fibrillation Gastrointestinal disorders: Diarrhea, vomiting Hepatobiliary disorders: Hepatocellular and cholestatic liver injury (including cases with jaundice leading to drug discontinuation) Upper respiratory system: Rhinitis Reproductive system: Priapism Dermatology: Rash, pruritus, urticaria, angioedema, toxic epidermal necrolysis Vascular disorders: Flushing Blood and lymphatic system disorders: Thrombocytopenia Contraindications Hypersensitivity Moderate to severe liver impairment Coadministration with potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir) or other alpha1-blocking agents Cautions Caution in coronary artery disease, liver disease, symptomatic orthostatic hypotension or coadministration with other drugs that lower blood pressure May cause syncope (first-dose effect) Discontinue treatment if angina occurs or worsens Rule out prostate cancer before initiating therapy (symptoms similar) Priapism may occur with use Rule out prostate cancer prior to treatment Caution with renal impairment (ieg, CrCl <30 mL/min) Caution with history of prolonged QT syndrome (shown to prolong QT interval) Intraoperative floppy iris syndrome during cataract surgery reported Advise patient regarding risk of priapism Do not chew or crush tablets Not for use as antihypertensive drug Pregnancy Drug is not indicated for use in women; there are no adequate data on developmental risk associated with use in pregnant women Animal data Based on findings from animal studies, alfuzosin administered during the period of organogenesis was not teratogenic, embryotoxic or fetotoxic at up to 1200 times the MRHD of 10 mg via AUC in rats and 3 times in rabbits, via body surface area Lactation Drug is not indicated for use in women; there are no data on presence in human milk, effect on breastfed child, or on milk productionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Selective antagonist of postsynaptic alpha-1-adrenoceptors; blockade of adrenoreceptors in the prostate, prostatic capsule, bladder neck and prostatic urethra Absorption Bioavailability: 49% Peak Plasma Time: 8 hr Peak Plasma Concentration: 13.6 ng/mL AUC: 194 ng.hr/mL Distribution Protein Bound: 82-90% Vd: 3.2 L/kg Metabolism Hepatic P450 enzyme CYP3A4 Elimination Half-life: 5-10 hr Excretion: Feces (69%); urine (24%) BRAND FORM. UNIT PRICE PILL IMAGE alfuzosin oral- 10 mg tabletalfuzosin oral- 10 mg tabletalfuzosin oral- 10 mg tabletalfuzosin oral- 10 mg tabletalfuzosin oral- 10 mg tabletalfuzosin oral- 10 mg tabletUroxatral oral- 10 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationalfuzosin oral ALFUZOSIN EXTENDED-RELEASE - ORAL (al-FUE-zoe-sin) COMMON BRAND NAME(S): Uroxatral USES: Alfuzosin is used by men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It does not shrink the prostate, but it works by relaxing the muscles in the prostate and the bladder. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night).Alfuzosin belongs to a class of drugs known as alpha blockers.Do not use this medication to treat high blood pressure. HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking alfuzosin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually once daily after a meal. This medication works best when taken with food. Taking alfuzosin on an empty stomach may make it not work as well.Swallow the tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.Alfuzosin may cause a sudden drop in your blood pressure, which could lead to dizziness or fainting, usually within a few hours after you take it. This risk is higher when you first start taking this drug or if you restart treatment after you stop taking it. During these times, avoid situations where you may be injured if you faint.To avoid injury from dizziness or fainting, your doctor may tell you to take your first dose of alfuzosin with food at bedtime so that your body can get used to its effects.Take this medication regularly to get the most benefit from it. To help you remember, take it after the same meal each day.Tell your doctor if your condition does not improve or if it worsens. SIDE EFFECTS: Dizziness or lightheadedness may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, fast/irregular heartbeat, chest pain.Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before taking alfuzosin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, heart problems (such as chest pain/angina, heart attack), low blood pressure, certain eye problems (cataracts, glaucoma).Alfuzosin may cause a condition that affects the heart rhythm (QT prolongation). 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 risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using alfuzosin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using alfuzosin safely.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery (including cataract/glaucoma eye surgery), tell your doctor or dentist if you are taking or have ever taken this medication, and about all the other products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially dizziness and low blood pressure when getting up from a sitting or lying position, and QT prolongation (see above). These side effects can also increase the risk of falling.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other alpha blocker drugs (such as prazosin, terazosin).If you are also taking a drug to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may need to adjust your medications to minimize this risk.Other medications can affect the removal of alfuzosin from your body, which may affect how alfuzosin works. Examples include azole antifungals (such as itraconazole, ketoconazole), clarithromycin, cobicistat, HIV protease inhibitors (such as lopinavir), mifepristone, nefazodone, ribociclib, ritonavir, telithromycin, among others. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting. NOTES: Do not share this medication with others.Lab and/or medical tests (such as prostate exams, blood pressure) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details. MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Information last revised December 2022. Copyright(c) 2023 First Databank, Inc. IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription