Dyufaloza (Syrup) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

A06AD11 (Lactulose)

Active Substance

Lactulose (Rec.INN registered by WHO)

Dosage Form

Dyufaloza

Syrup 667 mg/1 ml: bottle or jar 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 40 ml, 50 ml, 90 ml, 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 350 ml, 400 ml, 450 ml, 500 ml, 550 ml, 600 ml, 650 ml, 700 ml, 750 ml, 800 ml, 850 ml, 900 ml, 950 ml, or 1000 ml

Dosage Form, Packaging, and Composition

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

Excipients: citric acid – 0.5 mg, purified water – up to 1 ml.

10 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
15 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
20 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
25 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
30 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
40 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
50 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
90 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
100 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
150 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
200 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
250 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
300 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
350 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
400 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
450 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
500 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
550 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
600 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
650 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
700 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
750 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
800 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
850 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
900 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
950 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
1000 ml – bottles (1) with a spoon or measuring cup – cardboard packs.
10 ml – jars (1) – cardboard packs.
15 ml – jars (1) – cardboard packs.
20 ml – jars (1) – cardboard packs.
25 ml – jars (1) – cardboard packs.
30 ml – jars (1) – cardboard packs.
40 ml – jars (1) – cardboard packs.
50 ml – jars (1) – cardboard packs.
90 ml – jars (1) – cardboard packs.
100 ml – jars (1) – cardboard packs.
150 ml – jars (1) – cardboard packs.
200 ml – jars (1) – cardboard packs.
250 ml – jars (1) – cardboard packs.
300 ml – jars (1) – cardboard packs.
350 ml – jars (1) – cardboard packs.
400 ml – jars (1) – cardboard packs.
450 ml – jars (1) – cardboard packs.
500 ml – jars (1) – cardboard packs.
550 ml – jars (1) – cardboard packs.
600 ml – jars (1) – cardboard packs.
650 ml – jars (1) – cardboard packs.
700 ml – jars (1) – cardboard packs.
750 ml – jars (1) – cardboard packs.
800 ml – jars (1) – cardboard packs.
850 ml – jars (1) – cardboard packs.
900 ml – jars (1) – cardboard packs.
950 ml – jars (1) – cardboard packs.
1000 ml – jars (1) – cardboard packs.

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 intestinal 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; as well as 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 by 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

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 15-45 ml daily. Adjust the maintenance dose to 15-30 ml daily. Divide the total daily dose into two or three administrations if necessary.

For hepatic encephalopathy in adults, initiate with a dosage of 30-50 ml three to four times daily. Adjust the dose to produce two or three soft stools per day. The usual maintenance dose is 20-30 ml three times daily.

For children aged 7 to 14 years with constipation, administer 15 ml daily. For children aged 1 to 6 years, administer 5-10 ml daily. For infants under 1 year, initiate with up to 5 ml daily.

Use the provided measuring cup or spoon for accurate dosing. Mix the syrup with water, juice, or milk to improve palatability if desired.

Monitor for efficacy and adverse effects like diarrhea or flatulence. If diarrhea occurs, reduce the dosage immediately. For long-term therapy exceeding six months, monitor plasma levels of potassium, chloride, and carbon dioxide periodically.

Ensure adequate fluid intake of 1.5 to 2 liters per day during treatment. Do not use for more than one week without medical advice unless for chronic conditions under supervision.

Adverse Reactions

Metabolism and nutrition disorders very rarely – hypernatremia; frequency unknown – water-electrolyte balance disorders, which occur as a result of diarrhea.

Gastrointestinal disorders nausea, vomiting, abdominal pain, flatulence, diarrhea.

Contraindications

Hypersensitivity to lactulose; intestinal obstruction; fructose, 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 a verified diagnosis.

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

When used concomitantly 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.

Concomitant use of 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 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.