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.
To evaluate the effects of tolterodine extended release (ER) and alfuzosin for the treatment of Double-J stent-related lower urinary tract symptoms.
There was some evidence to suggest that alpha blockers increase the success rates of trial without catheter, and the incidence of adverse effects was low. There was some evidence of a decreased incidence of acute urinary retention. The need for further surgery, cost effectiveness and recommended duration of alpha blocker treatment after successful trial without catheter remain unknown as these were not reported by any trial. There is a lack of internationally agreed outcome measures for what constitutes successful trial without catheter. This makes meta-analysis difficult. Large, well-designed controlled trials, which use the recommendations set out in the CONSORT statement, and include clinically important outcome measures, are required.
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Based on the analysis of MSHQ scores before and after alfuzosin treatment, improvement was significant on ejaculatory function, in addition to improvement on LUTS and quality of life. MSHQ is a useful tool to evaluate the male sexual dysfunction.
In order to establish accurately the exact effect of any drug therapy for symptomatic benign prostatic hyperplasia (BPH) it is important to define the effect of placebo treatment. This effect was assessed by throughly analyzing the placebo arm, which included 101 patients, from a randomized, double-blind, placebo-controlled trial of the selective alpha-blocker alfuzosin and comparing the data with those of a variety of independent studies which followed a placebo group of patients with clinical BPH. Following 16 weeks of placebo treatment a decrease of 24% (p < 0.05) in Madsen-Iversen score and an increase of 14% (p < 0.05) in peak flow rate was demonstrated. The percentages of patients who reported worsening, improvement or no change in symptoms were 9.2%, 73.6% and 17.2% respectively. The maximal effect of placebo, approximately 40% reduction in symptom scores, is likely to be achieved within the first four to six months. After this, the placebo effect stabilizes and gradually wears off but is still present following 12 months of treatment. The duration of the placebo effect and the time until it has totally worn off, if ever, remains to be studied in long-term, placebo-controlled trials, including an untreated cohort. The present study emphasizes the importance of properly designed, double-blind, placebo-controlled studies in evaluating any pharmacological intervention in clinical BPH.
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Alfuzosin (dalphaz) has been tried in 32 patients with benign prostatic hyperplasia (BPH). The treatment lasted for 14 weeks: 2 weeks of placebo and 12 weeks of alfuzosin. The drug was given in a daily dose of 10 mg (5 mg twice a day). The response was registered in 87.5% of cases. Improvement of urination occurred by all the parameters of IPSS scale (the overall IPSS dropped by 10.5 scores). Dalphaz had a good hypotensive effect: high blood pressure lowered to normal, normal pressure did not change. Dalphaz was well tolerated in all the cases except one when an allergic eruption broke out.
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Seventy four patients were included: 39 in the terazosin group, 35 in the alfuzosin group. The 2 groups were not significantly different before treatment. Improvement of the IPSS score was similar in the 2 treatment groups (p = 0.97 at 3 weeks, and p = 0.29 at 16 weeks), as was the improvement of the quality of life score (p = 0.47 at 3 weeks and p = 0.71 at 16 weeks). Treatment was considered to be "effective or very effective" in 31 patients (86%) in the terazosin group, and in 28 patients (82%) in the alfuzosin group. The IPSS score was greater than or equal to 12 before treatment for all patients included in the study. Twenty-five patients had a score < 12 at 3 weeks versus 56 at 16 weeks (p = 0.0001). Seven patients had a quality of life score less than 2 before treatment, versus 38 at 3 weeks, and 56 at 16 weeks (p = 0.0001). No significant difference was observed between the 2 groups in terms of the number of adverse events reported, or the course of blood pressure and prostate specific antigen. No patient dropped out of the study because of treatment-related adverse events. Two deaths were observed in the terazosin group (2 patients aged 86 and 93 years), but any relation to treatment was excluded.
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This study was undertaken to determine simultaneously the effects of alfuzosin on urethral and blood pressures in the same conscious male rat. Alfuzosin (i.v., 3, 10 and 30 micrograms/kg) dose-dependently decreased urethral pressure without affecting mean arterial blood pressure. At the higher dose, blood pressure was only slightly and transiently decreased while a marked decrease (-40%) in urethral pressure was observed. Therefore, this experimental model is suitable to assess uroselectivity.
