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Tuesday, 24 April 2018 11:09

Onlac

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Onlac

Lactulose

 

Presentation

Onlac 100 ml: Each 5 ml concentrated oral solution contains Lactulose USP 3.35 gm.

Onlac 200 ml: Each 5 ml concentrated oral solution contains Lactulose USP 3.35 gm.

 

Description

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 ß-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.

 

Indication

1. Constipation (chronic constipation)

2. Hepatic encephalopathy (HE): treatment and prevention of hepatic coma or precoma

3. Intestinal flora disturbances: In damage to intestinal flora, following therapy with broad        spectrum antibiotics, gall bladder diseases and intestinal diseases (colitis, diverticulitis,                 megacolon etc.)

4. Increased blood ammonia levels (hyperammoniemia in hepatopathy, portal systemic            encephtopathy, precoma and coma)

 

Dosage & Administration

1. Constipation:

Adults: (including the elderly): 15 ml twice daily.

Children: 5 to 10 years: 10 ml twice daily.

Children under 5 years: 5 ml twice daily.

Babies under 1 year: 2.5 ml twice daily. Onlac solution may, if necessary, be taken with water or fruit juice, etc.

2. Hepatic encephalopathy:

Adults (including the elderly): Initially 30-50 ml three times a day. Subsequently adjust the dose to produce two or three soft stools each day.

Children: No dosage recommended for this indication.

3. In damaged intestinal flora (e.g. following long-term antibiotic treatment):

Adults: 5-10 ml daily.

Children: 5 ml daily.

4. To reduce blood ammonia level (In hepatopathy):

A maximum of 60-100 g lactulose daily.

 

Side-effects

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

 

Precautions

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

 

Use in Pregnancy and Lactation

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.

 

Contraindications

Lactulose is contraindicated in patients with galactosaemia and intestinal obstruction.

 

Drug Interactions

Nonabsorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH. Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose.

 

Overdosage

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.

 

Storage

Keep in a cool and dry place, away from light (below 25° C temperature). Keep out of the reach of children.

 

Commercial Pack

Onlac 100 ml: Each amber PET bottle contains 100 ml oral solution with a measuring cup.

Onlac 200 ml: Each amber PET bottle contains 200 ml oral solution with a measuring cup.

 

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