The document discusses Sofosbuvir, a breakthrough drug approved by the FDA in 2013 to treat hepatitis C. Sofosbuvir directly targets the hepatitis C virus, attaching to its RNA to stop it from multiplying in the liver. It is effective against genotypes 1-4 of the virus and offers all-oral treatment options without interferon for some genotypes. A 400mg dose of Sofosbuvir has been found effective in combination therapies lasting 12-24 weeks.

1. URO PRODUCTS

2. Prostate Glands
• The prostate (or prostate gland) is part of a man’s reproductive
and urinary systems lies below the urinary bladder and is
located in front of the rectum.
• It is about the size of a walnut in younger men, but it starts to
get larger when men reach their late 40s and early 50s.
• The seminal vesicles are located at the base of the prostate.

3. • The prostate gland is a pyramid-shaped organ with apex
(contact to the urethra and directed downward) and basis
(contact to the bladder and directed upward).
• Most men have continued prostate growth throughout life.
• In many men, this continued growth enlarges the prostate
enough to cause urinary symptoms or to significantly block
urine flow.

5. Seminal vesicles
• The seminal vesicles are glands found on each side of the prostate.
• They make most of the fluid in semen.
The prostate is divided into the following areas.
 The peripheral zone is the largest area of the prostate.
 The transition zone surrounds the part of the urethra that passes
through the prostate (called the prostatic urethra). This zone gets
bigger as men age, a condition called benign prostatic hyperplasia
(BPH).
 The central zone lies behind the transition zone and surrounds the
ejaculatory ducts, which run from the seminal vesicles to the
prostatic urethra.

7. Function
Prostatic secretion
The main function of the prostate is to make prostatic fluid.
 Prostatic fluid is rich in enzymes, proteins and minerals that
help protect and nourish sperm.
 When a man is sexually aroused, the prostate pushes
prostatic fluid through the ducts and into the urethra.
Prostatic fluid mixes with sperm and other fluids in the
urethra and is ejaculated as semen.

8. Control of urine or semen flow
• The prostate acts as a kind of valve, preventing urine flow
during the ejaculation and or permitting urine flow in between.

10. BPH
 Prostate gland enlargement is a common condition as men get
older. Also called benign prostatic hyperplasia (BPH), prostate
gland enlargement can cause bothersome urinary symptoms.
 Untreated, prostate gland enlargement can block the flow of
urine out of the bladder and cause bladder, urinary tract or
kidney problems.
 There are several effective treatments for prostate gland
enlargement, including medications, minimally invasive
therapies and surgery.

11. Symptoms
The severity of symptoms in people who have prostate gland
enlargement varies, but symptoms tend to gradually worsen over
time. Common signs and symptoms of BPH include:
 Frequent or urgent need to urinate
 Increased frequency of urination at night (nocturia)
 Difficulty starting urination
 Weak urine stream or a stream that stops and starts
 Straining while urinating
 Inability to completely empty the bladder
Less common signs and symptoms include:
 Urinary tract infection
 Inability to urinate
 Blood in the urine

12. Risk factors for prostate gland
enlargement include:
 Aging. Prostate gland enlargement rarely causes signs and symptoms in
men younger than age 40. About one-third of men experience moderate to
severe symptoms by age 60, and about half do so by age 80.
 Family history. Having a blood relative, such as a father or brother, with
prostate problems means you're more likely to have problems.
 Ethnic background. Prostate enlargement is less common in Asian men
than in white and black men. Black men might experience symptoms at a
younger age than white men.
 Diabetes and heart disease. Studies show that diabetes, as well as heart
disease and use of beta blockers, might increase the risk of BPH.
 Lifestyle. Obesity increases the risk of BPH, while exercise can lower your
risk.

13. Complications
 Sudden inability to urinate (urinary retention). need to have a tube
(catheter) inserted into your bladder to drain the urine. Some men
with an enlarged prostate need surgery to relieve urinary retention.
 Urinary tract infections (UTIs). Inability to fully empty the bladder
can increase the risk of infection in urinary tract.
 Bladder stones. These are generally caused by an inability to
completely empty the bladder. Bladder stones can cause infection,
bladder irritation, blood in the urine and obstruction of urine flow.
 Bladder damage. A bladder that hasn't emptied completely can
stretch and weaken over time. As a result, the muscular wall of the
bladder no longer contracts properly, making it harder to fully
empty your bladder.
 Kidney damage. Pressure in the bladder from urinary retention can
directly damage the kidneys or allow bladder infections to reach the
kidneys.

14. Medication
Medication is the most common treatment for mild to moderate symptoms of prostate
enlargement. The options include:
 Alpha blockers. These medications relax bladder neck muscles and muscle fibers in the
prostate, making urination easier. Alpha blockers — which include alfuzosin
(Uroxatral), doxazosin (Cardura), tamsulosin (Flomax), and silodosin (Rapaflo) —
usually work quickly in men with relatively small prostates.
 5-alpha reductase inhibitors. These medications shrink our prostate by preventing
hormonal changes that cause prostate growth. These medications — which include
finasteride (Proscar) and dutasteride (Avodart) — might take up to six months to
be effective. Side effects include retrograde ejaculation.
 Combination drug therapy. taking an alpha blocker and a 5-alpha reductase inhibitor
at the same time if either medication alone isn't effective.
 Tadalafil (Cialis). this medication, which is often used to treat erectile dysfunction, can
also treat prostate enlargement. However, this medication is not routinely used for BPH
and is generally prescribed only to men who also experience erectile dysfunction.

15. Alpha blockers
– Alfuzosin
– Doxazosin
– Prazosin
– Silodosin
– Tamsulosin
– Terazosin

16. ?
Receptor
a receptor is a protein molecule that receives
chemical signals from outside a cell
a molecule on the cell surface within a cell,
that recognizes and binds with specific molecules,
producing some effect in the cell.

