Lactulose

Composition: active ingredient: lactulose (in the form of liquid lactulose);

1 ml of syrup contains lactulose (as liquid lactulose) – 670 mg;

excipients: none.

Dosage form: Syrup.

Main physicochemical properties : transparent viscous liquid from colorless to brownish-yellow .

Pharmacotherapeutic group: Osmotic laxatives. ATC code: A06A D11.

Pharmacological properties.

Pharmacodynamics.

In the colon, lactulose is broken down by intestinal bacteria to low-molecular organic acids. These acids lower the pH in the lumen of the colon and, through the osmotic effect, increase the volume of intestinal contents. This stimulates colonic peristalsis and normalizes the consistency of stool. Constipation is corrected and the physiological rhythm of the intestine is restored.

In hepatic encephalopathy (or hepatic coma and precoma), the effect of the drug is due to the inhibition of the growth of proteolytic bacteria by increasing the number of acidophilic bacteria (for example, lactobacilli), binding of ammonia in ionic form due to acidification of the intestinal contents, cleansing of the large intestine due to low pH, as well as the osmotic effect, changing bacterial nitrogen metabolism by stimulating the utilization of ammonia by bacteria for the synthesis of bacterial proteins . In the context of the above, it is necessary, however, to note that the neuropsychiatric manifestations of hepatic encephalopathy cannot be explained only by hyperammonemia . However, ammonia can be considered as a model for other nitrogen compounds.

Lactulose, as a prebiotic, enhances the growth of beneficial bacteria such as bifidobacteria and lactobacteria, while potentially pathogenic bacteria such as clostridia and E. coli may be inhibited. This may lead to a more favorable balance of intestinal flora.

Pharmacokinetics.

Lactulose is almost not absorbed after oral administration and reaches the large intestine in an unchanged state, where it is metabolized by bacterial flora. When using the drug in a dose of 25–50 g, or 40–75 ml, lactulose is completely metabolized. In the case of using higher doses, part of lactulose may be excreted in an unchanged state.

Clinical characteristics.

Indication.

• Constipation: regulation of the physiological rhythm of the intestine.
• Conditions requiring relief of defecation (hemorrhoids, after operations on the colon and anorectal area).
• Hepatic encephalopathy: treatment and prevention of hepatic coma and precoma.

Contraindication.

Hypersensitivity to the active substance , Galactosemia; acute abdominal pain of unknown origin, nausea, vomiting, gastrointestinal obstruction/intestinal stenosis, rectal bleeding, gastrointestinal perforation or risk of gastrointestinal perforation, acute inflammatory bowel diseases such as ulcerative colitis, Crohn’s disease, severe dehydration .

Interaction with other drugs and other types of interactions.

If the patient is taking any other medications, you should definitely inform the doctor about this.

When taken with enteric-coated drugs with pH-dependent release, it is worth remembering that lactulose lowers the pH of the intestine.

When used simultaneously with broad-spectrum antibiotics or antacids, the therapeutic efficacy of lactulose may be reduced.

Lactulose may increase potassium loss induced by other drugs (e.g. thiazide diuretics, corticosteroids and amphotericin B). Potassium deficiency may potentiate the effect of cardiac glycosides.

It is not recommended to take Lactulose within 2 hours of taking other medications.

Application features.

A doctor’s consultation is recommended if:

– before starting treatment, there are painful symptoms in the abdominal area of unknown origin;

– the therapeutic effect within several days of treatment is insufficient.

The dose of the drug commonly used to treat constipation does not usually cause problems in people with diabetes. However, The dose for treating hepatic encephalopathy is usually much higher, so this should be taken into account when treating patients with diabetes.

Long-term use of the drug without dose adjustment or incorrect use may lead to diarrhea and electrolyte imbalance. In serious cases, dehydration or hypokalemia may develop. Hypokalemia may cause cardiac or neuromuscular dysfunction, especially in the case of concomitant treatment with cardiac glycosides, diuretics or corticosteroids. It is recommended to regularly monitor serum electrolyte levels, especially in elderly and debilitated patients.

