Pronunciation:

al-FUE-zoe-sin

Brand Names:

• Uroxatral

Dosage Forms:

• Tablet, Extended Release

Classifications:

Therapeutic—

Benign Prostatic Hypertrophy Agent

Pharmacologic—

Alpha-1 Adrenergic Blocker

Uses of This Medicine:

Alfuzosin is used to treat the signs and symptoms of benign enlargement of the prostate (benign prostatic hyperplasia or BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older. The prostate gland is located below the bladder. As the prostate gland enlarges, certain muscles in the gland may become tight and get in the way of the tube that drains urine from the bladder. This can cause problems with urinating, such as a need to urinate often, a weak stream when urinating, or a feeling of not being able to empty the bladder completely.

Alfuzosin helps relax the muscles in the prostate and the opening of the bladder. This may help increase the flow of urine or decrease the symptoms. However, alfuzosin will not shrink the prostate. The prostate may continue to get larger. This may cause the symptoms to become worse over time. Therefore, even though alfuzosin may lessen the problems caused by enlarged prostate now, surgery may still be needed in the future.

This medicine is usually given only to men. It is not normally given to women or children.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Alfuzosin is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alfuzosin in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults and are likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving alfuzosin.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Atazanavir
• Bepridil
• Boceprevir
• Cisapride
• Clarithromycin
• Cobicistat
• Conivaptan
• Darunavir
• Dronedarone
• Fluconazole
• Fosamprenavir
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Lopinavir
• Mesoridazine
• Nelfinavir
• Nirmatrelvir
• Pimozide
• Piperaquine
• Posaconazole
• Ritonavir
• Saquinavir
• Sparfloxacin
• Telaprevir
• Telithromycin
• Terfenadine
• Thioridazine
• Tipranavir
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Adagrasib
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Azithromycin
• Bedaquiline
• Bunazosin
• Buprenorphine
• Buserelin
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Dabrafenib
• Dapiprazole
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxazosin
• Droperidol
• Efavirenz
• Encorafenib
• Entrectinib
• Escitalopram
• Etrasimod
• Fedratinib
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Foscarnet
• Fosnetupitant
• Fostemsavir
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Ivabradine
• Ivosidenib
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lumefantrine
• Macimorelin
• Mavacamten
• Mefloquine
• Melphalan
• Methadone
• Metronidazole
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Moxisylyte
• Nafarelin
• Netupitant
• Nilotinib
• Norfloxacin
• Nortriptyline
• Ofloxacin
• Olanzapine
• Omaveloxolone
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Phenobarbital
• Phenoxybenzamine
• Phentolamine
• Pimavanserin
• Pitolisant
• Ponesimod
• Prazosin
• Primidone
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Selpercatinib
• Sertraline
• Sevoflurane
• Silodosin
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Tadalafil
• Tamsulosin
• Telavancin
• Terazosin
• Tetrabenazine
• Tolazoline
• Toremifene
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimazosin
• Trimipramine
• Triptorelin
• Urapidil
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Alprenolol
• Atenolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bucindolol
• Carteolol
• Carvedilol
• Celiprolol
• Dilevalol
• Diltiazem
• Esmolol
• Labetalol
• Levobunolol
• Mepindolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Propranolol
• Sildenafil
• Talinolol
• Tertatolol
• Timolol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain) or
• Heart rhythm problems (eg, congenital or acquired QT prolongation), or history of or
• Postural hypotension (low blood pressure)—Use with caution. May make these conditions worse.

• Hypertension (high blood pressure) or
• Liver disease, moderate or severe—Should not be used in patients with this condition.

• Kidney disease, severe or
• Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine with food and with the same meal every day.

Swallow the extended-release tablet whole. Do not break, crush, or chew it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended release tablets):
  • For benign prostatic hyperplasia (BPH):
    • Adults—10 milligrams (mg) once a day.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not use this medicine if you are taking ketoconazole (Nizoral®), itraconazole (Sporanox®), or ritonavir (Norvir®).

Dizziness, lightheadedness, or fainting may occur after you use this medicine, especially when you get up from a lying or sitting position. Getting up slowly may help lessen this problem. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

This medicine may cause some people to become dizzy or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Tell your eye doctor (ophthalmologist) that you have used or are using this medicine before cataract surgery or any other eye procedure. This medicine may cause a serious eye problem called Intraoperative Floppy Iris Syndrome (IFIS).

Call your doctor right away if you experience a prolonged erection. This is an extremely rare side effect, but if it goes untreated, can result in permanent erectile dysfunction (impotence).

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.

Benign prostatic hyperplasia can have the same symptoms as prostate cancer. They may also often occur together. Your doctor may test for the presence of the cancer before you start using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Chest pain

chills

cold sweats

confusion

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position

fainting

fast, pounding, or irregular heartbeat or pulse

painful or prolonged erection of the penis

Incidence not known

Arm, back, or jaw pain

black, tarry stools

bleeding gums

bloody urine

chest discomfort, tightness, or heaviness

clay-colored stools

dark urine

diarrhea

fever

headache

hives, welts, itching, skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

loss of appetite

nausea

pinpoint red spots on the skin

stomach pain

sweating

swelling

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Belching

body aches or pain

congestion

cough

cough producing mucus

decreased interest in sexual intercourse

difficulty breathing

difficulty having a bowel movement

dryness or soreness of the throat

ear congestion

heartburn

hoarseness

inability to have or keep an erection

indigestion

loss in sexual ability, desire, drive, or performance

loss of voice

nasal congestion

pain

pain or tenderness around the eyes and cheekbones

sneezing

sore throat

stomach discomfort or upset

stuffy or runny nose

tender, swollen glands in the neck

tightness in the chest

trouble with swallowing

unusual tiredness or weakness

voice changes

Incidence not known

Feeling of warmth

redness of the face, neck, arms, and occasionally, upper chest

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.