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 molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is:

UROXATRAL®
  (alfuzosin HCl) Structural Formula Illustration

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).

What are the possible side effects of alfuzosin (Uroxatral)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using alfuzosin and call your doctor at once if you have any of these serious side effects:

  • new or worsening chest pain;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • feeling like you might pass out; or
  • penis erection that is painful or lasts 4 hours...

Read All Potential Side Effects and See Pictures of Uroxatral »

What are the precautions when taking alfuzosin hcl (Uroxatral)?

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...

Read All Potential Precautions of Uroxatral »


Uroxatral Consumer (continued)

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.


Uroxatral Patient Information Including Side Effects

Brand Names: Uroxatral

Generic Name: alfuzosin (Pronunciation: al FUE zoe sin)

  • What is alfuzosin (Uroxatral)?
  • What are the possible side effects of alfuzosin (Uroxatral)?
  • What is the most important information I should know about alfuzosin (Uroxatral)?
  • What should I discuss with my healthcare provider before taking alfuzosin (Uroxatral)?
  • How should I take alfuzosin (Uroxatral)?
  • What happens if I miss a dose (Uroxatral)?
  • What happens if I overdose (Uroxatral)?
  • What should I avoid while taking alfuzosin (Uroxatral)?
  • What other drugs will affect alfuzosin (Uroxatral)?
  • Where can I get more information?

What is alfuzosin (Uroxatral)?

Alfuzosin is in a group of drugs called alpha-adrenergic blockers. Alfuzosin helps relax the muscles in the prostate and bladder neck, making it easier to urinate.

Alfuzosin is used to treat benign prostatic hyperplasia (enlarged prostate).

Alfuzosin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of alfuzosin (Uroxatral)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using alfuzosin and call your doctor at once if you have any of these serious side effects:

  • new or worsening chest pain;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • feeling like you might pass out; or
  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • dizziness or drowsiness;
  • headache, tired feeling;
  • warmth, redness, or tingly feeling under your skin;
  • mild stomach pain, diarrhea, constipation; or
  • sore throat, cough, runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about alfuzosin (Uroxatral)?

Do not use alfuzosin if you have severe liver disease, or if you are also using ketoconazole (Nizoral), itraconazole (Sporanox), or ritonavir (Norvir).

Alfuzosin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Stop using alfuzosin and call your doctor at once if you have new or worsening chest pain, or if you feel light-headed.

Alfuzosin can affect the pupils of your eyes during cataract surgery. If you have cataract surgery during your treatment with alfuzosin, tell the surgeon ahead of time that you are taking this medication. Do not stop using alfuzosin before surgery unless your surgeon tells you to.

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