Dinolak, emulsion 200 ml

Pharmacotherapeutic group:laxative

ATX code: AO6AD61

Pharmacological properties

Lactulose is a synthetic disaccharide composed of galactose and fructose. Humans do not have hydrolases capable of breaking the disaccharide down to the corresponding monosaccharides. This is why when taken orally lactulose is not metabolized, is not absorbed in the stomach and small intestine and enters the large intestine unchanged.

Lactulose is fermented to monosaccharides and then to short-chain carboxylic acids under the influence of disaccharidases of the microflora of the large intestine. Bacterial transformation of lactulose leads to a decrease in the pH of the intestinal contents, accumulation of short-chain fatty acids and increased peristalsis.

Short-chain carboxylic acids decrease the pH in the colon, which is accompanied by increased peristalsis and suppression of proteolytic microflora growth. Rapid adsorption of short-chain fatty acids in the distal parts of the colon improves absorption of water, sodium and other electrolytes.

As a result, lactulose has a laxative effect and normalizes bowel function while stimulating the growth and reproduction of normal intestinal microflora (bifidogenic factor).

Extracted from the body – with intestinal contents; only 3% of the drug are excreted by the kidneys.

Simethicone is a product with foaming properties. When taken orally it is not absorbed in the digestive tract and is eliminated from the body unchanged. By reducing the surface tension at the interface, it hinders the formation and promotes the destruction of gas bubbles in the contents of the gastrointestinal tract. The released gases can be absorbed by the intestinal walls or excreted from the body. It reduces the feeling of discomfort in the abdomen, sometimes accompanying the action of lactulose.

Indications

Constipation, stool regulation in hemorrhoids, the need for surgery on the colon and perianal area, Liver encephalopathy (hyperammonemia) in adults: treatment and prevention of hepatic coma/precoma. Normalization of intestinal activity. Treatment and prevention of dysbiosis of various etiologies. Restoration of intestinal normoflora after antibiotic therapy.

Composition

100 ml of the emulsion contains:

Active substances:

Lactulose (in terms of 100% substance) – 66.0 g,

Simethicone – 0.8 g;

Associates:

Ascorbic acid – 0.125 g,

Povidone K-90 – 1.2 g,

Povidone K-17 – 0,8 g,

Silicon dioxide colloid (aerosil 380) – 0,45 g.

5 ml of the emulsion contains:

Active ingredients:

Lactulose (in terms of 100% substance) – 3.3 g,

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Simethicone – 0.04 g;

Auxiliary substances:

Ascorbic acid – 0.00625 g,

Povidone K-90 – 0.06 g,

How to take, the dosage

Ingestion. If a single daily dose is prescribed, it should be taken at the same time (e.g., during breakfast). In constipation:

– children under 1 year: 5 ml/day.

– children from 1 to 6 years: 5-10 ml/day;

– children from 7 to 14 years: 15 ml/day;

– children over 14 years and adults: 15-45 ml/day for the first three days, then 10 – 30 ml/day.

Hepatic encephalopathy (hyperammonemia) in adults: treatment and prevention of hepatic precoma/coma: oral 30-50 ml 3 times daily, the daily dose may be 90-190 ml; then switch to an individually tailored maintenance dose so that soft stools are max 2-3 times daily.

In elderly patients, patients with renal and hepatic insufficiency – no dose adjustment is required, because the systemic effect of lactulose is very small.

In case of administration in children and adolescents under 18 years old – due to lack of clinical data the safety and efficacy of lactulose administration in children and adolescents with hepatic encephalopathy at the age of under 18 years old has not been established.

In case of intestinal dysbacteriosis:

Children over 7 years and adults: 5 ml 1-2 times a day. The dose is adjusted individually. When taking it, it is recommended to use a measuring cup.

When taking laxatives, it is recommended to take a sufficient amount of fluid (1.5-2 liters, which is 6-8 glasses) per day.

Shake before drinking.

Interaction

Antacids and antibiotics active against lactobacilli and bifidobacteria (neomycin, clindamycin, rifaximin) reduce the effect of lactulose.

In concomitant use of the preparation with thiazide and loop diuretics, glucocorticosteroids, amphotericin B it is possible to increase potassium excretion; with drugs which cause constipation (opiates, aluminum hydroxide) – the effect of lactulose may be decreased; with cardiac glycosides – their pharmacological action may be increased.

Special Instructions

In case of abdominal pain of unclear etiology before taking the drug or the lack of therapeutic effect a few days after the start of therapy, it is necessary to consult a physician. In children during therapy with the drug a disorder of the bowel emptying reflex may occur.

Periodic monitoring of plasma electrolyte concentrations should be performed in case of long-term use of high doses of the drug (in therapy of hepatic encephalopathy), especially in elderly patients.

It should be taken into account that the drug may contain small amounts of related sugars (e.g., lactose, galactose, fructose). In the treatment of hepatic (pre)coma, high doses of the drug are usually used, and its sugar content must be considered in patients with diabetes mellitus.

In the treatment of children, laxatives should be used exceptionally and under medical supervision.

Influence on ability to drive vehicles and machines

The use of the drug Dinolac® does not influence the ability to drive vehicles and machines or perform other activities requiring high concentration and quick psychomotor reactions.

Synopsis

Contraindications

Side effects

In case of using high doses of the drug during long-term treatment of hepatic encephalopathy, the patient may develop disorders of water-electrolyte balance, which may manifest as weakness, increased fatigue, dizziness, headache, nausea, myalgia, arrhythmias.

Gastrointestinal disorders:

Very common (>1/10): diarrhea.

Often (>1/100, <1/10): nausea, vomiting, abdominal pain.

A similar safety profile is expected when used in children compared to that in adults.

Overdose

Pregnancy use