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Lactulose (Syrup) Instructions for Use

ATC Code

A06AD11 (Lactulose)

Active Substance

Lactulose (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Laxative drug with osmotic properties. Hypoammonemic agent

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Laxative. Lactulose is a disaccharide consisting of galactose and fructose; it is not hydrolyzed by disaccharidases of the small intestinal mucosa.

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, the effect is attributed to the suppression of proteolytic bacteria by increasing the number of acidophilic bacteria (e.g., lactobacilli), the conversion of ammonia to the ionic form due to acidification of the colonic contents; bowel emptying due to decreased pH in the colon and the osmotic effect; and a reduction in the content 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, while simultaneously suppressing the growth of potentially pathogenic bacteria, such as Clostridium spp. and Escherichia coli, which provides a more favorable balance of intestinal flora.

Pharmacokinetics

Absorption is low. Lactulose is absorbed from the small intestine only 0.4-2%, then reaches the large intestine, where it is broken down by the intestinal microflora. It is metabolized to form simple organic acids – mainly lactic acid and, to a lesser extent, acetic and formic acid.

Indications

Chronic constipation, as well as conditions requiring facilitation of defecation. Prevention and treatment of hepatic encephalopathy in adults.

ICD codes

ICD-10 code Indication
K59.0 Constipation
K72 Hepatic failure, not elsewhere classified (including hepatic coma, hepatic encephalopathy)
ICD-11 code Indication
DB32.1 Slow-transit constipation
DB91.Z Unspecified acute or subacute liver failure
DB99.7 Hepatic failure, not specified as acute or chronic
DB99.8 Chronic hepatic failure
DB9Z Liver diseases, unspecified
DD91.1 Functional constipation
DE2Z Diseases of the digestive system, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally. Determine the dose, frequency, and duration individually based on indication, patient age, and clinical response.

For chronic constipation in adults and adolescents, initiate with 15-30 ml (equivalent to 10-20 g of lactulose) daily. Adjust the maintenance dose to 10-25 ml daily. Divide the daily dose into two administrations if necessary.

For hepatic encephalopathy in adults, initiate with a higher dose. Administer 30-50 ml three times daily. Adjust the dose to produce 2-3 soft stools per day. The usual daily dose ranges from 30-90 ml.

For children with constipation, use age-appropriate dosing. For children under 1 year, administer up to 5 ml daily. For children 1 to 6 years, administer 5-10 ml daily. For children 7 to 14 years, administer 10-15 ml daily initially, adjusting to a maintenance dose.

Take doses regularly at the same time each day, preferably with meals. Mix the syrup with water, juice, or milk to improve palatability if needed.

Onset of laxative effect typically occurs within 24-48 hours. Do not exceed the recommended dosage without medical supervision. If no bowel movement occurs after several days, or if rectal bleeding develops, discontinue use and consult a physician.

For long-term management of hepatic encephalopathy, titrate the dose to maintain 2-3 acidic soft stools daily and to reduce blood ammonia levels. Monitor plasma electrolytes during prolonged therapy exceeding six months.

Adverse Reactions

Metabolism disorders very rarely – hypernatremia; frequency unknown – water-electrolyte balance disorders that occur due to diarrhea.

Digestive system nausea, vomiting, abdominal pain, flatulence, diarrhea.

Contraindications

Hypersensitivity to lactulose; intestinal obstruction; fructose intolerance, galactose intolerance; lactase deficiency; glucose-galactose malabsorption; galactosemia; rectal bleeding (not caused by hemorrhoids); suspected appendicitis, acute inflammatory diseases of the abdominal organs.

With caution diabetes mellitus, colostomy or ileostomy.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

Can be used in children according to indications in age-appropriate recommended doses and dosage forms.

Special Precautions

Should not be used for abdominal pain, nausea, vomiting without diagnosis verification.

Should not be used for inflammatory bowel diseases in the acute stage, as well as for water-electrolyte balance disorders.

Use with caution in patients with gastrocardial syndrome. In such cases, treatment should be started with low doses and increased gradually to avoid the development of flatulence.

Use with caution in patients with diabetes mellitus, especially with inflammatory lesions of the colon.

During long-term treatment (more than 6 months), plasma levels of potassium, chloride, and carbon dioxide should be regularly monitored.

During therapy with laxatives, it is recommended to take a sufficient amount of fluid (1.5-2 l/day, which corresponds to 6-8 glasses of 250 ml volume).

Drug Interactions

With simultaneous use with diuretics, corticosteroids, amphotericin, an increase in potassium loss is possible.

Antacids and antibiotics active against lactobacilli and bifidobacteria (including neomycin, clindamycin, rifaximin) reduce the effects of lactulose.

With simultaneous use, Lactulose may disrupt the release of active substances from enteric-coated drugs with pH-dependent release due to the fact that it lowers the pH of the intestinal contents.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Avva Pharmaceuticals, Ltd. (Cyprus)

Manufactured By

Avva Rus, JSC (Russia)

Dosage Form

Bottle OTC Icon Lactulose Syrup 667 mg/1 ml: bottle 100 ml, 200 ml, 500 ml or 1000 ml.

Dosage Form, Packaging, and Composition

Syrup as a transparent, viscous liquid, from colorless to yellow with a brownish tint.

100 ml
Lactulose 66.7 g

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

100 ml – bottles with a measuring cup – cardboard boxes.
200 ml – bottles with a measuring cup – cardboard boxes.
500 ml – bottles with a measuring cup – cardboard boxes.
1000 ml – bottles with a measuring cup – cardboard boxes.

