Uroxatral Alfuzosin HCl
Refer to the “Also Known As” section to reference different products that include the same medication as Uroxatral.
Drug Basics
Brand Name: Uroxatral
Generic Name: ALFUZOSIN HCL
Drug Type: HUMAN PRESCRIPTION DRUG
Route: ORAL
Dosage Form: TABLET, EXTENDED RELEASE
Data Current As Of: 2020-01-20
indications & usage
UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
UROXATRAL is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1)
Important Limitations of Use:
UROXATRAL is not indicated for treatment of hypertension. (1.1)
UROXATRAL is not indicated for use in the pediatric population. (1.1, 8.4, 12.3)
important limitations of use
UROXATRAL is not indicated for the treatment of hypertension.
UROXATRAL is not indicated for use in the pediatric population.
drug interactions
cyp3a4 inhibitors
UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, since alfuzosin blood levels are increased [see Contraindications (4), Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)].
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 [see Warnings and Precautions (5.4)].
antihypertensive medication & nitrates
There may be an increased risk of hypotension/postural hypotension and syncope when taking UROXATRAL concomitantly with anti-hypertensive medication and nitrates [see Warnings and Precautions (5.1)].
pde5 inhibitors
Caution is advised when alpha adrenergic antagonists, including UROXATRAL, are co-administered 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 [see Warnings and Precautions (5.4)].
patient counseling information
See FDA-approved patient labeling.
hypotension / syncope
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. This is important for those with low blood pressure or who are taking antihypertensive medications or nitrates [see Warnings and Precautions (5.1)].
intraoperative floppy iris syndrome
Patients should be instructed to tell their ophthalmologist about their use of UROXATRAL before cataract surgery or other procedures involving the eyes, even if the patient is no longer taking UROXATRAL [see Warnings and Precautions (5.6)].
priapism
Patients should be advised about the possibility of priapism resulting from treatment with UROXATRAL and medications in the same class. 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)].
instructions of use
UROXATRAL should be taken with food and with the same meal each day.
Patients should be advised not to crush or chew UROXATRAL tablets.
Mfd. for: Concordia Pharmaceuticals
Distributed by:
Amdipharma Limited,
17 Northwood House
Dublin 9, Ireland
©2015. All rights reserved.
PATIENT INFORMATION
UROXATRAL® (yoo-ROX-uh-trahl)
(Alfuzosin hydrochloride extended-release tablets)
Read the Patient Information that comes with UROXATRAL before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or your treatment. You and your doctor should talk about all your medicines, including UROXATRAL, now and at your regular checkups.
What is the most important information I should know about UROXATRAL?
UROXATRAL can cause serious side effects, including a sudden drop in blood pressure, especially when you start treatment. This may cause you to faint, or to feel dizzy or lightheaded.
- Your risk of having this problem may be increased if you take UROXATRAL with certain other medicine that lowers blood pressure:
- medicines for high blood pressure
- a nitrate medicine for angina
Ask your doctor if you are not sure if you are taking one of these medicines.
- Do not drive, operate machinery, or do any dangerous activities until you know how UROXATRAL affects you. This is especially important if you already have a problem with low blood pressure or take medicines to treat high blood pressure.
- If you begin to feel dizzy or lightheaded, lie down with your legs and feet up. If your symptoms do not improve call your doctor.
See the section "What are the possible side effects of UROXATRAL?" for more information about side effects.
What is UROXATRAL?
UROXATRAL is a prescription medicine that is called an "alpha-blocker". UROXATRAL is used in adult men to treat the symptoms of benign prostatic hyperplasia (BPH). UROXATRAL may help to relax the muscles in the prostate and the bladder which may lessen the symptoms of BPH and improve urine flow.
Before prescribing UROXATRAL, your doctor may examine your prostate gland and do a blood test called a prostate specific antigen (PSA) test to check for prostate cancer. Prostate cancer and BPH can cause the same symptoms. Prostate cancer needs a different treatment.
UROXATRAL is not for use in women or children.
Some medicines called "alpha-blockers" are used to treat high blood pressure. UROXATRAL is not for the treatment of high blood pressure.
