Diagnosis

You can get help

Accidental bowel leakage (which your doctor may also call fecal incontinence) is not a normal part of aging. It is a medical problem, and most people can get some relief with the right treatment. Simply knowing more about your particular condition can give you a better sense of control. The first step is to talk to your doctor.

A doctor can usually make a diagnosis based on a physical exam, your medical history, and tests that will provide better insight about your condition. The tests can be completed during an outpatient visit.

Tests to diagnose fecal incontinence may include

Manometry. This is a test that checks the tightness of your anal muscles. They may be too weak to function
Anorectal ultrasound. This test checks the structure of your muscles. There may be something wrong, causing them not to work
Stool tests. These tests check to see if there’s a reason for diarrhea (such as infection)
Sigmoidoscopy. A camera fitted into a thin tube is used to see if there are problems such as tumors, inflammation, or scar tissue in the rectum or colon
DRE (digital rectal exam). This physical exam is used to identify patients with fecal impaction and overflow

Fecal incontinence can be treated. Talk to your doctor today.

Read more about accidental bowel leakage, how your bowels work, the causes of fecal incontinence, and the available treatment options.

Indication for SOLESTA

SOLESTA^® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg. diet, fiber therapy, anti-motility medications).

Important Safety Information about SOLESTA

It is important for you to know that SOLESTA^® (hyaluronic acid/dextranomer) does not work for everyone and you may not benefit from SOLESTA treatment. It is also important for you to know that you may not experience immediate improvement after your first treatment with SOLESTA and the full effects of SOLESTA may not be apparent until 3 to 6 months after treatment.

People who have an infection or who are currently experiencing bleeding in the rectum or anus should not receive SOLESTA. People who have problems in the rectum or anus, such as tumor, abnormal anatomy, large dilated blood vessels (hemorrhoids), or cracks in the tissue (anal fissures) should not receive SOLESTA. People who have active inflammation of their bowels (Crohn’s disease or ulcerative colitis) should not receive SOLESTA. People who have trouble fighting off infection (immunodeficiency disorder such as HIV/AIDS) or who take medication to suppress the immune system, such as those used in cancer or organ transplant patients, should not receive SOLESTA. If you already have a device or material placed in your rectum or anus, or if you have had radiation treatments in your pelvic area before, you should not receive SOLESTA.

The most common risks of treatment with SOLESTA in the clinical study were mild or moderate pain or discomfort in the rectum or anus, and minor to moderate bleeding or spotting from the rectum following treatment. Some patients experience fever, abdominal pain, diarrhea, or constipation after treatment.

More serious risks including infection and inflammation of the tissues in the anus may occur but are not common.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for SOLESTA.