Buy Duphalac syrup 667 mg/ml with plum flavor 500 ml
  • Buy Duphalac syrup 667 mg/ml with plum flavor 500 ml

Lactulose

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2019-09-19
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Clinical Pharmacology

Pharmacotherapeutic group:

Laxative

ATH:

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

A.06.A.D.11 Lactulose

Pharmacodynamics:

It has a hyperosmotic laxative effect, stimulates intestinal motility, improves the absorption of phosphates and Ca2 + salts, promotes the elimination of ammonium ions.

Lactulose is cleaved by the intestinal flora of the colon into low molecular weight organic acids, which leads to a decrease in pH and an increase in osmotic pressure and, consequently, an increase in the volume of intestinal contents. These effects stimulate intestinal motility and have an effect on stool consistency. As a result, the physiological rhythm of emptying 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, lactobacteria), the conversion of ammonia to the ionic form by acidifying the contents of the large intestine, emptying the pH in the large intestine and osmotic effect, and also reducing the nitrogen-containing toxic substances by stimulation of bacteria that utilize ammonia for bacterial protein synthesis.

Lactulose as a prebiotic substance enhances the growth of beneficial bacteria, such as bifidobacteria and lactobacteria, while it becomes possible to suppress the growth of potentially pathogenic bacteria, such as Clostridium and Escherichia coli, which provides a more favorable balance of intestinal flora.

Pharmacokinetics:

Low absorption. After ingestion comes to the colon in an unchanged form, where the intestinal flora is broken down. Fully 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 colon.

- Stool softening for medical purposes (hemorrhoids, conditions after surgery on the colon and in the anus).

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

Composition

Auxiliary substances: purified water - up to 100 ml, plum flavoring - 1.5 g.

Lactulose is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Duphalac Abbott USA syrup
Poslabin Lactulose Pharmacy Union Russia pills
Portalak Belupo Croatia syrup
Lactusan Felitsata Holding Russia bottle
Lactusan Inat-Pharma Russia bottle

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Lactulose

Dosage and Administration

The drug is intended for oral administration.

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

All dosages must be adjusted individually.

In case of appointment of a single daily dose, it must 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 cups) per day.

For accurate dosing of the drug in vials should use the supplied measuring cup. When using the drug in sachets, it is necessary to tear off the corner of the sachet and immediately take the contents.

Dose for treating constipation or for softening stools for medical purposes

The daily dose of lactulose can be taken once, or dividing it 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 occur 2-3 days after the start of the drug.

Age

Initial daily dose

Maintenance daily dose

Adults and teenagers

15-45 ml (1-3 sachets)

15-30 ml (1-2 sachets)

Children 7-14 years

15 ml (1 sachet)

10-15 ml (1 sachet)

Children 1-6 years

5-10 ml

5-10 ml

Children under 1 year

Up to 5 ml

Up to 5 ml

If the supporting 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, 30-45 ml.

Then they are transferred to an individually selected maintenance dose so that soft stools are maximally 2-3 times a day.

Contraindications

The safety and efficacy of the drug in children (up to 18 years) with hepatic encephalopathy has not been established due to lack of data.

Elderly patients and patients with renal or hepatic insufficiency

There are no special recommendations for dosing, since the systemic exposure to lactulose is negligible.

Adverse reactions

In the first days of taking lactulose, the appearance of flatulence is possible. It usually disappears after a few days.

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

Disorders of the gastrointestinal tract

Very often (≥1 / 10): diarrhea.

Often (≥1 / 100,

Other violations

Infrequently (≥1 / 1000,

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

- galactosemia;

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

- hypersensitivity to any component of the drug;

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

Carefully:

- undiagnosed rectal bleeding;

- colostomy, ileostomy;

- liver diseases, alcoholism, epilepsy, pregnancy, breastfeeding period, children's age due to the fact that the drug contains ethanol in the flavoring.

Drug interactions

Research on the interaction with other drugs have not been conducted.

Pregnancy and Lactation

No effect on the fetus or infant is assumed, since the systemic effect of lactulose on a pregnant or nursing woman is insignificant. Dufalak® can be prescribed during pregnancy and during breastfeeding.

It should be borne in mind that the drug Duphalac in the form of a syrup with a plum flavor contains 0.4% ethanol (see section "Special Instructions").

No effect on reproductive function is assumed, since the systemic exposure to lactulose is negligible.

Special instructions

In the case of abdominal pain of unknown origin before the start of treatment or the lack of a therapeutic effect a few days after the start of the drug, you should consult with your doctor.

