DUPHALAC Lactulose 3.3g / 5mL Syrup 45mL
NONRXDRUG-DRP-222-45
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Features
Brand
Duphalac
Full Details
Dosage Strength
3.3g / 5ml
Drug Ingredients
- Lactulose
Drug Packaging
Syrup 45ml
Generic Name
Lactulose
Dosage Form
Syrup
Registration Number
DRP-222
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Constipation: regulation of the physiological rhythm of the colon.
Where a soft stool is considered of medical benefit (hemorrhoids, post colonic/anal surgery).
Hepatic Encephalopathy (HE): treatment and prevention of hepatic coma or precoma (adults).
Duphalac: For bowel cleansing in preparation for colonoscopy (adults).
As a prebiotic, which helps create and maintain a healthy intestinal balance and stimulates the intestinal absorption of minerals like calcium and magnesium (adults).
Where a soft stool is considered of medical benefit (hemorrhoids, post colonic/anal surgery).
Hepatic Encephalopathy (HE): treatment and prevention of hepatic coma or precoma (adults).
Duphalac: For bowel cleansing in preparation for colonoscopy (adults).
As a prebiotic, which helps create and maintain a healthy intestinal balance and stimulates the intestinal absorption of minerals like calcium and magnesium (adults).
Dosage/Direction for Use
A single dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time.
The posology should be adjusted according to the individual needs of the patient.
In case of single daily dose, this should be taken at the same time, e.g. during breakfast.
During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 liters, equal to 6-8 glasses) during the day.
The lactulose (Duphalac) solution may be administered diluted or undiluted.
Dosing in constipation or where a soft stool is considered of medical benefit: Lactulose may be given as a single daily dose or in two divided doses, for lactulose (Duphalac/Duphalac Mom) in bottles the measuring cup may be used.
After a few days the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several days (2-3 days) of treatment may be needed before treatment effect occurs. (See Table 1.)
The posology should be adjusted according to the individual needs of the patient.
In case of single daily dose, this should be taken at the same time, e.g. during breakfast.
During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 liters, equal to 6-8 glasses) during the day.
The lactulose (Duphalac) solution may be administered diluted or undiluted.
Dosing in constipation or where a soft stool is considered of medical benefit: Lactulose may be given as a single daily dose or in two divided doses, for lactulose (Duphalac/Duphalac Mom) in bottles the measuring cup may be used.
After a few days the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several days (2-3 days) of treatment may be needed before treatment effect occurs. (See Table 1.)
Dosing in Hepatic Encephalopathy (for adults only): Starting dose: 3 to 4 times daily 20-30 g or 30-45 mL.
This dose may be adjusted to the maintenance dose to achieve 2 to 3 soft stools per day.
Special populations: Pediatric 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.
Duphalac: Method of Lactulose administration for bowel cleansing in preparation for colonoscopy (for adults only): A course of treatment consists of taking 10mg of bisacodyl in the evening before the examination and 1 liter of Lactulose (Duphalac) solution for six hours before colonoscopy. (e.g. one hour after a light breakfast on the day of the examination). Patients are allowed to drink water or tea up to three hours before colonoscopy.
Preparation of the solution: Lactulose (Duphalac) should be diluted in order to obtain a 12.5% lactulose solution. This can be achieved by diluting 200 mL in 800 mL of water or lemon juice. (the addition of lemon juice is to make the solution less sweet, should the sweetness impair palatability). (1 liter Lactulose (Duphalac) lactulose = 1334 grams, lactulose content = 667g/L, lactulose percentage = 667/1334 = 50% m/m). The density of the mixture of 200mL lactulose and 800mL water = 1067g/L. The content of lactulose of the mixture = 133g/L and the percentage of the mixture is therefore 12.5% (m/m).
When using lactulose and bisacodyl for bowel cleansing in preparation for colonoscopy, respective warnings, precautions and safety information from corresponding bisacodyl label needs to be taken into consideration. Safety in the pediatric population for bowel cleansing has not been extensively established.
Dosing in Prebiotic Indication (for adults only): Daily dose of 7.5 mL-15 mL lactulose (corresponding to 5g to 10g/day) exerts the prebiotic effects.
Missed Dose: No information available.
This dose may be adjusted to the maintenance dose to achieve 2 to 3 soft stools per day.
