Lactulose is a semi-synthetic disaccharide used in the treatment of constipation and hepatic encephalopathy. It consists of the monosaccharides fructose and galactose. In the colon, lactulose is broken down primarily to lactic acid, and also to small amounts of formic and acetic acids, by the action of b-galactosidase from colonic bacteria, which results in an increase in osmotic pressure and slight acidification of the colonic contents. This in turn causes an increase in stool water content and softens the stool. In treating hepatic diseases (hepatic encephalopathy), lactulose draws out ammonia from the body in the same way that it draws out water into the colon.

Treatment of chronic and habitual constipation.

Treatment of acute and the prevention and treatment of chronic Portal-systemic encephalopathy including

the stages of hepatic pre-coma and coma.

Constipation:
Adults: Initially 15 ml twice daily, adjusted according to patient's need.
Children: Under 1 year: 2.5 ml twice daily
1-5 years: 5 ml twice daily
5-10 years: 10 ml twice daily

Hepatic encephalopathy: 30-50 ml 3 times daily, subsequently adjusted to produce 2-3 soft stools daily.

Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhoea.

It should be used with caution in patients with lactose intolerance and diabetes.

Lactulose is contraindicated in patients with galactosaemia and intestinal obstruction.

Pregnancy
Pregnancy Category B. Lactulose oral solution has been shown to be safe and effective for the treatment of constipation associated with pregnancy when administered to women at different stages of pregnancy.
Lactation
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lactulose is administered to a nursing woman.

There have been no reports of accidental overdosage. In the event of acute overdosage it is expected that diarrhoea and abdominal cramps would be the major symptoms.

Inolac oral solution: Each amber glass bottle contains 100 ml oral solution with a measuring cup.