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

Pharmacotherapeutic group: laxative
ATX code: A06AD11

Pharmacological properties

Pharmacodynamics
It has hyperosmotic laxative effect, stimulates intestinal peristalsis, improves absorption of phosphates and Ca2+ salts, promotes removal of ammonium ions.
Lactulose is broken down by the intestinal flora of the large intestine into low-molecular organic acids, which lowers pH and increases osmotic pressure, and as a result, increases the volume of intestinal contents. These effects stimulate intestinal peristalsis 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 suppression of proteolytic bacteria by increasing the number of acidophilic bacteria (such as lactobacilli), the transition of ammonia into an ionic form by acidifying the contents of the colon, emptying the bowel due to lower 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 and Escherichia coli, ensuring 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 fully metabolized when administered in doses up to 40 – 75 ml. When administered in higher doses it is partially excreted unchanged.

Indications

Active ingredient

Composition

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 adjusted 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

Maintaining 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) with hepatic encephalopathy has not been established due to lack of data.

Elderly patients and patients with renal or hepatic impairment

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

Interaction

Special Instructions

Synopsis

Contraindications

Galactosemia;

Incontinence, 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

Rectal bleeding undiagnosed;

colostoma, ileostoma.

Side effects

Overdose

Pregnancy use

Similarities