Uroxatral Drug Description

Each UROXATRAL (alfuzosin hcl) 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 C₁₉H₂₇N₅O₄•HCl. The Stamazide molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is:

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).

SIDE EFFECTS:Dizziness/lightheadedness, headache, or decreased sexual ability may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness/weakness, severe stomach/abdominal pain, yellowing eyes/skin, persistent nausea/vomiting, dark urine.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat, chest pain.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

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 to other alpha blockers such as doxazosin, prazosin, terazosin; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver problems.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other prostate gland problems (e.g., prostate cancer), heart problems (e.g., angina, low blood pressure), kidney disease.

Alfuzosin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using alfuzosin, tell your doctor or pharmacist 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. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position, especially when you first start taking this drug or if your doctor changes your dose. Also, when you first start taking this drug, avoid situations where you may be injured if you faint.

Before having surgery (including cataract eye surgery), tell your doctor or dentist that you are taking this medication.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for dizziness while using this drug.

This medication is not recommended for use in women or children.

About Uroxatral Side Effects

Uroxatral is a prescription medication used to treat men with an enlarged prostate, a condition also called benign prostatic hyperplasia. It works by blocking lower urinary tract receptors that help the prostate to relax. This helps improve the flow of urine and treat some of the symptoms of an enlarged Stamina prostate. Uroxatral is a brand-name drug manufactured by Sanofi Aventis. In its generic form, it's called alfuzaosin.

Blood Pressure

• In rare cases, Uroxatral can cause blood pressure to drop suddenly to a dangerous level. This can cause lightheadedness, dizziness or fainting. Patients should avoid driving, operating machinery or doing other activities requiring focus and concentration until they know how the medication will affect them. It's also advisable for patients to take Uroxatral at bedtime to help prevent dizziness and lightheadedness.

Sexual Side Effects

• The vast majority of men taking Uroxatral don't experience any sexual side effects of the drug. But in rare cases, some men may experience a prolonged and painful erection lasting longer than 4 hours. Notify your doctor immediately if this occurs. Some men may also notice a decrease in sexual function and ability, and this should be reported to a doctor as well.

Non-Serious Side Effects

• According to clinical trials conducted by Sanofi Aventis, the most common side effects of Uroxatral are headaches, fatigue, dizziness and upper respiratory tract infections. These side effects are no cause for concern, but report them to your doctor if they become bothersome.

Serious Side Effects

• In rare cases, patients taking Uroxatral may experience serious side effects that may indicate a possible complication. Notify your doctor immediately if you experience any of the following: persistent or severe stomach pain; chest pain; back pain; fast or irregular heartbeat; pale stools and jaundice.

Drug Interactions

• Uroxatral is known to interact with several other medications, and in some cases may increase the likelihood of experiencing side effects. Taking Uroxatral with alpha-blockers, beta-blockers, HIV protease inhibitors, azole antifungals and phosphodiesterase Type 5 inhibitors increases the risk of experiencing serious side effects of Uroxatral, such as a dangerously low blood pressure.