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All alpha blocker drugs were statistically effective for preventing PE. Notably, silodosin seemed to be more effective for preventing PE than other alpha blockers (P < 0.05). However all alpha blockers provided development in QoL scores, silodosin was a little better than other drugs in statistical analyses. Furthermore statistical increase in IELT and decrease in PEP were provided more in Group 1 than other groups (P < 0.05).
To compare the efficacy of the selective alpha(1A)-adrenoceptor antagonist silodosin with those of doxazosin, terazosin, and alfuzosin against alpha-adrenoceptor agonist-induced contractions in mouse and hamster ureters.
Evaluation of drug candidates in in-vitro assays of action potential duration (APD) is one component of preclinical safety assessment. Current assays are limited by technically-demanding, time-consuming electrophysiological methods. This study aimed to assess whether a voltage-sensitive dye-based assay could be used instead.
The alfuzosin 10mg OD formulation showed a significant improvement in I-PSS as well as a significant improvement in urinary flow parameters (Q(max)and urinary voiding volume) lasting for 24 hours in patients with LUTS.
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Pediatric drug development is challenging when a product is studied for a pediatric disease that has a different underlying etiology and pathophysiology compared to the adult disease. Neurogenic bladder dysfunction (NBD) is such a therapeutic area with multiple unsuccessful development programs. The objective of this study was to critically evaluate clinical trial design elements that may have contributed to unsuccessful drug development programs for pediatric NBD. Trial design elements of drugs tested for pediatric NBD were identified from trials submitted to the U.S. Food and Drug Administration. Data were extracted from publically available FDA reviews and labeling and included trial design, primary endpoints, enrollment eligibilities, and pharmacokinetic data. A total of four products were identified. Although all four programs potentially provided clinically useful information, only one drug (oxybutynin) demonstrated efficacy in children with NBD. The lack of demonstrable efficacy for the remainder of the products illustrates that future trials should give careful attention to testing a range of doses, using objectively measured, clinically meaningful endpoints, and selecting clinical trial designs that are both interpretable and feasible. Compiling the drug development experience with pediatric NBD will facilitate an improved approach for future drug development for this, and perhaps other, therapeutic areas.
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Alpha(1)-adrenoceptors are functionally expressed by capsaicin-sensitive, nociceptive, primary sensory neurons of the rat urinary tract, and their activation may contribute to signal irritative and nociceptive responses arising from the urinary tract. It is possible that, at least, part of the beneficial effects of alpha(1)-adrenoceptor antagonists in the amelioration of storage symptoms in the lower urinary tract derives from their inhibitory effect on neurogenic inflammatory responses.
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This study was undertaken in order to establish the alpha1-antagonist effects of alfuzosin on phenylephrine-induced increases in urethral and arterial blood pressures at 1 and 6 hours post dosing (10 mg/kg, p.o.). At each time, plasma and prostatic concentrations of alfuzosin were measured and correlations between tissue concentrations and pharmacological effects were calculated. At one and six hours post dosing, alfuzosin markedly shifted the urethral and arterial dose response curve to phenylephrine. At one hour, prostatic concentration was 4.1 times greater than plasma concentration (363 ng/g vs 88 ng/ml) and at 6 hours this ratio reached 8.6 times (167 ng/g vs 20 ng/ml). By taking together the data points obtained at 1 and 6 hours we showed that the effects of alfuzosin on urethral pressure were correlated with prostate levels (r=0.906, p<0.01) and the effects on arterial blood pressure were correlated with plasma levels (r=0.941, p<0.01). These results suggest that a preferential distribution of alfuzosin in prostatic tissue may play a role in its functional uroselectivity.