Who should not take UROXATRAL?
Do not take UROXATRAL if you:
- have certain liver problems
- take antifungal medicines like ketoconazole or itraconazole (Sporanox)
- take anti-HIV medicines like ritonavir (Norvir, Kaletra)
- are allergic to alfuzosin hydrochloride or any of the ingredients in UROXATRAL.
See the end of this leaflet for a complete list of ingredients in UROXATRAL.
Before taking UROXATRAL, tell your doctor if you:
- have liver problems
- have kidney problems
- have had low blood pressure, especially after taking another medicine. Signs of low blood pressure are fainting, dizziness, and lightheadedness.
- have a heart problem called angina
- or any family members have a rare heart condition known as congenital prolongation of the QT interval.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Some of your other medicines may affect the way UROXATRAL works and cause serious side effects. See "What is the most important information I should know about UROXATRAL?"
Especially tell your doctor if you take:
- another alpha blocker medicine
- a medicine to treat high blood pressure
- a medicine to treat angina
- a medicine to treat erectile dysfunction (ED)
- the antifungal medicines like ketoconazole or itraconazole (Sporanox)
- the anti-HIV medicine like ritonavir (Norvir, Kaletra)
Ask your doctor or pharmacist if you are not sure if your medicine is one of those listed above.
What you need to know while taking UROXATRAL (alfuzosin HCl) tablets
- If you have an eye surgery for cataract (clouding of the eye) planned, tell your ophthalmologist that you are using UROXATRAL or have previously been treated with an alpha-blocker.
How do I take UROXATRAL?
- UROXATRAL comes in child-resistant package.
- Take UROXATRAL exactly as your doctor prescribes it.
- Take UROXATRAL after the same meal each day. Do not take it on an empty stomach.
- Swallow the UROXATRAL tablet whole. Do not crush, split, or chew UROXATRAL tablets.
- If you take too much UROXATRAL call your local poison control center or emergency room right away.
What are the possible side effects of UROXATRAL?
UROXATRAL can cause serious side effects, including:
- See "What is the most important information I should know about UROXATRAL?"
- A painful erection that will not go away. UROXATRAL can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, you may not be able to get an erection in the future.
The most common side effects with UROXATRAL are:
- dizziness
- headache
- tiredness
Call your doctor if you get any side effect that bothers you.
These are not all the side effects of UROXATRAL. For more information ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How do I store UROXATRAL?
- Store UROXATRAL between 59°F and 86°F (15°C and 30°C).
- Protect from light and moisture.
Keep UROXATRAL and all medicines out of the reach of children.
General information about UROXATRAL:
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use UROXATRAL for a condition for which it was not prescribed. Do not give UROXATRAL to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about UROXATRAL. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about UROXATRAL that is written for health professionals.
What are the ingredients of UROXATRAL?
Active Ingredient: alfuzosin hydrochloride
Inactive Ingredients: colloidal silicon dioxide (NF), ethylcellulose (NF), hydrogenated castor oil (NF), hydroxypropyl methylcellulose (USP), magnesium stearate (NF), mannitol (USP), microcrystalline cellulose (NF), povidone (USP), and yellow ferric oxide (NF).
Mfd. for: Concordia Pharmaceuticals
Distributed by:
Amdipharm Limited,
17 Northwood House
Dublin 9, Ireland
©2015. All rights reserved
principal display panel - 30 tablets bottle
NDC 59212-200-30
Uroxatral®
alfuzosin HCl 10 mg
Extended-Release Tablets
SWALLOW TABLETS WHOLE.
DO NOT CHEW OR CRUSH TABLETS.
CONCORDIA PHARMACEUTICALS
30 Tablets Rx only
principal display panel - 100 tablets bottle
NDC 59212-200-10
Uroxatral ®
alfuzosin HCl 10 mg
Extended-Release Tablets
SWALLOW TABLETS WHOLE.
DO NOT CHEW OR CRUSH TABLETS.
CONCORDIA PHARMACEUTICALS
100 Tablets Rx only
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