Dinolak^® (Emulsion) Instructions for Use

Marketing Authorization Holder

Avva Rus, JSC (Russia)

ATC Code

A06AD61 (Lactulose in combination with other drugs)

Active Substances

Simeticone (Rec.INN registered by WHO)

Lactulose (Rec.INN registered by WHO)

Dosage Form

Dinolak®

Oral emulsion 66 g+0.8 g/100 ml: 100 ml, 200 ml, 500 ml, or 1000 ml bottle with measuring cup

Dosage Form, Packaging, and Composition

Oral emulsion as a turbid liquid from almost colorless to yellow, homogeneous in appearance.

Excipients: povidone K90 – 1.2 g, povidone K17 – 0.8 g, colloidal silicon dioxide (aerosil 380) – 0.45 g, ascorbic acid – 0.125 g.

100 ml – high-density polyethylene bottles (1) with a measuring cup – cardboard boxes.
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.

Clinical-Pharmacological Group

Laxative drug

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Combined laxative drug.

Lactulose is a synthetic disaccharide consisting of galactose and fructose. Under the influence of disaccharidases of the colon microflora, Lactulose is broken down into monosaccharides and then into short-chain carboxylic acids.

Short-chain carboxylic acids lower the pH level in the large intestine, which is accompanied by increased peristalsis and suppression of the growth of proteolytic microflora.

The rapid absorption of short-chain fatty acids in the distal parts of the large intestine improves the absorption of water, sodium, and other electrolytes.

As a result, Lactulose has a laxative effect and normalizes bowel function by stimulating the growth and reproduction of normal intestinal microflora (bifidogenic factor).

After oral administration, the effect of lactulose occurs after 24-48 hours, which is due to the transit of the drug to the large intestine.

Simethicone is an agent with antifoaming properties. By reducing the surface tension at the phase interface, it impedes the formation and promotes the destruction of gas bubbles in the gastrointestinal contents.

The gases released in this case can be absorbed by the intestinal walls or eliminated from the body.

It reduces the feeling of abdominal discomfort that sometimes accompanies the action of lactulose.

Pharmacokinetics

Lactulose

Humans lack hydrolases capable of breaking down the disaccharide into the corresponding monosaccharides. Therefore, when taken orally, Lactulose is practically not metabolized, not absorbed in the stomach and small intestine, and enters the large intestine unchanged.

It is excreted from the body with intestinal contents, with only 3% of the drug excreted by the kidneys.

Simethicone

When taken orally, it is not absorbed in the digestive tract and is excreted from the body unchanged.

Indications

• Constipation;
• Regulation of bowel movements in hemorrhoids, the need for surgical operation on the colon and perianal area;
• Hepatic encephalopathy, hepatic precoma and coma (treatment and prevention);
• Hyperammonemia;
• Treatment and prevention of dysbiosis of various etiologies;
• Restoration of normal intestinal microflora after antibiotic therapy.

ICD codes

Dosage Regimen

The drug is taken orally. When a single daily dose is prescribed, the drug should be taken at the same time (for example, during breakfast).

For constipation, children under 1 year are prescribed 5 ml/day; children aged 1 to 6 years – 5-10 ml/day; children aged 7 to 14 years – 15 ml/day; children over 14 years and adults – in the first three days, 15-45 ml/day is prescribed, then – 10-30 ml/day.

For hepatic coma, precoma, hepatic encephalopathy and hyperammonemia – 30-50 ml 3 times/day. The daily dose can be 90-190 ml, then it is necessary to switch to using the drug in a maintenance dose, selected so that soft stools are maximum 2-3 times/day.

For intestinal dysbiosis, children over 7 years and adults are prescribed 5 ml 1-2 times/day, the dose is selected individually.

It is recommended to use the measuring cup when taking. The drug should be shaken before use.

During therapy with laxative drugs, a sufficient amount of fluid should be taken (1.5-2 l/day, which equals 6-8 glasses).

Adverse Reactions

When using the drug in high doses during long-term treatment of hepatic encephalopathy, the patient may develop water-electrolyte balance disorders, which may manifest as weakness, increased fatigue, dizziness, headache, nausea, myalgia, arrhythmias.

Contraindications

• Galactosemia;
• Intestinal obstruction;
• Fructose intolerance, galactose intolerance, lactase deficiency, glucose-galactose malabsorption;
• Hypersensitivity to the components of the drug.

With caution the drug should be taken in diabetes mellitus.

Use in Pregnancy and Lactation

If necessary, the drug can be prescribed during pregnancy and lactation (breastfeeding).

Pediatric Use

When treating children, laxative drugs should be used in exceptional cases, only under medical supervision.

Special Precautions

With long-term use (more than 6 months), periodic determination of plasma electrolyte levels is recommended.

It must be taken into account that the drug may contain insignificant amounts of related sugars (for example, lactose, galactose, fructose). When treating hepatic (pre)coma, the drug is usually used in high doses, and its sugar content should be taken into account in relation to patients with diabetes mellitus.

When treating children, laxative drugs should be used in exceptional cases, only under medical supervision.

Effect on ability to drive vehicles and mechanisms

The use of the drug Dinolak^® does not affect the ability to drive a car or operate machinery.

Overdose

Overdose may be marked by abdominal pain and diarrhea, which requires dose adjustment.

Drug Interactions

Antacids and antibiotics active against lacto- and bifidobacteria (neomycin, clindamycin, rifaximin) reduce the effect of lactulose.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.