Dextranomer and sodium hyaluronate

Name: Dextranomer and sodium hyaluronate

What is dextranomer and sodium hyaluronate?

Dextranomer and sodium hyaluronate are natural materials formed into a gel that is similar to certain substances that occur naturally in your body. This medicine works 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 diet changes and other medications have been tried without success.

Dextranomer and sodium hyaluronate may also be used for purposes not listed in this medication guide.

How is dextranomer and sodium hyaluronate given?

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

You will be given 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 determine where to properly place the needle when injecting dextranomer and sodium hyaluronate. You will be made to feel 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 your injections are completed. However, you should remain resting for about 60 minutes before leaving the clinic. Your caregivers will check you for any immediate side effects the injections may cause.

Do not take a hot bath or engage in 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 continue 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 be given antibiotic medication to help prevent infection. Use the antibiotic for the full prescribed length of time, even if you have no symptoms of infection.

Dextranomer and sodium hyaluronate is not effective in every person and you may continue to have fecal incontinence. It also may take 3 to 6 months before you notice the full effects of this medicine. Tell your doctor if your symptoms do not begin to improve after 1 month.

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

It is not known whether this medicine will continue to be effective for longer than 12 months.

Dextranomer and sodium hyaluronate side effects

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.

Call your doctor at once 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 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.

What other drugs will affect dextranomer and sodium hyaluronate?

It is not likely that other drugs you take orally or inject will have an effect on dextranomer and sodium hyaluronate used in the anal canal. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

How is this medicine (Dextranomer and Sodium Hyaluronate) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • This medicine is for rectal use only. Do not take dextranomer and sodium hyaluronate by mouth.
  • Your doctor will give this medicine.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Bleeding from rectum or rectal pain.
  • Bloody loose stools (diarrhea).
  • Fever.
  • Trouble passing urine.
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