I. Flomax Fact File

Flomax was launched by Boehringer Ingelheim.

Boehringer Ingelheim was founded in Ingelheim am Rhein (Germany) in 1885, where the corporate headquarters are still located today.

Boehringer Ingelheim headquartered in Ingelheim, Germany, currently has nearly 36,000 employees and 144 affiliated companies spread around the globe.

The business of Boehringer Ingelheim consists Prescription Medicines, Consumer Health Care and Animal Health. Activities grouped under Industrial Customer, include Fine Chemicals and Biopharmaceuticals.

The focus is on the production of innovative drugs and treatments that represent major therapeutic advances.

II. Flomax medication

Flomax medication is the most widely accepted branded alpha-blocker for Benign Prostatic Hyperplasia (BPH) in the U.S. Generic Flomax is a medication developed specifically to relieve the symptoms of BPH.

Generic Flomax medication does this by relaxing muscles in the prostate and the neck of the bladder resulting in improved urine flow. This is like releasing a pinched straw, which makes it easier for urine to pass out of the body. This may result in reducing the symptoms of Benign Prostatic Hyperplasia.

As with other alpha-adrenergic blocking medications, there is a potential risk of fainting. Patients beginning treatment with Flomax medication should be cautioned to avoid situations where injury could result should fainting occur.

Benign Prostatic Hyperplasia (BPH): Information

Benign Prostatic Hyperplasia (BPH), also known as benign prostatic hypertrophy, is a non-cancerous enlargement of the prostate, a small gland that encircles the urethra in males and produces a fluid that makes up part of semen. As the volume of the prostate increases, it can put pressure on the urethra, causing a slowdown in the urine stream, hesitancy in urinating, a frequent and urgent need to urinate, and sometimes dribbling of urine at the end of the flow. It can also cause urine retention, which can weaken the bladder muscle and increase the risk of developing a urinary tract infection (UTI) or kidney stones. In severe cases of BPH, urine may back up into and damage the kidneys. Rarely, BPH may prevent a patient from urinating at all, a situation that requires immediate medical attention.

BPH can also affect sexual functioning. It can lead to reduced sexual ability, painful orgasm, and impotence. The type and severity of symptoms experienced will vary from person to person and may vary over time. For many men, BPH never progresses beyond a minor to moderate annoyance; for others, it may represent a significant challenge to their quality of life. BPH becomes a very common condition in men as they age. According to the American Urology Association, about 50% of men will have some degree of BPH by the time they are 60 years old, and up to 90% will be affected by age 80. While BPH does not cause prostate cancer, both may be found together.

Diagram 1: Normal Prostate

Diagram 2: Enlarged Prostate

Causes of B PH

The cause of Benign Prostatic Hyperplasia is unknown. It is possible that the condition is associated with hormonal changes that occur as men age. The testes produce the hormone testosterone, which is converted to dihydrotestosterone (DHT) and estradiol (estrogen) in certain tissues. High levels of dihydrotestosterone, a testosterone derivative involved in prostate growth, may accumulate and cause hyperplasia. How and why levels of DHT increase remains a subject of research.

Signs and Symptoms of B PH

Common symptoms of Benign Prostatic Hyperplasia include the following:

• Blood in the urine (i.e., hematuria), caused by straining to void
• Dribbling after voiding
• Feeling that the bladder has not emptied completely after urination
• Frequent urination, particularly at night (i.e., nocturia)
• Hesitant, interrupted, or weak urine stream caused by decreased force
• Leakage of urine (i.e., overflow incontinence)
• Pushing or straining to begin urination
• Recurrent, sudden, urgent need to urinate

In severe cases of BPH, another symptom, acute urinary retention (the inability to urinate), can result from holding urine for a long time, alcohol consumption, long period of inactivity, cold temperatures, allergy or cold medications containing decongestants or antihistamines, and some prescription drugs (e.g., ipratropium bromide, albuterol, epinephrine). Any of these factors can prevent the urinary sphincter from relaxing and allowing urine to flow out of the bladder. Acute urinary retention causes severe pain and discomfort. Catheterization may be necessary to drain urine from the bladder and obtain relief.

Treatment of B PH

There are several treatment options for men with benign prostate hyperplasia, depending on the severity of symptoms. If symptoms do not threaten the man's health, he may choose not to be treated. If symptoms are severe enough to cause discomfort, interfere with daily activities, or threaten health, treatment is usually recommended.

• Watchful waiting
  Men with mild symptoms may choose to return for annual examinations. The physician will perform an examination that includes a DRE, PSA tests, and a urinary flow rate. The patient will be asked to describe symptoms in order to determine if the condition is worsening.
  
