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COLAZAL – balsalazide disodium

Living with UC




Managing Ulcerative Colitis

This information is intended for U.S. residents only.

Stress and UC

Although stress does not cause UC, significant stress may aggravate the symptoms of your disease. Try to do your best to manage the stress in your life both at work and at home. It may be helpful to call on your friends and family to help you, or to seek the advice of your physician. Many people find that joining a support group devoted to inflammatory bowel disease (IBD) is beneficial because they can share their experiences and concerns with others who have the disease, and learn tips from others on how they deal with the additional pressures of having the disease.

Try to manage stress in the way that works best for you, such as practicing meditation, doing yoga, exercising or just resting. Do the things that relax you and make you happy!

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Family Planning

The age ranges for women developing UC and for those who may consider starting a family coincide. Because women may develop UC during their reproductive years, it is important for women to discuss their wishes with their physician. Early discussion of these issues may help to ensure the safest outcome for both mother and child.

Fertility in Men and Women - Fertility does not appear to be reduced in men or women with UC. However, there is some controversy about the effects of using some medications to treat IBD in men prior to and during fertilization.1

Pregnancy and Ulcerative Colitis - Most women with UC successfully conceive and give birth to healthy children. However, studies have shown that the risk of preterm birth, fetal complications and stillbirth are higher in women with UC than in healthy women. For women wishing to have children, the most important factor to bear in mind is that the outcome of pregnancy is largely influenced by disease activity at the time of conception.2 If UC is inactive before conception, it is likely to remain inactive during pregnancy; but if the disease is active at the time of conception, it may worsen.

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Colon Cancer and UC

Colon cancer is a complication that can arise in patients with UC. The longer someone has UC, the more he or she is at risk of developing colon cancer. The risk of developing colon cancer is also higher for patients with extensive colon involvement in their disease. In order to detect or prevent the occurrence of colon cancer, it is recommended that patients with UC undergo a colonoscopy (for more on colonoscopy see section on diagnosis). The frequency with which this diagnostic test is administered depends on how long you have had the disease and the extent to which your colon is affected.

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UC Support

Seeking understanding and support from loved ones, your doctor and local support groups can be very comforting.

For more information, for online support and for a list of support groups in your local area, please see the following list of related organizations and helpful links on the World Wide Web.

American Autoimmune Related Diseases Association, Inc.

www.aarda.org
22100 Gratiot Avenue
East Detroit, MI 48021
Phone: (586) 776-3900 or
(800) 598-4668 for literature requests

Provides information on various autoimmune-related diseases. You can read articles from the Association's newsletter, read tips on coping with an autoimmune disorder and learn about upcoming special events.

American College of Gastroenterology (ACG)

www.acg.gi.org
4900 B South 31st Street
Arlington, VA 22206-1656
Phone: (703) 820-7400
Fax: (703) 931-4520

Provides consumer guides on various gastroenterological disorders and common problems, offers digestive health tips, and has a physician locator to find an ACG member in your area.

American Gastroenterological Association

www.gastro.org
7910 Woodmont Avenue
7th Floor
Bethesda, MD 20814
Phone: (301) 654-2055
Fax: (301) 652-3890

The public section of this Web site offers a digestive health resource, a digestive health message board, a gastro- enterologist locator service and various helpful Web links.

American Society for Parenteral and Enteral Nutrition (ASPEN)

www.clinnutr.org
8630 Fenton Street
Suite 412
Silver Spring, MD 20910
Phone: (301) 587-6315
Fax: (301) 587-2365

Provides general information about parenteral and enteral nutrition (PEN), and includes a directory of different PEN products.

Crohn's and Colitis Foundation of America (CCFA)

www.ccfa.org
386 Park Avenue South
17th Floor
New York, NY 10016
Phone: (800) 932-2423
Fax: (212) 779-4098

View the latest news about Crohn's disease and colitis; learn about the latest biomedical research projects; ask physicians your questions about IBD; view general educational information about IBD; find your local CCFA chapter, support groups and their events; find a physician in your area; and read about books offered in the online book store.

Crohn's Disease Resource Center

www.healingwell.com/ibd

Provides information on medical news and includes patient stories and directories of Web sites for patients and family members.

