Clinical Information
Gen. Code and Des.
45052 alfuzosin HCl ORAL TAB ER 24H 10 MG
GCN and Des.
92024 alfuzosin HCl ORAL TAB ER 24H 10 MG
Strength
10MG ER
Dose Form
TABLET, EXTENDED RELEASE 24 HR
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
12160412 SELECTIVE ALPHA-1-ADRENERGIC BLOCK.AGENT
Active Ingredients
5432 alfuzosin HCl 81403681
Inactive Ingredients
2537 povidone 9003398
UROXATRAL- alfuzosin hydrochloride tablet, extended release
Concordia Pharmaceuticals Inc.
1 INDICATIONS AND USAGE
UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
1.1 Important Limitations of Use
UROXATRAL is not indicated for the treatment of hypertension.UROXATRAL is not indicated for use in the pediatric population.
2 DOSAGE AND ADMINISTRATION
The recommended dosage is one 10 mg UROXATRAL (alfuzosin HCl) extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, Uroxatral should be taken with food and with the same meal each day. The tablets should not be chewed or crushed.
3 DOSAGE FORMS AND STRENGTHS
UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10.
4 CONTRAINDICATIONS
UROXATRAL is contraindicated for use:
in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
in patients with known hypersensitivity, such as urticaria and angioedema, to alfuzosin hydrochloride or any component of UROXATRAL tablets [see Adverse Reactions (6.2)]
DESCRIPTION
Each UROXATRAL extended-release tablet contains 10 mg alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white crystalline powder that melts at approximately 240�C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane.
Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The empirical formula of alfuzosin hydrochloride is C19 H27 N5 O4 �HCl. The molecular weight of alfuzosin hydrochloride is 425.9
The tablet also contains the following 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).
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Alfuzosin is a selective antagonist of post-synaptic alpha1 -adrenoreceptors, which are located in the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra.
HOW SUPPLIED/STORAGE AND HANDLING
UROXATRAL is supplied as follows:
Package NDC Number
Bottles of 100 59212-200-10 & 59212-200-20
UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10.
Store at 25�C (77�F); excursions permitted to 15� to 30�C (59� to 86�F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as described in the USP.
Protect from light and moisture.
Keep UROXATRAL out of reach of children.
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?
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.
You may also visit our website at www.concordiarx.com.
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).
Manufactured for:
Concordia Pharmaceuticals Inc.
St. Michael, Barbados BB11005
�2015 Concordia Pharmaceuticals Inc. All rights reserved.
