TM Owner Advanz Pharma (US) Corp.
Uroxatral 10mg Extended-release tablet
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Indications & Clinical Uses
- Uroxatral 10 mg contains alfuzosin hydrochloride, an alpha-adrenergic blocker (alpha-blocker) in the form of an extended-release tablet taken once daily.
- It is used to treat the signs and symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate causing urgency, frequency and difficulty passing urine) in adult men.
- It is not indicated for high blood pressure, for use in children or for use in women.
- Uroxatral is the US brand name; the label is now held by Advanz Pharma (US) Corp. and was earlier held by Sanofi.
- It is an extended-release tablet that must be swallowed whole, so do not substitute other alfuzosin products for it without your prescriber's advice.
Side Effects
- The most common side effects, seen in at least 2% of men and more often than with placebo, were dizziness (5.7%), upper respiratory tract infection (3.0%), headache (3.0%) and tiredness (2.7%).
- Serious effects to recognise include fainting or a sudden drop in blood pressure on standing (postural hypotension), worsening or new chest pain (angina), and priapism, a painful erection unrelated to sex that is very rare (probably fewer than 1 in 50,000 men) and can cause permanent impotence if untreated.
- Uroxatral has no boxed warning.
- Stand up slowly, avoid driving or hazardous tasks until you know how it affects you, and seek urgent help for a painful erection that does not go away.
Precautions & Warnings
- Uroxatral must not be used in moderate or severe liver impairment, with potent CYP3A4 inhibitors, or if you are allergic to alfuzosin.
- Take it once daily with food, after the same meal each day, and swallow the tablet whole; crushing, chewing or splitting releases the whole dose at once.
- Use caution in severe kidney impairment, mild liver impairment, and in people with a history of QT prolongation (a heart rhythm change) or who take medicines that prolong the QT interval.
- Prostate cancer should be ruled out before starting.
- Tell your eye surgeon you take it before cataract surgery, because of intraoperative floppy iris syndrome.
- It is not for women.
- Stop and seek advice if chest pain starts or worsens.
- Store at 25°C, protected from light and moisture.
Avoid Interactions
- Medicines that increase the effect or risk: potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir are contraindicated because they raise alfuzosin levels.
- Other alpha-blockers should not be combined with Uroxatral.
- Antihypertensive medicines, nitrates and PDE5 inhibitors (medicines for erectile dysfunction) can add to the blood-pressure-lowering effect and may cause symptomatic low blood pressure and fainting.
- Use caution with any medicine that prolongs the QT interval.
- The sections of the label reviewed do not highlight medicines that reduce its effect.
- Tell your healthcare provider and pharmacist about all prescription and over-the-counter medicines and supplements you take before starting Uroxatral.
References
Frequently Asked Questions
Uroxatral (alfuzosin) is a once-daily 10 mg extended-release tablet that treats the symptoms of an enlarged prostate (benign prostatic hyperplasia) in adult men, such as urgency, frequency and difficulty passing urine. It is not for high blood pressure, children or women.
Take one Uroxatral (alfuzosin) 10 mg extended-release tablet once daily, with food, after the same meal each day. Swallow it whole. Do not crush, chew or split it, because that releases the whole dose at once and raises the risk of side effects.
Common Uroxatral (alfuzosin) side effects are dizziness (5.7%), upper respiratory infection, headache and tiredness. Seek urgent help for fainting, chest pain, or a painful erection that will not go away (priapism, very rare). The label has no boxed warning.
Do not take Uroxatral (alfuzosin) with ketoconazole, itraconazole or ritonavir, or with other alpha-blockers. Blood pressure medicines, nitrates and erectile dysfunction tablets can cause dizziness and fainting. Avoid driving until you know how it affects you, and stand up slowly.
Yes. Tell your eye surgeon if you take or have taken Uroxatral (alfuzosin) before cataract surgery. Alpha-blockers can cause intraoperative floppy iris syndrome, a complication during the operation, so the surgeon can plan for it.
No. Uroxatral (alfuzosin) is not indicated for women or children. It is approved only for adult men with an enlarged prostate. The label has no adequate pregnancy data and says it is not for use in women.
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