It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is R,S -N-[3-[ 4-amino-6,7-dimethoxyquinazolinyl methylamino] propyl] tetrahydrofurancarboxamide hydrochloride. The molecular weight of alfuzosin hydrochloride is Its structural formula is:. The tablet also contains the following inactive ingredients: Therefore, Uroxatral should be taken with food and with the same meal each asprin anti cancer. The tablets should not be chewed or uroxatral alpha blockers and potassium depletion. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The incidence of adverse reactions has been ascertained from 3 placebo-controlled clinical trials involving 1, men where daily doses of 10 and 15 mg alfuzosin were evaluated. In general, the adverse reactions seen in long-term use were similar in type and frequency to the events text structure and format lesson plan below for the 3-month trials. Signs and Symptoms of Orthostasis in Clinical Trials: The adverse reactions related to orthostasis that occurred in the double-blind phase 3 trials with alfuzosin 10 mg are summarized in Table 2.
Testing top anti viral herbs and vitamins blood uroxatral alpha blockers and potassium depletion changes or orthostatic hypotension was conducted in three controlled studies. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: Blood and lymphatic system disorders: Alpha adrenergic antagonists and PDE5 inhibitors are both vasodilators that can lower blood pressure. Postural hypotension with or without symptoms e. As with other alpha adrenergic antagonists, there is a potential for syncope. Patients should be warned of the animal birth control pill occurrence of such events and should avoid situations where injury could result should syncope occur.
PDE5-inhibitors are also vasodilators. Carcinoma of the prostate and benign prostatic uroxatral alpha blockers and potassium depletion BPH cause many of the same symptoms.
These two diseases frequently coexist. IFIS has been observed during cataract surgery in some patients on or previously treated with alpha adrenergic antagonists. This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions.
There does not appear to be a benefit of stopping alpha adrenergic antagonist therapy prior to cataract surgery, uroxatral alpha blockers and potassium depletion. Rarely probably less than 1 in 50,alfuzosin, like other alpha adrenergic antagonists, has been associated with priapism persistent painful penile erection unrelated to sexual activity. Patients should be told about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when beginning UROXATRAL, and they should be cautioned about driving, operating machinery, or performing hazardous tasks during this period.
The highest dose tested in female mice may not have constituted a maximally tolerated dose. Alfuzosin showed no evidence of mutagenic effect in the Ames and mouse lymphoma assays, and was free of any clastogenic effects in the Chinese hamster ovary cell and in vivo mouse micronucleus assays. Alfuzosin treatment did not induce DNA repair in a human cell line, uroxatral alpha blockers and potassium depletion.
The trial included a week efficacy phase followed by a week safety extension period. The adverse reactions reported for the whole month trial period, which included the open-label extension, were similar in type and frequency to the reactions observed during the week period. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position.
If this measure is inadequate, then the administration of intravenous fluids should be considered. If necessary, vasopressors should then be used, and the renal function should be monitored and supported as needed. Alfuzosin is a selective antagonist of post-synaptic alpha1-adrenoreceptors, which are located in the prostatebladder base, bladder neck, prostatic capsule, and prostatic urethra. Alfuzosin exhibits selectivity for alpha adrenergic receptors in the lower urinary tract.
Blockade of these adrenoreceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow and a reduction in symptoms of BPH.
The effect of 10 mg and 40 mg alfuzosin on QT interval was evaluated in a double-blind, randomized, placebo and active-controlled moxifloxacin mg4-way crossover single dose study in 45 healthy white male subjects aged 19 to 45 years. The QT interval was measured at the time of peak alfuzosin plasma concentrations.
The 40 mg dose of alfuzosin was chosen because this dose achieves higher blood levels than uroxatral alpha blockers and potassium depletion achieved with the co-administration of UROXATRAL and ketoconazole mg.
Table 3 summarizes the effect on uncorrected QT and mean corrected QT interval QTc with different methods of correction Fridericia, population-specific and subject-specific correction methods at the time of peak alfuzosin plasma concentrations.
No single one of these correction methodologies is known to be more valid. The mean change of heart rate associated with a 10 mg dose of alfuzosin in this study was 5. The change in heart rate with moxifloxacin was 2. The QT effect appeared greater for 40 mg compared to 10 mg alfuzosin. The effect of the highest alfuzosin dose four times the therapeutic dose studied did not appear as large as that of the active control moxifloxacin at its therapeutic dose.
This study, however, was not designed to make direct statistical comparisons between the drugs or the dose levels.
There has been no signal of Torsade de Pointes in the extensive post-marketing experience with alfuzosin outside the United States. A separate post-marketing QT study evaluated the effect of the co-administration of 10 mg alfuzosin with a drug of similar QT effect size. In this study, the mean placebo-subtracted QTcF increase of alfuzosin 10 mg alone was 1, uroxatral alpha blockers and potassium depletion.
