Composition, form of production and packaging
? The syrup is transparent, viscous, from colorless to light yellow with a brownish hue.
100 ml
lactulose 66.7 g
Excipients: purified water - up to 100 ml.
15 ml - disposable sachets (10) - packs of cardboard.
200 ml - polyethylene bottles (1) complete with a measuring cup.
500 ml - polyethylene bottles (1) complete with a measuring cup.
1 L - polyethylene bottles (1) complete with a measuring cup.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Laxative drug. 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 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 (eg, lactobacilli), transferring 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 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. After ingestion, it reaches the large intestine in unchanged form, where it is split by intestinal flora.
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 (with hemorrhoids, conditions after surgery on the large intestine and in the anal region);
- hepatic encephalopathy in adults: treatment and prevention of hepatic coma or precoma.
DOSING MODE
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 doses 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.
Dosage in the treatment of constipation or to soften the 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 therapeutic 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 5-10 ml 5-10 ml
Children up to 1 year up to 5 ml 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 that the drug be used in vials.
Dosage in the treatment of hepatic encephalopathy (adults):
The initial dose: 3-4 times / day for 30-45 ml. Then they switch to an individually selected maintenance dose so that the soft stool is maximum 2-3 times / day.
Safety and effectiveness of the drug in children and adolescents under the age of 18 years with hepatic encephalopathy is not established due to the lack of data.
In elderly patients and patients with renal or hepatic insufficiency, there are no special recommendations for dosing, The systemic effect of lactulose is negligible.
SIDE EFFECT
In the early days of lactulose, the appearance of flatulence is possible. As a rule, it disappears in a few days.
In the case of high doses for a long time in the treatment of hepatic encephalopathy, the patient may develop disturbances in the water-electrolyte balance due to diarrhea.
From the side of the digestive system: very often (? 1/10) - diarrhea; often (? 1/100, <1/10) - flatulence, abdominal pain, nausea, vomiting.
Other: 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.
CONTRAINDICATIONS
- galactosemia;
- intestinal obstruction;
- perforation or risk of perforation of the gastrointestinal tract;
- intolerance to galactose or fructose, deficiency of lactase or glucose-galactose malabsorption;
- Hypersensitivity to any component of the drug.
With caution should prescribe the drug with undiagnosed rectal bleeding; with colostomy, ileostome.
PREGNANCY AND LACTATION
It is not expected that there will be any effect on the fetus or infant; The systemic effect of lactulose on a pregnant or lactating woman is negligible.
Dufalac В® can be administered during pregnancy and during breastfeeding.
It is not assumed that there is any effect on reproductive function. The systemic effect of lactulose is negligible.
APPLICATION FOR FUNCTIONS OF THE LIVER
In patients with renal insufficiency, there are no special recommendations for dosing, since The systemic effect of lactulose is negligible.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In patients with hepatic insufficiency, there are no special recommendations for dosing, since The systemic effect of lactulose is negligible.
APPLICATION FOR CHILDREN
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.
Safety and effectiveness of the drug in children under the age of 18 years with hepatic encephalopathy is not established due to the lack of data.
APPLICATION IN ELDERLY PATIENTS
In elderly patients there are no special recommendations for dosing, because The systemic effect of lactulose is negligible.
SPECIAL INSTRUCTIONS
In the case of abdominal pain of unknown origin, before starting therapy or lack of therapeutic effect for several days, the patient should consult a doctor.
It should be noted that Dufalac В® may contain insignificant amounts of bound sugars (for example, lactose, galactose, epilactose and fructose).
The content of residual sugars present in Dufalac В® is about 0.075 XE in 5 ml of syrup.
When used at the dose 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, which should be taken into account in patients with diabetes mellitus.
Long-term use in 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.
Impact on the ability to drive vehicles and manage mechanisms
The use of Dufalac В® does not affect or has little effect on the ability to drive a car or operate machinery and machinery.
OVERDOSE
Symptoms: when taking the drug in a very high dose, pain in the abdominal region 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.
DRUG INTERACTION
Studies on interactions with other drugs have not been conducted.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
