I. Urecholine Fact File

Urecholine was introduced by Odyssey Pharmaceuticals.

Odyssey Pharmaceuticals, Inc. was established in February 2000 as a wholly owned subsidiary of Sidmak Laboratories, a leading U.S. - based pharmaceutical manufacturer. In July of 2002, Sidmak Laboratories was acquired by PLIVA D.D., Zagreb, Croatia, the largest pharmaceutical company in Central and Eastern Europe.

Odyssey Pharmaceuticals, Inc. is now a wholly owned subsidiary of PLIVA, Inc. The name change from Sidmak Laboratories, Inc. to PLIVA, Inc. took place in March of 2003. There has been no name change to Odyssey Pharmaceuticals, Inc.

The Odyssey product line now includes seven marketed products. These include medicines to treat alcoholism, depression, asthma, and acute, non-obstructive urinary retention. Odyssey is also developing eight new products, including products for the treatment of diabetes, Amyotrophic Lateral Sclerosis (ALS) or Lou Gehrigs's Disease, asthma, sleep disorders, and chronic headache.

II. Urecholine Medication

Urecholine is a tablet that helps people with acute non-obstructive urinary retention to urinate and empty their bladders.

Urecholine (bethanechol chloride) is indicated for the treatment of acute post-operative and post partum non-obstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

Non-obstructive (functional) urinary retention: When people cannot urinate or completely empty their bladders, they have urinary retention. Sometimes urinary retention happens when the flow of urine is blocked. This is called obstructive urinary retention. Other times the muscles in the bladder that normally squeeze or contract to push the urine out, do not work properly. This type of urinary retention is non-obstructive.

Normally a natural chemical called a neuro-transmitter carries “directions” to the bladder muscles, telling them to contract and squeeze the bladder until it empties. Urecholine works like the body's natural chemical. It tells the bladder muscles to squeeze when the natural signal is not working properly. Sometimes doctors use Urecholine after a patient has been catheterized and sometimes they use it in place of a catheter.

Urecholine may start working as early as 30 minutes after the tablet is taken. Its greatest effects usually occur within 60 to 90 minutes.

Acute Urinary Retention: Information

Anyone can experience acute urinary retention. The causes and rate of occurrence varies greatly between genders. At about the age of 60, men are more often affected as a result of benign prostatic hyperplasia (BPH).

In a certain number of men, BPH eventually leads to more serious problems. In a recent study that followed over 3,000 men with enlarged prostates and moderate to severe symptoms of BPH for over four years, one in seven untreated patients experienced a condition known as acute urinary retention (AUR) or had to undergo surgery by the end of the study.

Acute urinary retention (i.e., the sudden inability to urinate) is usually symptomatic of another condition that requires treatment. Acute urinary retention (i.e., the sudden inability to urinate) is usually symptomatic of another condition that requires treatment.

In acute urinary retention, pressure from the enlarged prostate cuts off the flow of urine, making it impossible to urinate. This is an emergency, usually requiring the insertion of a tube through the penis into the bladder to allow urine to drain. The tube may need to stay in place for several weeks. Surgery is often necessary when symptoms become severe or cannot be controlled with drug therapy.

Risk Factors of Acute Urinary Retention

Kidney stones, prostate cancer, prostatitis, and BPH are risk factors in men. Women with a history of kidney stones or urinary tract infections (UTIs), pregnant women, and those who have had recent gynecological surgery are at higher risk.

Causes of Acute Urinary Retention

Acute urinary retention may be caused by obstruction in the bladder or in the tube that carries urine from the bladder outside the body (urethra), by a disruption of sensory information in the nervous system (e.g., spinal cord or nerve damage), or by distention (swelling) of the bladder (e.g., by delaying urination for a long period of time).

Factors associated with acute urinary retention include the following:

• Alcohol consumption
• Allergy or cold medications containing decongestants or antihistamines
• Certain prescription drugs (e.g., ipratropium bromide, albuterol, epinephrine) that cause the urethra to narrow
• Delaying urination for a long time
• Long period of inactivity or bed rest
• Prolonged exposure to cold temperatures
• Spinal cord injury/nerve damage
• Surgery (e.g., complication of anesthesia)
• Urinary system obstruction (e.g., BPH, kidney stones)
• Urinary tract infection

Signs and Symptoms of Acute urinary Retention

Acute urinary retention produces severe lower abdominal pain, a distended abdomen, and/or the sudden inability to pass urine.

Complications that may develop with untreated urinary retention include bladder damage and chronic kidney failure.

The Prostate: Information

The prostate is a small gland located just below the bladder. It surrounds the urethra, the tube through which urine flows. The prostate produces fluid that combines with sperm and other fluids to form semen.

The prostate reaches its adult size, a little less than an ounce, by age 20. Typically, growth stops at this time, then begins again at about age 45 and continues throughout life.

Diagram 4: Healthy Prostate

Side Effects of Urecholine

Although side effects from Urecholine (bethanechol) are not common, they can occur. Do let your doctor know if any of these symptoms are severe or do not go away:

• upset stomach
• vomiting
• dizziness
• sweating or flushing

If you experience any of the following symptoms, call your doctor immediately:

• shortness of breath
• fainting
• slow heart rate (pulse less than 50 beats per minute).

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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

About.com Health section

http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682849.html#side-effects

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 of clotting

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