Alfuzosin hydrochloride

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

Should overdose of alfuzosin hydrochloride extended-release tablets lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then the administration of intravenous fluids should be considered. If necessary, vasopressors should then be used, and the renal function should be monitored and supported as needed. Alfuzosin is 82% to 90% protein bound; therefore, dialysis may not be of benefit.

11 DESCRIPTION

DESCRIPTION SECTION

Each alfuzosin hydrochloride extended-release tablet, USP contains 10 mg alfuzosin hydrochloride, USP as the active ingredient. Alfuzosin hydrochloride is a white to almost white 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 molecular formula of alfuzosin hydrochloride is C 19 H 27 N 5 O 4 •HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is: The tablet also contains the following inactive ingredients: hypromellose, lactose monohydrate, povidone, colloidal silicon dioxide and magnesium stearate. Meets USP Dissolution test 4 .

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

Three randomized placebo-controlled, double-blind, parallel-arm, 12-week trials were conducted with the 10 mg daily dose of alfuzosin. In these three trials, 1,608 patients [mean age 64.2 years, range 49-92 years; Caucasian (96.1%), Black (1.6%), Asian (1.1%), Other (1.2%)] were randomized and 473 patients received alfuzosin hydrochloride extended-release tablets 10 mg daily. Table 4 provides the results of the three trials that evaluated the 10 mg dose. There were two primary efficacy variables in these three studies. The International Prostate Symptom Score (IPSS, or AUA Symptom Score) consists of seven questions that assess the severity of both irritative (frequency, urgency, nocturia) and obstructive (incomplete emptying, stopping and starting, weak stream, and pushing or straining) symptoms, with possible scores ranging from 0 to 35 with higher numerical scores on the IPSS total symptom score representing greater severity of symptoms. The second efficacy variable was peak urinary flow rate. The peak flow rate was measured just prior to the next dose in study 2 and on average at 16 hours post-dosing in trials 1 and 3. 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). Table 4 — Mean Change (SD) from Baseline to week 12 in International Prostate Symptom Score in Three Randomized, Controlled, Double Blind Trials a Difference between baseline and week 12. Symptom Score Trial 1 Trial 2 Trial 3 Placebo ( n = 167 ) Alfuzosin Hydrochloride Extended - Release Tablets 10 mg ( n = 170 ) Placebo ( n = 152 ) Alfuzosin Hydrochloride Extended - Release Tablets 10 mg ( n = 137 ) Placebo ( n = 150 ) Alfuzosin Hydrochloride Extended - Release Tablets 10 mg ( n = 151 ) Total symptom score Baseline 18.2 (6.4) 18.2 (6.3) 17.7 (4.1) 17.3 (3.5) 17.7 (5.0) 18.0 (5.4) Change a -1.6 (5.8) -3.6 (4.8) -4.9 (5.9) -6.9 (4.9) -4.6 (5.8) -6.5 (5.2) p-value 0.001 0.002 0.007 Peak urinary flow rate was increased statistically significantly from baseline to last assessment (Week 12) versus placebo in trials 1 and 2 (Table 5 and Figures 5, 6, and 7). Table 5 — Mean (SD) Change from Baseline to Week 12 in Peak Urine Flow Rate (mL/sec) in Three Randomized, Controlled, Double-Blind Trials a Difference between baseline and week 12. Trial 1 Trial 2 Trial 3 Placebo ( n = 167 ) Alfuzosin Hydrochloride Extended - Release Tablets 10 mg ( n = 170 ) Placebo ( n = 147 ) Alfuzosin Hydrochloride Extended - Release Tablets 10 mg ( n = 136 ) Placebo ( n = 150 ) Alfuzosin Hydrochloride Extended - Release Tablets 10 mg ( n = 151 ) Mean Peak flow rate Baseline 10.2 (4.0) 9.9 (3.9) 9.2 (2.0) 9.4 (1.9) 9.3 (2.6) 9.5 (3.0) Change a 0.2 (3.5) 1.7 (4.2) 1.4 (3.2) 2.3 (3.6) 0.9 (3.0) 1.5 (3.3) p-value 0.0004 0.03 0.22 Mean total IPSS decreased at the first scheduled observation at Day 28 and mean peak flow rate increased starting at the first scheduled observation at Day 14 in trials 2 and 3 and Day 28 in trial 1.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Afluzosin Hydrochloride Extended-Release Tablets, USP 10 mg White, round, beveled edged tablets with '155' debossed on one side and 'U' debossed on other side. Bottles of 30 : NDC 51655-967-52 Store at 20 0 to 25 0 C (68 0 to 77 0 F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep this and all drugs out of reach of children.