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A 60-year-old man who had uveitic glaucoma, presented with gradual decrease of visual acuity in the left eye over 3 months. There were no signs of increased intraocular pressure or recurrence of uveitis; however, the best-corrected visual acuity of the left eye had decreased from 20/20 to 20/70. Decreased color vision and a relative afferent pupillary defect were present in the left eye. The patient had been taking a combination regimen of alfuzosin and finasteride for the past 6 months to treat BPH. He reported experiencing frequent episodes of dizziness after starting the BPH medication. Under the impression that he had ischemic optic neuropathy due to systemic hypotension caused by the medication, we switched his regimen to a monotherapy of tamsulosin. After 1 month, the visual acuity and color vision of the left eye was recovered.
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Men 50 years old or older with lower urinary tract symptoms secondary to benign prostatic obstruction and International Prostate Symptom Score 8 or greater were enrolled and treated with 10 mg alfuzosin XL for 12 months. Before treatment, face-to-face interviews were conducted to identify the single most bothersome symptoms and to set treatment goals for the symptoms in individual patients. After treatment, patients described perceptions of goal achievement using a 5-point Likert scale. Changes in International Prostate Symptom Score/quality of life score, International Continence Society male short form questionnaire, 3-day voiding diary and uroflowmetry parameters were analyzed to evaluate the correlations between goal achievement and traditional outcome measures.
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In order to assess the efficacy and safety of alfuzosin, an alpha-1 blocker, in symptomatic patients with benign prostatic hyperplasia (BPH), 131 patients who had completed a 6-month placebo-controlled trial conducted on parallel groups entered a 12-month open study; 122 patients were treated with alfuzosin for 12 months and 56 patients for 18 months. After 12 months, all obstructive and irritative symptoms assessed according to the Boyarsky scale were significantly improved, as were peak flow rates in obstructed patients and mean flow rates and residual urine in the whole population. Voiding symptoms showed sustained improvement after treatment for 12 to 18 months. Only 5.3% of patients experienced vasodilatory side effects, none of which led to withdrawal from the study. No side effect related to long-term administration was reported. Alfuzosin has a beneficial effect on voiding symptoms in patients with BPH and can be safely used in long-term administration.
Currently alpha(1)-adrenergic receptor blocking agents are first line treatment for BPH. Although all alpha-blocking compounds show similar levels of efficacy for LUTS treatment, newer agents such as alfuzosin tend to demonstrate improved selectivity for the prostate and bladder with few vasodilatory effects and they have tolerability advantages over older alpha-blocking compounds. Immediate, sustained and newer extended release alfuzosin formulations significantly improve LUTS indicative of BPH but extended release alfuzosin may be more convenient to administer and it tends to show better vasodilatory tolerability than the older immediate release formulation.
The efficacy and safety of using alpha(1)-adrenergic blockers for treating primary bladder neck obstruction in young and middle-aged men was assessed as the first therapeutic step, before surgery, in a symptomatic non-neurogenic selected group of patients.
Enlargement of the prostate is common among aging men, with an incidence of 90% by the age of 85 years. It is a progressive condition, with growth in prostate size accompanied by lower urinary tract symptoms that can result in long-term complications (eg, acute urinary retention [AUR], need for enlarged prostate-related surgery). Current pharmacologic treatment options include alpha-blockers (alfuzosin, doxazosin, tamsulosin, and terazosin) and 5alpha-reductase inhibitors (5ARIs) (finasteride and dutasteride).
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In the current study we have profiled a range of compounds at alpha 1 adrenoceptor subtypes in vitro and have assessed their effects in vivo using the anesthetized dog in an attempt to elucidate the predominant alpha 1 adrenoceptor subtype mediating contractile responses of the canine prostate.
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Two single-dose, crossover studies were performed. In study 1, CV alpha1-adrenoceptor antagonism was assessed by measuring the inhibition of phenylephrine (PE)-induced increases in diastolic blood pressure (DBP) and total peripheral resistance (TPR) before and after dosing with placebo, tamsulosin OCAS, and alfuzosin XL in 18 young subjects. In study 2, orthostatic stress tests (OTs) were performed before and after dosing with tamsulosin OCAS and alfuzosin XL in 40 elderly subjects. Pharmacokinetics were assessed in both studies.
The conclusions are interpreted within the context of the subdivision of the alpha 1-adrenoceptor into alpha 1A, alpha 1B, and alpha 1D subtypes.
