alfuzosin extended-release – oral, Uroxatral

This medication is used to treat the symptoms of a prostate gland condition called BPH (benign prostatic hyperplasia, also known as enlarged prostate). It is an alpha blocker that works by relaxing the muscles in the bladder neck and prostate. This leads to relief of BPH symptoms such as frequent or urgent urination, difficulty starting urine flow, weak stream, and nighttime urination. This medication should not be used to treat high blood pressure.

This section contains uses of this drug that are not listed in the approved professional labeling but may be prescribed by your healthcare professional. Use this drug for a condition listed in this section only if prescribed by your healthcare professional. Alfuzosin may also be used to help pass kidney stones.

HOW TO USE:

Read the Patient Information Leaflet provided by your pharmacist before starting alfuzosin and each refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth once daily after a meal or as directed by your doctor. It works best when taken with food. Do not crush or chew extended-release tablets. Swallow the whole or split tablet without crushing or chewing.

This medication may cause dizziness and lightheadedness. Take your first dose of alfuzosin with food at bedtime until your body adjusts to the medicine. Anytime the dosage is changed, take the first new dose with food at bedtime. Use this medication regularly to get the most benefit from it.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS:

Dizziness, headache, or decreased sexual ability may occur. If any of these effects persist or worsen, tell your doctor or pharmacist.

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.

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, 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.

PRECAUTIONS:

Tell your doctor or pharmacist if you are allergic to alfuzosin or other alpha blockers, or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medication, tell your doctor or pharmacist your medical history, especially of other prostate gland problems, heart problems, or kidney disease.

Alfuzosin may cause a condition that affects the heart rhythm. The risk of this condition may be increased if you have certain medical conditions or are taking other drugs. Talk to your doctor about using alfuzosin safely.

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.

Older adults may be more sensitive to the side effects of this drug.

During pregnancy, alfuzosin should be used only when clearly needed. It is unknown if this medication passes into breast milk.

DRUG INTERACTIONS:

Drug interactions may change how your medications work or increase your risk for serious side effects. Keep a list of all the products you use and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include drugs to treat erectile dysfunction or pulmonary hypertension, and other medications that lower blood pressure. Other medications can affect the removal of alfuzosin from your body, which may affect how it works.

Many drugs, including alfuzosin, may affect the heart rhythm. Report all medications you are currently using to your doctor or pharmacist.

OVERDOSE:

If overdose is suspected, contact a poison control center or emergency room immediately. Symptoms of overdose may include fainting and irregular heartbeat.

NOTES:

Do not share this medication with others.

Laboratory and/or medical tests should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE:

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose.

STORAGE:

Store at room temperature away from light and moisture. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

This information is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. It is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. A healthcare professional should be consulted before taking any drug, changing any diet, or commencing or discontinuing any course of treatment.