Pronunciation:

mon-OK-ta-noin

Uses of This Medicine:

Monoctanoin is used to dissolve cholesterol gallstones. Gallstones, which are found in the gallbladder or bile duct, sometimes remain in the bile duct even after the gallbladder has been removed by surgery. These stones may be too large to pass out of the body on their own. A catheter or tube is used to put the solution of monoctanoin into the bile duct where it will come in contact with the gallstone or gallstones and dissolve them. This process continues for 2 to 10 days.

Monoctanoin is administered only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of monoctanoin in children with use in other age groups.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of monoctanoin in the elderly with use in other age groups.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bile duct blockage—The chance of serious side effects may be increased

• Biliary tract problems (other) or
• Jaundice or
• Pancreatitis (inflammation of the pancreas)—Monoctanoin may make these conditions worse

• Duodenal ulcer (recent) or
• Intestinal problems—Monoctanoin may make these conditions worse and may increase the chance of bleeding

• Liver disease (severe)—Unwanted effects may occur if the liver is not working properly

Proper Use of This Medicine:

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For irrigation dosage form:
  • For gallstone disease:
    • Adults and teenagers—The usual dose is 3 to 5 milliliters (mL) per hour given through a catheter or tube. The dose is given over a period of 2 to 10 days.
    • Children—Use and dose must be determined by your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Abdominal or stomach pain (severe)

back pain (severe)

chills, fever, or sore throat

drowsiness (severe)

nausea (continuing)

shortness of breath (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach pain (mild) or burning sensation

Less common or rare

Back pain (mild)

diarrhea

flushing or redness of face

loss of appetite

metallic taste

nausea or vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.