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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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More than 80% of patients with BPH suffer ejaculatory abnormalities, which are closely related to the severity of prostate symptoms and increased age. When initiating alpha-blocker treatment, we should consider that alfuzosin is the one with less negative impact on ejaculatory function.
Acute urinary retention (AUR) is a common urological emergency, characterized by a sudden and painful inability to pass urine. There is high variability within and among countries in its management, which can be explained not only by differences in access to care but also by a lack of harmonization and consensus on the best way to proceed. Immediate treatment consists of bladder decompression, usually by a urethral catheter, although a suprapubic catheter offers several advantages not often exploited by urologists. Until recently, secondary management consisted almost exclusively of prostatic surgery within a few days (emergency surgery) or a few weeks (elective surgery) after a first AUR episode. The greater morbidity and mortality associated with emergency surgery, and the potential morbidity associated with prolonged catheterization, has led to the increasing use of a trial without catheter; this involves catheter removal after 1-3 days, allowing the patient to void in 23-40% of cases, and surgery, if needed, at a later stage. Alpha1-adrenergic blockers given before catheter removal improve the chances of success. A high prostate-specific antigen level and postvoid residual urine volume, and response to alfuzosin treatment after a first AUR episode managed conservatively, may help to identify patients at risk of an unfavourable outcome.
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α1-Adrenoceptor antagonists (α-blockers) represent first-line drug treatment for male lower urinary tract symptoms. Their adverse events (AEs) include asthenia, dizziness, nasal congestion, arterial (orthostatic) hypotension and intraoperative floppy iris syndrome (IFIS).
Receipt of medical therapy for incident BPH (ie, selective α-1 blockers [prazosin (released 1976), terazosin (1987), doxazosin (1990), tamsulosin (1997), alfuzosin (2003), silodosin (2009)] and 5-ARIs [finasteride (1992) and dutasteride (2002)]).
Men over the age of 50 years with LUTS secondary to BPH and an International Prostate Symptom Score (IPSS) 8 or higher, were randomized to receive 10 mg alfuzosin (n = 25), 10 mg tadalafil (n = 25) or the combination of both the drugs (n = 25) once daily for 3 months. Symptoms were assessed at baseline, 6 weeks and 3 months. The primary endpoint was the change in IPSS from the baseline. Secondary endpoints were changes in IPSS storage and voiding subscores, peak urinary flow rate, residual urine volume, IPSS quality of life score and erectile domain score.
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A total of 137 patients with a diagnosis of chronic bacterial prostatitis (CBP) were subjected to combination pharmacological therapy with antibacterial agents (ciprofloxacin/azithromycin), alpha-blockers (alfuzosin) and Serenoa repens extracts. Of those, 88 patients (64.2%) showed microbiological eradication at the completion of a 6-week cycle of therapy. Of the remaining 49 patients showing persistence of the causative organism(s) or reinfection at the end of treatment, 36 completed a second cycle of combination therapy for 6 weeks: 27 patients (75%) showed eradication of the causative organism, whereas in nine cases persistence or reinfection was observed. The cumulative eradication rate of the present study - calculated on a total of 137 enrolled patients - is 83.9%. Clinical examination showed a marked improvement of signs and symptoms linked to prostatitis. Remarkably, combination therapy could attenuate CBP symptoms prior to microbiological eradication, thus rapidly decreasing the impact of the disease on the quality of life of patients. Clinical remission was extended throughout a follow-up period of 30 months for 94% of patients, whereas seven patients showed relapse of the disease. In summary, our results indicate that about 20% of patients enrolled in this study, who were refractory to a protocol of 6-week combination therapy, could be 'rescued' by a second cycle of treatment. Clinical follow-up data show that combination therapy could ensure extended relief from CBP symptoms, and a general improvement in quality of life.
dutasteride, fesoterodine and finasteride were classified as beneficial in older persons or frail elderly people (FORTA B). For most drugs, in particular those from the group of α-blockers and antimuscarinics, use in this group seems questionable (FORTA C) or should be avoided (FORTA D).