Special populations: Pediatric 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.
Duphalac: Method of Lactulose administration for bowel cleansing in preparation for colonoscopy (for adults only): A course of treatment consists of taking 10mg of bisacodyl in the evening before the examination and 1 liter of Lactulose (Duphalac) solution for six hours before colonoscopy. (e.g. one hour after a light breakfast on the day of the examination). Patients are allowed to drink water or tea up to three hours before colonoscopy.
Preparation of the solution: Lactulose (Duphalac) should be diluted in order to obtain a 12.5% lactulose solution. This can be achieved by diluting 200 mL in 800 mL of water or lemon juice. (the addition of lemon juice is to make the solution less sweet, should the sweetness impair palatability). (1 liter Lactulose (Duphalac) lactulose = 1334 grams, lactulose content = 667g/L, lactulose percentage = 667/1334 = 50% m/m). The density of the mixture of 200mL lactulose and 800mL water = 1067g/L. The content of lactulose of the mixture = 133g/L and the percentage of the mixture is therefore 12.5% (m/m).
When using lactulose and bisacodyl for bowel cleansing in preparation for colonoscopy, respective warnings, precautions and safety information from corresponding bisacodyl label needs to be taken into consideration. Safety in the pediatric population for bowel cleansing has not been extensively established.
Dosing in Prebiotic Indication (for adults only): Daily dose of 7.5 mL-15 mL lactulose (corresponding to 5g to 10g/day) exerts the prebiotic effects.
Missed Dose: No information available.
Overdosage
If the dose is too high, the following may occur: Symptom: diarrhea and abdominal pain.
Treatment: cessation of treatment or dose reduction. Extensive fluid loss by diarrhea or vomiting may require correction of electrolyte disturbances.
Treatment: cessation of treatment or dose reduction. Extensive fluid loss by diarrhea or vomiting may require correction of electrolyte disturbances.
Administration
May be taken with or without food: Swallow dose immediately, do not keep in mouth for an extended period of time. For single daily dose, take at the same time eg, during breakfast.
Contraindications
Hypersensitivity to the active substance or to any of the ingredients.
Galactosemia.
Gastrointestinal obstruction, digestive perforation or risk of digestive perforation.
Duphalac: Lactulose (Duphalac) solution for bowel cleansing should not be administered to unconscious patients or those with impaired consciousness and patients prone to aspiration or regurgitation, general weakness, with severe dehydration or impaired swallowing reflex.
Galactosemia.
Gastrointestinal obstruction, digestive perforation or risk of digestive perforation.
Duphalac: Lactulose (Duphalac) solution for bowel cleansing should not be administered to unconscious patients or those with impaired consciousness and patients prone to aspiration or regurgitation, general weakness, with severe dehydration or impaired swallowing reflex.
Special Precautions
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.
Lactulose should be administered with care to patients who are intolerant to lactose (see Description).
Chronic use of unadjusted doses and misuse can lead to diarrhea and disturbance of the electrolyte balance.
The dose normally used in constipation should not pose a problem for diabetics.
The dose used in the treatment of HE is usually much higher and may need to be taken into consideration for diabetics.
This product contains lactose, galactose and small amounts of fructose. Therefore, patients with the rare hereditary problem of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Duphalac: Diarrhea is an expected effect resulting from the use of lactulose for bowel cleansing in preparation for colonoscopy, esp. also in combination with bisacodyl. Should nausea, vomiting, abdominal distension or abdominal pain arise, the rate of administration should be slowed down or temporarily stopped until symptoms subside.
In certain patients at risk, e.g. elderly or debilitated patients, patients with clinically significant renal impairment, careful monitoring of the electrolyte and fluid balance is required.
This product contains lactose, galactose and small amounts of fructose. Therefore, patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Lactulose should be administered with care to patients who are intolerant to lactose.
Effects on Ability to Drive and Use Machines: Lactulose 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 defecation reflex could be disturbed during the treatment.
Insufficient therapeutic effect after several days.
Lactulose should be administered with care to patients who are intolerant to lactose (see Description).
Chronic use of unadjusted doses and misuse can lead to diarrhea and disturbance of the electrolyte balance.
The dose normally used in constipation should not pose a problem for diabetics.
