of Astellas Pharma Limited, UK under fed conditions. Blood samples were collected pre-dose up to 72 h post dose for determination of plasma Alfuzosin and Solifenacin concentrations and calculation of the pharmacokinetic parameters. ANOVA was performed on the log (natural)-transformed pharmacokinetic parameters. A 90% confidence interval for the ratios of the test and reference product averages (least square means) were calculated for alfuzosin and solifenacin. The 90% confidence intervals obtained for alfuzosin for Cmax, AUC0-t and AUC0-∞ were 102.74-122.75%, 95.84-116.96% and 95.82-116.76%, respectively. The 90% confidence intervals obtained for Solifenacin for Cmax, and AUC0-72 were 89.55-97.91% and 90.47-99.38%, respectively. Based on the results, the fixed dose combination was concluded to be bioequivalent to individually administered products.
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