Lactulose solution 3.3 g/5ml.
Clear, viscous, colourless or pale brownish-yellow liquid for oral administration for oral administration containing 3.3g lactulose per 5ml.
Pharmacology: Pharmacodynamics: Lactulose is broken down by colonic bacteria mainly into lactic acid which exerts a local osmotic effect in the colon resulting in increased faecal bulk and stimulation of peristalsis. It may take up to 48 hours before an effect is obtained.
In hepatic encephalopathy, when larger doses are given, the pH in the colon is reduced significantly by this acid production and the absorption of ammonium ions and other toxic nitrogenous compounds is decreased leading to a fall in blood ammonia concentration and an improvement in mental health.
Pharmacokinetics: Lactulose passes essentially unchanged into the large intestine where it is metabolised by saccharolytic bacteria with the formation of simple organic acids, mainly lactic acid and small amounts of acetic and formic acids. The small amount of absorbed lactulose is subsequently excreted unchanged in the urine.
For constipation and the treatment of hepatic encephalopathy.
Constipation: Adults and adolescents: Starting dose is 15-45ml per day, in a single or two divided doses. This dose can later be adjusted to 15-30ml per day, in a single or two divided doses.
Children 7-14 years: Starting dose is 15ml per day, in a single or two divided doses. This dose can later be adjusted to 10-15ml per day, in a single or two divided doses.
Children 1-6 years: The usual dose is 5-10ml per day.
Infants under 1 year: The usual dose is up to 5ml per day.
Hepatic encephalopathy (adults only): Adults: Starting dose is 30-45ml, to be taken three to four times per day.
Children: No information is available for treatment of children (newborn to 18years of age) with hepatic encephalopathy.
Use in elderly patients or patients with renal or hepatic insufficiency: No special dosage recommendations.
Mode of Administration: Oral.
Lactulose overdose may produce nausea, vomiting, diarrhoea 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.
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.
Pregnancy: Lactulose can be used during pregnancy.
Lactation: 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 few 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) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhoea. Hypernatremis has been reported.
Lactulose should not be taken with other laxatives.
Store below 30°C. Protect from light and moisture.
Shelf-Life: 24 months.
A06AD11 - lactulose ; Belongs to the class of osmotically acting laxatives.
Oral soln 3.3 g/5 mL (clear, viscous, colourless or pale brownish-yellow liquid) x 100 mL, 200 mL.