17. There are 3 types of alpha-1 receptors
alpha-1 (α1) adrenergic receptor
1. Alpha 1A
2. Alpha 1B
3. Alpha 1D

18. Alpha-1A and 1D receptors
• Found in the bladder, ureters, and prostate
• Stimulating alpha-1A and 1D receptors inhibits urine flow
Alpha-1B receptors
• Found in arteries and veins
• Stimulating alpha-1B receptors causes vasoconstriction and raises blood
pressure

19. Alpha blockers differ by which types of alpha-1 receptors they block:
Antihypertensive Drugs
• Doxazosin - nonselective (blocks all alpha receptors)
• Terazosin - nonselective (blocks all alpha receptors)
• Prazosin - nonselective (blocks all alpha receptors)
• Prostate Relaxation
• Silodosin - selective for Alpha-1A and Alpha-1D
• Tamsulosin - selective for Alpha-1A and Alpha-1D
• Alfuzosin - selective for Alpha-1A and Alpha-1D
• Doxazosin
• Terazosin

20. FDA-APPROVED INDICATIONS
Alfuzosin - Benign prostatic hyperplasia (BPH)
Doxazosin
– Benign prostatic hyperplasia (BPH)
– Hypertension
Doxazosin - Benign prostatic hyperplasia (BPH)
Prazosin - Hypertension
Silodosin - Benign prostatic hyperplasia (BPH)
Tamsulosin - Benign prostatic hyperplasia (BPH)
Terazosin
– Benign prostatic hyperplasia (BPH)
– Hypertension

21. The dynamic component of BPH is associated with prostatic smooth muscle
tone.. Excessive stimulation of postsynaptic α1-adrenergic receptors causes
the smooth muscle of the prostate, prostatic capsule, bladder neck, and
proximal urethra to contract, and causes a decrease in the urethral lumen.
Resultant obstructive voiding
 symptoms include difficulty in urination, a decreased force of urinary
stream, urinary hesitancy,
 straining to void, incomplete bladder emptying, urinary dribbling, and
intermittent urinary
 Administration of α1-blockers relaxes both the bladder
neck and prostatic smooth muscle, thus decreasing
pressure in the bladder and urethra and improving
urinary flow.20 These agents are more effective at
improving obstructive symptoms than irritative symptoms

22. There are two commonly associated male
physiological events that have a similar etiology.
 Enlarged prostate or benign prostatic hyperplasia (BPH) and
 male pattern baldness are both related to the enzyme 5-
reductase.
 Hirsutism (Hirsutism is the presence of excess hair in
women.)in women is also related to this enzyme.
 An excess in activity of 5- reductase has been
shown to be responsible for enlarged prostate and
male pattern baldness, as well as hirsutism in
women

23. 5α-reductase, which is an enzyme responsible
for conversion of testosterone to
dihydrotestosterone.
 Inhibition of such conversion maintains prostate health.
 5- Reductase catalyzes the conversion of testosterone to
5 dihydrotestosterone (5 DHT).
5DHT:- Responsible for Prostate
enlargement

24. Two isoenzymes of 5AR exist:
Type 1 and Type 2
• Type 1 is most abundant in the liver and skin,
but is found, to a lesser degree, in the prostate
as well.
• It is also the dominant isoform in sebaceous
glands.

25. Type 2
Type 2 is the dominant isoenzyme in the prostate,
and is minimally present in the liver and skin.
Their primary function is to convert testosterone
to DHT.
Finasteride has proven to selectively inhibit the
Type 2 isoenzyme whereas dutasteride
competitively inhibits both forms of the enzyme.

26.  The guidelines state that the 5α-reductase inhibitors
finasteride and dutasteride are appropriate and
effective treatments for patients with LUTS
associated with demonstrable prostatic enlargement,
 but they are not appropriate treatments for men with
LUTS who do not have evidence of prostatic
enlargement.

27. • patients exhibiting symptomatic prostatic
enlargement but without an impact on their daily
life
• 5α-reductase inhibitor could prevent progression
of the disease.

32. URO PRODUCTS

33. • US FDA has approved Sofosbuvir under the
brand name Sovaldi for the treatment
chronic HCV infection in6 December, 2013.

34. • Sofosbuvir—a breakthrough medicine that
directly targets the hepatitis C (Hep C) virus.
Combination therapy with SOFOSBUVIR has
been shown to be effective for people with
Hep C genotypes 1, 2, 3, and 4.

35. • What is a genotype?
• Just as there are different blood types, there
are also different types of Hep C, called
genotypes. There are 6 main genotypes.
SOFOSBUVIR has been shown to work in
genotypes 1, 2, 3, and 4. SOFOSBUVIR
combination therapy is the first all-oral
treatment for genotypes 2 and 3.

36. • What the Hep C virus does ?
• The Hep C virus infects a liver cell. Then, it
uses the cell to create new copies of itself.
These copies then leave the cell and move on
to infect other liver cells, creating more copies

37. • What Sofosbuvir does?
• Sofosbuvir directly targets the Hep C virus to
stop it from making copies of itself in the
liver. Sofosbuvir attaches itself to the genetic
information, called RNA, to block the virus
from multiplying.

38. • A dose of 400 mg of sofosbuvir has been
found to be most effective, with treatment
durations ranging from 12 to 24 weeks, in
various combinations of PEG-IFN and
ribavirin

39. • Sofosbuvir is a promising therapy for chronic
HCV infection, as it offers several advantages
over the existing therapies, particularly in
dealing with patients with decompensated
liver disease and patients who cannot tolerate
interferon-containing therapies.