Active substanceLactuloseLactulose
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  • Dosage form: & nbspsyrup
    Composition:

    100 ml of syrup contain 66.7 g of lactulose concentrate.

    Excipients: purified water.
    Description:

    Transparent viscous liquid from colorless to brownish-yellow color.

    Pharmacotherapeutic group:laxative
    ATX: & nbsp

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

    A.06.A.D.11   Lactulose

    Pharmacodynamics:

    Has a hyperosmotic, laxative effect, stimulates the intestinal peristalsis, improves the absorption of phosphates and Ca2 + salts, promotes the excretion of ammonium ions. Under the influence of lactulose, reproduction occurs Lactobacillus acidophilus, Lactobacillus bifidus in the intestines, which in turn leads to a decrease in pH in the lumen of the large intestine and activation of its peristalsis. Along with the volume increases and softening of stool occurs. The drug has a laxative effect, without directly affecting the mucosa and smooth muscles of the large intestine.

    Under the influence of lactulose, the formation of nitrogen-containing toxic substances in the proximal part of the colon and their absorption into the systemic blood flow decreases. The concentration of ammonium ions decreases in the blood by 25-50%, reduces the severity of hepatic encephalopathy, improves the mental state and normalizes the EEG.

    The drug has the ability to inhibit the growth of salmonella in the large intestine. The effect of the drug comes in 24 - 48 hours after ingestion as the drug passes through the digestive tract.

    Pharmacokinetics:

    Lactulose is almost not absorbed from the gastrointestinal tract (absorbed no more than 3% of the dose), does not reduce the absorption of vitamins, is not addictive.

    Indications:

    - Constipation (including chronic)

    - the need to soften the stool for medical purposes (with hemorrhoids,the need for a surgical operation on the large intestine and / or anus, pain syndrome after removal of hemorrhoids, postoperative period)

    - intestinal dysbiosis

    - hepatic encephalopathy

    - hepatic precoma and coma (treatment and prevention)

    - hyperammonemia

    - enteritis caused by salmonella, shigella, salmonella

    - a syndrome of putrefactive dyspepsia (in children of early age as a result of acute food poisoning).

    Contraindications:

    Hypersensitivity to lactulose or other components of the drug, galactosemia, intestinal obstruction, rectal bleeding (which is not caused by hemorrhoids), colo-, ileostoma, suspicion of appendicitis.

    Dosing and Administration:

    The dose of the drug is selected individually.

    In the treatment of constipation and softening of the stool:


    initial dose (three days)

    continuation of treatment

    Children under 1 year old

    5 ml syrup
    (1 teaspoon)

    5 ml syrup
    (1 teaspoon)

    children from 1 year to 6 years

    5-10 ml of syrup
    (1-2 teaspoons)

    5-10 ml of syrup
    (1-2 teaspoons)

    children from 7 to 14 years old

    15 ml syrup
    (1 tablespoon)

    10 ml syrup
    (2 teaspoons)

    adults

    15-45 ml of syrup
    (1 -3 tablespoons)

    15-30 ml of syrup
    (1-2 tablespoons)

    The drug should be taken in the morning during or after meals, once or divided into two doses. The drug can be drunk with water or another liquid. The patient can select and change the dose and time of taking the drug as needed. The laxative effect of the drug develops during the first two days of admission.

    The duration of treatment for constipation is from 4 weeks to 3-4 months.

    In the treatment of hepatic (portal) encephalopathy, hepatic coma and precoma:

    30-50 ml of syrup (2-3 tablespoons) three times a day.

    In the initial phase of treatment, doses of 30-45 ml of syrup can be given every 1-2 hours to achieve a rapid effect (the first evacuation of the intestine). Then go to the maintenance dose, picking it up individually to get a soft stool 2-3 times a day.

    In the treatment of dysbacteriosis and for the normalization of intestinal microflora:

    The drug is prescribed during or after meals, 2-4 times a day.


    Single dose

    Children under 1 year old

    1.5-3 ml syrup

    Children from 1 to 3 years old

    3 ml syrup

    Children from 3 to 7 years old

    5 ml syrup (1 teaspoon)

    Adults and children over 7 years of age

    5-10 ml of syrup (1-2 teaspoons)

    Duration of treatment is 10-14 days, repeated courses are appointed with weekly breaks.

    Side effects:

    Adverse events are, as a rule, mild and reversible, and are a consequence of exceeding the dose. Spasms, a feeling of discomfort or pain in the abdomen, as well as diarrhea can be eliminated by lowering the dose.

    The flatulence appearing at the beginning of treatment, as a rule, passes in 1-2 days.

    There were cases of skin reactions (rash).

    With prolonged therapy with high doses of lactulose in the treatment of hepatic encephalopathy, a disturbance of the water-electrolyte balance can result, and as a result, convulsions, nausea, headache, dizziness, arrhythmias, myalgia, fatigue, weakness.
    Overdose:Taking too high doses of the drug can cause diarrhea and a violation of the water-electrolyte balance. Treatment: cancellation of the drug.
    Interaction:

    When therapeutic doses of lactulose were used, there were no clinically significant interactions with other drugs, however, PORTHALAC should not be taken within two hours after taking another medication.

    At simultaneous reception lactulose can inactivate drugs for the release of which in the large intestine will create an unfavorable environment (eg, drugs,containing mesalazine).

    Antibiotics (neomycin) and antacids reduce the effect.

    Special instructions:If the constipation is not eliminated within a few days of taking the drug, as well as with the resumption of constipation after stopping the drug, you should consult a doctor.

    Due to the presence of minor amounts of sugars in the preparation (15 ml of syrup contain up to 1.7 g of galactose and up to 1 g of lactose), precautions should be taken when prescribing a patient with diabetes mellitus and lactose intolerance.

    With caution appoint the drug to patients with gastro-cardiac syndrome. In this case, treatment starts with low doses and increases them gradually to avoid the occurrence of flatulence.

    In the treatment of hepatic encephalopathy, especially in the initial phase of therapy, you can not use other laxatives. Intensified emptying of the intestine can lead to the erroneous conclusion that an adequate dose has been achieved for the therapy of encephalopathy.

    Lactulose can be safely used in pregnant and lactating mothers.

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

    At recommended doses, PORTALAC does not affect the ability to drive vehicles and mechanisms.

    Form release / dosage:

    Syrup 667 mg / ml.

    Packaging:250 ml and 500 ml of the preparation into a bottle of high density polyethylene with a screwed polypropylene cover, with a sealed ring of expanded polyethylene. One bottle together with the instruction for use is placed in a cardboard box.
    Storage conditions:

    At a temperature of no higher than 25 ° C. Do not freeze because of the possible crystallization of lactulose!

    Keep out of the reach of children!
    Shelf life:3 years.
    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N015059 / 01
    Date of registration:05.11.2008
    The owner of the registration certificate:Beluga, medicines and cosmetics.Beluga, medicines and cosmetics. Croatia
    Manufacturer: & nbsp
    Representation: & nbspBeluga, medicines and cosmetics. Beluga, medicines and cosmetics. Croatia
    Information update date: & nbsp23.05.2012
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