Monoctanoin (Injection)

Monoctanoin is used to dissolve cholesterol gallstones. Gallstones, which can be found in the gallbladder or bile duct, may sometimes stay in the bile duct even after the gallbladder has been removed by surgery. These stones might be too large to leave the body on their own. A catheter or tube is used to deliver the monoctanoin solution into the bile duct, where it will contact the gallstone or gallstones and dissolve them. This process lasts for 2 to 10 days.

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

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Research on this medicine has only been conducted with adult patients, and there is no specific information comparing the use of monoctanoin in children to its use in other age groups.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction could occur. In these situations, your doctor may want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating or with certain types of food, as interactions may happen. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Bile duct blockage—The risk of serious side effects may be higher

• Other biliary tract problems or
• Jaundice or
• Pancreatitis (inflammation of the pancreas)—Monoctanoin may worsen these conditions

• Recent duodenal ulcer or
• Intestinal problems—Monoctanoin may worsen these conditions and increase the risk of bleeding

• Severe liver disease—Unwanted effects may occur if the liver is not functioning properly

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, 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 happen 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, 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.

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.