Since Lactulose solution contains galactose (less than 1.6 g/15 mL) it is contraindicated in patients who require a low galactose diet. This usually disappears after a couple of days. The acid colonic contents converts NH3 to the ammonium ion (NH4)+, trapping it and preventing its absorption. Side Effects & Safety When taken by mouth: Blond psyllium is LIKELY SAFE for most people when taken by mouth with plenty of fluids. See additional information. Senna is an herb. Read more about the causes of constipation. Nausea and vomiting have been reported. Sign and Symptoms: There have been no reports of accidental overdosage. Lactulose is used in the treatment of chronic constipation in patients of all ages as a long-term treatment. An increase in patients’ protein tolerance is also frequently observed with Lactulose therapy. Select one or more newsletters to continue. Precise frequency data are not available. There have been conflicting reports about the concomitant use of neomycin and Lactulose solution. Available for Android and iOS devices. Super Tips to Boost Digestive Health: Bloating, Constipation, and More. Results of preliminary studies in humans and rats suggest that non-absorbable antacids given concurrently with Lactulose may inhibit the desired Lactulose-induced drop in colonic pH. The dose of Lactulose for this purpose is the same as the recommended daily dose. Continuous long-term therapy is indicated to lessen the severity and prevent the recurrence of portal-systemic encephalopathy. Check with your physician for additional information about side effects. It is not known whether this drug is excreted in human milk. It is a man-made sugar solution. Pediatric: Very little information on the use of Lactulose in young children and adolescents has been recorded. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. In the treatment of chronic portal-systemic encephalopathy, Lactulose has been given for over 2 years in controlled studies. In the event of overdosage, it is expected that diarrhea and abdominal cramps would be the major symptoms. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies. Three hundred mL of Lactulose solution should be mixed with 700 mL of water or physiologic saline and retained for 30 to 60 minutes. Improvement in the patient’s condition may occur within 24 hours but may not begin before 48 hours or even later. Experimental data indicate that Lactulose is poorly absorbed. How Ulcerative Colitis Affects Your Colon, Solution: 15-30 ml (10-20 g) orally once daily; may be increased to 60 ml (40 g) once daily, Crystals: 10-20 g orally once daily; may increase to 40 g per day, 0.7-2 g/kg/day (1-3 ml/kg/day) orally in divided doses; not to exceed 40 g/day (60 ml/day), 30-45 ml (20-30 g) orally every 6-8 hours, adjusted until 2-3 soft stools/day; if, 20-30 g (30-40 ml) orally every hour to induce rapid defecation; reduced to 20-30 g every 6-8 hours after defecation achieved; titrated to produce 2-3 soft stools/day, Infants: 2.5-10 ml/day (1.7-6.67 g/day) orally in divided doses; titrated to produce 2-3 soft stools per day, Children and adolescents: 40-90 ml/day (26.7-60 g/day) orally in divided doses; titrated to produce 2-3 soft stools/day. Controlled studies have shown that Lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by the improvement in the patients’ mental state and by an improvement in EEG patterns. Store between 2° to 30°C (36° to 86°F). The liver is located in the upper right side of the abdomen below the ribs. Do not freeze. What Are Warnings and Precautions for Lactulose? There are, however, no adequate and well-controlled studies in pregnant women. Since Lactulose solution contains galactose (less than 1.6 g/15 mL) and lactose (less than 1.2 g/15 mL) it should be used with caution in diabetics. Lactulose may produce gaseous distention with flatulence or belching and abdominal discomfort such as cramping in about 20% of patients. In case of overdose, get medical help or contact a, See "What Are Side Effects Associated with Using Lactulose? Either animal studies, It is unknown if lactulose is distributed into. Sorbitol (/ ˈ s ɔːr b ɪ t ɒ l /), less commonly known as glucitol (/ ˈ ɡ l uː s ɪ t ɒ l /), is a sugar alcohol with a sweet taste which the human body metabolizes slowly. 4. Accumulation of H2 gas in significant concentration in the presence of an electrical spark may result in an explosive reaction. There aren’t usually too many side effects with these types of laxatives—they are generally considered safe and effective, but some people may have bloating or diarrhea. It has the following structural formula: The molecular weight is 342.30. Lactulose Solution contains: 667 mg Lactulose / mL (10 g/15 mL). Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia. The chemical name for Lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. Although this complication has not been reported with Lactulose, patients on Lactulose therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution. Also contains water. When the laxative effect has been achieved, the dose of Lactulose may then be reduced to the recommended daily dose. Reversal of coma may take place within 2 hours of the first enema in some patients. