Dufalac syrup 667mg/ml, 200ml

Composition

Active ingredients:

lactulose 66.7 g.

Auxiliary substances:

purified water-up to 100 ml

Pharmacological action

Pharmacodynamics

A laxative drug. It has a hyperosmotic laxative effect, stimulates intestinal motility, improves the absorption of phosphates and calcium salts, and promotes the elimination of ammonium ions.

Lactulose is broken down by the intestinal flora of the large intestine into low-molecular organic acids, which leads to a decrease in pH and an increase in osmotic pressure and, as a result, an increase in the volume of intestinal contents. These effects stimulate intestinal motility and affect the consistency of the stool. As a result, the physiological rhythm of emptying the large intestine is restored.

In hepatic encephalopathy, the effect is attributed to the suppression of proteolytic bacteria by increasing the number of acidophilic bacteria (for example, lactobacilli), the transition of ammonia to the ionic form due to acidification of the contents of the colon, bowel emptying due to a decrease in the pH in the colon and osmotic effect, and the reduction of nitrogen-containing toxic substances by stimulating bacteria that utilize ammonia for bacterial protein synthesis.

Lactulose as a prebiotic substance enhances the growth of beneficial bacteria such as bifidobacteria and lactobacilli, while it becomes possible to inhibit the growth of potentially pathogenic bacteria such as Clostridium spp. and Escherichia coli, which provides a more favorable balance of the intestinal flora.

Pharmacokinetics

Absorption is low. After ingestion, it reaches the large intestine in unchanged form, where it is broken down by the intestinal flora.

It is completely metabolized when used in doses up to 45-70 ml. When used in higher doses, it is partially excreted unchanged.

Indications

• Constipation: regulation of the physiological rhythm of colon emptying;
• softening of stool for medical purposes (for hemorrhoids, conditions after surgery on the colon and in the anal area);
• hepatic encephalopathy in adults: treatment and prevention of hepatic coma or precoma.

Use during pregnancy and lactation

No effect on the fetus or children is expected, as the systemic effect of lactulose on a pregnant or lactating woman is negligible.

Dufalac® can be prescribed during pregnancy and lactation.

No effect on reproductive function is expected, as systemic exposure to lactulose is negligible.

Contraindications

• galactosemia;
• obstruction, perforation or risk of perforation of the gastrointestinal tract;
• hypersensitivity to any component of the drug;
• galactose or fructose intolerance, lactase deficiency or glucose-galactose malabsorption.

With caution: the drug should be prescribed for undiagnosed rectal bleeding; for colostomy, ileostomy.

Side effects

In the first days of lactulose use, flatulence may occur. As a rule, it disappears after a few days.

If high doses are used for a long time in the treatment of hepatic encephalopathy, the patient may develop water-electrolyte disturbances due to diarrhea.

From the digestive system: very often (≥1/10) – diarrhea; often (≥1/100,

Other: infrequently (≥1/1000,

When used in children, a similar safety profile is expected compared to that in adults.

Interaction

Interaction studies with other medicinal products have not been conducted.

How to take, course of use and dosage

The drug is intended for oral use.

Lactulose solution can be taken both in diluted and undiluted form. It is necessary to immediately swallow the taken single dose, without holding it in the mouth.

All doses should be selected individually. If a single daily dose is prescribed, it should be taken at the same time, for example, during breakfast. During laxative therapy, it is recommended to take a sufficient amount of liquid (1.5-2 liters, which is equal to 6-8 glasses) per day.

For accurate dosage of the drug in vials, use the supplied measuring cup. When using the drug in sachets, it is necessary to tear off the corner of the sachet and immediately take the contents.

Dosage for the treatment of constipation or for softening the stool for medical purposes:

The daily dose of lactulose can be taken once, or divided into two, using a measuring cup.

After a few days, the initial dose can be adjusted to the maintenance dose, depending on the response to the drug.

The therapeutic effect may occur 2-3 days after the start of taking the drug.

• Adults and adolescents: the initial daily dose is 15-45 ml (1-3 sachets); the maintenance daily dose is 15-30 ml (1-2 sachets).
• Children aged 7-14 years: the initial daily dose is 15 ml (1 sachet); the maintenance daily dose is 10-15 ml (1 sachet).
• Children 1-6 years: initial daily dose-5-10 ml; maintenance daily dose-5-10 ml.
• Children under 1 year of age: initial daily dose-up to 5 ml; maintenance daily dose-up to 5 ml.

If the maintenance daily dose is less than 15 ml, as well as for accurate dosing in children under 7 years of age, it is recommended to use the drug in vials.

Dosage in the treatment of hepatic encephalopathy (adults)

Initial dose: 3-4 times / day for 30-45 ml. Then they switch to an individually selected maintenance dose so that the soft stool is maximum 2-3 times / day.

The safety and efficacy of the drug in children and adolescents under 18 years of age with hepatic encephalopathy has not been established due to a lack of data.

In elderly patients and patients with renal or hepatic insufficiency, there are no specific dosage recommendations, since the systemic effect of lactulose is insignificant.

Overdose

Symptoms: when taking the drug in a very high dose, abdominal pain and diarrhea may occur.

Treatment: discontinuation of the drug or reduction of the dose.

If there is a large loss of fluid due to diarrhea or vomiting, correction of water-electrolyte balance disorders may be required.

Description

Transparent viscous liquid from colorless to light yellow with a brown tinge.

Special instructions

If abdominal pain of unknown origin occurs before starting therapy or if there is no therapeutic effect for several days, the patient should consult a doctor.

Please note that Dufalac® may contain small amounts of bound sugars (for example, lactose, galactose, epilactose and fructose).

The content of residual sugars present in Dufalac® is about 0.075 XE in 5 ml of syrup.

When used at the recommended dose for the treatment of constipation, the sugar content should not pose a problem for patients with diabetes. In the treatment of hepatic encephalopathy, higher doses of the drug are usually prescribed, which should be taken into account in patients with diabetes mellitus.

Long-term use in doses exceeding those recommended in the instructions, or improper use can lead to diarrhea and impaired water-electrolyte balance.

When treating children, laxatives should be used in exceptional cases and under the supervision of a doctor. It should be borne in mind that during treatment, disorders of the emptying reflex may occur.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

The use of Dufalac® does not affect or has a slight effect on the ability to drive a car or control machines and mechanisms.

Form of production

Syrup for oral use

Storage conditions

In a dark place, at a temperature of 10-25 °C

Shelf life

1 year

Active ingredient

Lactulose

Dosage form

solution for oral use

Description

Pregnant women as prescribed by a doctor, For children, For adults, Nursing mothers as prescribed by a doctor

Indications

Liver Damage, Hemorrhoids, Constipation, Dysbiosis