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PATIENT INFORMATION Alfuzosin Hydrochloride Extended-Release Tablets, USP (al fue′ zoe sin hye′′ droe klor′ ide) Read the Patient Information that comes with alfuzosin hydrochloride extended-release tablets 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 alfuzosin hydrochloride extended-release tablets, now and at your regular checkups. What is the most important information I should know about alfuzosin hydrochloride extended-release tablets? Alfuzosin hydrochloride extended-release tablets 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 alfuzosin hydrochloride extended-release tablets 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 alfuzosin hydrochloride extended-release tablets affect 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 alfuzosin hydrochloride extended-release tablets?" for more information about side effects. What are alfuzosin hydrochloride extended-release tablets? Alfuzosin hydrochloride extended-release tablets are a prescription medicine that is called an "alpha-blocker". Alfuzosin hydrochloride extended-release tablets are used in adult men to treat the symptoms of benign prostatic hyperplasia (BPH). Alfuzosin hydrochloride extended-release tablets 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 alfuzosin hydrochloride extended-release tablets, 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. Alfuzosin hydrochloride extended-release tablets are not for use in women or children. Some medicines called "alpha-blockers" are used to treat high blood pressure. Alfuzosin hydrochloride extended-release tablets are not for the treatment of high blood pressure. Who should not take alfuzosin hydrochloride extended-release tablets? Do not take alfuzosin hydrochloride extended-release tablets if you: have certain liver problems take antifungal medicines like ketoconazole (Nizarol*) or itraconazole (Sporanox*) take anti-HIV medicines like ritonavir (Norvir*, Kaletra*) are allergic to alfuzosin hydrochloride or any of the ingredients in alfuzosin hydrochloride extended-release tablets. See the end of this leaflet for a complete list of ingredients in alfuzosin hydrochloride extended-release tablets. Before taking alfuzosin hydrochloride extended-release tablets, 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 alfuzosin hydrochloride extended-release tablets work and cause serious side effects. See "What is the most important information I should know about alfuzosin hydrochloride extended-release tablets?" 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 (Nizoral*) 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 alfuzosin hydrochloride extended-release tablets If you have an eye surgery for cataract (clouding of the eye) planned, tell your ophthalmologist that you are using alfuzosin hydrochloride extended-release tablets or have previously been treated with an alpha-blocker. How do I take alfuzosin hydrochloride extended-release tablets? Alfuzosin hydrochloride extended-release tablet comes in child-resistant package. Take alfuzosin hydrochloride extended-release tablets exactly as your doctor prescribes it. Take alfuzosin hydrochloride extended-release tablets after the same meal each day. Do not take it on an empty stomach. Swallow the alfuzosin hydrochloride extended-release tablet whole. Do not crush, split, or chew alfuzosin hydrochloride extended-release tablets. If you take too much alfuzosin hydrochloride extended-release tablets call your local poison control center or emergency room right away. What are the possible side effects of alfuzosin hydrochloride extended-release tablets? Alfuzosin hydrochloride extended-release tablets can cause serious side effects, including: See "What is the most important information I should know about alfuzosin hydrochloride extended-release tablets?" A painful erection that will not go away. Alfuzosin hydrochloride extended-release tablets 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 alfuzosin hydrochloride extended-release tablets are: dizziness headache tiredness Call your doctor if you get any side effect that bothers you. These are not all the side effects of alfuzosin hydrochloride extended-release tablets. 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 alfuzosin hydrochloride extended-release tablets? Store alfuzosin hydrochloride extended-release tablets between 68°F to 77°F (20°C to 25°C). Protect from light and moisture. Keep alfuzosin hydrochloride extended-release tablets and all medicines out of the reach of children. General information about alfuzosin hydrochloride extended-release tablets: Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use alfuzosin hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give alfuzosin hydrochloride extended-release tablets to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about alfuzosin hydrochloride extended-release tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about alfuzosin hydrochloride extended-release tablets that is written for health professionals. What are the ingredients of alfuzosin hydrochloride extended-release tablets? Active Ingredient: alfuzosin hydrochloride Inactive Ingredients: hypromellose, lactose monohydrate, povidone, colloidal silicon dioxide, magnesium stearate. * The brands listed are registered trademarks of their respective owners. Additional patient information leaflets can be obtained by calling Unichem at 1-866-562-4616. Manufactured by...

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NDC: 51655-967-52