Uroxatral

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• dizziness
• fainting
• lightheadedness
• blurred vision
• nausea

• Uroxatral^®

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alfuzosin in the elderly. However, elderly patients are more like to have age-related kidney or liver problems, which may require caution in patients receiving alfuzosin.

If you take too much Uroxatral, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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

Swallow the extended-release tablet whole. Do not break, crush, or chew it.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended release tablets):
  • For benign prostatic hyperplasia (BPH):
    • Adults—10 milligrams (mg) once a day.
    • Children—Use is not recommended.

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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take Uroxatral with food with the same meal each day.
• Swallow whole. Do not chew, break, or crush.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

Uroxatral is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.

Important Limitations of Use

Uroxatral is not indicated for the treatment of hypertension.
Uroxatral is not indicated for use in the pediatric population.

Uroxatral (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10.

CYP3A4 Inhibitors

Uroxatral is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, since alfuzosin blood levels are increased [see Contraindications (4), Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)].

Alpha Adrenergic Antagonists

The pharmacokinetic and pharmacodynamic interactions between Uroxatral and other alpha adrenergic antagonists have not been determined. However, interactions may be expected, and Uroxatral should not be used in combination with other alpha adrenergic antagonists [see Warnings and Precautions (5.4)].

Antihypertensive Medication and Nitrates

There may be an increased risk of hypotension/postural hypotension and syncope when taking Uroxatral concomitantly with anti-hypertensive medication and nitrates [see Warnings and Precautions (5.1)].

PDE5 Inhibitors

Caution is advised when alpha adrenergic antagonists, including Uroxatral, are co-administered with PDE5 inhibitors. Alpha adrenergic antagonists and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension [see Warnings and Precautions (5.4)].

Each Uroxatral 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:

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).

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol with this medicine can cause side effects.