The concomitant administration of the two drugs showed an increased QT effect when compared with either drug alone. This QTcF increase [5. Although this study was not designed to make direct statistical comparisons between drugs, the QT increase with both drugs given together appeared to be lower than the QTcF increase seen with the positive control moxifloxacin mg [ The clinical impact of these QTc changes is unknown.
Cmax and AUC are Steady-state alfuzosin plasma concentrations are 1. The volume of distribution following intravenous administration in healthy male middle-aged volunteers was 3.
Alfuzosin is metabolized by three metabolic pathways: The metabolites are not pharmacologically active. CYP3A4 is the principal hepatic enzyme isoform involved in its metabolism. In a pharmacokinetic assessment during phase 3 clinical studies in patients with BPH, there was no relationship between peak plasma concentrations of alfuzosin and age.
However, trough levels were positively correlated with age. These clearances were calculated by the Cockcroft-Gault formula. This reduction in clearance results in three to four-fold higher plasma concentrations of alfuzosin in these patients compared to healthy subjects. Alfuzosin increased the Cmax and AUC of diltiazem 1.
Multiple dose administration of an immediate release tablet formulation of alfuzosin 5 mg twice daily for six days to six healthy male volunteers did not affect the pharmacological response to a single 25 mg oral dose of warfarin. Single administration of mg atenolol with a single dose of 2, uroxatral alpha blockers and potassium depletion. In this study, the combination of alfuzosin with atenolol caused significant reductions in mean blood pressure and in mean heart rate. Single administration of 25 mg hydrochlorothiazide did not modify the pharmacokinetic parameters of alfuzosin.
There was no evidence of pharmacodynamic interaction between alfuzosin and hydrochlorothiazide uroxatral alpha blockers and potassium depletion the 8 patients in this study. Three randomized placebo-controlled, double-blind, parallel-arm, week trials were conducted with the 10 mg daily dose of alfuzosin. In these three trials, 1, patients [mean age Table 4 provides the results of the three trials that evaluated the 10 mg dose.
There were two primary efficacy variables in these three studies. The International Prostate Symptom Score IPSS, or AUA Symptom Score consists of seven questions that assess the severity of both irritative frequency, urgency, nocturia and obstructive incomplete emptying, stopping and starting, uroxatral alpha blockers and potassium depletion, weak stream, and pushing or straining symptoms, with possible scores ranging from 0 to 35 with higher numerical scores on the IPSS total symptom score representing greater severity of symptoms.
The second efficacy variable was peak urinary flow rate. The peak flow rate was measured just prior to the next dose in study 2 and on average at 16 hours post-dosing in trials 1 and 3. There was a statistically significant reduction from baseline to last assessment Week 12 in the IPSS total symptom score versus placebo in all three studies, indicating a reduction in symptom severity Table 5 and Figures 2, 3, and 4. Peak urinary flow rate was increased statistically significantly from baseline to last assessment Week 12 versus placebo in trials 1 and 2 Table 5 and Figures 5, 6, and 7.
Mean total IPSS decreased at the first scheduled observation at Day 28 and mean peak flow rate increased starting at the first scheduled observation at Day 14 in trials 2 and 3 and Day 28 in trial 1. You are encouraged to report negative side effects of prescription drugs to the FDA.
Last reviewed on RxList: Prostate Cancer Slideshow Pictures. Take the Enlarged Prostate Quiz! Find Lowest Uroxatral alpha blockers and potassium depletion on. Protect from light and moisture. Distributed by Covis Pharmaceuticals, Inc. SIDE EFFECTS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Body as a whole: Prostatic Carcinoma Carcinoma of the prostate and benign prostatic hyperplasia BPH cause many of the same symptoms. Priapism Rarely uroxatral alpha blockers and potassium depletion less than 1 in sed rate and breast cancer,alfuzosin, like other alpha adrenergic antagonists, has been associated with priapism persistent painful penile erection unrelated to sexual activity.
Alfuzosin hydrochloride was not studied in patients below the age of 2. Pharmacodynamics Alfuzosin exhibits selectivity for alpha adrenergic receptors in the lower urinary tract. Cardiac Electrophysiology The effect of 10 mg and 40 mg alfuzosin on QT interval was evaluated in uroxatral alpha blockers and potassium depletion double-blind, randomized, placebo and active-controlled moxifloxacin mg4-way crossover single dose study in 45 healthy white male subjects aged 19 to 45 years.
Specific Populations Geriatric Use: Clinical Studies Three randomized placebo-controlled, double-blind, parallel-arm, week trials were conducted with the 10 mg daily dose of alfuzosin.
Trial 1 Figure 3: