Duflocik (Syrup) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

A06AD11 (Lactulose)

Active Substance

Lactulose (Rec.INN registered by WHO)

Dosage Form

Duflocik

Syrup 667 mg/ml

Dosage Form, Packaging, and Composition

Syrup

1000 ml – bottles – cardboard packs /with a measuring cup/ – Over-the-Counter
200 ml – bottles – cardboard packs /with a measuring cup/ – Over-the-Counter
500 ml – bottles – cardboard packs /with a measuring cup/ – Over-the-Counter

Clinical-Pharmacological Group

Laxative drug with osmotic properties. Hypoammonemic agent

Pharmacotherapeutic Group

Drugs for the treatment of constipation; osmotic laxatives

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 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 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. Use the provided measuring cup for accurate dosing.

For chronic constipation in adults and adolescents: start with 15-30 ml once daily. Adjust the dose to achieve 1-2 soft stools per day.

For chronic constipation in children: administer 5-10 ml once daily for children 7-14 years old. Administer 5 ml once daily for children 1-6 years old.

Adjust the maintenance dose every 1-2 days by 5 ml until the desired therapeutic effect is achieved. The maximum daily dose for adults is 60 ml; for children, it is 30 ml.

For the prevention of hepatic encephalopathy in adults: administer 30-50 ml three times daily. Adjust the dose to produce 2-3 soft stools daily.

For the treatment of hepatic encephalopathy in adults: start with 30-50 ml three times daily. Further adjustment is based on the patient’s clinical condition and stool pH.

The initial effect may be delayed for 24-48 hours. Do not exceed the recommended maximum daily doses.

During long-term therapy, monitor plasma electrolyte levels. Maintain adequate fluid intake of 1.5-2 liters per day.

Adverse Reactions

Metabolism and nutrition disorders: very rarely – hypernatremia; frequency unknown – water-electrolyte balance disorders that 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

It 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 gastrocardiac 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 2°C (36°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.