Facts About Flomax (Tamsulosin)

Flomax (tamsulosin hydrochloride) is a drug used to treat an enlarged prostate and chronic prostate inflammation. It is one of the most commonly prescribed drugs in older men and one of the 200 most prescribed drugs overall, according to the Pharmacy Technician Certification Board (PTCB).

Flomax was granted approval by the U.S. Food and Drug Administration (FDA) in 1997. In 2009, the drug manufacturer Boehringer Ingelheim lost its patent exclusivity of the drug molecule, and, as a result, there are numerous low-cost generics now available.

Flomax belongs to a class of medications known as alpha-adrenergic blockers that work by relaxing both the bladder neck muscles and the muscle of the prostate gland itself. By doing so, men with prostate problems are able to urinate more freely, reduce the need for nighttime urination (nocturia), and improve urinary urgency and frequency.

Flomax is indicated to treat a number of common medical conditions in men, including:

• Benign prostatic hyperplasia (BPH), a common age-associated prostate gland enlargement
• Chronic prostatitis, the inflammation of the prostate gland not associated with bacterial infection
• Passage of kidney stones
• Urinary retention, the inability to empty the bladder

Despite the fact that Flomax can decrease blood pressure, it is not approved for the treatment of hypertension (high blood pressure).

Flomax is available in a 0.4-milligram (mg) capsule. It is taken daily approximately 30 minutes after a meal, ideally at the same time every day.

The effects of the drug can usually be felt within the first 48 hours. Complete urinary relief may take up to three weeks. If a 0.4-mg dose is unable to provide relief, your doctor may recommend that you double the dose to 0.8 mg once daily. It is important, however, that you never increase the dose unless directed to do so by your doctor.

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and proceed as usual. Never take a double dose of Flomax as this may lead to a steep drop in blood pressure (hypotension).

Many urologists today will prescribe Flomax as part of a dual therapy. The 2008 CombAT (combination of Avodart and tamsulosin) study concluded that tamsulosin taken with Avodart (dutasteride) was far better at alleviating symptoms of BPH than either drug on its own. The dual approach overcomes one of the common concerns about Avodart, namely that it can take up to six months to take full effect.

In 2010, a combination drug containing tamsulosin called Jalyn (dutasteride 0.5 mg/tamsulosin 0.4 mg) was granted approval by the FDA.

While Flomax is considered safe to use over the long term, there are a number of side effects to be aware of. The most common include (by the frequency of occurrence):

• Headaches
• Dizziness
• Rhinitis (hay fever)
• Ejaculation problems (including retrograde ejaculation)
• Abnormal weakness
• Back pain
• Diarrhea
• Sore throat
• Chest pain
• Cough
• Drowsiness
• Nausea
• Sinus infection
• Insomnia
• Decreased libido
• Blurred vision
• Rash
• Priapism (a painful erection lasting four hours or more)

Other more problematic side effects include dizziness, vertigo, postural hypotension (low blood pressure when rising), and fainting. Collectively known as orthostasis, these symptoms tend to occur within the first eight weeks of treatment. Due to its potential effect on blood pressure, people with low blood pressure, mechanical heart problems, and congestive heart failure should be monitored closely while taking Flomax.

Call your doctor if your urination doesn't improve within two weeks or you experience any severe, persistent, or worsening side effects, including rash, priapism, or fainting.

Flomax is contraindicated for use in persons with a known allergy to Flomax or any of its components.

Flomax should not be used with certain CYP3A4 inhibitors. These are drugs that block the CYP3A4 enzyme, a substance produced by the liver that can affect the bioavailability (concentration) of Flomax in the blood. Taking a strong CYP3A4 inhibitor may increase the bioavailability of Flomax and the severity of side effects (most typically low blood pressure).

In some cases, your blood pressure may need to be monitored while on treatment. In others, one of the two drugs may need to be substituted.

Speak with your doctor if you take any of the following:

• Alpha-blockers used to treat high blood pressure, including (Cardura) doxazosin, Dibenzyline (phenoxybenzamine), and Minipress (prazosin)
• Anti-arrhythmia drugs like Multaq (dronedarone) and Nexterone (amiodarone)
• Antibiotics like Amoxil (amoxicillin), (Biaxin) clarithromycin, and Ketek (telithromycin)
• Antifungal drugs like itraconazole, ketoconazole, omeprazole, lansoprazole, and voriconazole
• Anti-tuberculosis drugs like isoniazid and rifampin
• Darvon (propoxyphene), an opioid pain reliever
• Erectile dysfunction drugs like Viagra (sildenafil), Cialis (tadalafil), and Levitra (vardenafil)
• HIV protease inhibitors such as Reyataz (atazanavir), Prezista (darunavir), and Kaletra (lopinavir/ritonavir)
• Qualaquin (quinine), used to treat malaria
• Ranexa (ranolazine), used to treat angina
• Serzone (nefazodone), an antidepressant
• Varubi (rolapitant), used to treat chemotherapy-related nausea
• Viekira Pak (ombitasvir/paritaprevir/ritonavir/telaprevir), used to treat hepatitis C

Flomax should also not be used in people with end-stage kidney failure. Meanwhile, people with kidney impairment should be regularly monitored due to the increased risk of an exaggerated hypotensive response.

If you are scheduled to have cataract or glaucoma surgery, tell your doctor if you are either using or have recently used Flomax. A serious eye disorder called Intraoperative floppy iris syndrome (IFIS) has been known to occur in around two percent of those who have undergone cataract surgery while on Flomax.

As such, Flomax is contraindicated for use two weeks prior to cataract surgery due to an increased risk of a detached retina or lost lens.

Flomax should only be used in pregnant women when needed and only after a discussion about the possible risks and benefits of use. While human research is limited, animal studies have revealed no evidence of harm to the fetus even at 50 times the relative human dose.

Because BPH closely resembles prostate cancer, men with prostate problems should undergo tests to rule out cancer before starting treatment.

Due to its potential impact on blood pressure, it is important to advise your doctor if you have dizziness while taking Flomax. Take care when rising from the bed in the morning to avoid falling or blacking out. The same applies if you are planning to drive given the risk of vision impairment and dizziness. In some cases, treatment may need to be stopped if the drug interferes with your ability to function normally.

Following the end of Boehringer Ingelheim's patent exclusivity in 2009, the FDA approved the first Flomax generic in March 2010. Today, there is a total of 11 tamsulosin 0.4-mg generics available in the United States, ranging in price from $10 to $30 for a 30-day supply.

For its part, Boehringer Ingelheim offers the brand name Flomax at an online price of $35 for 30 capsules or $90 for 90 capsules with free home delivery.

Meanwhile, users of Jalyn who qualify can enroll with the GlaxoSmithKline's GSKForU Patient Assistance Program to obtain the drug at a low to no cost. If you live in the United States, have no insurance drug benefit, and meet certain income requirements, you may be eligible. The current monthly retail price of Jalyn is between $120 and $250.