Lactulose

What is Lactulose?

• Lactulose is a synthetic galactosylfructose disaccharide used in the treatment of constipation and hepatic encephalopathy.
• Lactulose is made from the milk sugar lactose, which is composed of two simple sugars, galactose and glucose.

Lactulose structure

Lactulose ball-and-stick

What are the uses of this medicine?

• Lactulose is used in the treatment of chronic constipation in patients of all ages as a long-term treatment. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
• Lactulose is useful in treating hyperammonemia (high blood ammonia), which can lead to hepatic encephalopathy. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%.
• It is also used as a colon cleansing agent prior to colonoscopy.

How does this medicine work?

In Treatment of chronic constipation:

• Lactulose is poorly absorbed from the gastrointestinal tract and no enzyme capable of hydrolysis of this disaccharide is present in human gastrointestinal tissue.
• As a result, oral doses of lactulose reach the colon virtually unchanged.
• 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 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 hyperammonemia:

• Lactulose causes a decrease in blood ammonia concentration and reduces the degree of portal-systemic encephalopathy.
• Bacterial degradation of lactulose in the colon acidifies the colonic contents.
• This acidification of colonic contents results in the retention of ammonia in the colon as the ammonium ion.
• Since the colonic contents are then more acid than the blood, ammonia can be expected to migrate from the blood into the colon to form the ammonium ion.
• The acid colonic contents convert NH3to the ammonium ion [NH4]+, trapping it and preventing its absorption.
• The laxative action of the metabolites of lactulose then expels the trapped ammonium ion from the colon.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who require a low galactose diet.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• especially antacids, antibiotics including neomycin (Mycifradin), and other laxatives.

Is this medicine FDA approved?

• Lactulose was first made in 1929, and has been used medically since the 1950s.

How should this medicine be used?

Recommended dosage: In Treatment of chronic constipation:

• The usual dose is 1 to 2 tablespoonfuls (15 to 30 mL, containing 10 g to 20 g of lactulose) daily.
• The dose may be increased to 60 mL daily if necessary.
• Twenty-four to 48 hours may be required to produce a normal bowel movement.

In Treating hyperammonemia:

• The usual adult oral dosage is 2 to 3 tablespoonfuls (30 to 45 mL, containing 20 g to 30 g of lactulose Solution) three or four times daily.
• The dosage may be adjusted every day or two to produce 2 or 3 soft stools daily.

Administration:

• Lactulose comes as liquid to take by mouth.
• It usually is taken once a day for treatment of constipation and three or four times a day for liver disease.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Lactulose Solution, USP

This medicine is available in fallowing brand namesː

• Lactulose is available as a generic medication
• Cholac
• Constilac Syrup
• Constulose
• Enulose
• Evalose Syrup
• Generlac
• Heptalac
• Kristalose
• Laxilose
• Portalac

• This branded product is no longer on the market.

What side effects can this medication cause?

The most common side effects of this medicine include:

• flatulence
• intestinal cramps
• diarrhea
• loss of fluids
• hypokalemia
• hypernatremia
• Nausea
• vomiting

What special precautions should I follow?

• Since lactulose solution contains galactose (less than 1.6 g/15 mL) and lactose (less than 1.2 g/15 mL), it should be used with caution in diabetics.
• In the event that an unusual diarrheal condition occurs, contact your physician.
• Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically.
• Non-absorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH.
• 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 solution is administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• diarrhea
• abdominal cramps

Management of overdosage:

• In the event of overdosage medication should be terminated.
• Dialysis data are not available for lactulose.
• Its molecular similarity to sucrose, however, would suggest that it should be dialyzable.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are, however, no adequate and well-controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Each 15 mL of lactulose contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water.

Who manufactures and distributes this medicine?

Manufactured For:

• Morton Grove Pharmaceuticals, Inc.
• Morton Grove, IL

Packaged By:

• Morton Grove Pharmaceuticals, Inc.
• Morton Grove, IL

Distributed By: Wockhardt USA, LLC Parsippany, NJ

What should I know about storage and disposal of this medication?

• Store at 20 ° to 25 °C (68 ° to 77 °F).
• Do Not Freeze.

• Dailymed label info on Lactulose
• FDA Lactulose