The dose used in the treatment of HE is usually much higher and may need to be taken into consideration for diabetics.
This product contains lactose, galactose and small amounts of fructose. Therefore, patients with the rare hereditary problem of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Duphalac: Diarrhea is an expected effect resulting from the use of lactulose for bowel cleansing in preparation for colonoscopy, esp. also in combination with bisacodyl. Should nausea, vomiting, abdominal distension or abdominal pain arise, the rate of administration should be slowed down or temporarily stopped until symptoms subside.
In certain patients at risk, e.g. elderly or debilitated patients, patients with clinically significant renal impairment, careful monitoring of the electrolyte and fluid balance is required.
This product contains lactose, galactose and small amounts of fructose. Therefore, patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Lactulose should be administered with care to patients who are intolerant to lactose.
Effects on Ability to Drive and Use Machines: Lactulose 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 defecation reflex could be disturbed during the treatment.
Use In Pregnancy & Lactation
Pregnancy: No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible.
Lactulose (Duphalac/Duphalac Mom) can be used during pregnancy.
Lactation: No effects on the breastfed newborn/infant are anticipated, since the systemic exposure of the breast-feeding woman to lactulose is negligible.
Lactulose (Duphalac/Duphalac Mom) can be used during breast-feeding.
Fertility: No effects are to be expected, since systemic exposure to lactulose is negligible.
Lactulose (Duphalac/Duphalac Mom) can be used during pregnancy.
Lactation: No effects on the breastfed newborn/infant are anticipated, since the systemic exposure of the breast-feeding woman to lactulose is negligible.
Lactulose (Duphalac/Duphalac Mom) can be used during breast-feeding.
Fertility: No effects are to be expected, since systemic exposure to lactulose is negligible.
Adverse Reactions
Summary of the safety profile: Flatulence may occur during the first few days of treatment. As a rule it disappears after a few days.
When dosages higher than instructed are used, abdominal pain and diarrhea may occur. In such a case the dosage should be decreased.
If high doses (normally only associated with hepatic encephalopathy, HE) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhea.
Pediatric population: The safety profile in children is expected to be similar as in adults.
Duphalac: Hypersensitivity reactions mainly limited to the skin have been observed and identified as potential adverse reactions during post approval 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 frequencies indicated as follows 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 post approval use [frequency not known (a precise frequency cannot be estimated from the available data)]. (See Table 2.)
When dosages higher than instructed are used, abdominal pain and diarrhea may occur. In such a case the dosage should be decreased.
If high doses (normally only associated with hepatic encephalopathy, HE) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhea.
Pediatric population: The safety profile in children is expected to be similar as in adults.
Duphalac: Hypersensitivity reactions mainly limited to the skin have been observed and identified as potential adverse reactions during post approval 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 frequencies indicated as follows 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 post approval use [frequency not known (a precise frequency cannot be estimated from the available data)]. (See Table 2.)
For bowel cleansing in preparation for colonoscopy (adults): Diarrhea is an expected outcome of bowel preparation. Due to the nature of the intervention, undesirable effects occur during the process of bowel preparation. Nausea, vomiting, abdominal distension, abdominal pain has been observed in patients undergoing bowel preparation, and these undesirable effects were also observed in the clinical studies with lactulose for bowel preparation. Undesirable effect data were actively elicited in clinical studies regarding lactulose for bowel preparation. The mainly observed undesirable effects are gastrointestinal in nature.
Duphalac Mom: Tabulated list of adverse reactions: The following undesirable effects have been experienced with the indicated frequencies as follows 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)]. (See Table 3.)
Duphalac Mom: Tabulated list of adverse reactions: The following undesirable effects have been experienced with the indicated frequencies as follows 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)]. (See Table 3.)
Drug Interactions
No interaction studies have been performed.
Duphalac: Up to several hours before, during or up to one hour after taking Lactulose (Duphalac) solution for bowel cleansing, as with other bowel cleansing regimens, orally administered medicines may possibly be washed out of the gastrointestinal tract or may not, or only partially, be absorbed. If administration of a medicine is absolutely necessary for a life-threatening indication shortly before or whilst taking the treatment regimen for bowel cleansing, oral administration may have to be withheld and a switch made to an alternative.
