Dufalac, 667 mg/ml syrup 200 ml

Pharmacodynamics

Laxative drug. It has hyperosmotic laxative effect, stimulates intestinal peristalsis, improves absorption of phosphates and calcium salts, promotes excretion of ammonium ions.

Lactulose is broken down by the intestinal flora of the large intestine into low-molecular organic acids, which lead to a decrease in pH and an increase in osmotic pressure and as a consequence an increase in the volume of intestinal content. These effects stimulate intestinal peristalsis and influence 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 suppression of proteolytic bacteria by increasing the number of acidophilic bacteria (such as lactobacilli), conversion of ammonia into an ionic form by acidifying the contents of the colon, emptying the intestine by reducing the pH in the colon and osmotic effect, and reducing nitrogenous 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 suppressing the growth of potentially pathogenic bacteria such as Clostridium spp. and Escherichia coli, resulting in a more favorable balance of intestinal flora.

Pharmacokinetics

Absorption is low. After oral administration it reaches the large intestine unchanged, where it is broken down by the intestinal flora.

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

Indications

Active ingredient

Composition

Active substances:

Lactulose 66.7 g.

Excipients:

Purified water – up to 100 ml.

How to take, the dosage

The drug is intended to be taken orally as well as rectally.

Lactulose solution can be taken either diluted or undiluted.

All dosages must be taken individually.

The single dose taken should be swallowed immediately, without retaining it in the mouth.

If a single daily dose is prescribed, it should be taken at the same time, such as at breakfast.

In therapy with laxatives, it is recommended that sufficient fluids be taken (1.5-2 liters, which is equivalent to 6-8 glasses) per day.

For accurate dosing of the drug in bottles, use the measuring cup provided. When using the product in sachets, tear off the corner of the sachet and immediately take the contents.

Dose for the treatment of constipation or to soften stools for medicinal purposes

The daily dose of lactulose may be taken alone or divided in two using the measuring cup.

The starting dose may be adjusted to a maintenance dose after a few days, depending on how people respond to the medication. The laxative effect may appear 2-3 days after starting the drug.

Age

Starting

daily dose

Maintenance daily dose

Adults and teens

15-45 ml (1-3 sachets)

15-30 ml (1-2 sachets)

Children 7 – 14 years

15 ml (1 sachet)

10-15 ml (1 sachet*)

Children 1 – 6 years

5-10 ml

5-10 ml

Children under 1 year

to 5 ml

to 5 ml

*If the maintenance daily dose is less than 15 ml, it is recommended to use the drug in vials.

For accurate dosing in children under 7 years of age, it is recommended that the drug be used in vials.

Dose in the treatment of hepatic encephalopathy (adults)

For oral administration:

The initial dose: 3-4 times a day in 30-45 ml (2-3 sachets).

Thereafter, switch to an individually tailored maintenance dose so that soft stools are max 2-3 times a day.

For rectal administration:

In case of precoma or coma, the drug may be administered as an enema with retention (300 ml of drug/700 ml of water). The enema should be held for 30-60 minutes, and the procedure should be repeated every 4-6 hours until oral administration is possible.

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

Patients of advanced age and patients with renal or hepatic impairment

There are no specific dosing recommendations because the systemic effects of lactulose are negligible.

Interaction

Special Instructions

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

Please note that Dufalac® may contain small amounts of related sugars (e.g., lactose, galactose, epilactose and fructose).

The content of residual sugars present in Dufalac® is approximately 0.075 CFU in 5 ml of syrup.

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

Long-term use at doses higher than those recommended in the instructions or improper use may lead to diarrhea and electrolyte imbalances.

In children, laxatives should only be used exceptionally, and under a doctor’s supervision. It should be taken into account that disruption of the emptying reflex may occur during treatment.

Impact on ability to drive vehicles and other mechanisms requiring high concentration

The use of the drug Dufalac® has no effect or a slight effect on the ability to drive or operate machines and mechanisms.

Synopsis

Contraindications

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 while treating hepatic encephalopathy, the patient may develop a water-electrolyte imbalance due to diarrhea.

In placebo-controlled clinical trials, the following adverse effects have been observed in patients receiving lactulose with the following frequencies: [very common (≥1/10); common (≥1/100 to < 1/10); infrequent (≥1/1000 to < 1/100); rare (≥1/10 000 to < 1/1000); very rare (< 1/10 000)], or they were reported spontaneously during post-registration use of the drug [unknown frequency (exact frequency cannot be determined based on available data)].

The immune system

Infrequency unknown: hypersensitivity.

Gastrointestinal tract

Very common: diarrhea.

Often: flatulence, abdominal pain, nausea, vomiting.

Skin and subcutaneous fat

Ifffrequent unknown: rash, skin itching, urticaria, erythema.

Laboratory and instrumental data

Infrequent: disorders of water-electrolyte balance due to diarrhea.

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

Overdose

Symptoms: abdominal pain and diarrhea may occur if a very high dose is taken.

Treatment: Stop taking the drug or decrease the dose.

In case of large fluid loss due to diarrhea or vomiting, correction of electrolyte and water balance disorders may be necessary.

Pregnancy use

No effect on the fetus or the infant is expected because the systemic effects of lactulose on pregnant or breastfeeding women are negligible.

Dufalac® can be prescribed during pregnancy and during breastfeeding.

No effect on reproductive function is expected because the systemic effects of lactulose are negligible.

Similarities