This medicinal product contains lactose, galactose and small amounts of fructose. Therefore, patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Patients with gastrocardiac syndrome (Remheld’s syndrome) should use lactulose only after consulting a doctor. In order to prevent the occurrence of flatulence, it is recommended to increase the dose gradually. If flatulence occurs, the dose should be reduced or treatment should be discontinued.

If the signs of the disease do not disappear or, on the contrary, the state of health worsens, or undesirable phenomena appear, it is necessary to stop taking the drug and consult a doctor regarding further use.

Use during pregnancy or breastfeeding.

Pregnancy.

No effects are expected during pregnancy, as the systemic effects of lactulose on the pregnant woman are negligible.

Lactulose, Syrup can be used during pregnancy.

Breastfeeding period.

No effects on the newborn/infant are expected during breastfeeding, as the systemic exposure of lactulose to the breastfeeding woman is negligible.

Lactulose, Syrup can be used during breastfeeding.

Fertility.

No effects are expected, as the systemic exposure to lactulose is negligible.

The ability to influence the reaction speed when driving vehicles or other mechanisms.

Lactulose has no or negligible influence on the ability to drive and use machines.

Method of administration and doses.

Lactulose can be taken in both diluted and undiluted form.

The dose should be adjusted according to the individual needs of the patient.

A single dose should be swallowed immediately and should not be held in the mouth for a long time.

If the patient is prescribed a once-daily dose, the dose should always be taken at the same time of day, for example, during breakfast. During laxative therapy, it is recommended to drink sufficient fluid: 1.5–2 liters, which corresponds to 6–8 glasses, during the day.

Dosage for constipation or to soften stools for medical purposes

To measure the dose, use the dosing cup included in the medicine kit.

The daily dose of Lactulose can be taken at once or divided into 2 doses.

After a few days, the initial dose may be adjusted to a maintenance dose based on response to treatment. It may take several days of therapy (2–3 days) before a therapeutic effect is seen.

Dosage for hepatic encephalopathy (adults only)

Initial dose: 30–45 ml 3–4 times a day.

This dose may be adjusted to a maintenance dose to achieve soft stools 2 to 3 times daily.

The safety and efficacy of the medicinal product in children (ages from birth to 18 years) with hepatic encephalopathy have not been established. Data are not available.

Elderly patients and patients with renal or hepatic insufficiency

Since the systemic exposure to lactulose is negligible, there are no specific dosage recommendations for these patient groups.

Children.

The use of laxatives in children should be in exceptional cases and requires medical supervision.

There are no data on the use of the drug in children with hepatic encephalopathy.

It should be noted that the defecation reflex may be impaired during treatment.

Overdose.

If the dose is too high, symptoms such as abdominal pain and diarrhea may occur. Recommended treatment includes stopping the drug or reducing the dose, and correcting electrolyte imbalances in case of excessive fluid loss due to diarrhea or vomiting.

If overdose symptoms persist, seek immediate medical attention.

Adverse reactions.

During the first few days of treatment, flatulence may occur, which usually disappears after a few days. When using the drug in doses exceeding the recommended ones, abdominal pain and diarrhea may occur. In such cases, the dose should be reduced. When using high therapeutic doses for a long time (usually only in patients with hepatic encephalopathy), electrolyte imbalance may occur due to diarrhea.

During post-marketing use, hypersensitivity reactions, mainly limited to skin manifestations, have been observed and identified as possible adverse reactions. As these reactions were reported spontaneously and the patient population is not established, it is not possible to reliably estimate their frequency.

The frequency of adverse reactions is determined according to the following classification: very common ( ³≥1/10), ³common (≥1/100, <1/10), uncommon ( ³≥1/1000, <1/100), rare ( ³≥1/10,000, <1/1000), very rare (<1/10,000), frequency unknown (cannot be estimated from the available data).

Children: The safety profile in children is expected to be the same as in adults.

Reporting adverse reactions after registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua .

Expiration date. 4 years.

Shelf life after opening the bottle is 2 months at a temperature not exceeding 25 °C.

Storage conditions. Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Do not freeze due to the ability of lactulose to crystallize.

Packaging: 200 ml or 300 ml or 500 ml in a bottle; 1 bottle with a dosing cup in a pack.

Release category : Over-the-counter.