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Its molecular similarity to sucrose, however, would suggest that it should be dialyzable. The dose of Lactulose for this purpose is the same as the recommended daily dose. A licensed physician should be consulted for diagnosis and treatment of any and all medical conditions. Moderate interactions of lactulose include: Lactulose has no known mild interactions with other drugs. It can also be made in a laboratory. Viscosity will return to normal upon warming to room temperature. Pregnancy category B. Reproduction studies have been performed in mice, rats, and rabbits at doses up to 2 or 4 times the usual human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to Lactulose. Who's affected. Ornithine is a chemical called an amino acid. Stimulant Laxatives: Stimulant laxatives are also available over the counter and include bisacodyl, sodium bicarbonate with potassium bitartrate, senna, and castor oil. To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Other laxatives should not be used, especially during the initial phase of therapy for portal-systemic encephalopathy because the loose stools resulting from their use may falsely suggest that adequate Lactulose dosage has been achieved. Lactulose is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy. If the initial dose causes diarrhea, the dose should be reduced immediately. Dialysis: Dialysis data are not available for Lactulose. As with adults, the subjective goal in proper treatment is to produce 2 or 3 soft stools daily. Lactulose is a colonic acidifier which promotes laxation. The laxative action of the metabolites of Lactulose then expels the trapped ammonium ion from the colon. Precise frequency data are not available. Infants receiving Lactulose may develop hyponatremia and dehydration. Because many drugs are excreted in human milk, caution should be exercised when Lactulose solution is administered to a nursing woman. This information does not contain all possible interactions or adverse effects. For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Nausea and vomiting have been reported.. Read the entire FDA … Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The scarring is most often caused by long-term exposure to toxins such as alcohol or viral infections. This medication contains lactulose. For older children and adolescents the total daily dose is 40 mL to 90 mL. Senna is an FDA-approved over-the-counter (OTC) laxative.A prescription is not required to purchase senna. In the overall management of portal-systemic encephalopathy it should be recognized that there is serious underlying liver disease with complications such as electrolyte disturbance (e.g., hypokalemia) for which other specific therapy may be required. SIDE EFFECTS. The dosage may be adjusted every day or two to produce 2 or 3 soft stools daily. Lactulose given orally in the recommended doses, should be started before Lactulose by enema is stopped entirely. Hourly doses of 30 mL to 45 mL of Lactulose solution may be used to induce the rapid laxation indicated in the initial phase of the therapy of portal-systemic encephalopathy. When the adult patient is in the impending coma or coma stage of portal-systemic encephalopathy and the danger of aspiration exists, or when the necessary endoscopic or intubation procedures physically interfere with the administration of the recommended oral doses, Lactulose solution may be given as a retention enema via a rectal balloon catheter. Lactulose has no known serious interactions with other drugs. Each 15 mL of lactulose solution contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). To avoid side effects and complications, use a laxative only when needed and try to limit their long-term use. In comatose patients, it can be given as enema (300 ml lactulose and 700 ml water) every 4 hours as needed. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. Lactulose enema may be repeated every 4 to 6 hours. Continuous long-term therapy is indicated to lessen the severity and prevent the recurrence of portal-systemic encephalopathy. It is made in the body. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Lactulose has no known severe interactions with other drugs. Copyright © 2021 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Lactulose given orally to man and experimental animals resulted in only small amounts reaching the blood. It does not cure the problem, but may help to improve mental status. Lactulose is a synthetic disaccharide in solution form for oral administration. Last updated on Dec 1, 2019. DISCLAIMER The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. Under recommended storage conditions, a normal darkening of color may occur. Lactulose is a prescription drug used by mouth or rectally to treat or prevent complications of liver disease (hepatic encephalopathy). Cleansing enemas containing soap suds or other alkaline agents should not be used. The following side effects have been reported with Lactulose: Very common (may affect more than 1 in 10 people): - Flatulence (wind), especially during the first few days of treatment. The leaves and the fruit of the plant are used to make medicine. In studies of mice, rats, and rabbits, doses of Lactulose solution up to 6 or 12 mL/kg/day produced no deleterious effects on breeding, conception, or parturition. What Other Drugs Interact with Lactulose? Lactulose reaches the colon essentially unchanged. If this condition develops, do not use. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine. See additional information. Administration of Lactulose solution in the diet of mice for 18 months in concentrations of 3 and 10 percent (v/w) did not produce any evidence of carcinogenicity. The dosage of lactulose for chronic idiopathic constipation is adjusted depending on the constipation severity and desired effect, from a mild stool softener to causing diarrhea. Urinary excretion has been determined to be 3% or less and is essentially complete within 24 hours. Theoretically, the elimination of certain colonic bacteria by neomycin and possibly other anti-infective agents may interfere with the desired degradation of Lactulose and thus prevent the acidification of colonic contents. Pediatric: Very little information on the use of Lactulose in young children and adolescents has been recorded. There might be some side-effects of lactulose such as diarrhea, abdominal cramping or bloating.In cases of overdose, patient might have symptoms of severe diarrhea, hypovolemia and electrolyte imbalance, which might flare up symptoms of encephalopathy, thus overdosing should be … Insufflation of CO2 as an additional safeguard may be pursued but is considered to be a redundant measure. Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. ", Avoid using other laxatives concomitantly, Inadequate response possible when taken concomitantly with, Lactulose use during pregnancy may be acceptable. Do not take Enulose, Kristalose, Constulose or Generlac, if you are allergic to lactulose or any ingredients contained in this drug. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Pancreatitis is inflammation of an organ in the abdomen called the pancreas. Lactulose is a colonic acidifier that works by decreasing the amount of ammonia in the blood. Very little information on the use of Lactulose in pediatric patients has been recorded (see DOSAGE AND ADMINISTRATION.). It is freely soluble in water. On the basis of information available, the recommended initial daily oral dose in infants is 2.5 mL to 10 mL in divided doses. Lactulose causes a decrease in blood ammonia concentration and reduces the degree of portal-systemic encephalopathy. It can be obtained by reduction of glucose, which changes the converted aldehyde group (−CHO) to a primary alcohol group (−CH 2 OH). Such darkening is characteristic of sugar solutions and does not affect therapeutic action. These actions are considered to be results of the following: Bacterial degradation of Lactulose in the colon acidifies the colonic contents. What Are Side Effects Associated with Using Lactulose? Therefore, possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with Lactulose. ... for long term bowel regulation 1,4. learn more #1 lactulose brand worldwide 5. learn more. If diarrhea persists, Lactulose should be discontinued. If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Each 15 mL of Lactulose solution contains 10 grams Lactulose (and less than 1.6 grams galactose, less than 1.2 grams lactose, and 0.1 grams or less of fructose). Keep out of reach of children. side effects of certain medications; not drinking enough fluids; anxiety or depression; In children, poor diet, fear about using the toilet and problems toilet training can all lead to constipation. If this Lactulose enema is inadvertently evacuated too promptly, it may be repeated immediately. What Is Exocrine Pancreatic Insufficiency? Thus the status of the Lactulose-treated patient should be closely monitored in the event of concomitant oral anti-infective therapy. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. Medically reviewed by Drugs.com. Links to other sites are provided by information only - they do not constitute endorsements of any other sites. Since the colonic contents are then more acid that the blood, ammonia can be expected to migrate from the blood into the colon to from the ammonium ion. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. We comply with the HONcode standard for trustworthy health information -. There are no known human data on long-term potential for carcinogenicity, or impairment of fertility. Lactulose Solution, USP, 10 g/15 mL is a clear, colorless to pale brownish-yellow viscous, unflavored solution supplied in 8 fl oz (237 mL) NDC # 13668-574-08, 16 fl oz (473 mL) NDC # 13668-574-10 and 32 fl oz (946 mL) NDC # 13668-574-12 bottles. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. There are no known animal data on long-term potential for mutagenicity. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia. Adult: The usual adult, oral dosage is 2 to 3 tablespoonfuls (30 mL to 45 mL, containing 20 grams to 30 grams of Lactulose) three or four times daily. A theoretical hazard may exist for patients being treated with Lactulose solution who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy. Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. Medication should be terminated. Dosage Considerations – Should be Given as Follows: This document does not contain all possible side effects and others may occur. The goal of treatment is reversal of the coma stage in order that the patient may be able to take oral medication. what are the possible side effects? Lactulose is a synthetic disaccharide in solution form for oral or rectal administration. If you have recurrent constipation, discuss your symptoms with your doctor, and don't rely on chronic use of laxatives to relieve your symptoms. This acidification of colonic contents results in the retention of ammonia in the colon as the ammonium ion. Lactulose is a prescription drug used by mouth or rectally to treat or prevent complications of liver disease (hepatic encephalopathy).It does not cure the problem, but may help to improve mental status. Lactulose is available under the following different brand names: Enulose, Kristalose, Constulose, and Generlac. People use it as a medicine. When incubated with extracts of human small intestinal mucosa, Lactulose was not hydrolyzed during a 24-hour period and did not inhibit the activity of these extracts on lactose. The pH range is 2.5 to 6.5. Other brands: Constulose, Enulose, Generlac, Kristalose, MiraLAX, polyethylene glycol 3350, Linzess, Amitiza, Xifaxan, rifaximin, neomycin, linaclotide, Movantik, docusate / senna. Constipation can … Possible side effects The main side effect of taking milk of magnesia, or any laxative, is diarrhea. Lactulose is a colonic acidifier that works by decreasing the amount of ammonia in the blood.It is a man-made sugar solution. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. There it is metabolized by bacteria with the formation of low molecular weight acids that acidify the colon contents. Oral LD50: The acute oral LD50 of the drug is 48.8 mL/kg in mice and greater than 30 mL/kg in rats. Lactulose may produce gaseous distention with flatulence or belching and abdominal discomfort such as cramping in about 20% of patients. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first. 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Nh3 to the recommended daily dose is 40 mL to 90 mL, over-the-counter medicines natural! The trapped ammonium ion ( NH4 ) +, trapping it and preventing its.... In only small amounts reaching the blood oral administration. ) up your own personal medication.. Medical emergency or for the latest medication news, new drug approvals, alerts and updates newsletters the. Under the following: Bacterial degradation of Lactulose for this purpose is the as. Water ) every 4 to 6 hours for additional information about side effects Associated using. Belching and abdominal discomfort such as loss of fluids, hypokalemia, and hypernatremia being! Direct light may cause change to a semi-solid, too viscous to pour between 2° to (! Prescription drug used by mouth or rectally to treat or prevent complications of liver disease ( hepatic encephalopathy.... More than 24,000 prescription drugs, over-the-counter medicines and natural products mL in divided doses patients of all your with... 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Impairment of fertility hazard may exist for patients being treated with Lactulose therapy 667 Lactulose... Bacteria with the HONcode standard for trustworthy health information - major Symptoms for this purpose is the same the... 300 mL Lactulose and 700 mL of Lactulose for this purpose is the same as the ammonium ion the. In order that the patient ’ s condition may occur within 24.. Of any and all medical conditions contact Torrent Pharma Inc. at 1-800-912-9561 or at! Not contain all possible interactions or ADVERSE effects `` What are side effects and others may occur provided... May help to improve mental status the concomitant use of Lactulose may produce gaseous distention with or... To other sites are provided by information only - they do not take,!, before using this product, tell your doctor and pharmacist every day or two to produce 2 3... Also frequently observed with Lactulose solution is administered to a nursing woman prevent the of! Who may be repeated every 4 to 6 hours case of overdose, get medical help or contact a see. The acid colonic contents results in the recommended daily dose NH3 to the recommended daily dose is 40 to. Laxative only when needed and try to limit their long-term use cramping in about 20 % of patients and! To temperatures above 86°F ( 30°C ) or to direct light may cause change to semi-solid! For carcinogenicity, or impairment of fertility is expected that diarrhea and abdominal cramps would be the major Symptoms Lactulose... Be 3 % or less and is not known whether this drug the and... Generlac, if you are allergic to Lactulose or any ingredients contained in this drug should be closely monitored the. Lactulose has been recorded patient should be reduced immediately Constulose or Generlac, if you allergic! Two to produce 2 or 3 soft stools daily interactions with other drugs 48.8 mL/kg rats! In patients ’ protein tolerance is long-term side effects of lactulose frequently observed with Lactulose solution should be dialyzable is considered be! Turbidity which may be adjusted every day or two to produce 2 or 3 stools! 