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Potencies of alfuzosin, apomorphine or the combination to relax norepinephrine (NE) precontracted corpus cavernosum tissue of spontaneous hypertensive rats (SHR) were determined. In anaesthetized rats, intracavernous and blood pressures were recorded after administration of apomorphine (10-250microg/kg s.c.) and alfuzosin (3-30microg/kg i.v.).
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In the TEA trial, one of the four primary outcomes showed a reduction (prescription of alfuzosin compared to tamsulosin and terazosin in benign prostatic hyperplasia: prescribing ratio -8.5%, p = 0.03). Another primary outcome (prescription of risedronate) showed a reduction at 24 and 48 months (-7.6%, p = 0.02; and -9,8%, p = 0.03), but not at six months (-5.1%, p = 0.36). In the SIDRO trial both primary outcomes showed a statistically significant reduction (prescription of barnidipine -9.8%, p = 0.02; prescription of prulifloxacin -11.1%, p = 0.04), which persisted or increased over time.
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Alfuzosin may be less effective in improving symptom scores, PVR, and Qmax in the treatment of LUTS/BPH in the presence of IPP.
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The patients were divided into four age groups, i.e. < 56, 56-65, 66-75 and > 75 years. All groups of patients showed a mean IPSS decrease of 11-12 (55.8-65.4% from baseline) at the end of the study, while the QoL decreased by 2-3 points (55.6-63.6% from baseline). There were no relevant effects of age on the efficacy of the treatment. Moreover, alfuzosin was well tolerated independently of the age of the patient; 1.2% of the patients enrolled withdrew because of adverse events. The qualitative distribution of vasodilatory/nonvasodilatory adverse events was similar in all age groups. The incidence of asymptomatic orthostatic hypotension was low (0.58%) and not affected by the age of the patients.
In all, 5999 sexually active men with LUTS completed the International Prostate Symptom Score (IPSS) which rates LUTS severity, and the MSHQ long-form, which evaluates seven EjD symptoms and bother due to EjD. Concomitant intake of medical treatments for BPH and previous BPH-related surgery were collected. The impact of treatments on EjD was compared to a control group (i.e. no previous BPH-related surgery and no medical treatment for BPH). The relationship between EjD, bother due to EjD and selected clinical characteristics was analysed using multiple regression analysis.
The causal role of ranolazine in our case of bladder hypotonia is probable according to the Naranjo criteria. The mechanism of bladder dysfunction is tentatively ascribed to blockage of late sodium current in smooth muscle cells. Although drug plasma concentrations were not measured, they were probably elevated, since the metabolic activity of CYP3A4 was at the lower end of the reference range. Enzyme inhibition produced by diltiazem may have contributed to decreasing CYP3A4 activity.
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Objective : Prospective randomized study to compare the efficacy and safety of alfuzosin and tamsulosin in patients suffering from acute urinary retention caused by benign prostatic hyperplasia (BPH). Methods : Patients with acute urinary retention (AUR) due to BPH (total 150) were catheterized and randomized into three groups: Group A: alfuzosin 10 mg (50 patients), Group B: tamsulosin 0.4 mg (50 patients), Group C: placebo (50 patients). After three days, catheter was removed, and patients were put on trial without catheter (TWOC). Patients with successful TWOC were followed up for three months, taking into account the prostate symptom score (AUA Score), post-void residual urine volume (PVRV), and peak flow rate (PFR). ANOVA was used for statistical analysis. Results : Both group A (alfuzosin) and group B (tamsulosin) had similar results of TWOC (group A - 66%, group B - 70%), which were significantly superior than group C (placebo) - 36%. In follow up, three (9.1%) patients in group A, three (8.6%) patients in group B and eight (44.4%) patients in group C had retention of urine, requiring recatheterization. These patients were withdrawn from the study. After three months, alfuzosin- or tamsulosin-treated patients showed a significant decrease in AUA score and PVRV; and a significant increase in PFR as compared to placebo. Conclusions : TWOC was more successful in men treated with either alfuzosin or tamsulosin and the subsequent need for recatheterization was also reduced. Tamsulosin was comparable to alfuzosin in all respects, except a small but significant side effect of retrograde ejaculation.
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