Duphalac Side Effects

Generic Name: lactulose

Note: This page contains information about the side effects of lactulose. Some of the dosage forms included on this document may not apply to the brand name Duphalac.

Not all side effects for Duphalac may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to lactulose: oral powder and solution

Side effects include:

Gaseous distention, belching, flatulence, borborygmi, abdominal discomfort (e.g., cramping). Dehydration and hyponatremia in infants.

For Healthcare Professionals

Applies to lactulose: compounding solution, oral powder for reconstitution, oral syrup, oral and rectal liquid

Gastrointestinal

Diarrhea is an indication of overdose. Severe diarrhea may lead to hypovolemia, hypokalemia, and hypernatremia, especially in elderly or acutely ill patients. If diarrhea develops, the dosage should be reduced.

Pneumatosis cystoides intestinalis may occur with lactulose (the active ingredient contained in Duphalac) therapy as a result of increased intracolonic pressure caused by ammonia sequestration in the bowel, and particularly when there is a concomitant breach of intestinal mucosal integrity.

Gastrointestinal side effects have included abdominal cramps, gaseous distention, flatulence, belching, bowel distention, cramping, nausea and vomiting, and with excessive doses, diarrhea. Colonic dilatation has been reported in elderly patients. Rare cases of pneumatosis cystoides intestinalis have been reported.

Metabolic

Metabolic side effects have included hypernatremia, hypokalemia and hyperchloremic metabolic acidosis. An isolated case of severe and intractable lactic acidosis has been reported.

Fluid and electrolyte disturbances, including severe hypokalemia, hypernatremia and hyperchloremic metabolic acidosis, typically occur as a result of severe diarrhea and subsequent fluid loss. A case of fatal lactulose-induced lactic acidosis in the absence of diarrhea has also been reported. Elderly and/or acutely ill patients may be at increased risk for adverse metabolic effects with lactulose.

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