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What is Uroxatral (alfuzosin)?
Common side effects of Uroxatral include:
Serious side effects of Uroxatral include:
Drug interactions of Uroxatral include:
Uroxatral is not used by women; however, studies in animals have shown no evidence of fetal toxicity, even with exceedingly high doses of Uroxatral. Uroxatral is not prescribed for women and is unlikely to be used during pregnancy or while breastfeeding.
What are the important side effects of Uroxatral (alfuzosin)?
- The most common side effects of alfuzosin are:
- These side effects occur in fewer than 1 per every 15 patients.
- As with other alpha blockers, postural hypotension (decreasing blood pressure upon standing, with or without dizziness) may develop within a few hours following ingestion of alfuzosin and can cause fainting.
- Prostate cancer and benign prostatic hyperplasia can co-exist. Therefore, patients being treated for benign prostatic hyperplasia should be evaluated to exclude the presence of prostate cancer.
Possible serious side effects include:
- chest pain,
- priapism (persistent painful penile erection),
- liver injury, and
- floppy eye syndrome.
Uroxatral (alfuzosin) side effects list for healthcare professionals
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.
- The incidence of adverse reactions has been ascertained from 3 placebo-controlled clinical trials involving 1,608 men where daily doses of 10 and 15 mg alfuzosin were evaluated. In these 3 trials, 473 men received Uroxatral (alfuzosin HCl) 10 mg extended-release tablets. In these trials, 4% of patients taking Uroxatral (alfuzosin HCl) 10 mg extended-release tablets withdrew from the trial due to adverse reactions, compared with 3% in the placebo group.
- Table 1 summarizes adverse reactions that occurred in ≥2% of patients receiving Uroxatral, and at a higher incidence than that of the placebo group. In general, the adverse reactions seen in long-term use were similar in type and frequency to the events described below for the 3-month trials.
Table 1 : Adverse Reactions Occurring in ≥2% of Uroxatral-Treated Patients and More Frequently than with Placebo in 3-Month Placebo-Controlled Clinical Trials
|Dizziness||19 (2.8%)||27 (5.7%)|
|Upper respiratory tract infection||4 (0.6%)||14 (3.0%)|
|Headache||12 (1.8%)||14 (3.0%)|
|Fatigue||12 (1.8%)||13 (2.7%)|
The following adverse reactions, reported by between 1% and 2% of patients receiving Uroxatral and occurring more frequently than with placebo, are listed alphabetically by body system and by decreasing frequency within body system:
Body as a whole: pain
Reproductive system: impotence
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. Approximately 20% to 30% of patients in these trials were taking antihypertensive medication.
Table 2: Number (%) of Patients with Symptoms Possibly Associated with Orthostasis in 3-Month Placebo-Controlled Clinical Trials
|Dizziness||19 (2.8%)||27 (5.7%)|
|Hypotension or postural hypotension||0||2 (0.4%)|
Testing for blood pressure changes or orthostatic hypotension was conducted in three controlled studies.
- Decreased systolic blood pressure (≤90 mm Hg, with a decrease ≥20 mm Hg from baseline) was observed in none of the 674 placebo patients and 1 (0.2%) of the 469 Uroxatral patients.
- Decreased diastolic blood pressure (≤50 mm Hg, with a decrease ≥15 mm Hg from baseline) was observed in 3 (0.4%) of the placebo patients and in 4 (0.9%) of the Uroxatral patients.
- A positive orthostatic test (decrease in systolic blood pressure of ≥20 mm Hg upon standing from the supine position) was seen in 52 (7.7%) of placebo patients and in 31 (6.6%) of the Uroxatral patients.
The following adverse reactions have been identified during post-approval use of Uroxatral. 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.
General disorders: edema
Gastrointestinal disorders: diarrhea
Hepatobiliary disorders: hepatocellular and cholestatic liver injury (including cases with jaundice leading to drug discontinuation)
Respiratory system disorders: rhinitis
Reproductive system disorders: priapism
Vascular disorders: flushing
Blood and lymphatic system disorders: thrombocytopenia
During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in some patients on or previously treated with alpha adrenergic antagonists.
What drugs interact with Uroxatral (alfuzosin)?
Uroxatral is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, since alfuzosin blood levels are increased.
