Instructions for use Lactiol-source powder for oral use 5 g in sachet No. 20
Composition
active ingredient: lactitol monohydrate;
1 sachet contains 5 g or 10 g of lactitol monohydrate;
1 plastic container contains 200 g or 500 g of lactitol monohydrate.
Dosage form
Powder for oral use.
Main physicochemical properties: white or almost white crystalline powder.
Pharmacotherapeutic group
Osmotic laxatives.
ATX code A06AD12.
Pharmacological properties
Pharmacodynamics.
Lactitol, a disaccharide derivative consisting of galactose and sorbitol, is not hydrolyzed by disaccharidases in the small intestine. As a result, it passes through the small intestine with minimal absorption and enters the large intestine unchanged. In the large intestine, under the influence of microflora (mainly Bacteroides and Lactobacilli), lactitol is metabolized mainly to acetic, propionic and butyric acids. Acidification of the colonic contents reduces the absorption of ammonia. The conversion of lactitol into short-chain organic acids increases the osmotic pressure in the colon. This leads to an increase in the water content of the feces and their volume, which is what causes the laxative effect.
In hepatic encephalopathy, the effect is achieved through the migration of ammonia from the blood into the large intestine (due to a decrease in pH, an increase in osmotic pressure in the intestinal lumen), the removal of retained ammonium ions and other nitrogen-containing toxic substances from the large intestine.
Lactitol as a prebiotic enhances the growth of beneficial bacteria such as bifidobacteria and lactobacteria, while inhibiting the growth of proteolytic bacteria. This contributes to an increase in the dry mass of intestinal contents, which has a beneficial effect on its emptying.
Lactitol does not pose a danger to tooth enamel.
Pharmacokinetics.
Lactitol is not absorbed in the small intestine, it acts in the colon, where it is broken down by the colonic flora. Lactitol is absorbed in minimal amounts. Up to 2% is found in the urine in an unchanged state. Lactitol has no general systemic effect.
Indication
Use for symptomatic treatment of constipation, in conditions requiring relief of defecation (after operations on the large intestine and anorectal area, in hemorrhoids).
For the treatment of chronic or acute hepatic encephalopathy.
Contraindication
Hypersensitivity to the active substance.
Inflammatory bowel disease (ulcerative colitis, Crohn's disease).
Intestinal obstruction, occlusive or subocclusive syndrome.
Presence of ileostomy, enterostomy.
Gastrointestinal perforation or suspected perforation.
Presence of any symptoms or suspicion of organic damage to the digestive tract, abdominal pain and/or rectal bleeding.
Before using laxatives, coprostasis should be treated in other ways.
Contraindicated in breastfed infants and infants with autosomal recessive hereditary fructose intolerance.
Galactosemia (incomplete metabolism of lactitol can lead to the development of fructosemia and galactosemia and associated complications).
Pre-existing fluid and electrolyte imbalance.
Interaction with other medicinal products and other types of interactions
When using the drug "Lactitol-Istok" with enteric-coated drugs of pH-dependent release, it should be taken into account that lactitol reduces the pH of the intestine.
When lactitol is used simultaneously with neomycin, the latter can neutralize the acidifying effect of lactitol on intestinal contents, therefore, this combination is not recommended for patients with cirrhosis with hepatic encephalopathy, however, neomycin does not change the laxative effect of the drug in patients with constipation.
"Lactiol-Istok", like other laxatives, may increase potassium loss induced by other drugs (e.g. thiazide diuretics, corticosteroids, carbenoxolone, amphotericin B). Potassium deficiency increases the risk of developing toxic effects of cardiac glycosides during concomitant treatment.
Antibacterial agents (drugs used to treat infections) and oral antacids reduce the effect of the drug "Lactiol-Istok" on the bacterial flora of the intestine.
Laxatives should not be taken simultaneously with other medications: it is not recommended to use "Lactiol-Istok" within 2 hours of taking other medications.
Application features
In elderly and debilitated patients, with prolonged use of the drug "Lactiol-Istok", it is necessary to regularly monitor serum electrolytes. Before starting treatment with any laxatives, it is necessary to restore the disturbed electrolyte balance, if it has occurred. When using the drug "Lactiol-Istok", hydrogen may accumulate in the intestines. If such a patient requires a galvanocaust procedure, it is necessary to first cleanse the intestines with solutions that do not cause fermentation.
Patients with rare hereditary problems of galactose or fructose intolerance, galactosemia, lactase deficiency or glucose-galactose malabsorption should not take Lactiol-Istok.
Patients with nausea should take "Lactiol-Istok" with meals.
"Lactiol-Istok" is not recommended for ileostomy and colonostomy.
"Lactiol-Istok" has a low calorie content (2 kcal/g, or 8.5 kJ/g) and does not affect the level of insulin and glucose in blood serum - it can be used by people with diabetes.
