Lactulose Stade - instructions for use, dose, side effects, contraindications

Has a hyperosmotic, laxative effect, stimulates intestinal peristalsis, improves absorption of phosphates and salts of calcium ions, promotes the excretion of ammonium ions.

The drug is cleaved by the intestinal microflora of the thick intestine to low-molecular 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, which in turn leads to an increase in the intestinal motility and a change in the consistency of the stool. The physiological rhythm of emptying the thick intestine is restored.

The action occurs 24-48 hours after the administration (the delay is due to the passage of the drug through the gastrointestinal tract).

In hepatic encephalopathy or hepatic precoma, the effect of the drug is due to the suppression of proteolytic bacteria by increasing the number of acidophilic bacteria (eg, lactobacilli), emptying the bowels by lowering the pH in the colon and osmotic effect, and by reducing nitrogen-containing toxic substances by stimulating bacteria that utilize ammonia for bacterial protein synthesis. Hypoammonemic action is achieved due to the transition of ammonia into the ionic form due to acidification of the contents of the colon. Lactulose Stada® reduces the concentration of ammonium ions in the blood by 25-50%.

Has the ability to inhibit the growth of Salmonella in the intestine, to shorten the period of bacterial release.

Pharmacokinetics:

Absorption is low. Virtually not absorbed, reaches the thick intestine, where it is split by intestinal microflora.

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

Indications:

Constipation, regulation of the physiological rhythm of emptying the large intestine; softening of the stool for medical purposes (including hemorrhoids, the need for surgical intervention on thick gut and / or in the anal region); pain syndrome after removal of hemorrhoids; hepatic encephalopathy: treatment and prevention of hepatic precoma and coma; hyperammonemia; intestinal dysbiosis; enteritis caused by salmonella, shigella, salmonellosis in the stage of bacterial transport; canker dyspepsia syndrome (y children of early age as a result of acute food poisoning).

Contraindications:

Hypersensitivity to the components of the drug, rectal bleeding,colo-, ileostoma, suspicion of appendicitis, galactosemia, intolerance to lactose, galactose or fructose, intestinal obstruction.

Carefully:

Diabetes.

Dosing and Administration:

Inside, during meals (in the morning), the dose is set individually.

For constipation or softening of the stool for medical purposes (including in the postoperative period): in the first 3 days for 15-45 ml, then -15-30 ml. Children 7-14 years - in the first 3 days 15 ml, then 10-15 ml / day; children from 1 year to 6 years - 5-10 ml / day; Infants - 5 ml / day.

Typically, the dose may be reduced after 2 days of admission, depending on the needs of the patient. Clinical effect occurs after 2 days. The dose is increased if there is no improvement in the patient's condition within 2 days of taking the drug.

With hepatic coma, precoma, encephalopathy: 30-50 ml 3 times a day, the daily dose can be 90-190 ml; then in an individually selected maintenance dose (providing a pH of stool 5.0 - 5.5) 2-3 times a day.

With intestinal dysbiosis: adults and children over 7 years - 10 ml / day, children 4-6 years - 5 ml / day, children 1-3 years - 3 ml / day, children under 1 year - 1.5 ml / day.

With salmonella enteritis: in the first 10-12 days to 15 ml 3 times a day, after a one-week break in the same dose 5 times a day.

Side effects:

From the digestive system: in the first days, flatulence is possible (usually passes on its own in 2 days); possibly - nausea, vomiting; when using the drug in high doses - abdominal pain and diarrhea (dose adjustment is required).

From the side of metabolism: when used in elevated doses for a long time in the treatment of hepatic encephalopathy due to concomitant diarrhea, electrolyte imbalances are possible.

Possible manifestations of electrolyte balance disorders: convulsions, headache, dizziness, arrhythmia, myalgia, fatigue, weakness.

Overdose:

No cases of overdose have been reported.

When using the drug in very high doses, nausea, vomiting, abdominal pain, diarrhea, loss of electrolytes due to diarrhea and vomiting are possible.

Treatment: reduction of dose or discontinuation of the drug.

Interaction:

Antibiotics (neomycin) and antacids reduce the effect.

Changes pH-dependent release of enteric-soluble drugs.

It is not recommended to take the drug within 2 hours after taking other medications.

Special instructions:

In the absence of therapeutic effect for 2 days or with the resumption of constipationand after treatment the patient should consult a doctor.

The drug should be used with caution - patients with diabetes, especially in the treatment of hepatic encephalopathy, tk. The dose used in the treatment of hepatic encephalopathy is much higher than the dose used to treat constipation.

With prolonged use of the drug (more than 6 months) in elevated doses, the level of electrolytes in the blood plasma should be regularly monitored.

When using the drug in patients with lactase deficiency, it should be noted that 15 ml of syrup contains up to 1.5 g of galactose and up to 0.9 g of lactose.

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

The use of the drug has no effect on the speed of psychomotor reactions and on the ability to drive a car or drive machinery and mechanisms.

Form release / dosage:Syrup 667 mg / ml.

Packaging:200 ml, 500 ml, 1000 ml in a plastic bottle of brown, sealed with a screw cap white. Each bottle with a graduated cup and instruction for medical use of the drug is placed in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not take the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:PL-000485

Date of registration:01.03.2011

Expiration Date:01.03.2016

The owner of the registration certificate:SHTADA Artznajmittel AGSHTADA Artznajmittel AG Germany

Manufacturer: & nbsp

STADA Arzneimittel, AG Germany

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp11.02.2018

Illustrated instructions

Instructions

Lactulose Stade® (Lactulose Stada)