Alpha Adrenergic Antagonists
The pharmacokinetic and pharmacodynamic interactions between Uroxatral and other alpha adrenergic antagonists have not been determined. However, interactions may be expected, and Uroxatral should not be used in combination with other alpha adrenergic antagonists.
Antihypertensive Medication And Nitrates
Caution is advised when alpha adrenergic antagonists, including Uroxatral, are coadministered with PDE5 inhibitors. Alpha adrenergic antagonists and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension.
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Related Disease Conditions
The prostate is a gland that is part of the male reproductive system and is located between the bladder and penis. Signs and symptoms of prostate problems include painful ejaculation, burning or pain while urinating, blood in the urine or semen, dribbling urine, frequent urination, urinary incontinence, and pain in the lower back, hips, upper thighs, or the pelvic or rectal area. Common causes of prostate problems in men are prostatitis, enlargement of the prostate gland (benign prostatic hyperplasia (BPH), and prostate cancer. Causes of prostate problems can assist in diagnosing prostate cancer. Treatments for prostate problems include medications, surgery, and hormone or radiation therapy.
Prostatitis (Inflammation of the Prostate Gland)
Prostatitis is an inflammation of the prostate gland. Signs and symptoms of prostatitis include painful or difficulty urinating; fever; chills; body aches; blood in the urine; pain in the rectum, groin, abdomen, or low back; and painful ejaculation or sexual dysfunction. Causes of prostatitis include STDs, bacteria from urinary tract infections, or E. coli. Treatment for prostatitis depends on if it is a bacterial infection or chronic inflammation of the prostate gland.
Prostate Cancer Staging and Prognosis
The prognosis for prostate cancer, as with any cancer, depends on how advanced the cancer has become, according to established stage designations. The patient's PSA score at diagnosis, as well as their Gleason score (the grading system used to determine the aggressiveness of prostate cancer) determines the prognosis and final stage designation. Prostate cancer has a high survival rate in general, but your chances depend on the stage of the cancer.
Enlarged Prostate (BPH, Benign Prostatic Hyperplasia)
Benign prostatic hyperplasia (BPH or enlarged prostate) is very common in men over 50 years of age. Half of all men over the age of 50 develop symptoms of BPH, but few need medical treatment. This noncancerous enlargement of the prostate can impede urine flow, slow the flow of urine, create the urge to urinate frequently and cause other symptoms like complete blockage of urine and urinary tract infections. More serious symptoms are urinary tract infections (UTIs) and complete blockage of the urethra, which may be a medical emergency. BPH is not cancer. Not all men with the condition need treatment, and usually is closely monitored if no symptoms are present. Treatment measures usually are reserved for men with significant symptoms, and can include medications, surgery, microwave therapy, and laser procedures. Men can prevent prostate problems by having regular medical checkups that include a prostate exam.
Prostatitis vs. BPH (Enlarged Prostate): What Is the Difference?
Prostatitis and BPH (benign prostatic hyperplasia, enlarged prostate gland) are both conditions of the prostate gland. There are four types of prostatitis that can be caused by infections (usually bacterial) or other health conditions or problems, acute bacterial prostatitis (type I), chronic bacterial prostatitis (type II), chronic prostatitis and chronic pelvic pain syndrome (type III), and asymptomatic inflammatory prostatitis (type IV). BPH is inflammation of the prostate gland, and most men have the condition by age 50. Doctor's don't know what causes this inflammation, but they theorize that it may be related to hormones. Both of these conditions can cause similar symptoms like low back pain, pain during urination, or difficulty or the inability to urinate. However, prostatitis has many more symptoms and signs than BPH, and they based on the type of prostatitis. Examples include low back pain and/or abdominal pain, painful urination, fever, chills, feeling tired, recurrent urinary tract infections (UTIs), painful urination intermittently, intermittent obstruction urinary tract symptoms (frequent, painful, or incomplete urination), pelvic pain and/or discomfort, pain with ejaculation, and erectile dysfunction (ED). If you think you have either of these conditions contact your doctor or other health care professional. Bacterial prostatitis can be cured with antibiotics; however, there is no cure for BPH.
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Prostate Cancer (Prostatic Cancer) Symptoms and Causes
Difficulty with urination – frequency, weak stream, trouble getting started, etc. – is usually the first sign of prostate cancer. But these and other early symptoms of prostatic cancer can also come from benign prostate conditions, so diagnostic testing is important, including PSA tests and digital rectal exam.