In order to prevent the occurrence of flatulence, it is recommended to start treatment with the lowest doses, gradually increasing the dose until the effect is achieved. If flatulence occurs, the dose should be reduced or treatment should be discontinued.
You should consult a doctor if the therapeutic effect is insufficient within a few days of treatment.
Use during pregnancy or breastfeeding
Pregnancy: Animal studies do not indicate direct or indirect toxic effects of lactitol monohydrate on reproductive function.
Due to the lack of data on the effects of the drug "Lactiol-Istok" on pregnant women, the use of the drug during the first trimester of pregnancy is recommended only as prescribed by a doctor, when the expected benefit of treatment for the mother is higher than the possible risk to the fetus or child.
Breastfeeding: The excretion of lactitol monohydrate in breast milk has not been studied.
No effects on breastfed newborns/infants are expected, as the systemic exposure to lactitol monohydrate is negligible.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
The medicine can be added to food that needs to be sweetened (drinks, yogurt, cereals, etc.).
For the symptomatic treatment of constipation or conditions requiring relief of defecation
"Lactiol-Istok" should be taken orally, once a day in the morning or evening during meals, preferably added to food or mixed with liquid. After each dose, it is recommended to drink 1–2 glasses of liquid (200 ml). The dosage regimen (morning or evening) should be selected according to the patient's needs: the laxative effect usually develops a few hours after administration. However, the first laxative effect may appear on the second or third day of use.
The recommended doses of the drug "Lactiol-Istok" are given below. Since the response of patients may vary, it is necessary to select an individual dose to achieve daily bowel movements.
Adults (including the elderly): the initial daily dose is 0.3 g/kg body weight, which is approximately 20 g (2 sachets of 10 g or 4 teaspoons of powder) - the entire daily dose should be taken once in the morning or evening. After a few days, the daily dose can be reduced to 10 g (1 sachet of 10 g or 2 teaspoons of powder).
If there is no laxative effect, you can take a maximum initial daily dose of 30 g (6 teaspoons of powder).
Children: the initial average daily dose is 0.25 g/kg body weight:
from 1 to 6 years: from 2.5 to 5 g per day (½ or 1 sachet of 5 g or ½ – 1 teaspoon of powder);
from 6 to 12 years: from 5 to 10 g per day (1 or 2 sachets of 5 g or 1–2 teaspoons of powder);
from 13 to 16 years: from 10 to 20 g per day (from 1 to 2 sachets of 10 g or 2–4 teaspoons of powder).
1 teaspoon contains an average of 5 g of lactitol.
For the treatment of chronic or acute hepatic encephalopathy.
The dose of the drug should be selected individually for each patient, depending on the individual response (2 soft bowel movements per day should be achieved).
Oral administration: the drug is prescribed in an initial daily dose of 0.5–0.7 g/kg of body weight, which should be divided into 3 doses during meals.
Administration via nasogastric tube or retention enema via rectal balloon catheter in hospitalized patients
Preparation of 40% solution of the drug
Add 200 g of the drug "Lactiol-Istok" to 200 ml of hot distilled water, stirring constantly until the powder dissolves; bring the resulting solution to a volume of 500 ml with distilled water.
When administered via a retention enema, this amount of solution can be administered 4 to 6 times per day.
When administered via nasogastric tube or by mouth, the initial daily dose is 1 to 2 ml/kg body weight of a 40% solution prepared as above, corresponding to 0.4–0.8 g/kg body weight per day of lactitol monohydrate.
Children.
Use in children from 1 year of age on the recommendation of a doctor.
Overdose
Symptoms
Excessive doses may cause abdominal pain and diarrhea. Diarrhea is a sign of overdose, which may also lead to changes in serum electrolyte levels.
Reducing the dose or stopping the drug, correcting electrolyte imbalance in case of excessive fluid loss due to diarrhea.
Side effects
At the beginning of treatment with the drug, you may experience abdominal discomfort, flatulence, pain, nausea. These phenomena usually decrease or disappear after a few days of treatment.
Depending on individual sensitivity, diarrhea may occur when using the drug in recommended doses. In such cases, the dose should be reduced.
When using high therapeutic doses for a long time in the treatment of hepatic encephalopathy, patients may experience electrolyte imbalance due to diarrhea.
The following classification is used to describe the frequency of side effects: very common (≥1/10), common (≥1/100 - <1/10), uncommon (≥1/1000 - <1/100), rare (≥1/10000 - <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data).
Gastrointestinal disorders: very rarely - vomiting, abdominal pain or discomfort, diarrhea, abdominal bloating, anal itching, nausea, flatulence; frequency unknown - abdominal rumbling.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
5 g of powder in a sachet, 20 sachets in a cardboard box.
10 g of powder in a sachet, 15 sachets in a cardboard box.
200 g or 500 g of powder in a plastic container.
Vacation category
Without a prescription.
Producer
Limited Liability Company "Istok-Plus".
Address
Ukraine, 69032, Zaporizhia, Makarenka St., building 4.
