Alfuzosin is in a class of medications called alpha blockers. To avoid injury from dizziness or fainting, your doctor may tell you to take your first dose of Alfuzosin Hydrochloride with food at bedtime so that your body can get used to its effects. "Mayo," "Mayo Clinic," "MayoClinic.org," "Mayo Clinic Healthy Living," and the triple-shield Mayo Clinic logo are trademarks of Mayo Foundation for Medical Education and Research. More frequently reported side effects include: dizziness. UROXATRAL(yoo-ROX-uh-trahl)(Alfuzosin hydrochloride) extended-release tablets. Excretion Alfuzosin hydrochloride extended-release tablets are not for the treatment of high blood pressure. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=3814af05-9f29-4c95-a764-159220b68ccf, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Store in a cool and dry place, protected from light, You find simplified version here Alfuzosin Hydrochloride, Alfuzosin Hydrochloride It is partially metabolised and excreted mainly in the bile and faeces. Table 4 provides the results of the three trials that evaluated the 10 mg dose. Events, (What Although this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence) [see Warnings and Precautions (5.7)]. Do not take it on an empty stomach. 2021 Apr 12;13:1756287221993283. doi: 10.1177/1756287221993283. Xatral (alfuzosin)." The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Swallow the UROXATRAL tablet whole. Benign enlargement of the prostate is a problem that can occur in men as they get older. Alfuzosin hydrochloride extended-release tablets can cause serious side effects, including a sudden drop in blood pressure, especially when you start treatment. This risk is higher when you first start taking. CYP3A4 is the principal hepatic enzyme isoform involved in its metabolism. or any family members have a rare heart condition known as congenital prolongation of the QT interval. Although no changes in blood pressure were observed in this study, diltiazem is an antihypertensive medication and the combination of alfuzosin hydrochloride extended-release tablets and antihypertensive medications has the potential to cause hypotension in some patients [see Warnings and Precautions (5.1)]. Store UROXATRAL between 59F and 86F (15C and 30C). It is not normally given to women or children. These side effects may go away during treatment as your body adjusts to the medicine. If you take too much UROXATRAL call your local poison control center or emergency room right away. 1. The concentrations in subjects 75 years of age were approximately 35% greater than in those below 65 years of age. Condition. ), More about getting RSS News & Updates from DailyMed, 100 in 1 BOTTLE; Type 0: Not a Combination Product, 103 Store at 20 to 25C (68 to 77F); excursions permitted between 15 and 30C (59 and 86F) [see USP Controlled Room Temperature]. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Talk to your doctor or . ED is often a symptom of another health problem or health-related factor. Ask your doctor if you are not sure if you are taking one of these medicines. What is the most important information I should know about UROXATRAL? Renal Impairment: The Pharmacokinetic profiles of alfuzosin hydrochloride extended-release10 mg tablets in subjects with normal renal function (CLCR>80 mL/min), mild impairment (CLCR 60 to 80mL/min), moderate impairment (CLCR 30 to 59 mL/min), and severe impairment (CLCR <30 mL/min) were compared. Tablets should not be chewed or crushed. Read and follow these instructions carefully. Who should not take alfuzosin hydrochloride extended-release tablets? Repeated administration of 1 g/day cimetidine increased both alfuzosin Cmax and AUC values by 20%. Sun Pharmaceutical Industries, Inc. See full prescribing information for ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. UROXATRAL is not for use in women or children. Adults, 10 milligrams (mg) once a day. It is used to treat benign prostatic hyperplasia. This monograph has been modified to include the generic and brand name in many instances. Postural hypotension (low blood pressure)Use with caution. UROXATRAL is not for the treatment of high blood pressure. government site. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. All rights reserved. This medicine comes with a patient information leaflet. Digoxin: Repeated coadministration of alfuzosin hydrochloride extended-release 10 mg tablets and digoxin 0.25mg/day for 7 days did not influence the steady-state pharmacokinetics of either drug. Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. The symptoms associated with benign prostatic hyperplasia (BPH) such as urinary frequency, nocturia, weak stream, hesitancy and incomplete emptying are related to two components, anatomical (static) and functional (dynamic). The Quest for Type 2 Diabetes Subgroups Identification: Literature Review for a New Subtype Proposal. This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. Results: QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The volume of distribution following intravenous administration in healthy male middle-aged volunteers was 3.2 L/kg. Check with your doctor immediately if any of the following side effects occur while taking alfuzosin: Some side effects of alfuzosin may occur that usually do not need medical attention. Inactive Ingredients: pregelatinized maize starch, hypromellose, hydroxypropyl cellulose, basic butylated methacrylate copolymer, colloidal silicon dioxide, magnesium stearate, and talc. Getting up slowly may help lessen this problem. See What is the most important information I should know about UROXATRAL?. and transmitted securely. Some