Constipation: regulation of the physiological function of the colon. Cases of stool softening due to medical reasons (haemorrhoids, after surgery within the large intestine or rectum). Hepatic encephalopathy (EW): treatment and prevention of hepatic coma or pre-coma.
Composition:
1 ml oral solution contains 667 mg lactulose.
Action:
A laxative with an osmotic effect. In the colon, Lactulose is broken down by the bacteria of the large intestine into low molecular weight organic acids. These acids cause a decrease in pH in the lumen of the colon, and through osmotic effects - an increase in the volume of colonic content. These actions stimulate colonic peristalsis and lead to the restoration of normal stool consistency. Lactulose as a prebiotic substance intensifies the growth of beneficial bacteria, such asBifidobacteriumspp. andLactobacillus spp., thus the growth of pathogenic bacteria, such asClostridium andEscherichia coli it can be stopped. This can lead to a better balance of the intestinal flora. In subjects with hepatic encephalopathy, the effect of the drug was attributed to the inhibition of the growth of proteolytic bacteria due to an increase in acidophilus bacteria (eg lactobacilli), stabilization of ammonia in the ionic form due to acidification of colonic contents, purification due to low pH in the colon and osmotic effect, also changes in bacterial nitrogen metabolism as a result of bacterial stimulation for the use of ammonia for the synthesis of bacterial proteins. Lactulose is only slightly absorbed after oral administration. It reaches the colon unchanged. There it is metabolized by the bacterial flora of the large intestine. It is completely metabolised at doses up to 40-75 ml; at higher doses, some of the administered amount of the drug may be excreted unchanged.
Contraindications:
Hypersensitivity to the active substance or any of the ingredients. Galactosemia. Gastrointestinal obstruction, perforation or risk of gastrointestinal perforation.
Precautions:
A medical consultation is recommended if: pre-existing abdominal symptoms accompanied by pain of undetermined cause; unsatisfactory therapeutic effect after a few days of use. Long-term use of ill-chosen doses and improper use can lead to diarrhea and electrolyte imbalance. Laxatives can be used in children in special cases; it should be taken into account that during the treatment the defecation reflex may be disturbed. Due to the lactose, galactose and small amounts of fructose, the drug should not be used in patients with rare hereditary problems of galactose or fructose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose. The dose usually used to treat constipation should not be a problem for people with diabetes. The dose used to treat hepatic encephalopathy is generally much higher and it may be necessary to consider its effect in patients with diabetes. The safety and efficacy of the drug in children (up to 18 years) with hepatic encephalopathy have not been established.
Pregnancy and lactation:
The drug can be used during pregnancy and breastfeeding.
Side effects:
Very often: diarrhea. Common: bloating, abdominal pain, nausea, vomiting. Uncommon: electrolyte imbalance as a result of diarrhea.
Dosage:
Orally.Constipation or cases of necessity to soften stool due to medical reasons. Adults and adolescents: initial dose 15-45 ml per day, maintenance dose 15-30 ml per day; children 7-14 years: initial dose 15 ml daily, maintenance dose 10-15 ml per day; children 1-6 years: initial dose 5-10 ml daily, maintenance dose 5-10 ml per day; infants (under 1 year): starting dose up to 5 ml per day, maintenance dose up to 5 ml per day. Lactulose can be used in a single daily dose or in two divided doses. After a few days, the starting dose can be adjusted to the maintenance dose based on the response you receive.The healing effect may occur after a few days (2-3 days) of treatment.Hepatic encephalopathy (only in adults): initial dose 30-45 ml 3-4 times a day; this dose can be adjusted to the maintenance dose so that the patient passes a loose stool 2-3 times a day.Way of giving. The lactulose solution can be administered diluted or undiluted. For one daily dose, it should be taken at the same time, eg during breakfast. The single dose should be swallowed without too much holding in the mouth.