It must be borne in mind that Dufalac® may contain minor amounts of bound sugars (for example, lactose, galactose, epilactose and fructose).

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

The content of residual sugars present in the preparation Dufalak® is about 0.075 XE in 5 ml of syrup.

Prolonged use of doses exceeding those recommended in the instructions, or improper use may lead to diarrhea and disruption of water and electrolyte balance. The drug Duphalac® in the form of a plum-flavored syrup contains 0.4% ethanol (ethyl alcohol) in the flavoring composition, that is, up to 160 mg at the maximum daily dose taken in the treatment of constipation, which corresponds to 4 ml of beer or 2 ml of wine. This may be unfavorable for patients with alcoholism. The alcohol content must be taken into account when used during pregnancy and during breastfeeding, as well as in children and patients at high risk with liver disease or epilepsy.

When treating children, laxatives should be used in exceptional cases and under the supervision of a physician. It must be borne in mind that during treatment disorders of the reflex of emptying may occur.

Impact on the ability to drive trans. Wed and fur .:

Use of the drug Dyufalak® does not affect or has a negligible effect on the ability to drive and mechanisms.

Overdosage

Symptoms: If you take a very high dose, abdominal pain and diarrhea are possible.

Treatment: stop taking the drug or reduce the dose. In case of large fluid loss due to diarrhea or vomiting, correction of water-electrolyte imbalance may be required.

  • Brand name: Duphalac
  • Active ingredient: Lactulose
  • Dosage form: Syrup
  • Manufacturer: Abbott

Studies and clinical trials of Lactulose (Click to expand)

  1. Die Heyns-Umlagerung in neuem Licht: außergewöhnlich einfache Synthese von D-Lactosamin aus Lactulose
  2. Experimental and clinical study of lactulose in obstructive jaundice
  3. Prevention of postoperative renal dysfunction in patients with obstructive jaundice: A multicentre study of bile salts and lactulose
  4. Wheat fibre, lactulose and rectal mucosal proliferation in individuals with a family history of colorectal cancer
  5. Lactulose as an antiendotoxin in experimental colitis
  6. Die fermentative Spaltung von Lactose, Lactulose und Neolactose (Über Emulsin, XXXVI. Mitteil.)
  7. ChemInform Abstract: Selective Detection of D-Lactulose by a Porphyrin-Based Diboronic Acid
  8. Kontinuierliche enzymatische Herstellung von Lactulose
  9. Cochrane Review: Lactulose versus Polyethylene Glycol for Chronic Constipation
  10. Summary of ‘Lactulose versus polyethylene glycol for chronic constipation’
  11. Commentary on ‘Lactulose versus polyethylene glycol for chronic constipation’
  12. A Lactulose Bienzyme Biosensor Based on Self-Assembled Monolayer Modified Electrodes
  13. Die intestinal-enzymatische Spaltung von Galakto-Oligosacchariden im Darm von Tier und Mensch mit besonderer Berücksichtigung von Lactobacillus bifidus 2. Mitt. Zum intestinalen Verhalten der Lactulose
  14. Increased concentrations of liver cholesterol in rats fed lactulose (Short communication)
  15. H. Kleinbach-Sauter: Mikrobiologische, ernährungsphysiologische und technologische Aspekte von bifidobakterienhaltigen Milcherzeugnissen mit/ohne den bifidogenen Faktor Lactulose (Milchwissenschaft Gießen Band 13. Hrsg. E. Renner). 141 Seiten, 14 Abb., 26 Tab. Justus-Liebig-Universität Gießen/Verlag B. Renner, Gießen 1992. Preis: 25,80 DM
  16. Galactosamine Hepatitis, Endotoxemia, and Lactulose
  17. Lactitol vs. lactulose in the treatment of acute hepatic encephalopathy in cirrhotic patients: A double-blind, randomized trial
  18. Hepatic Encephalopathy. Management with Lactulose and Related Carbohydrates. Edited by H. O. Conn and J. Bircher, 363 pp. East Lansing, Michigan: Med-Ed Press, 1988. $49.00
  19. Effect of lactulose on the metabolism of short-chain fatty acids
  20. Lactitol or lactulose in the treatment of chronic hepatic encephalopathy: Results of a meta-analysis
  21. The effect of oral-administered lactulose on colonic nitrogen metabolism and excretion
  22. Lactulose improves cognitive functions and health-related quality of life in patients with cirrhosis who have minimal hepatic encephalopathy
  23. Lactulose treatment for hepatic encephalopathy, gastrointestinal symptoms, and health-related quality of life
  24. Clinical efficacy of lactulose in cirrhotic patients with and without subclinical hepatic encephalopathy

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