Xatral XL (known as Uroxatral in the U.S.)

Drug monograph for the active ingredient in Xatral XL (known as Uroxatral in the U.S.)

The following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

ALFUZOSIN (Systemic)

Some commonly used brand names are:

In the U.S.—

• Uroxatral;

In Canada—

• Xatral

Category

• Benign prostatic hyperplasia therapy agent

Description

Alfuzosin((al-FYOO-zoe-sin)) is used to treat the signs and symptoms of benign enlargement of the prostate (benign prostatic hyperplasia or BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older. The prostate gland is located below the bladder. As the prostate gland enlarges, certain muscles in the gland may become tight and get in the way of the tube that drains urine from the bladder. This can cause problems in urinating, such as a need to urinate often, a weak stream when urinating, or a feeling of not being able to empty the bladder completely. Alfuzosin helps relax the muscles in the prostate and the opening of the bladder. This may help increase the flow of urine and/or decrease the symptoms.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For alfuzosin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to alfuzosin. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking alfuzosin, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Alpha blockers (medicine for high blood pressure)— This medicine should not be used at the same time as alfuzosin.

• Atenolol (e.g., Tenormin) — Using this medicine at the same time as alfuzosin can cause very low blood pressure and a slower heart beat.

• Cimetidine (e.g., Tagamet) — Using this medicine at the same time as alfuzosin can cause there to be more alfuzosin in your body.

• Diltiazem (e.g., Cardizem) — Using this medicine at the same time as alfuzosin can cause very low blood pressure.

• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral) or
• Ritonavir (e.g., Norvir) — These medicines may cause there to be more alfuzosin in your body and they should not be used at the same time as alfuzosin.

Other medical problems—The presence of other medical problems may affect the use of alfuzosin. Make sure you tell your doctor if you have any other medical problems, especially:

• Prostatic carcinoma (cancer of the prostate) — This medical condition may have the same symptoms as your medical condition. Your doctor will want to know because different treatment is need for prostatic carcinoma.

• Liver disease, moderate or severe— Patients with this condition should not use alfuzosin.

Proper Use of This Medicine

This medicine should be taken with food and with the same meal every day.

It is very important to not chew or crush the tablets.

Dosing—The dose of alfuzosin will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of alfuzosin. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • • Adults—10 milligrams (mg) once a day taken after the same meal each day, tablets should be swallowed whole. Not for use in women.
    • Children—Not for use in children

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Chest pain; fast, pounding, or irregular heartbeat or pulse; painful or prolonged erection of the penis

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

More Common

Dizziness

Less common

Abdominal pain; acid or sour stomach; belching; body aches or pain; chills; congestion; cough; cough producing mucus; decreased interest in sexual intercourse; difficulty breathing; difficulty having a bowel movement (stool); dryness or soreness of throat; ear congestion; fever; headache; heartburn; hoarseness; inability to have or keep an erection; indigestion; loss in sexual ability, desire, drive, or performance; loss of voice; nasal congestion; nausea; pain; pain or tenderness around eyes and cheekbones; runny nose; shortness of breath; sneezing; sore throat; stomach discomfort, upset, or pain; stuffy or runny nose; tender, swollen glands in neck; tightness in chest; trouble in swallowing; unusual tiredness or weakness; wheezing; voice changes

Rare

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 01/20/2004
Revised: 03/05/2004

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