For the treatment of constipation

age initial dose maintenance dose

agults 15-45ml 10-30 ml

Children aged 7-14 years 15ml 10-15 ml

Children aged 1 -6 years 5-10 ml 5-10 ml

Children under 1 year of age 5 ml 5 ml

The dose may be generally reduced following 2 days of use in relation to the patients needs. The drug should be better taken during a meal once a day. Its clinical effect occurs in two days. This is typical of the effect of lactulose. The dosage or dosing frequency should be increased if there is no improvement within two days of the drugs administration.

2. For stool softening:

The drug is given in the same doses as in constipation.

3. For the treatment of hepatic coma and precoma:

Its initial dose is 30-45 mg 3-4 times daily.

Then the patient should be swiched to the individually adjusted maintaining dose so that he/she should have 2-3 soft stools daily and so that the stool pH values should be in the of 5 to 5.5.

Adverse reactions

There may be flatulence within the first days of use of the drug. This is usually over in two days. In case of overdosage there may be abdominal pain and diarrhea, which requires that the dose should be adjusted. When higher doses are long used in the treatment of hepatic encephalopathy, the patient may develop electrolyte imbalance due to diarrhea.

Gastrointestinal disorders:

Flatulence, abdominal pain, nausea vomiting. There may be diarrhea when higher doses are used.

Other disorders.

Electrolyte imbalance due to diarrhea.

Overdosage

Cases of overdosage have not been reported. When a very high dose of the drug is used, there may be abdominal pain and diarrhea. In this case it is sufficient to reduce its dose or discontinue the use of the drug.

Drug interactions

Colonic pH-dependent release drugs, such as 5-aminosalicylic acid, may be

inactivated due to the mechanism of action of lactulose, which reduces colonic pH values.

Precautions

If there is no therapeutic effect within two days or there is constipation after therapy, a physician should be consulted.

When the drug is given to patients with lactose intolerance, it is necessary to

take into account its content of lactose.

The dose usually used in constipation should not present a problem to patients with diabetes mellitus. The dose used in the treatment of hepatic (pre)coma is usually much higher, thus it should be taken into account when the drug is given to diabetic patients.

Plasma electrolyte levels should be regularly monitored when the drug is used in higher doses long (for more than 6 months).