Duphalac

Lactulose.

Duphalac oral solution contains 667 g lactulose per 1000 ml.
Duphalac oral solution does not contain any excipients, but may contain small amounts of related sugars (e.g. lactose, galactose, epilactose, fructose) derived from the route of synthesis.

Pharmacotherapeutic group: Osmotically acting laxatives. ATC Code: A06A D11.
Pharmacology: Pharmacodynamics: The following is a detailed description of how Duphalac oral solution works. If the patient would like an explanation or further information regarding this, consult a doctor.
In the colon lactulose is broken down by colonic bacteria into low-molecular organic acids. These acids lower the pH in the colonic lumen and increase the volume of the colonic contents via an osmotic effect. These effects stimulate peristalsis of the colon and return normal consistency of the stool. Constipation is corrected and the physiological rhythm of the colon is reinstated.
In hepatic encephalopathy (HE), the effect has been attributed to suppression of proteolytic bacteria by an increase of acidophilic bacteria (e.g. lactobacillus), trapping of ammonia in the ionic form by acidification of the colonic contents, catharsis due to the low pH in the colon as well as an osmotic effect and alteration of bacterial nitrogen metabolism by stimulating the bacteria to utilize ammonia for bacterial protein synthesis. Within this context, however, it should be realized that hyperammonemia alone cannot explain the neuropsychiatric manifestations of HE. The ammonia might, however, serve as a model compound for other nitrogenous substances.
Lactulose as a prebiotic substance strengthens the growth of health promoting bacteria, like Bifidobacterium and Lactobacillus, whereas potentially pathogenic bacteria, like Clostridium and Escherichia coli may be suppressed.
This may lead to a more favorable balance of the intestinal flora.
Pharmacokinetics: The following is a detailed description of how Duphalac oral solution is metabolized in the body. If the patient would like an explanation or further information regarding this, consult a doctor.
Lactulose is poorly absorbed after oral administration and reaches the colon unchanged. There it is metabolised by the colonic bacterial flora. Metabolism is complete at doses up to 25-50 g or 40-75 ml; at higher dosages, a proportion may be excreted unchanged.

Constipation: regulation of the physiological rhythm.
When soft stool is considered of medical benefit (haemorroids, post colonic/anal surgery)
Hepatic encephalopathy (HE): treatment and prevention of hepatic coma or precoma.

Always take Duphalac oral solution exactly as the doctor told. If the patient has any questions, he/she should check with the doctor or pharmacist.
The patient may take Duphalac oral solution diluted or undiluted. Take the dose of lactulose in one swallow; do not hold the solution in the mouth for any length of time.
The doctor will adjust the dosage according to patient's response to the medicine. If the patient has been prescribed a single daily dose, always take it at the same time of day, e.g. during breakfast.
During therapy with laxatives its is important for the patient to drink sufficient amounts of fluids (1.5-2 litres, equal to 6-8 glasses) during the day.
Dosing in constipation or where soft stool is considered of medical benefit: Duphalac may be taken as a single daily dose or in two divided doses. The doctor will tell the patient which frequency to use.
For Duphalac in a bottle, the measuring cup may be used.
Based upon treatment response the doctor may adjust the starting dose to the maintenance dose after a few days. Several (2-3) days of treatment may be needed before treatment effect occurs. (See Table 1.)

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Doing in HE (for adults only): Starting dose: 3 to 4 times daily 30-45 ml.
The dose should be adjusted by the doctor to the maintenance dose to achieve 2 to 3 soft stools per day.
Paediatric population: The safety and efficacy in children (newborn to 18 years of age) with HE have not been established. No data are available.
Elderly patients and patients with renal or hepatic insufficiency. No special dosage recommendations exist, since systemic exposure to lactulose is negligible.

If the patient has taken too high a dose, he/she may experience the following symptoms: diarrhea and/or abdominal pain.
Under these circumstances, the treatment should be stopped or the dosage reduced sufficiently for the symptoms to subside.
Extensive fluid loss (dehydration) secondary to diarrhoea or vomiting may require the intake of extra electrolytes. Ask the doctor or pharmacist for advice.

Do not take Duphalac oral solution: If the patient is hypersensitive (allergic) to lactose or to any of the ingredients of Duphalac oral solution; if the patient suffers from galactosaemia; if the patient suffers from gastrointestinal obstruction, digestive perforation or risk of digestive perforation.

Consultation of a physician is advised in case of: Painful abdominal symptoms of undetermined cause before the treatment is started.
Insufficient therapeutic effect after several days.
If the desired results are not observed after several days of treatment, consult the doctor. Patients who are intolerant to lactose should take Duphalac oral solution with care (because it contains lactose, see Important information about the ingredients as follows).
The dose normally used in constipation should not pose a problem for diabetics. However, the dose used in the treatment of HE is usually much higher and should be taken into consideration for diabetics.
Chronic use of unadjusted doses and misuse can lead to diarrhea and disturbance of the electrolyte balance.
Important information about the ingredients: Duphalac oral solution contains lactose monohydrate. If the patient has been told by his/her doctor that he/she has an intolerance to some sugars, especially lactose, contact the doctor before taking this medicinal product.
Effects on the ability to drive or use machines: Duphalac oral solution has no or negligible influence on the ability to drive and use machines.
Use in Children: Use of laxatives in children should be exceptional and under medical supervision. It should be taken into account that the defaecation reflex could be disturbed during the treatment.
May take protective measures, such as using diapers, for a small child.
This product contains lactose, galactose and small amounts of fructose. Therefore, patients with the rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Ask the doctor or pharmacist for advice before taking any medicine.
Pregnancy: During pregnancy, no effects to the feotus are anticipated, since systemic exposure of lactulose to the pregnant woman is negligible.
Duphalac can be used during pregnancy.
Lactation: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of lactulose to the breast-feeding woman is negligible.
Duphalac oral solution can be used during breastfeeding.
Fertility: No effect are to expected, since systemic exposure to lactulose is negligible.

Like all medicines, Duphalac oral solution may cause side effects, although not everyone experiences them.
If the patient notices any side effects not mentioned in the monograph, or if any of the side effects gets serious, inform the doctor or pharmacist.
Summary of the safety profile: Flatulence may occur during the first few days of treatment. As a rule, it disappears after a few days.
Diarrhoea and abdominal pain may be experienced if the patient takes a higher dose than instructed. If this occurs, the dosage should be decreased to reflect the recommended dosage (see Overdosage).
If the patient is taking a high dose (normally only with hepatic encephalopathy HE) for an extended period of time, the patient may experience an electrolyte imbalance (not enough electrolytes in the blood) due to diarrhea.
Hypersensitivity reactions mainly limited to the skin have been observed and identified as potential adverse reactions during postapproval use. Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.*
Tabulated list of adverse reactions: The following undesirable effects have been experienced with the following indicated frequencies in lactulose-treated patients in placebo-controlled clinical trials [very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) or have been reported spontaneously during postapproval use [frequency not known (a precise frequency cannot be estimated from the available data)]. (See Table 2.)

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Paediatric population: The safety profile in children is expected to be similar as in adults.

Tell the doctor or pharmacist if the patient is taking or has recently taken any other medicines including medicines obtained without a prescription.
No interaction studies with other medications have been performed.

Incompatibilities: Not applicable.

Shelf life: 2 years.
Do not store above 30°C.

Laxatives, Purgatives / Cholagogues, Cholelitholytics & Hepatic Protectors

A06AD11 - lactulose ; Belongs to the class of osmotically acting laxatives.