Dextranomer and sodium hyaluronate

Dextranomer and sodium hyaluronate are natural materials made into a gel that is similar to some substances found in your body. dextranomer and sodium hyaluronate helps by thickening the tissues in your anal canal.

Dextranomer and sodium hyaluronate is injected as an implant into your anal canal to treat fecal incontinence (loss of bowel control) in adults.

This medicine is usually given after trying diet changes and other medications that did not work.

Dextranomer and sodium hyaluronate may also be used for reasons not mentioned in this medication guide.

A healthcare provider will give you dextranomer and sodium hyaluronate in an outpatient clinic. Dextranomer and sodium hyaluronate is given as 4 injections directly into the tissues of your anal canal.

You will get an enema to clean out your rectum just before dextranomer and sodium hyaluronate is injected.

You will receive the injections while lying on your side. A small tube called an anoscope will be gently inserted just a few inches into your rectum. This will help the doctor know where to place the needle for the injections of dextranomer and sodium hyaluronate. You will be made as comfortable as possible while the medicine is injected.

Tell your caregivers if you feel severe pain during the injections.

You will be able to get up after the injections are done. However, you should rest for about 60 minutes before leaving the clinic. Your caregivers will check you for any immediate side effects from the injections.

Do not take a hot bath or do physical activity during the first 24 hours after your injection procedure.

You may use a stool softener to make your first bowel movement more comfortable after treatment. Do not keep using the stool softener unless your doctor tells you to.

Dextranomer and sodium hyaluronate injections can cause rectal bleeding or a rectal infection. Call your doctor if rectal bleeding is heavy or you have severe rectal irritation or signs of infection (pain, warmth, swelling, itching, or drainage).

You will be given antibiotic medication to help prevent infection. Use the antibiotic for the full prescribed length of time, even if you do not have symptoms of infection.

Dextranomer and sodium hyaluronate is not effective for everyone, and you may still have fecal incontinence. It may also take 3 to 6 months before you notice the full effects of this medicine. Tell your doctor if your symptoms do not start to improve after 1 month.

You may need more than one treatment with dextranomer and sodium hyaluronate.

It is not known if this medicine will remain effective for longer than 12 months.

You should not receive dextranomer and sodium hyaluronate if you have: rectal infection or bleeding, rectal fissure, rectal tumor, rectal malformation, rectal prolapse, an abnormal passageway between the rectum and vagina, stenosis (narrowing) of your anal canal, a rectal or anal implant (other than Solesta), congested blood vessels in the anus or rectum, inflammatory bowel disease, a history of radiation to your pelvic area, or a weak immune system.

You should not receive this medicine if you are allergic to dextranomer or sodium hyaluronate, or if you have:

• rectal infection, rectal bleeding or inflammation;
• a rectal fissure, rectal tumor, or genetic malformation of your rectum;
• a prolapsed rectum;
• an abnormal passageway between the rectum and the vagina;
• a narrowing (stenosis) of your anal canal;
• any type of implant (other than Solesta) in your anus or rectum;
• congested blood vessels in the anus or rectum;
• active inflammatory bowel disease;
• a history of radiation to your pelvic area; or
• a weak immune system (caused by disease or by using certain medicine).

To make sure dextranomer and sodium hyaluronate is safe for you, tell your doctor if you have:

• an enlarged prostate;
• long-term rectal pain;
• a bleeding or blood clotting disorder such as hemophilia;
• a history of rectal or intestinal surgery, or hemorrhoid repair; or
• if you are pregnant or breast-feeding.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Dextranomer and sodium hyaluronate may cause serious side effects. Call your doctor right away if you have:

• fever;
• sudden or constant urge to pass bowel movements, or feeling like you cannot completely empty your bowels;
• heavy rectal bleeding;
• diarrhea that is bloody;
• painful or difficult urination;
• severe rectal itching, swelling, pain, or drainage (pus);
• bulging tissue from your rectum; or
• sharp pain or stinging sensation during a bowel movement.

Common side effects of dextranomer and sodium hyaluronate may include:

• constipation, diarrhea;
• pain where the medicine was injected;
• mild rectal bleeding;
• mild rectal itching or discomfort;
• dizziness, chills, cold sweat;
• stomach pain; or
• pain during sexual intercourse.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Since dextranomer and sodium hyaluronate is given all at one time, it does not have a daily dosing schedule.

Since dextranomer and sodium hyaluronate is given by a healthcare professional in a medical setting, an overdose is unlikely to happen.

For at least 1 week after your injections, avoid all strenuous activities including sexual intercourse, jogging, horseback riding, bicycling, or vigorous exercise.

For at least 1 month after injection, do not insert anything into your rectum (such as a suppository, enema, or rectal thermometer).

Do not use anti-diarrhea medicine for at least 1 week after treatment with dextranomer and sodium hyaluronate.

Ask your doctor before taking any medication to relieve pain or swelling from your injection procedure. Avoid taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others.

It is unlikely that other drugs you take by mouth or inject will affect dextranomer and sodium hyaluronate used in the anal canal. However, many drugs can interact with each other. Inform all your healthcare providers about all the medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.