D- Oral Solution (Concentrated)

Constipation (Chronic Constipation): In every case of chronic constipation, initial treatment should consist of a diet rich in fiber (vegetables, salads, fruits etc.) a generous amount of liquids and much physical exercise. Lactulose is only to be taken when these measures prove insufficient.

Intestinal flora disturbances:

• In damaged to intestinal flora (e.g. following long-term antibiotic treatment)
• gall bladder diseases
• intestinal diseases ( Colitis, Diverticulosis, Megacolon)

Increased blood ammonia levels (hyper ammoniemia in hepatopathy, portal-systemic encephalopathy).

Lactulose is a synthetic disaccharide. Lactulose is metabolized in the colon by the saccharolytic bacteria, producing low molecular weight organic acids (mainly lactic acid), which lowers the pH of the colon contents, promote the retention of water by an osmotic effect; thus increasing peristaltic activity. Lactulose is minimally absorbed; therefore, the pharmacokinetics of the absorbed material are not relevant to the principal therapeutic action.

In constipation ( chronic constipation):

• Adults: Initially 3-6 tea-spoons daily, In long-term therapy 1½-6 tea-spoons daily
• Children up to 14 years: Initially 3 tea-spoons daily, In long-term therapy 1-2 tea-spoons daily
• Infants and toddlers: Initially 1-2 tea-spoons daily, In long-term therapy 1 tea-spoon daily

In damaged intestinal flora:

• Adults: 1-2 tea-spoons daily
• Children: 1 tea-spoon daily

For reduction of blood ammonia level:

• Hyper-ammoniemia in hepatopathy: a maximum of 18-30 tea-spoons daily.
• In portal systemic encephalopathy: hourly doses of 6-9 tea-spoons of Lactulose solution may be used to induce the rapid laxation. When the laxative effect has been achieved, the dose may then be reduced.

There is no significant drug interactions with lactulose. The glycosidic effect of cardiac glycosides can be intensified by potassium deficiency in abuse.

Hypersensitivity to either galactose and or lactose; galactose-free diet, gastro-cardial symptom complex, suspected intestinal obstruction.

Occasionally flatulence, cramp and abdominal discomfort can occur at the beginning of treatment; this is rapidly eliminated by reducing the dose. Overdose can result in diarrhoea. In abuse, loss of electrolytes (primarily potassium).

US FDA Pregnancy Category of Lactulose is B. Studies show that Lactulose has no adverse effects. Decisions regarding use during pregnancy and lactation must be made by registered physician.

Lactulose should be administered with care to patients who are intolerant to lactulose. The dose used in the treatment of (pre) coma hepaticum is usually much higher and may need to be taken into consideration for diabetics.

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.

Osmotic purgatives.

Keep in a dry place away from light and heat. Keep out of the reach of children.