Dufalac syrup 667mg/ml with plum flavour, 500ml

Composition

100 ml contains: Active substances: lactulose 66.7 g;auxiliary substances: purified water – up to 100 ml, plum flavor – 1.5 g.

pharmacological action

Pharmacotherapeutic group:  Laxative means:  

• A. 06. A. D. Laxatives with osmotic properties
• A. 06. A. D. 11 Lactulose

Pharmacodynamics : It has a hyperosmotic laxative effect, stimulates intestinal peristalsis, absorption of phosphates and Ca 2+ salts, promotes the excretion of ammonium ions. Lactulose is broken down by the intestinal flora of the colon into low molecular weight organic acids, which leads to a decrease in pH and an increase in osmotic pressure and, as a consequence, an increase in the volume of intestinal contents. These effects stimulate intestinal motility and affect the consistency of stool. As a result, the physiological rhythm of emptying of 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 ionic form due to acidification of the contents of the colon, bowel emptying due to a decrease in pH in the colon and osmotic effect, as well as a decrease in nitrogen-containing toxic substances by stimulating bacteria, utilizing ammonia for bacterial protein synthesis. Lactulose as a prebiotic substance enhances the growth of beneficial bacteria, such as bifidobacteria and lactobacteria, while it becomes possible to suppress the growth of potentially pathogenic bacteria, such as Clostridium and Escherichia coli, which provides a more favorable balance of intestinal flora. Pharmacokinetics: Absorption is low. After ingestion, it reaches the large intestine unchanged, where it is split by intestinal flora. It is completely metabolized when used in doses up to 40-75 ml. When used in higher doses, it is partially excreted unchanged.

Indications

– Constipation: regulation of the physiological rhythm of colon emptying. – Softening of the stool for medical purposes (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

Can be prescribed during pregnancy and during breastfeeding

Contraindications

– galactosemia;

– obstruction, perforation or risk of perforation of the gastrointestinal tract;

– hypersensitivity to any component of the drug;

– intolerance to galactose or fructose, lactase deficiency or glucose-galactose malabsorption.

With caution:

– undiagnosed rectal bleeding;

– colostomy, ileostomy;

– liver diseases, alcoholism, epilepsy, pregnancy, breastfeeding, childhood due to the fact that the drug contains ethanol in the flavor structure.

Side effects

In the first days of taking lactulose, 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 balance disorders due to diarrhea. Disorders of the gastrointestinal tract:

• Very common (≥1/10): diarrhea.
• Often (≥1/100, <1/10): flatulence, abdominal pain, nausea, vomiting.

Other violations:

• Infrequently (≥1/1000, <1/100): violations of the water-electrolyte balance due to diarrhea.

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

Interaction

Studies on interaction with other drugs 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 single dose taken without holding it in the mouth.

All dosages should be selected individually.

If a single daily dose is prescribed, it must 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 dosing of the drug in vials, the attached measuring cup should be used. When using the drug in sachets, it is necessary to tear off the corner of the sachet and immediately take the contents.

Dose for the treatment of constipation or for softening the stool for medical purposes

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

After a few days, the initial dose can be adjusted to a maintenance dose, depending on the reaction to taking the drug. The laxative effect may appear 2-3 days after the start of taking the drug.

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

Dose in the treatment of hepatic encephalopathy (adults)

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

Then they switch to an individually selected maintenance dose so, to have a soft stool as much as 2-3 times a day.

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

Elderly patients and patients with renal or hepatic insufficiency

There are no special recommendations for dosing, since the systemic effect of lactulose is insignificant.

Overdose

Symptoms: when taking a very high dose, abdominal pain and diarrhea are possible. Treatment: discontinuation of the drug or dose reduction. In case of a large loss of fluid due to diarrhea or vomiting, correction of water-electrolyte balance disorders may be required.

Description

Syrup (with plum flavor) in the form of a transparent viscous liquid from colorless to light yellow with a brown tinge of color.

Special instructions IF abdominal pain of unknown origin occurs before starting treatment or there is no therapeutic effect a few days after the start of taking the drug, it is necessary to consult a doctor. It is necessary to take into account, that Dufalac® may contain insignificant amounts of bound sugars (e. g. Lactose, Lactose, epiLactose and fructose). When taking the doses recommended for the treatment of constipation, the sugar content should not pose a problem for patients with diabetes mellitus. In the treatment of hepatic encephalopathy, higher doses of the drug are usually prescribed, and the sugar content in it should be taken into account in relation to patients with diabetes mellitus. The content of residual sugars present in the Dufalac® formulation is about 0.075 XE in 5 ml of syrup. Prolonged intake of doses exceeding those recommended in the instructions, or improper use can lead to diarrhea and disruption of the water-electrolyte balance. The drug Dufalac® in the form of plum-flavored syrup contains 0.4% ethanol (ethyl alcohol) in the flavor structure, that is, up to 160 mg in the maximum daily dose taken in the treatment of constipation, which corresponds to 4 ml of beer or 2 ml of wine. This may be unfavorable for patients with alcoholism. The alcohol content should be taken into account when used during pregnancy and during breastfeeding, as well as in children and high-risk patients with liver disease or epilepsy. In the treatment of 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 manage transp. cf. and fur. : The use of the drug Dufalac® does not affect or has a negligible effect on the ability to drive a car and mechanisms.

Product form

Syrup.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of reach of children!

Shelf life

1 year.

Active ingredient

Lactulose

Dosage form

oral solution

Purpose

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

Indications

Dysbiosis, Constipation, Hemorrhoids, Liver damage