Lactulose USP 10 g / 15 ml
Clear, viscous, brownish yellow liquid for oral administration.
Lactulose is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of lactulose solution contains 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). Lactulose solution contains potassium sorbate as an inactive ingredient. Lactulose is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy.The chemical name for lactulose is 4-O-ß-D-galactopyranosyl-D-fructofuranose. It has the following structural formula:
The molecular weight is 342.30. It is freely soluble in water
Bacteria in the colon degrade lactulose into lactic acid, acetic acid and formic acid resulting in an increase in osmotic pressure and acidification of intestinal contents which in turn, softens the stool by promoting stool water content.
In hepatic encephalopathy (HE); hepatic coma, the effect has been attributed to suppression of proteolytic bacteria by an increase of acidophilic bacteria (e.g. Lactobacillus), trapping of ammonia in the ionic form by acidification of the colonic contents, catharsis due to the low pH in the colon as well as an osmotic effect, and alteration of the bacterial nitrogen metabolism by stimulating the bacteria to utilize ammonia for bacterial protein synthesis.
Lactulose is poorly absorbed after oral administration and reaches the colon unchanged. Only 0.4 - 2% of a lactulose dose is absorbed from the small intestine, and this proportion is excreted unchanged in urine. The acids produced in the colon are absorbed and metabolised only in part.
Indicated for constipation, conditions requiring facilitated bowel movements and for the treatment of hepatic encephalopathy.
Adult: Oral dosage is 2 to 3 tablespoonful (30 to 45 mL, containing 20 g to 30 g of lactulose) three or four times daily. The dosage may be adjusted every day or two to produce 2 or 3 soft stools daily. Hourly doses of 30 to 45 mL of lactulose solution may be used to induce the rapid laxation indicated in the initial phase of the therapy of portal-systemic encephalopathy. When the laxative effect has been achieved, the dose of lactulose may then be reduced to the recommended daily dose.
Pediatric: The recommended initial daily oral dose in infants is 2.5 to 10 mL in divided doses. For older children and adolescents the total daily dose is 40 to 90 mL. If the initial dose causes diarrhea, the dose should be reduced immediately. If diarrhea persists, lactulose should be discontinued
Starting dose is 20-30 gram three to four times daily.
Maintenance dose should be adjusted by doctor to achieve 2 to 3 soft stools per day.
No dosage recommendations for this indication.
It is contraindicated in patients with hypersensitivity to lactose or to any of the excipients and suffering from Galactosaemia and bowel obstruction
Patients who are intolerant to lactose should take Lactulose with care.
The dose normally used in constipation should not pose a problem for diabetics. However, the dose used in the treatment of hepatic encephalopathy (HE); hepatic coma is usually much higher and should be taken into consideration for diabetics.
Laxatives (of any kind) should be used in children only when deemed absolutely necessary and only under medical supervision.
Faecal retention abilities could be disturbed during treatment with Lactulose oral solution.
Lactulose should not be taken with other laxatives.
Lactulose can be used during pregnancy.
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of lactulose to the breast-feeding woman is negligible. Lactulose oral solution can be used during breastfeeding
Flatulence may occur during the first few days of treatment. As a rule it disappears after a couple of days. Nausea and vomiting has been reported. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased.
If high doses (normally only associated with hepatic encephalopathy(HE); hepatic coma) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhoea. Dosage should then be adjusted to obtain two or three formed stools per day.
Lactulose overdose may produce nausea, vomiting, diarrhea and water and electrolyte loss, which may have to be corrected by appropriate drug therapy.
Treatment: cessation of treatment or dose reduction. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances. There is no specific antidote, only symptomatic treatment should be given.
Store between 36°-86°F (2°-30°C). Do not freeze
EMILOOZ liquid 10 g/15 mL, is available in 100ml bottle pack
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