Laevolac

/ Megapharm

The lactulose solution may be administered diluted or undiluted. The dose should be titrated according to the clinical response. Lactulose may be given as a single daily dose or up to three divided daily doses, using the measuring cup.
A single dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time.
The posology should be adjusted according to the individual needs of the patient. The starting dose can be adjusted after adequate treatment effect individually (maintenance dose). Several days (2-3 days) of treatment may be needed in some patients before adequate treatment effect occurs. In case of single daily dose, this should be taken at the same time of the day, e.g. during breakfast. During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 l/day, equal to 6-8 glasses).
Constipation: 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
If diarrhoea occurs, the dosing regimen should be reduced.
Treatment of portal systemic encephalopathy – for adults only: Beginning with 30 – 50 ml 3 times daily (corresponding to 60 – 100 g Lactulose).
The dosage has to be adopted to get 2-3 soft stools daily, pH of the stools should be between 5.0 to 5.5.
Children: The safety and efficacy in children aged 0 – 18 years has not been established. No data are available.
In elderly patients and patients with renal or hepatic insufficiency no special dosage recommendations exist.
Duration of treatment: The duration of treatment has to be adopted according to the symptoms.

Constipation, acute and chronic encephalopathy.

– Hypersensitivity to any of the components of the product.
– Use in patients with galactosaemia.
– Acute inflammatory bowel disease (ulcerative colitis, Crohn’s disease), gastrointestinal obstruction or subocclusive syndromes, digestive perforation or risk of digestive perforation, painful abdominal syndromes of undetermined cause.

See prescribing information for full details.

Flatulence may occur during the first few days of treatment. As a rule it disappears after a couple of days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased.
Gastrointestinal disorders:
Very common (≥ 1/10): Flatulence, abdominal pain,
Common (≥ 1/100 < 1/10): nausea and vomiting; if dosed too high, diarrhoea.
Investigations: Electrolyte imbalance due to diarrhoea.

Lactulose may increase the loss of potassium induced by other drugs (e.g. thiazides, steroids and amphothericin B). Concomitant use of cardiac glycosides can increase the effect of the glycosides through potassium deficiency.
With increasing dosage a decrease of pH-value in the colon is found. Therefore drugs which are released in the colon pH-dependently (e.g. 5-ASA) can be inactivated.

Limited data on pregnant patients indicate no malformative nor foeto/neonatal toxicity.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
The use of lactulose may be considered during pregnancy if necessary.

If the dose is too high, the following may occur:
Symptom: diarrhoea and abdominal pain.
Treatment: cessation of treatment or dose reduction. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.