Lactulose chemical structure
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Acilac

Lactulose (Generlac®, Cholac®, Constilac®, Enulose®, Acilac®) is a synthetic sugar used in the treatment of constipation and liver disease. It consists of the monosaccharides fructose and galactose. more...

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Constipation

In the treatment of chronic constipation, its metabolites draw water into the bowel, causing a cathartic effect through osmotic action.

Hepatic encephalopathy

In treating hepatic encephalopathy, lactulose helps "draw out" ammonia (NH3) from the body. The effectiveness of lactulose is somewhat controversial, and whether or not its effects are through ammonia is also controversial as well. Lactulose is metabolized in the colon by bacterial flora to short chain fatty acids, acidifying the colonic contents. This favors the formation of the nonabsorbable NH4+ from NH3, trapping NH3 in the colon and effectively reducing plasma NH3 concentrations.

Bowel Withholding

Lactulose can be used to treat children that withhold their bowel movements out of fear. The usual dosage is 1 tsp. for each year of the child's age, up to 30 ml. Mixed with juice, it is undetectable and works within four hours.

Side effects

Side effects include diarrhea and resultant dehydration and high sodium levels. In rare cases or with excess amounts can cause stomach pain, gas, vomiting, or diarrhea.

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US FDA Approval of Technilab's Mirabel Complex - a
From Business Wire, 2/11/98

MIRABEL, Quebec--(BUSINESS WIRE)--Feb. 11, 1998--TECHNILAB PHARMA(ME:TAB.) (TSE:TAB.) Technilab Pharma Inc. announced today that US FDA (Food and Drug Administration) approval has been recently received for the manufacture, at its new Mirabel complex, of Acilac(R), a gastro-intestinal pharmaceutical drug.

Technilab is already marketing Acilac(R) in the American market on the basis of prior US FDA approval of its older Montreal manufacturing plant. The company's new Mirabel complex was inspected by the FDA in December 1997 and was found to comply with US standards for pharmaceutical manufacturing of Acilac(R). The new approval allows Technilab to consolidate all manufacturing operations in its Mirabel complex and increase production efficiency.

The site approval process took two years and was completed on schedule. Technilab has a strong record of compliance with regulatory authorities and, although the Canadian and US standards are comparable, the US requires the implementation of different operational systems. Many of Technilab's scientists and professionals accomplished a task which represents a significant undertaking for any Canadian pharmaceutical manufacturer.

"The approval is right on time," explained Technilab Chairman and CEO, Jean-Guy Sabourin at the company's annual shareholders meeting, held this morning. "The $10 million expansion program of our new Mirabel complex, started two years ago, is now complete. The new complex houses all our research, development, laboratory and manufacturing facilities and will allow us to better meet the increasing demand for generic medicines in Canada and in strongly- expanding export markets. The FDA approval will also facilitate future applications for new product marketing in the American market. As US sales develop in line with our marketing objectives, we expect to increase employment by an additional 40 to 50 persons who will join a team of highly-educated and scientifically-trained employees, working with some of the most sophisticated technology available in the world."

Technilab Pharma Inc. develops, manufactures and sells pharmaceutical products. The company, Canada's leading manufacturer of generic drugs in liquid and topical dosage forms, currently markets some 90 prescription and over-the-counter products. Headquartered in Mirabel, the company was founded in 1974 and employs a staff of 225. The company benefits from highly-advanced facilities, a solid scientific team and a Canada-wide sales force.

CONTACT: Technilab Pharma Inc.

Vincent Taillefer, 514/433-7673 extension 337

COPYRIGHT 1998 Business Wire
COPYRIGHT 2000 Gale Group

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