Alfuzosin

What is Alfuzosin?

• Alfuzosin (Uroxatral) is a nonselective alpha-1 adrenergic antagonist used in the therapy of benign prostatic hypertrophy.

Alfuzosin

Alfuzosin ball-and-stick

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Alfuzosin

What are the uses of this medicine?

• Alfuzosin (Uroxatral) is a prescription medicine that is called an "alpha-blocker".
• Alfuzosin hydrochloride is used in adult men to treat the symptoms of benign prostatic hyperplasia (BPH).
• Alfuzosin hydrochloride may help to relax the muscles in the prostate and the bladder which may lessen the symptoms of BPH and improve urine flow.

Limitations of use:

• Alfuzosin hydrochloride is not for use in women or children.
• Some medicines called "alpha-blockers" are used to treat high blood pressure.
• Alfuzosin hydrochloride is not for the treatment of high blood pressure.

How does this medicine work?

• Alfuzosin is a quinazoline compound with smooth muscle-relaxing activity.
• Alfuzosin (al fue' zoe sin) is an alpha-1 adrenergic antagonist.
• Alfuzosin selectively binds to and antagonizes post-synaptic alpha-1-adrenoreceptors in smooth muscle of the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra, initiating relaxation of smooth muscle and resulting in improvement of urine flow and the symptoms of benign prostatic hyperplasia (BPH).
• This agent also blocks alpha-1-adrenoreceptors in peripheral vascular smooth muscle, resulting in vasodilatation and a decrease in peripheral vascular resistance.
• The effects of the agent on smooth muscle of the bladder and prostate causes improvement in urine flow in men with partial obstruction due to benign prostatic hypertrophy.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have certain liver problems
• take antifungal medicines like ketoconazole or itraconazole (Sporanox)
• take anti-HIV medicines like ritonavir (Norvir, Kaletra)
• are allergic to alfuzosin hydrochloride or any of the ingredients in alfuzosin hydrochloride.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention the medications listed below:

• amiodarone (Cordarone)
• aprepitant (Emend)
• atenolol (Tenormin)
• cimetidine (Tagamet)
• cisapride (not available in the U.S.)
• clarithormycin (Biaxin, in Prevpac)
• cyclosporine (Neoral, Sandimmune)
• danazol (Danocrine)
• delavirdine (Rescriptor)
• diltiazem (Cardizem, Dilacor, Tiazac, others)
• disopyramide (Norpace)
• dofetilide (Tikosyn)
• efavirenz (Sustiva)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• fluconazole (Diflucan)
• fluoxetine (Prozac, Sarafem)
• fluvoxamine (Luvox)
• HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), and saquinavir (Fortovase, Invirase)
• hormonal contraceptives (birth control pills, rings, and patches)
• isoniazid (INH, Nydrazid); lovastatin (Adivicor, Altocor, Mevacor)
• medications for high blood pressure
• medications for erectile dysfunction (ED) such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra)
• metronidazole (Flagyl); moxifloxacin (Avelox)
• nefazodone
• other alpha blockers such as doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), and tamsulosin (Flomax)
• pimozide (Orap)
• procainamide (Procanbid, Pronestyl)
• quinidine (Quinidex)
• sertraline (Zoloft)
• sotalol (Betapace,)
• sparfloxacin (Zagam)
• thioridazine (Mellaril)
• troleandomycin (TAO)
• verapamil (Calan, Covera, Isoptin, Verelan)
• zafirlukast (Accolate)

Is this medicine FDA approved?

• Alfuzosin was approved for use in the United States in 2003 for treatment of symptoms of urinary hesitancy due to benign prostatic hypertrophy.
• Alfuzosin is not approved for use in hypertension.

How should this medicine be used?

Recommended dosage:

• The recommended dosage is one 10 mg alfuzosin hydrochloride extended-release tablet once daily.

Administration:

• Alfuzosin comes as an extended-release (long-acting) tablet to take by mouth.
• It is usually taken once a day, immediately after a meal.
• The extent of absorption of alfuzosin is 50% lower under fasting conditions.
• Therefore, alfuzosin hydrochloride should be taken with food and with the same meal each day.
• The tablets should not be chewed or crushed.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Extended-release tablet: 10 mg

This medicine is available in fallowing brand namesː

• Uroxatral

What side effects can this medication cause?

The most common side effects of this medicine include:

• dizziness
• headache
• tiredness

Alfuzosin hydrochloride can cause serious side effects, including:

• sudden drop in blood pressure
• A painful erection that will not go away

What special precautions should I follow?

• Do not drive, operate machinery, or do any dangerous activities until you know how alfuzosin hydrochloride affects 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.
• Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of alfuzosin hydrochloride. Care should be taken in patients with symptomatic hypotension or who have had a hypotensive response to other medications or are concomitantly treated with antihypertensive medication or nitrates.
• Caution should be exercised when alfuzosin hydrochloride is administered in patients with severe renal impairment (creatinine clearance < 30 mL/min).
• Alfuzosin hydrochloride is contraindicated for use in patients with moderate or severe hepatic impairment. Alfuzosin hydrochloride have not been studied in patients with mild hepatic impairment, caution should be exercised when alfuzosin hydrochloride is administered to such patients.
• Carcinoma of the prostate and benign prostatic hyperplasia (BPH) cause many of the same symptoms. Therefore, patients thought to have BPH should be examined to rule out the presence of carcinoma of the prostate prior to starting treatment with alfuzosin hydrochloride.
• Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with alpha adrenergic antagonists.
• Rarely (probably less than 1 in 50,000), alfuzosin, like other alpha adrenergic antagonists, has been associated with priapism.
• If symptoms of angina pectoris should appear or worsen, alfuzosin hydrochloride should be discontinued.
• Use with caution in patients with acquired or congenital QT prolongation or who are taking medications that prolong the QT interval.
• Alfuzosin is associated with a low rate of transient serum aminotransferase elevations and with rare instances of clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypotension

Management of overdosage:

• 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.

Can this medicine be used in pregnancy?

• Alfuzosin hydrochloride extended-release tablets is not indicated for use in women.
• There are no adequate data on the developmental risk associated with use of Alfuzosin hydrochloride extended-release tablets in pregnant women.

Can this medicine be used in children?

• Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• ALFUZOSIN HYDROCHLORIDE

Inactive Ingredients:

• CELLULOSE, MICROCRYSTALLINE
• GUAR GUM
• HYPROMELLOSES
• SILICON DIOXIDE
• MAGNESIUM STEARATE

Who manufactures and distributes this medicine?

Manufactured by:

• InvaGen Pharmaceuticals, Inc.
• (a subsidiary of Cipla Ltd.)
• Hauppauge, NY

Manufactured for:

• Exelan Pharmaceuticals, Inc.
• Boca Raton, FL

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Protect from light and moisture.
• Dispense in a tight, light-resistant container as defined in the USP.
• Keep alfuzosin hydrochloride out of reach of children.

Alpha-blockers used to treat benign prostatic hypertrophy (BPH):

• Alfuzosin
• Doxazosin
• Silodosin
• Tamsulosin
• Terazosin

5-Alpha Reductase Inhibitors

• Dutasteride
• Finasteride

• Dailymed label info on Alfuzosin
• FDA Alfuzosin

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