medicines called alpha-blockers are used to treat high blood pressure. What are the ingredients of alfuzosin hydrochloride extended-release tablets? In these cases, your doctor may want to change the dose, or other precautions may be necessary. What are the possible side effects of UROXATRAL? The extent of absorption of alfuzosin is 50% lower under fasting conditions. However, trough levels were positively correlated with age. Couteau N, Duquesne I, Frdric P, Thiounn N, Timsit MO, Mejean A, Pinar U, Audenet F. J Clin Med. Events, DrugBank Accession Number. Therefore, UROXATRAL is contraindicated for co-administration with potent inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, or ritonavir) because of increased alfuzosin exposure[see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]. Check with your doctor right away if you have arm, back or jaw pain, chest pain or discomfort, chest tightness or heaviness, fast or irregular heartbeat, nausea, or sweating. BJU Int. 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). Sexual dysfunction was highly prevalent (reduced stiffness of erection, 65.3%; reduced volume of ejaculate, 63.2%; pain/discomfort on ejaculation, 20.2%), and was strongly related to the severity of LUTS and impairment of quality of life. BJU Int. Cerner Multum, Inc. "UK Summary of Product Characteristics." & Articles, All As an antagonist of the adrenergic receptor. Drug class: alpha-adrenoreceptor antagonists, painful or prolonged erection of the penis, chest discomfort, tightness, or heaviness, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, loss in sexual ability, desire, drive, or performance, pain or tenderness around the eyes and cheekbones, redness of the face, neck, arms, and occasionally, upper chest. In another study, repeated oral administration of a lower (200 mg/day) dose of ketoconazole increased alfuzosin Cmax by 2.1-fold and AUClast by 2.5-fold, following a single 10 mg dose of alfuzosin. Alfuzosin is metabolized by three metabolic pathways: oxidation, O-demethylation, and N-dealkylation. Hansen BJ, Nordling J, Mensink HJ, Walter S, Meyhoff HH "Alfuzosin in the treatment of benign prostatic hyperplasia: effects on symptom scores, urinary flow rates and residual volume. Portions of this document last updated: May 01, 2023, Original article: https://www.mayoclinic.org/drugs-supplements/alfuzosin-oral-route/side-effects/DRG-20061611. Take after a meal. In human liver microsomes, at concentrations that are achieved at the therapeutic dose, alfuzosin did not inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6 or 3A4 isoenzymes. Atenolol: Single administration of 100 mg atenolol with a single dose of 2.5 mg of an immediate release alfuzosin tablet in eight healthy young male volunteers increased alfuzosin Cmax and AUC values by 28% and 21%, respectively. In primary culture of human hepatocytes, alfuzosin did not induce CYP1A, 2A6 or 3A4 isoenzymes. Do not give UROXATRAL to other people, even if they have the same symptoms you have. You may report side effects to the FDA at 1-800-FDA-1088. sanofi-aventis (2003): 3. You and your doctor should talk about all your medicines, including alfuzosin hydrochloride extended-release tablets, now and at your regular checkups. Alfuzosin hydrochloride extended-release tablets can cause serious side effects, including a sudden drop in blood pressure, especially when you start treatment. Warfarin: 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. Pediatric Use: Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population [see Indications and Usage (1.1) and Use in Specific Populations (8.4)]. each day. Do not take other medicines unless they have been discussed with your doctor. 1996-2023 RxList, Inc. An Internet Brands company. Alfuzosin hydrochloride extended-release tablets should be taken with food and with the same meal each day. Liver disease, mildUse with caution. If your dose is different, do not change it unless your doctor tells you to do so. Tell your eye doctor (ophthalmologist) that you have used or are using this medicine before cataract surgery or any other eye procedure. Therefore, alfuzosin hydrochloride extended-release tablets are contraindicated in patients with moderate to severe hepatic impairment [see Contraindications (4), Warnings and Precautions (5.3) and Use in Specific Populations (8.7)]. The clearance of alfuzosin is increased in renal insufficiency (with or without dialysis), due to an increase in the free fraction. Alfuzosin Hydrochloride Hydrochloride tablet is contraindicated for hypersensitivity to Alfuzosin Hydrochloride Hydrochloride, history of orthostatic hypotension, combination with other alpha-1 receptor blockers, hepatic insufficiency. For more information ask your doctor or pharmacist. I have been taking Uroxatral (alfuzosin) for a couple of months and although my trips to the bathroom at night was fewer, I suffered migraine headaches, flu symptoms, body aches, lethargy, low sex drive, erectile dysfunction, and dry mouth for over three weeks after I stopped taking this drug. Some side effects may not be reported. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. It may harm them. Disclaimer. This medicine may cause a serious eye problem called Intraoperative Floppy Iris Syndrome (IFIS). The metabolites are not pharmacologically active. Generic Name. Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Alfuzosin can cause dizziness which may affect your ability to drive. UROXATRAL can cause serious side effects, including a sudden drop in blood pressure, especially when you start treatment. 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