Lactulose syrup

Instructions for use for Lactulose syrup

Brand name: Lactulose

International nonproprietary name: lactulose

Dosage form: syrup

Composition:

100 ml of the preparation contains:

active substance: lactulose (calculated as the active substance) – 66.7 g;

excipients: citric acid – 0.05 g, purified water up to 100 ml.

Description:

Transparent viscous liquid, from colorless to yellow with a brownish tint.

Pharmacotherapeutic group: laxative.

ATC code: A06AD11

Pharmacological properties

Pharmacodynamics

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

Lactulose is broken down by the colonic flora into low-molecular-weight 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 peristalsis and affect stool consistency. The physiological rhythm of colon emptying is restored.

In hepatic encephalopathy and hepatic (pre)coma, the effect is due to the suppression of proteolytic bacteria by increasing the number of acidophilic bacteria (e.g., lactobacilli); conversion of ammonia to the ionic form by acidifying the colonic contents; bowel emptying due to decreased pH in the colon and the osmotic effect; and 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, 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.

It has the ability to inhibit the growth and reproduction of Salmonella and Shigella. Does not reduce vitamin absorption and does not cause habituation.

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

Pharmacokinetics

Absorption is low (renal excretion is 3%). Without being absorbed, it reaches the large intestine, where it is broken down by the intestinal flora. Completely metabolized at doses of 40-75 ml; at higher doses, it is partially excreted through the intestines unchanged.

Indications for use

• Constipation: regulation of the physiological rhythm of colon emptying;
• Stool softening for medical purposes (hemorrhoids; postoperative period after surgical interventions on the colon or in the anal area);
• Hepatic encephalopathy: treatment and prevention of 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;
• Colostomy, ileostomy;
• Suspected appendicitis.

With caution

• Diabetes mellitus.

Use during pregnancy and breastfeeding

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

Dosage and administration

The preparation is intended for oral administration, during or after meals.

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

All dosages should be selected individually. If a single daily dose is prescribed, it should be taken at the same time each day, for example, during breakfast.

For 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: 15-45 ml/day for the first three days, then 10-30 ml/day.

The laxative effect of the drug develops within the first two days of administration. The duration of treatment is from 4 weeks to 3-4 months.

For hepatic coma, precoma, encephalopathy:

The initial dose is 30-45 ml 3 times a day. Then the dose is adjusted to achieve soft stools 2-3 times a day. Treatment can last up to 3 months or longer.

For hepatic coma, precoma, and hepatic encephalopathy: orally, 30-50 ml 3 times a day; the daily dose can be 90-190 ml; then, an individually selected maintenance dose (ensuring stool pH of 5-5.5) 2-3 times a day.

In the postoperative period:

Adults: 10-30 ml 3 times a day.

Children over 1 year: 5-10 ml 2-3 times a day.

Children under 1 year: 5 ml 2-3 times a day.

The preparation is prescribed 18-24 hours after surgery for a duration of 3-5 days.

Side effects

Side effects are usually mild and reversible, and are a consequence of overdose.

In the first days of taking lactulose, flatulence may occur, which usually disappears after 1-2 days. In case of using high doses for a long time in the treatment of hepatic encephalopathy, the patient may develop electrolyte imbalances as a result of diarrhea and, consequently, cramps, flatulence, nausea, headache, dizziness, arrhythmia, myalgia, increased fatigue, weakness.

Overdose

Abdominal pain and diarrhea are possible when using a very high dose. In this case, it is necessary to reduce the dose or stop taking the drug. Significant fluid loss due to diarrhea or vomiting may require correction of water-electrolyte imbalance.

Interaction with other medicinal products

No clinically significant interactions with other medicinal products have been observed when using therapeutic doses of lactulose; nevertheless, it is not recommended to take the drug within two hours after taking another medicine.

Antibiotics and antacids reduce the effect of Lactulose. Alters the pH-dependent release of enteric-coated medicines.

Special instructions

If there is no therapeutic effect within two days or if constipation recurs after treatment, the patient should consult a doctor.

The drug should be prescribed with caution to patients with galactose intolerance. It must be taken into account that the drug may contain insignificant amounts of related sugars (e.g., lactose, galactose, epilactose).

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

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

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

With long-term use of the drug (more than 6 months), the concentration of potassium, chlorine, and carbon dioxide in the blood plasma should be regularly monitored.

In case of gastrocardiac syndrome, doses should be increased gradually to avoid flatulence.

Effect on ability to drive vehicles and mechanisms

Lactulose does not affect the speed of psychomotor reactions or the ability to drive a car or operate machinery and mechanisms requiring increased attention.

Dosage form

Syrup 667 mg/ml

100 ml, 200 ml, 500 ml, or 1000 ml of syrup in high-density polyethylene bottles. The bottle is sealed with a polyethylene cap with a first-opening control ring. A transparent measuring cup made of high-density polyethylene is placed over the cap. A self-adhesive label is affixed to the bottle. Each bottle, together with the instructions for use, is placed in a cardboard carton.

Storage conditions

In a place protected from light, at a temperature of 5 to 25 °C. Keep out of reach of children.

Shelf life

3 years. Do not use after the expiration date.

Prescription status

Available without a prescription.

Name and address of the legal entity in whose name the registration certificate is issued / Organization accepting claims:

JSC "AVVA RUS", Russia,

121614, Moscow, Krylatskie Kholmy st., 30, building 9.

Tel./Fax: +7 (495) 956-75-54

Manufacturer:

JSC "AVVA RUS", Russia,

610044, Kirov region, Kirov, Luganskaya st., 53a.

Tel.: +7 (8332) 25-12-29; +7 (495) 956-75-54

avva.com.ru