Lactulose - instructions for use, dose, side effects, contraindications

Has a hyperosmotic laxative effect, stimulates the intestinal peristalsis, improves the absorption of phosphates and calcium salts, promotes the excretion of ammonium ions.

Lactulose is cleaved by intestinal flora of the colon to low molecular weight organic acids, which leads to a decrease in pH and an increase in osmotic pressure and, consequently, an increase in the volume of intestinal contents. These effects stimulate intestinal peristalsis and affect the consistency of the stool. The physiological rhythm of emptying the thick intestine is restored.

In hepatic encephalopathy and hepatic (precoma), the effect is due to the suppression of proteolytic bacteria by increasing the number of acidophilic bacteria (eg, lactobacilli); transition of ammonia to the ionic form due to acidification of the contents of the large intestine; evacuation of the intestine due to a decrease in pH in the large intestine and osmotic effect; as well as the reduction of nitrogen-containing toxic agentsby stimulating bacteria that utilize ammonia for bacterial protein synthesis.

Lactulose as a prebiotic substance enhances the growth of beneficial bacteria such as bifido- and lactobacilli, which in turn helps suppress the growth of potentially pathogenic bacteria such as Clostridium and E. coli, and provides a more favorable balance of intestinal flora.

Has the ability to inhibit the growth and reproduction of Salmonella and Shigella. Does not reduce the absorption of vitamins and is not addictive.

The action occurs 24-48 hours after taking (the delay is due to the passage of the drug through the gastrointestinal tract).

Pharmacokinetics:Absorption is low (excretion by the kidneys - 3%). Not absorbed, reaches the thick intestine, where it is split by intestinal flora. Fully metabolized at doses of 40 - 75 ml; at higher dosages is partially excreted through the intestine in an unchanged form.

Indications:

- Constipation: regulation of the physiological rhythm of emptying the large intestine;

- Softening of the stool for medical purposes (hemorrhoids, postoperative period of surgical interventions on the large intestine or in the anal area);

- Hepatic encephalopathy: treatment and profilektic of the hepatic coma and precoma.

Contraindications:

- Hypersensitivity to any component of the drug;

- Galactosemia;

- Intolerance to galactose and / or fructose, lactase deficiency, glucose galactose malabsorption;

- Intestinal obstruction;

- Rectal bleeding;

- Colo-, Ileostomy;

- Suspicion of appendicitis.

Carefully:

Diabetes.

Pregnancy and lactation:

If necessary, lactulose can be administered during pregnancy and lactation.

Dosing and Administration:

The drug is intended for ingestion, during or after a meal.

Lactulose can be given as a single daily dose or this dose can be divided into two doses using a measuring cup.

All dosages should be selected individually. In case of appointment of reception of one dose per day, it should be taken at the same time, for example, during breakfast.

With constipation:

- Children under 1 year: 5 ml / day;

- children from 1 to 6 years: 5-10 ml / day;

children from 7 to 14 years: 15 ml / day;

- Children over 14 years and adults: in the first three days of 15-45 ml / day, then 10-30 ml / day. The laxative effect of the drug develops during the first two days of admission. Duration of treatment from 4 weeks to 3-4 months.

With hepatic coma, precoma, encephalopathy:

The initial dose is 30-45 ml 3 times a day. Then the dose is selected so that the soft stool is 2-3 times a day. Treatment can last up to 3 months or more.

With hepatic coma, precoma and hepatic encephalopathy: inside 30-50 ml 3 times a day,the daily dose can be 90-190 ml; then individually selected maintenance dose (providing fecal pH 5-5.5) 2-3 times a day.

In the postoperative period:

Adults - 10-30 ml 3 times a day for children older than 1 year of 5-10 ml 2-3 times a day, up to 1 year - 5 ml 2-3 times a day. The drug is prescribed after 18-24 h after the operation for 3-5 days.

Side effects:

Side effects are usually mild and reversible, and are the result of exceeding the dose.

In the first days of taking lactulose, the appearance of flatulence is possible, which, as a rule, disappears after 1-2 days. In the case of the use of elevated doses for a long timetime in the treatment of hepatic encephalopathy in patients due to diarrhea may develop electrolyte imbalance and, as a consequence, cramps, bloating, nausea, headache, dizziness, arrhythmia, myalgia, fatigue, and weakness.

Overdose:If you use a very high dose, you may have abdominal pain and diarrhea. In this case, you need to reduce the dose or stop taking the drug. A large loss of fluid due to diarrhea or vomiting may require correction of the water electrolyte balance disturbance.

Interaction:

When using therapeutic doses of lactulose, there were no clinically significant interactions with other drugs, however, it is not recommended to take the drug within two hours after taking another medication.

Antibiotics and antacids reduce the effect of lactulose. Changes the pH-dependent release of enteric-soluble drugs.

Special instructions:

If there is no therapeutic effect for two days or if constipation is restored after treatment, the patient is recommended to consult a doctor. The drug should be administered with caution to patients with intolerance to galactose. It should be taken into account that the preparation may contain insignificant amounts of bound sugars (for example, lactose, galactose, epilactose).

In the treatment of hepatic (pre) coma, higher doses are usually prescribed, which should be taken into account in patients with diabetes mellitus.

In the treatment of children laxatives should be used in exceptional cases and under the supervision of a doctor. It must be taken into account that during the treatment there may be disorders of the emptying reflex.

Patients with rare congenital disorders, such as galactose intolerance, Lappease lactase deficiency or glucose-galactose malabsorption, should not use this medication.

With prolonged use of the drug (more than 6 months), you should regularly monitor the concentration of potassium, chlorine and carbon dioxide in the blood plasma.

In gastrocardial syndrome, you should increase doses gradually to avoid flatulence.

Effect on the ability to drive transp. cf. and fur:

Lactulose has no effect on the speed of psychomotor reactions and on the ability to drive a car or drive machines and mechanisms that require increased attention.

Form release / dosage:

Syrup 667 mg / ml.

Packaging:200 ml, 500 ml or 1000 ml in plastic bottles with a screwed plastic cover. A measuring cup is put on top of the lid. The label is self-adhesive on the vial. Each bottle, together with the instructions for use, is placed in a pack of cardboard.

Storage conditions:In the dark place at a temperature of 5 to 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002556

Date of registration:31.07.2014 / 21.06.2017

Expiration Date:31.07.2019

The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia

Manufacturer: & nbsp

AVVA RUS, OJSC Russia

Information update date: & nbsp11.02.2018

Illustrated instructions

Instructions

Lactulose (Lactulose)