•   Medication
  5-Alpha reductase inhibitors such as finasteride (Proscar) and dutasteride (Avodart) prevent the conversion of testosterone to the hormone dihydrotestosterone (DHT). In many cases, a treatment period of 6-month is necessary to see if the therapy is going to work. These drugs are taken orally, once a day.
  
• Alpha blockers relax smooth muscle tissue in the bladder neck and prostate, which increases urinary flow. They typically are taken orally, once or twice a day.

Commonly prescribed alpha blockers include the following:

• alfuzosin (UroXatral), extended-release tablet taken once daily
• doxazosin (Cardura), tablet taken once daily
• prazosin (Minipress), capsule taken 2 or 3 times daily
• tamsulosin hydrochloride (Flomax), capsule taken once daily
• terazosin (Hytrin), capsule taken once daily

Patients taking an alpha blocker require follow-up during the first 3 or 4 weeks to evaluate the effect on symptoms and adjust the dosage, if necessary.

• Prostatic stents
  
  Although a Prostatic stent is not a medical treatment, neither does it fall under the classification of a surgical procedure. Prostatic stents are used most often for patients with significant medical problems that prohibit medication or surgery. It is a tiny, spring like device inserted into the urethra. When expanded, it pushes back the surrounding tissue and widens the urethra. Prostatic stents have several advantages:
  
• They can be placed in less than 15 minutes under regional anesthesia.
• Bleeding during and after surgery is minimal.
• The patient can be discharged the same day or the next morning.

There are also several disadvantages:

• Prepositioning can be difficult.
• They may cause irritation and frequent urination.
• They may cause pain or incontinence.
• Removing them (necessary in one-third of cases) can be difficult.
  
• There are several surgical procedures all of which are performed under some form of anesthesia, which you and your doctor may wish to consider. Following, you find brief descriptions of the most common surgical procedures and how they work:

1. Transurethral needle ablation (TUNA) of the prostate
   The doctor destroys the prostate tissue that is causing the obstruction using radiofrequency energy. This is one of the newer techniques.
   
2. Transurethral resection of the prostate (TURP)
   While the patient is under anesthesia, the doctor inserts an instrument into the penis to get to the urethra and removes a part of the inside of the prostate. This reduces the pressure on the urethra and, in turn, symptoms.
   
3. Visual laser ablation of the prostate (VLAP)
   In this procedure, the prostate tissue is cut using a laser fiber, rather than cutting tissue away with a loop as in TURP.
   
4. Transurethral incision of the prostate (TUIP)
   This procedure is similar to TURP, but is used when the prostate is not as enlarged. In TUIP, instead of removing prostate tissue, one or two small cuts are made in the prostate. This also reduces the pressure on the urethra.
   
5. Open prostatectomy
   If the prostate is very large, an incision may be made in the lower abdomen to remove part of the inside of the prostate.

Side effects of BPH Medications

• Side effects of Proscar & Avodart include reduced libido, impotence, breast tenderness and enlargement, and reduced sperm count. Long-term risks and benefits have not been studied.
• Women who may be pregnant must avoid handling dutasteride capsules and broken or crushed finasteride tablets because exposure to the drugs may cause serious side effects to the fetus. Intact tablets are coated to prevent absorption through the skin during normal handling. Patients should wait at least 6 months after dutasteride treatment to donate blood to prevent pregnant women from being exposed to the drug through blood transfusion.
• Side effects of Alpha blockers include headache, dizziness, low blood pressure, fatigue, weakness, and difficulty breathing. Long-term risks and benefits have not been studied.

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III. Useful links

http://www.cdc.gov/

http://www.fda.gov/

http://www.fda.gov/cder/ogd/

http://www.nih.gov/

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi

http://www.health.gov.on.ca/

National Library of Medicine

World Health Organization

http://www.mayoclinic.com/index.cfm

MedicineNet.com

Drugdigest.org

Healthsquare.com

http://www.flomax-bph.com/

http://www.boehringer-ingelheim.com/corporate/corp/corp_hist.htm

http://www.boehringer-ingelheim.com/corporate/asp/global/global.asp

http://www.boehringer-ingelheim.com/corporate/products/products.htm

http://www.labtestsonline.org/understanding/conditions/bph.html

http://www.urologychannel.com/prostate/bph/index.shtml

http://www.urologychannel.com/prostate/bph/treatment_med.shtml

http://www.urologychannel.com/prostate/bph/treatment_med.shtml

Pharmacy sites

http://www.roche.com/home/company/com_hist.htm

http://www.healthdigest.org/Bactrim-DS(Oral)_2006_PRO.php

http://www.hsforum.com/stories/storyReader$1509

http://www.hsforum.com/stories/storyReader$1516

http://www.hsforum.com/stories/storyReader$1504

http://www.people.vcu.edu/~urdesai/atc.htm#Process%20of%20clotting

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