Active substanceLactuloseLactulose
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  • Dosage form: & nbspfromhippo
    Composition:

    In 1 ml contains:

    active substance: lactulose liquid (1320 mg), in terms of lactulose 667 mg.

    Description:Transparent, colorless or slightly brownish-yellow viscous liquid.
    Pharmacotherapeutic group:Laxative
    ATX: & nbsp

    A.06.A.D   Laxative preparations with osmotic properties

    A.06.A.D.11   Lactulose

    Pharmacodynamics:

    Lactulose - a disaccharide consisting of galactose and fructose, is not hydrolyzed by the disaccharidases of the small intestine mucosa. Has a hyperosmotic laxative effect, stimulates the intestinal peristalsis, improves the absorption of phosphates and calcium salts, promotes the excretion of ammonium ions.

    Lactulose is cleaved by intestinal flora of the colon to low-molecular organic acids, which leads to a decrease in pH and an increase in osmotic pressure and. as a consequence, an increase in the volume of intestinal contents. These effects stimulate intestinal peristalsis and affect the consistency of the stool. The physiological rhythm of emptying of the large intestine is restored.

    In hepatic encephalopathy, the effect is attributed to the suppression of proteolytic bacteria by increasing the number of acidophilic bacteria (eg, lactobacilli), the transition of ammonia to the ionic form by acidifying the contents of the colon, emptying the bowels due to a decrease in pH in the large intestine and osmotic effect, and also reducing the 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 it becomes possible to suppress 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 by 0.4-2%, then reaches the thick intestine, where it is split by the intestinal microflora.

    Fully metabolized when used in doses up to 45-70 ml. When used in higher doses, it is partially excreted unchanged.

    Indications:

    - Chronic constipation, as well as diseases that require relief of defecation;

    - prevention and treatment of hepatic encephalopathy in adults.

    Contraindications:

    - Hypersensitivity to lactulose or other components of the drug;

    - intestinal obstruction;

    - intolerance to fructose, galactose;

    - deficiency of lactase; glucose-galactose malabsorption;

    - galactosemia;

    - rectal bleeding (the cause of which is not hemorrhoids);

    - colo- or ileostomy;

    - suspicion of appendicitis, acute inflammatory diseases of the abdominal cavity.

    Carefully:

    Diabetes.

    Pregnancy and lactation:

    Lactulose-Teva is used during pregnancy and during breast-feeding only if the benefit to the mother exceeds the potential risk to the fetus and the baby.

    Dosing and Administration:

    Inside. Regardless of food intake.

    The drug Lactulose-Teva can be dissolved in water and other liquids and taken diluted.

    With chronic constipation, as well as diseases that require relief of defecation The daily dose can be taken once, or divided into two doses, using a measuring cup. After a few days, the dose can be adjusted to a maintenance dose, depending on the response to taking the drug.

    Age

    Initial daily dose

    Maintenance daily dose

    In children over 14 years of age and adults

    15-45 ml

    15-30 ml

    At children from 6 till 14 years

    15 ml

    10-15 ml

    At children from 1 year till 6 years

    5-10 ml

    5-10 ml

    In children under 1 year old

    up to 5 ml

    up to 5 ml

    With hepatic encephalopathy dozu should be increased gradually.

    In adults, starting from 7.5-15 ml 3-4 times a day, increase to 30-45 ml 3-4 times a day.
    Side effects:

    The frequency of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%: rarely - not less than 0.01%, but less than 0.1%; very rarely (including isolated cases) - less than 0.01%; frequency is unknown - insufficient data for estimating the frequency of the phenomenon in the population.

    From the side of nutrition and metabolism: very rarely - hypernatremia: frequency unknown - disturbance of water-electrolyte metabolism.

    From the gastrointestinal tract (GIT): very often - nausea, vomiting, abdominal pain, flatulence, bloating, diarrhea.

    Overdose:

    Symptoms: nausea, vomiting, diarrhea, hypokalemia, hypernatremia.

    Treatment: symptomatic.

    Interaction:

    When used simultaneously with diuretics, glucocorticosteroids, amphotericin B, an increase in potassium loss is possible.

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

    Special instructions:

    The drug Lactulose-Teva should not be used in inflammatory diseases of the gastrointestinal tract at the stage of exacerbation, as well as in violation of water-electrolyte metabolism.

    In patients with diabetes mellitus or other disorders of carbohydrate metabolism, the content of digestible carbohydrates should be taken into account. In 100 ml of syrup contains 17 g of digestible carbohydrates, in particular fructose, lactose and galactose, which corresponds to 1.4 grain units (XE). In the treatment of constipation, a daily dose of 5 ml / day corresponds to 0.07 XE, a daily dose of 45 ml / day - 0.64 XE.In the treatment of hepatic encephalopathy, a daily dose of 22.5 ml / day corresponds to 0.32 XE, a daily dose of 180 ml / day - 2.56 XE.

    The laxative effect may occur after 2-10 hours, but with insufficient dosage - after 24-48 hours.

    Effect on the ability to drive transp. cf. and fur:

    The use of the drug Lactulose-Teva does not affect the performance of actions requiring increased concentration of attention and rapidity of psychomotor reactions.

    Form release / dosage:

    Syrup, 667 mg / ml.

    Packaging:

    For 200 ml, 500 ml or 1000 ml in a bottle of high-density polyethylene with a plastic screw cap with the control of the first opening complete with a measuring cup of polypropylene.

    1000 ml per bottle of high-density polyethylene and a plastic screw cap with the control of the first opening complete with a measuring cup of polypropylene and a nozzle for the extraction of the drug.

    One bottle of 200 ml, 500 ml, 1000 ml complete with a measuring cup or one bottle of 1000 ml, complete with a measuring cup and a nozzle for extracting the drug, together with instructions for use, are placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. After the first autopsy - 6 months.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003409
    Date of registration:13.01.2016
    Expiration Date:13.01.2021
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp11.02.2018
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