Dufalac - instructions for use, dose, side effects, contraindications

Has a hyperosmotic laxative effect, stimulates intestinal peristalsis, improves the absorption of phosphates and Ca salts²⁺, promotes the excretion of ammonium ions.

Lactulose is cleaved by intestinal flora of the colon to low molecular weight 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. These effects stimulate intestinal peristalsis and affect the consistency of the stool. As a result, 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 (for example, 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 nitrogen-containing toxic substances by stimulation of bacteria, utilizing ammonia for bacterial protein synthesis.

Lactulose as a prebiotic substance enhances the growth of beneficial bacteria, such as bifidobacteria and lactobacilli, while suppression is possible growth of potentially pathogenic bacteria, such as Clostridium and Escherichia coli, which provides a more favorable balance of intestinal flora.

Pharmacokinetics:Absorption is low. After ingestion, it reaches the large intestine in unchanged form, where it is split by intestinal flora. Completely metabolized when used in doses up to 40-75 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 (hemorrhoids, conditions after surgery on the large intestine and in the anal area).

- Hepatic encephalopathy in adults: treatment and prevention of hepatic coma or precoma.

Contraindications:

- galactosemia;

- obstruction, perforation or risk of perforation of the gastrointestinal tract;

- hypersensitivity to any component of the drug;

- intolerance to galactose or fructose, deficiency of lactase or glucose-galactose malabsorption.

Carefully:

- rectal bleeding undiagnosed;

- colostomy, ileostomy.

Pregnancy and lactation:

It is not expected that there will be any effect on the fetus or infants, since the systemic effect of lactulose on a pregnant or lactating woman is negligible.Dufalac® can be administered during pregnancy and during breastfeeding.

It is not expected that there will be any effect on reproductive function, since the systemic effect of lactulose is negligible.

Dosing and Administration:

The drug is intended for oral administration.

A solution of lactulose can be taken in both diluted and undiluted form. It is necessary to immediately swallow the taken single dose, without delaying in the mouth.

All dosages should be selected individually.

In the case of a single daily dose, it should be taken at the same time, for example, during breakfast.

During therapy with laxatives, it is recommended to take a sufficient amount of liquid (1.5-2 liters, which is 6-8 glasses) per day.

To accurately dispense the drug in vials should use the attached measuring cup. When applying the drug in bags it is necessary to tear off the corner of the sachet and immediately take the contents.

Dose for treatment of constipation or for softening of stool for medical purposes

The daily dose of lactulose can be taken once, or divided into two, using a measuring cup.

After a few days, the initial dose can be adjusted to a maintenance dose, depending on the response to taking the drug. The laxative effect may appear 2-3 days after the start of the drug.

Age	Initial daily dose	Maintenance daily dose
Adults and teenagers	15-45 ml (1-3 packets)	15-30 ml (1-2 sachets)
Children 7-14 years old	15 ml (1 sachet)	10-15 ml (1 sachet)
Children 1-6 years old	5-10 ml	5-10 ml
Children under 1 year old	Up to 5 ml	Up to 5 ml

If the maintenance daily dose is less than 15 ml, as well as for accurate dosing in children under 7 years of age, it is recommended to use the drug in vials.

Dose in the treatment of hepatic encephalopathy (adults)

Initial dose: 3-4 times a day for 30-45 ml.

Then they switch to an individually selected maintenance dose so that the soft stool is maximum 2-3 times a day.

The safety and effectiveness of the drug in children (under 18 years old) with hepatic encephalopathy is not established due to the lack of data.

Elderly patients and patients with renal or hepatic insufficiency

There are no special recommendations for dosing, since the systemic effect of lactulose is negligible.

Side effects:

In the first days of taking lactulose, the appearance of flatulence is possible. As a rule, it disappears in a few days.

In the case of the use of elevated doses for a long time in the treatment of hepatic encephalopathy, the patient may develop violations of the water-electrolyte balance due to diarrhea.

Disorders from the gastrointestinal tract

Often (≥ 1/10): diarrhea.

Often (≥ 1/100, <1/10): flatulence, pain in the abdomen, nausea, vomiting.

Other violations

Infrequently (≥ 1/1000, <1/100): violations of the water-electrolyte balance due to diarrhea.

When used in children, a similar safety profile is expected compared to that of adults.

Overdose:

Symptoms: when taking a very high dose, pain in the abdomen and diarrhea are possible.

Treatment: discontinuation of the drug or dose reduction. In the case of a large loss of fluid due to diarrhea or vomiting, correction of water-electrolyte balance disorders may be required.

Interaction:Studies on interactions with other drugs have not been conducted.

Special instructions:

In the case of abdominal pain of unknown origin before starting treatment or lack of therapeuticeffect in a few days after the start of the drug should be consulted with a doctor.

It should be noted that Dufalac® may contain insignificant amounts of bound sugars (for example, lactose, galactose, epilactose and fructose).

When taking the doses recommended for the treatment of constipation, the sugar content should not be a problem for patients with diabetes mellitus. In the treatment of hepatic encephalopathy, higher doses of the drug are usually prescribed, and the sugar content in it should be taken into account in patients with diabetes mellitus.

The content of residual sugars present in Dufalac® is about 0.075 XU in 5 ml of syrup.

Prolonged intake of doses exceeding those recommended in the instructions, or improper application can lead to diarrhea and disturbance of the water-electrolyte balance.

In the treatment of children laxatives should be used in exceptional cases and under the supervision of a doctor. It must be taken into account that during the treatment there may be disorders of the emptying reflex.

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

The use of Dufalac® does not affect or has a negligible effect on the ability to drive and machines.

Form release / dosage:

Syrup 667 mg / ml.

Packaging:

200 ml, 500 ml or 1000 ml in a bottle of high density polyethylene of white color with a screw cap of polypropylene with control of the first opening. A cap (made of polypropylene) is placed on top of the lid, serving as a measuring cup. A label with instructions for use is applied to the vial.

For 15 ml in disposable bags made of polyethylene and aluminum foil. For 10 bags with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

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 N011717 / 02

Date of registration:04.02.2010

The owner of the registration certificate:Abbott Helskea Products BVAbbott Helskea Products BV Netherlands

Manufacturer: & nbsp

ABBOTT BIOLOGICALS, B.V. Netherlands

Representation: & nbspABBOTT LABORATORIES LLC ABBOTT LABORATORIES LLC Russia

Information update date: & nbsp13.08.2014

Illustrated instructions

Instructions

Dufalac® (Duphalac®)