Rapaflo (silodosin)
Potential health benefits   2008
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ALL RIGHTS RESERVED ZHION 2008. DO NOT TRANSFER THIS ARTICLE TO OTHER
WEBSITES OR BLOGS. CONSULT WITH YOUR DOCTOR FOR ANY QUESTION OR BEFORE
TAKING ANY SUPPLEMENT OR MEDICINE. THIS ARTICLE IS FOR YOUR REFERENCE ONLY.
APPROVAL / USE / INDICATIONS

The U.S. Food and Drug Administration on October 10, 2008 approved Rapaflo
(silodosin) capsules for the treatment of symptoms due to benign prostatic
hyperplasia (BPH), a condition also known as an enlarged prostate.

STRENGTHS

Rapaflo will be available in a once-daily capsule. An 8 milligram (mg) daily dose is
recommended for men who do not suffer from kidney or liver impairment. A 4 mg
daily dose will be available for men with moderate kidney (renal) impairment. Rapaflo
is not recommended for men with severe kidney (renal) or liver (hepatic) impairment
and is not approved for pediatric use.

MECHANISM

Benign prostatic hyperplasia is a male disease wherein the prostate gland – located
between the bladder, which stores urine, and the urethra, the tube through which
urine exits the body – enlarges in men as they age. By age 50, roughly 50 percent of
all men suffer from BPH. By age 80, that number jumps to 75 percent.

As men age, their prostate gland enlarges and begins to press against their urethra.
This pressure can impede the flow of urine and make it difficult to eliminate it from
the body. In the early stages of BPH, the disease can also create a need to urinate
more frequently, or cause dribbling after urination. BPH can also lead to an
increased risk of urinary tract infections and urinary retention. Urinary retention can
damage the kidneys and cause urinary tract infections by mixing urine from the
ureter with urine from the bladder that is heavily laden with bacteria.

Rapaflo works by blocking the alpha-1 adrenoreceptors in the prostate, bladder, and
urethra. By blocking these receptors, this treatment allows the smooth muscle in
these tissues to relax, resulting in a reduction in BPH symptoms.

Rapaflo will be available in a once-daily capsule. An 8 milligram (mg) daily dose is
recommended for men who do not suffer from kidney or liver impairment. A 4 mg
daily dose will be available for men with moderate kidney (renal) impairment. Rapaflo
is not recommended for men with severe kidney (renal) or liver (hepatic) impairment
and is not approved for pediatric use.

The safety and efficacy of Rapaflo were shown in two 12-week, randomized, double-
blind, placebo-controlled, multicenter studies using an 8 mg daily dose of Rapaflo.
There were 923 male participants in the studies with an average age of 64.6 years.
Of the 923, 89.3 percent were Caucasian, 4.9 percent were Hispanic, 3.9 percent
were African-American, 1.2 percent were Asian and 0.8 percent were identified as
"other." The participants were randomized and, of the 923 patients, 466 received an
8 mg daily dose of Rapaflo. In these studies, Rapaflo produced a statistically
significant improvement in BPH symptoms and urinary flow rate when compared to
placebo.

COMMON SIDE EFFECTS / SAFETY ISSUES / CONTRAINDICATION

It is important that patients know and health care professionals recognize that cancer
of the prostate gland and BPH cause many of the same symptoms and that these
two diseases, BPH and prostate cancer, frequently co-exist. Therefore, patients
thought to have BPH should be examined prior to starting therapy with Rapaflo to
rule out the presence of prostate cancer.

The most common side effect seen with Rapaflo is reduced or no semen during
orgasm. This side effect does not pose a safety concern and is reversible with
discontinuation of the product. Other side effects included dizziness, light-
headedness, diarrhea, orthostatic hypotension (drop in blood pressure upon
standing), headache, nasopharyngitis (a contagious viral infection of the nose and
upper portion of the throat), and nasal congestion. Patients planning cataract
surgery must notify their ophthalmologist that they are taking Rapaflo because of the
possibility of a condition called Intraoperative Floppy Iris Syndrome (IFIS), a
complication associated with cataract surgery in patients on alpha-1 adrenoreceptor
blocker medications. In IFIS the iris of the eye becomes limp and moves in waves as
a result of increases in fluid levels within the eye. This can result in a painful and
extended recovery period in those who have undergone cataract surgery and a
reduction in visual acuity (sharpness). Patients on alpha-blockers or those who have
severe kidney or liver impairment should not use Rapaflo.

MANUFACTURER

Rapaflo is manufactured by Watson Pharmaceuticals Inc., Corona, Calf., and will be
distributed by Watson Pharma Inc. under license from Kissei Pharmaceutical Co.
Ltd., Nagano, Japan.

SALES/MARKET/COMPETITION

Analysts say the drug could gin about $35 million in sales in 2010. The total market
for BPH drugs in the U.S. is about $2 billion. [2]

Reference
[1] FDA News 2008 [2] Watson wins regulatory OK for Rapaflo fiercebiotech.com
October 9, 2008