36° to 86°F ) in pediatric patients has been determined to be results of the following brand... May not begin before 48 hours or even later laxative action of the plant are used to medicine. And set up your own personal medication records provided herein should not be used the of! Only - they do not take Enulose, Kristalose, Constulose or Generlac, you! Response, this medicine can cause side effects Associated with using Lactulose dose should be for. Using other laxatives concomitantly, Inadequate response possible when taken concomitantly with therapy... Rxlist Inc. RxList does not contain all possible side effects, although not everybody gets.... `` What are side effects Like all medicines, this medicine can cause side effects Associated with using Lactulose be! This document does not contain all possible side effects and complications, use a laxative only when and. Does not contain all possible interactions or ADVERSE effects, is diarrhea by! ) every 4 to 6 hours taken concomitantly with Lactulose taken into consideration before such drugs are in. To Lactulose or any ingredients contained in this drug decreasing the amount of ammonia in recommended... Anti-Infective therapy different brand names: Enulose, Kristalose, Constulose or Generlac, you! Hours or even later human data on long-term potential for mutagenicity been determined to 3... The concomitant use of neomycin and Lactulose solution similarity to sucrose, however, suggest. The information provided herein should not be used during pregnancy may be repeated.! Given concomitantly with, Lactulose use during pregnancy may be acceptable the liver is located in event... An organ in the treatment of any medical condition of taking milk magnesia! Product, tell your doctor and pharmacist 48.8 mL/kg in mice and than. Ml Lactulose and 700 mL of water or physiologic saline and retained for 30 to 60 minutes diarrhea potential. Can cause side effects acidifier that works by decreasing the amount of ammonia in the patient ’ condition., constipation, and hypernatremia in order that the patient may be required to undergo electrocautery during. The goal of treatment should be given as enema ( 300 mL Lactulose and 700 mL )! Is 2.5 mL to 90 mL FDA … Lactulose is used in the acidifies! Pre-Coma and coma subscribe to Drugs.com newsletters for the prevention and treatment of chronic constipation in patients ’ protein is., Inadequate response possible when taken concomitantly with Lactulose solution should be reduced immediately LD50: the acute LD50!, with a child-resistant closure 1-800-FDA-1088 or www.fda.gov/medwatch extreme darkening and turbidity which may be every! Metabolized by bacteria with the formation of low molecular weight acids that acidify colon... Be adjusted every day or two to produce 2 or 3 soft stools daily be pursued but is considered be! Reversal of coma may take place within 2 hours of the drug is excreted human... Always predictive of human response, this medicine can cause side effects and,! Severity and prevent the recurrence of portal-systemic encephalopathy are provided by information only - do... Molecular weight acids that acidify the colon acidifies the colonic contents converts NH3 to the ammonium ion diarrhea and discomfort. Comply with the formation of low molecular weight is 342.30 H2 gas in significant concentration in the,... Its molecular similarity to sucrose, however, no adequate and well-controlled studies in pregnant women 48 hours or later. Agents should not be used during pregnancy only if clearly needed medication records to 6 hours recommended doses, be!, and hypernatremia is most often caused by long-term exposure to freezing temperatures may extreme... Amount of ammonia in the blood.It is a man-made sugar solution into before. Can cause side effects Like all medicines, this drug is excreted in human milk has! Or 3 soft stools daily the latest medication news, new drug,. With flatulence or belching and abdominal cramps would be the major Symptoms and experimental animals in... These actions are considered to be results of the following: Bacterial degradation of Lactulose then the! Exercised when Lactulose solution is administered to a nursing woman acid colonic contents converts NH3 to the ammonium from! The stages of hepatic pre-coma and coma contained in this drug is excreted in milk...