Marketing Authorization Holder

Avva Rus, JSC (Russia)

Dosage Form

Bottle OTC Icon Lactulose Syrup 667 mg/1 ml: 100 ml, 200 ml, 500 ml or 1000 ml bottle

Dosage Form, Packaging, and Composition

Syrup as a transparent viscous liquid from colorless to yellow with a brownish tint.

1 ml
Lactulose 667 mg

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

100 ml – bottles (1) with a measuring cup – cardboard boxes.
200 ml – bottles (1) with a measuring cup – cardboard boxes.
500 ml – bottles (1) with a measuring cup – cardboard boxes.
1000 ml – bottles (1) with a measuring cup – cardboard boxes.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Lactulose Syrup 667 mg/1 ml: bottle 200 ml with a measuring spoon

Dosage Form, Packaging, and Composition

Syrup as a transparent, viscous liquid, from colorless to slightly yellowish or brownish-yellow.

1 ml
Lactulose (in the form of liquid lactulose) 667 mg

Excipients: purified water.

200 ml – bottles (1) with a measuring spoon – cardboard boxes.

Marketing Authorization Holder

Vifitech, CJSC (Russia)

Dosage Form

Bottle OTC Icon Lactulose Syrup 667 mg/ml: 5 ml, 10 ml or 15 ml sachets 10 or 20 pcs.; 100 ml, 200 ml, 250 ml, 500 ml or 1000 ml bottle

Dosage Form, Packaging, and Composition

Syrup as a transparent, viscous liquid from colorless or from light yellow to yellow with a brownish tint.

100 ml
Lactulose 66.7 g

Excipients: purified water – up to 100 ml.

5 ml – sachets (10) – cardboard boxes.
5 ml – sachets (20) – cardboard boxes.
10 ml – sachets (10) – cardboard boxes.
10 ml – sachets (20) – cardboard boxes.
15 ml – sachets (10) – cardboard boxes.
15 ml – sachets (20) – cardboard boxes.
100 ml – bottles – cardboard boxes.
200 ml – jars – cardboard boxes.
250 ml – bottles – cardboard boxes.
500 ml – bottles – cardboard boxes.
1000 ml – bottles – cardboard boxes.

Marketing Authorization Holder

Pharminnovation, LLC (Russia)

Dosage Form

Bottle OTC Icon Lactulose Syrup 667 mg/1 ml: sachets 15 ml 10 pcs., bottles or jars 100 ml, 200 ml, 500 ml or 1000 ml 1 pc.

Dosage Form, Packaging, and Composition

Syrup as a transparent, viscous liquid from colorless to light yellow with a brownish tint; may contain crystals that disappear upon heating.

1 ml
Lactulose 667 mg

Excipients: purified water – up to 1 ml.

15 ml – single-use sachets (10) – cardboard boxes.
100 ml – bottles (1) – cardboard boxes.
200 ml – bottles (1) – cardboard boxes.
500 ml – bottles (1) – cardboard boxes.
1000 ml – bottles (1) – cardboard boxes.
100 ml – jars (1) – cardboard boxes.
200 ml – jars (1) – cardboard boxes.
500 ml – jars (1) – cardboard boxes.
1000 ml – jars (1) – cardboard boxes.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Manufactured By

Vifitech, CJSC (Russia)

Dosage Form

Bottle OTC Icon Lactulose Canon Syrup 667 mg/ml: 200 ml, 500 ml or 1000 ml bottle

Dosage Form, Packaging, and Composition

Syrup as a transparent, viscous liquid from colorless to light yellow with a brownish tint; may contain crystals that disappear upon heating.

1 ml
Lactulose 667 mg

Excipients: purified water – up to 1 ml.

200 ml – bottles (1) with a measuring cup – cardboard boxes.
500 ml – bottles (1) with a measuring cup – cardboard boxes.
1000 ml – bottles (1) with a measuring cup – cardboard boxes.

Marketing Authorization Holder

Poli Industria Chimica, S.p.A. (Italy)

Manufactured By

Doppel Farmaceutici, S.r.l. (Italy)

Dosage Form

Bottle OTC Icon Lactulose Poli Syrup 50%: bottle 200 ml

Dosage Form, Packaging, and Composition

Syrup 50% 100 ml
Lactulose 66.7 g

200 ml – dark glass bottles (1) – cardboard boxes.

Marketing Authorization Holder

Stada Arzneimittel, AG (Germany)

Manufactured By

Hemofarm Koncern Zorka Pharma A.D. (Serbia and Montenegro)

Dosage Form

Bottle OTC Icon Lactulose Stada Syrup 667 mg/ml: bottle 200 ml, 500 ml or 1 L

Dosage Form, Packaging, and Composition

Syrup 50% 100 ml
Lactulose 66.7 g

200 ml – dark glass bottles (1) – cardboard boxes.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Merckle, GmbH (Germany)

Dosage Form

Bottle OTC Icon Lactulose-Teva Syrup 667 mg/1 ml: bottle 200 ml, 500 ml or 1000 ml

Dosage Form, Packaging, and Composition

Syrup transparent, viscous, colorless or slightly brownish-yellow.

1 ml
Lactulose liquid 1320 mg,
   Which corresponds to lactulose content 667 mg

200 ml – high-density polyethylene bottles (1) with a measuring cup – cardboard boxes.
500 ml – high-density polyethylene bottles (1) with a measuring cup – cardboard boxes.
1000 ml – high-density polyethylene bottles (1) with a measuring cup – cardboard boxes.
1000 ml – high-density polyethylene bottles (1) with a measuring cup and a device for extracting the drug – cardboard boxes.

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