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Lactulose solution may be taken diluted or undiluted. The dose should be titrated according to the clinical response. Lactulose may be given as a single daily dose or in two divided doses, using the measuring cup.
A single dose of lactulose should be swallowed in one and should not be held in the mouth for any length of time.
The posology should be adjusted according to the needs of the patient. In cases when a single daily dose is prescribed, the dose should be taken consistently at the same time of day, e.g. during breakfast. During therapy with laxatives a sufficient amount of fluid intake (1.5 – 2 litres, equal to 6-8 glasses) per day is recommended.
Dosing in constipation or where a soft stool is considered of medical benefit: After a few days the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several days (2-3 days) of treatment may be needed before treatment effect occurs.
Adults and adolescents:
Starting dose: 15 – 30 ml
Maintenance dose: 15 – 30 ml
Children (7 – 14 years):
Starting dose: 15 ml
Maintenance dose: 10 – 15 ml
Children (1 – 6 years):
Starting dose: 5 – 10 ml
Maintenance dose: 5 – 10 ml
infants under 1 year:
Starting dose: Up to 5 ml
Maintenance dose: Up to 5 ml
Dosing in acute and chronic hepatic encephalopathy (for adults only):
Starting dose: 3 times daily 30 –50 ml.
Maintenance dose: should be adjusted so that soft stools are produced 2 – 3 times per day.
Acute and chronic hepatic encephalopathy.
Hypersensitivity to the active substance or to any of the ingredients.
Galactosaemia. Bowel Obstruction.
In case of insufficient therapeutic effect after several days consultation of a physician is advised.
Lactulose should be administered with care to patients who are intolerant to lactose. With regard to sugar content, the dose normally used in constipation should not pose a problem for diabetics. However, the dose used to treat (pre) coma hepaticum is usually much higher and sugar content of the medicine should be taken into consideration for diabetics.
Use of laxatives in children should be exceptional and requires medical supervision. It should be taken into account that the defecation reflex could be disturbed during the treatment.
This product contains lactose, galactose fructose. Therefore, patients with the rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Flatulence may occur during the first few days of treatment. As a rule, it disappears after a few days. 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 portosystemic encephalopathy, PSE) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhoea.
Because the following reactions were reported spontaneously from a population of uncertain size it is not possible to reliably estimate their frequency.
Gastrointestinal disorders: Flatulence, abdominal pain, nausea and vomiting; if dosed too high, diarrhoea.
Investigations: Electrolyte imbalance due to diarrhoea.
No interaction studies have been performed.
Pregnancy and Lactation
Pregnancy: During pregnancy, no effects to the feotus are anticipated since systemic exposure of lactulose to the pregnant woman is negligible.
A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor foeto/neonatal toxicity of lactulose.
Avilac oral solution can be used during pregnancy.
Lactation: No effects on the breastfed newborn/infant are anticipated since systemic exposure of lactulose to the breast-feeding woman is negligible.
Avilac oral solution can be used during breastfeeding.
If the dose is too high, the following symptoms may occur: diarrhoea and abdominal pain.
Recommended treatments include the cessation of treatment or dose reduction and correction of electrolyte disturbances when extensive fluid loss secondary to diarrhoea or vomiting has occurred.