The concomitant use of other laxatives (bisacodyl) may enhance the gastrointestinal side effects of lactulose.
Duphalac: Up to several hours before, during or up to one hour after taking Lactulose (Duphalac) solution for bowel cleansing, as with other bowel cleansing regimens, orally administered medicines may possibly be washed out of the gastrointestinal tract or may not, or only partially, be absorbed. If administration of a medicine is absolutely necessary for a life-threatening indication shortly before or whilst taking the treatment regimen for bowel cleansing, oral administration may have to be withheld and a switch made to an alternative.
The concomitant use of other laxatives (bisacodyl) may enhance the gastrointestinal side effects of lactulose.
Caution For Usage
Incompatibilities: Not applicable.
Storage
Duphalac: Store at temperatures not exceeding 25°C.
Shelf life: 36 months.
Duphalac Mom: Store at temperatures not exceeding 30°C.
Shelf-Life: 2 years.
Shelf life: 36 months.
Duphalac Mom: Store at temperatures not exceeding 30°C.
Shelf-Life: 2 years.
Action
Pharmacotherapeutic group: Osmotically acting laxatives. ATC code: A06A D11.
Pharmacology: Pharmacodynamics: In the colon lactulose is broken down by colonic bacteria into low-molecular organic acids. These acids lead to a lowering of pH in the colonic lumen and via an osmotic effect to an increase of the volume of the colonic contents. These effects stimulate the peristalsis of the colon and return the consistency of the stools. The constipation is cleared 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 the 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 however might 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.
Duphalac: As a prebiotic substance, lactulose intensifies the growth of Bifidobacterium and Lactobacillus, while Clostridium and Escherichia coli may be suppressed. This may lead to alleviation of the constipation and, in this way, have a favorable effect on the patient's state of health.
For bowel cleansing in preparation for colonoscopy, a regimen is proposed of bisacodyl (10mg) the evening before the colonoscopy and on the day of colonoscopy a 12.5% lactulose solution (m/m). Bisacodyl is a stimulant laxative and lactulose is an osmotic laxative. The pharmacodynamic effect consists of a strong cathartic effect and initiation of diarrhea. The bowel is subsequently emptied and cleansed.
Pharmacokinetics: Lactulose is poorly absorbed after oral administration and it reaches the colon unchanged. There it is metabolized 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.
Toxicology: Preclinical Safety Data: The results of acute, sub-chronic and chronic toxicity studies in various species indicate that the compound has very low toxicity. The effects observed, appear to be more related to the effect of bulk in the gastrointestinal tract than to a more specific toxic activity.
In reproduction and teratology experiments in rabbits, rats or mice no adverse effects were found.
Pharmacology: Pharmacodynamics: In the colon lactulose is broken down by colonic bacteria into low-molecular organic acids. These acids lead to a lowering of pH in the colonic lumen and via an osmotic effect to an increase of the volume of the colonic contents. These effects stimulate the peristalsis of the colon and return the consistency of the stools. The constipation is cleared 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 the 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 however might 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.
Duphalac: As a prebiotic substance, lactulose intensifies the growth of Bifidobacterium and Lactobacillus, while Clostridium and Escherichia coli may be suppressed. This may lead to alleviation of the constipation and, in this way, have a favorable effect on the patient's state of health.
For bowel cleansing in preparation for colonoscopy, a regimen is proposed of bisacodyl (10mg) the evening before the colonoscopy and on the day of colonoscopy a 12.5% lactulose solution (m/m). Bisacodyl is a stimulant laxative and lactulose is an osmotic laxative. The pharmacodynamic effect consists of a strong cathartic effect and initiation of diarrhea. The bowel is subsequently emptied and cleansed.
Pharmacokinetics: Lactulose is poorly absorbed after oral administration and it reaches the colon unchanged. There it is metabolized 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.
Toxicology: Preclinical Safety Data: The results of acute, sub-chronic and chronic toxicity studies in various species indicate that the compound has very low toxicity. The effects observed, appear to be more related to the effect of bulk in the gastrointestinal tract than to a more specific toxic activity.
In reproduction and teratology experiments in rabbits, rats or mice no adverse effects were found.
MedsGo Class
Cholagogues, Cholelitholytics & Hepatic Protectors / Laxatives, Purgatives
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