Food and Drug Administration

www.fda.gov
5600 Fishers Lane
Rockville, MD 20857
Phone: (888) 463-6332 for general inquires

Find out information on foods and specific prescription drugs; review safety alerts, recent product approvals and more.

Foundation for Clinical Research in IBD

www.MyIBD.org
c/o Harris Baio & McCullough
520 South Front Street
Philadelphia, PA 19147

The Foundation for Clinical Research in IBD has provided support for many years to the professional community, to encourage and enable continued clinical research into IBD and its treatments.

Foundation for Digestive Health and Nutrition

www.fdhn.org

The Foundation for Digestive Health and Nutrition (FDHN) is the foundation of the American Gastroenterological Association (AGA), the leading professional society representing gastroenterologists and hepatologist worldwide

International Foundation for Functional Gastrointestinal Disorders (IFFGD)

www.iffgd.org
P.O. Box 170864
Milwaukee, WI 53217-8076
Phone: (414) 964-1799 or (888) 964-2001
Fax: (414) 964-7176

Provides information about gastrointestinal disorders, events and meetings of consumer interest, and links to other IFFGD educational Web sites (i.e. - www.aboutIBS.org).

Kids IBD

www.kidsibd.org

Kids IBD is sponsored by the Children's Digestive Health and Nutrition Foundation. The Web site provides information on inflammatory bowel disease (IBD) in children and adolescents.

Medhelp

www.medhelp.org

In the "Ask the Doctor" forum, read questions and answers on Crohn's disease, ulcerative colitis and other disorders; access news articles from the library.

National Institute of Diabetes & Digestive & Kidney Diseases

www.niddk.nih.gov
NIH/ NIDDK
Building 31, Room 9A04
Center Drive, MSC 2560
Bethesda, MD 20892-2560

Access health information on various digestive diseases, information on the Institute's health education programs and clinical trials.

North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN)

www.naspghan.org
P.O. Box 6
Flourtown, PA 19031
Phone: (215) 233-0808
Fax: (215) 233-3939

Provides general information on pediatric gastrointestinal disorders, hepatology and nutrition; offers links to other valuable resources and a "locate a pediatric gastroenterologist" service.

Society of American Gastrointestinal Endoscopic Surgeons (SAGES)

www.sages.org
2716 Ocean Park Boulevard
Suite 3000
Santa Monica, CA 90405
Phone: (310) 314-2404
Fax: (310) 314-2585

Provides information on gastrointestinal procedures and surgeries; offers a "find a SAGES" member in your area service; has an online catalog and store of educational videos; provides legislative updates and access to other helpful Web sites.

Society of Laparoendoscopic Surgeons

www.sls.org
7330 SW 62nd PlaceSuite 410
Miami, FL 33143-4825
Phone: (305) 665-9959 or (800) 446-2659
Fax: (305) 667-4123

Provides information about laparoscopy and endoscopy; offers a "find an SLS surgeon member" service and general patient information on surgery.

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References

  1. Rajapakse R, Korelitz BI. Inflammatory Bowel Disease During Pregnancy. Curr Treat Options Gastroenterol. 2001;4(3):245-251.
  2. Green JRB, Lobo AJ, Holdsworth CD, Leicester RJ, Gibson JA, Kerr GD, et al., and The ABACUS Investigator Group. Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis. Gastroenterology. 1998;114:15-22.


COLAZAL® (balsalazide disodium) Capsules 750 mg are indicated for the treatment of mildly to moderately active Ulcerative Colitis in patients 5 years of age and older. COLAZAL does not relieve symptoms in all patients; your patients' results may vary. In four well-controlled clinical trials, patients receiving a COLAZAL dose of 6.75g/day most frequently reported the following events (reporting frequency > 3%): headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable to placebo. In the pediatric trial, patients most frequently reported the following adverse events: headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%), nasopharyngitis (6%) and, pyrexia (6%). COLAZAL is contraindicated in patients with a hypersensitivity to salicylates or the components of COLAZAL capsules or balsalazide metabolites. The safety and effectiveness of COLAZAL beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.

Consult with your physician to see if this product is right for you.

For complete Prescribing Information, please click here.


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