Lactulose Solution

For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma.

Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients' protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose has been given for over 2 years in controlled studies.

Precise frequency data are not available.

Lactulose may produce gaseous distention with flatulence or belching and abdominal discomfort such as cramping in about 20% of patients. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia. Nausea and vomiting have been reported.

Signs and Symptoms: There have been no reports of accidental overdosage. In the event of overdosage, it is expected that diarrhea and abdominal cramps would be the major symptoms. Medication should be terminated.

Oral LD50: The acute oral LD50 of the drug is 48.8 mL/kg in mice and greater than 30 mL/kg in rats.

Dialysis: Dialysis data are not available for lactulose. It's molecular similarity to sucrose, however, would suggest that it should be dialyzable.

Lactulose is a type of sugar. It is broken down in the large intestine into mild acids that draw water into the colon, which helps soften the stools.

Lactulose is used to treat chronic constipation.

Lactulose is sometimes used to treat or prevent certain conditions of the brain that are caused by liver failure, which can lead to confusion, problems with memory or thinking, behavior changes, tremors, feeling irritable, sleep problems, loss of coordination, and loss of consciousness.

Lactulose may also be used for purposes not listed in this medication guide.

You should not use this medication if you are on a special diet low in galactose (milk sugar).

To make sure you can safely take lactulose, tell your doctor if you have other medical conditions, especially:

• diabetes; or
• if you need to have any type of intestinal test using a scope (such as a colonoscopy).

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether lactulose passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Your pharmacist can provide more information about lactulose.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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