Prostate cancer is the most common cancer in men after skin cancer. Risk factors include age, family history, ethnicity, and diet. Prostate cancer is diagnosed by digital rectal exam, prostate specific antigen (PSA) test, and prostate biopsy. Symptoms may include frequent need to urinate, incontinence, pain, blood in the urine, fatigue, and more. Prognosis and treatment depend on cancer staging. Watchful waiting, surgery, radiation, cryotherapy, and other management strategies are available. Research and clinical trials strive to find new and better treatments for prostate cancer.
Having to urinate more than eight times a day or waking up to go to the bathroom more than once a night is considered frequent urination. Symptoms include urgency, frequency, hesitancy, dribbling, straining, hematuria, and urinary incontinence. Treatment of frequent urination depends upon the underlying cause.
Prostate Cancer Facts
Prostate cancer is a leading cause of cancer and cancer death in males; in some men, identifying it early may prevent or delay metastasis and death from prostate cancer. The prostate is a walnut-shaped gland that is a part of the male reproductive system that wraps around the male urethra at it exits the bladder. Prostate cancer is common in men over 50 years of age, with the risk of developing prostate cancer increases with aging.
Early-Stage Prostate Cancer Treatment
If prostate cancer is detected early and appears to be slow-growing, invasive procedures, chemotherapy, radiation and other approaches can sometimes do more harm than good. Many prostate cancer treatments come with side effects, like incontinence or impotence, so it’s in the patient’s interest to put off invasive treatments as long as is medically safe. Active surveillance is where doctors "watch and wait" for changes that could prompt medical intervention.
How Is Prostate Cancer Diagnosed?
Prostate cancer is largely a disease of men over 40, so it’s around this age doctors recommend the first prostate screening. The first exam is a blood test to determine if there are abnormal prostate specific antigen (PSA) levels in your blood – PSA is produced by the prostate. If the PSA is high, your doctor will perform a digital rectal exam, during which the doctor feels your prostate from inside your rectum with a gloved finger. Other diagnostic tests include an endoscopic biopsy of tumor tissue for analysis in a lab.
Prostate Cancer Treatment: Radical Prostatectomy Surgery
Radical prostatectomy, or surgical removal of the entire prostate gland, isn’t typically the first choice in prostate cancer treatment. Sometimes a radical approach is necessary to keep the cancer from metastasizing, however. Some cases are too severe or diagnosed too late for drugs or radiation to have much effect. In these cases, treatment teams may opt for a radical prostatectomy, despite potential side effects like impotence and incontinence.
Prostate Cancer Treatment: Hormonal Therapy
Prostate cancer is highly sensitive to, and dependent on, the level of the male hormone testosterone, which drives the growth of prostate cancer cells. Testosterone belongs to a family of hormones called androgens, and today front-line hormonal therapy for advanced and metastatic prostate cancer is called androgen deprivation therapy (ADT).
Prostate Cancer Treatment: Radiation, Brachytherapy and Radiopharmaceuticals
Radiation treatment for prostate cancer is a powerful tool at doctors’ disposal. Using radiation vs. surgery or other invasive treatments to kill cancer cells may still cause side effects, but ideally they are less severe. Radiation therapy can be performed via external beam therapy (EBRT) or the placement of radioactive seeds into the prostate (prostate brachytherapy) or using radioactive drugs (radiopharmaceuticals).
Prostate Cancer Treatment: Chemotherapy, Bone-Targeted and Immune Therapy
Doctors may introduce chemotherapy and immune therapy if other measures fail to cure a case of prostate cancer. However, unlike with other forms of cancer, chemotherapy isn’t the first choice for early prostate cancer. Immune therapy uses the body's own immune system to attack the prostate tumor, while bone-targeted therapy aims to preserve bone and prevent metastasis.
Prostate Cancer Treatment: Focal Therapy and Other Experimental Treatments
Several new and experimental treatments for prostate cancer are under study, including treatments that use ultrasound, lasers, tissue-freezing gas, and new ways of administering radiation. These new methods are types of focal therapy, that is, treatment focused on the cancer cells in the prostate, rather than systemic therapy that administers medications or other treatments to the whole body with the aim of treating the prostate.
Treatment & Diagnosis
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.